Prospective analysis of anatomic features predisposing patients to intraoperative floppy iris syndrome.

PURPOSE: To aid preoperative risk assessment by identifying anatomic parameters corresponding with a higher risk of intraoperative floppy iris syndrome (IFIS) during cataract surgery. METHODS: Prospective cohort study of 55 patients with α1-adrenergic receptor antagonist (α1-ARA) treatment and 55 controls undergoing cataract surgery. Anterior segment optical coherence tomography (AS-OCT), video pupilometer, and biometry measurements were performed preoperatively and analyzed regarding anatomic parameters that corresponded with a higher rate of IFIS. Those statistically significant parameters were evaluated with logistic regression analysis and receiver operating characteristic (ROC) curve. RESULTS: Pupil diameter was significantly smaller in patients who developed IFIS compared to those who did not develop IFIS (AS-OCT 3.29 ± 0.85 vs. 3.63 ± 0.68, p = 0.03; Pupilometer 3.56 ± 0,87 vs. 3.95 ± 0.67, p = 0.02). Biometric evaluation revealed shallower anterior chambers in the IFIS group (ACD 3.12 ± 0.40 vs. 3.32 ± 0.42, p = 0.02). Cutoff values for 50% IFIS probability (p = 0.5) were PD = 3.18 mm for pupil diameter and ACD = 2.93 mm for anterior chamber depth. ROC curves of combined parameters were calculated for α1-ARA medication with pupil diameter and anterior chamber depth, which yielded an AUC of 0.75 for all IFIS grades. CONCLUSION: The combination of biometric parameters with history of α1-ARA medication can improve assessment of risk stratification for IFIS incidence during cataract surgery.

Effect of intravitreal injections due to neovascular age-related macular degeneration on retinal nerve fiber layer thickness and minimum rim width: a cross sectional study.

PURPOSE: The present study tested the hypothesis that repeated anti-VEGF injections are associated with reduced retinal nerve fiber layer (RNFL) and minimum rim width (MRW) of the optic nerve head. PATIENTS AND METHODS: Sixty-six patients with a history of intravitreal injections due to neovascular age-related macular degeneration were included. RNFL and MRW were measured using optical coherence tomography (Spectralis OCT, Heidelberg Engineering, Heidelberg, Germany). RESULTS: Mean global RNFL was 90.62 µm and both RNFL as well as MRW significantly decreased with advanced age (p = 0.005 and p = 0.019, respectively). Correlating for the number of injections, no significant impact on RNFL was found globally (p = 0.642) or in any of the sectors. In contrast, however, global MRW was significantly reduced with increasing numbers of intravitreal injections (p = 0.012). The same holds true when adjusted for the confounding factor age (RNFL p = 0.566 and MRW p = 0.023). CONCLUSION: Our study shows that repeated intravitreal injections due to choroidal neovascularization seem to have a deleterious effect on MRW but not on RNFL. This suggests that MRW is a more sensitive marker than RNFL for evaluating the effect of frequent intravitreal injections on the optic nerve head since it seems to be the first structure affected.

Benchmarking medical laboratory performance: survey validation and results for Europe, Middle East, and Africa.

OBJECTIVES: Medical laboratory performance is a relative concept, as are quality and safety in medicine. Therefore, repetitive benchmarking appears to be essential for sustainable improvement in health care. The general idea in this approach is to establish a reference level, upon which improvement may be strived for and quantified. While the laboratory community traditionally is highly aware of the need for laboratory performance and public scrutiny is more intense than ever due to the SARS-CoV-2 pandemic, few initiatives span the globe. The aim of this study was to establish a good practice approach towards benchmarking on a high abstraction level for three key dimensions of medical laboratory performance, generate a tentative snapshot of the current state of the art in the region of Europe, Middle East, and Africa (EMEA), and thus set the stage for global follow-up studies. METHODS: The questionnaire used and previously published in this initiative consisted of 50 items, roughly half relating to laboratory operations in general with the other half addressing more specific topics. An international sample of laboratories from EMEA was approached to elicit high fidelity responses with the help of trained professionals. Individual item results were analyzed using standard descriptive statistics. Dimensional reduction of specific items was performed using exploratory factor analysis and assessed with confirmatory factor analysis, resulting in individual laboratory scores for the three subscales of "Operational performance", "Integrated clinical care performance", and "Financial sustainability". RESULTS: Altogether, 773 laboratories participated in the survey, of which 484 were government hospital laboratories, 129 private hospital laboratories, 146 commercial laboratories, and 14 were other types of laboratories (e.g. research laboratories). Respondents indicated the need for digitalization (e.g. use of IT for order management, auto-validation), automation (e.g. pre-analytics, automated sample transportation), and establishment of formal quality management systems (e.g. ISO 15189, ISO 9001) as well as sustainably embedding them in the fabric of laboratory operations. Considerable room for growth also exists for services provided to physicians, such as "Diagnostic pathways guidance", "Proactive consultation on complex cases", and "Real time decision support" which were provided by less than two thirds of laboratories. Concordantly, the most important kind of turn-around time (TAT) for clinicians, sample-to-result TAT, was monitored by only 40% of respondents. CONCLUSIONS: Altogether, the need for stronger integration of laboratories into the clinical care process became apparent and should be a main trajectory of future laboratory management. Factor analysis confirmed the theoretical constructs of the questionnaire design phase, resulting in a reasonably valid tool for further benchmarking activities on the three aimed-for key dimensions.

External quality assessment providers' services appear to more impact the immunohaematology performance of laboratories than national regulatory and economic conditions.

OBJECTIVES: Medical laboratories may, at their own discretion, exceed but not undercut regulatory quality requirements. Available economic resources, however, may drive or hinder eagerness to exceed minimum requirements. Depending on the respective scopes of regulatory and economic framework conditions, differing levels of quality efforts to safeguard laboratory performance can be anticipated. However, this has not yet been investigated. METHODS: Immunohaematology external quality assessment (EQA) results collected by 26 EQA providers from their participant laboratories in 73 countries from 2004 to 2019 were evaluated. Error rates were aggregated in groups according to the respective national regulatory and economic framework conditions, to whether or not expert advice was provided in case of incorrect results, and the frequency of EQA samples. RESULTS: These representative data indicate no association between national regulatory (mandatory participation in EQA, monitoring of performance of individual laboratories by authorities, financial consequences of incorrect results) and economic (level of national income, share of national health expenditure) conditions to the quality performance of medical laboratories in immunohaematology. However, EQA providers' support for laboratories in the event of incorrect results appear to be associated with lower error rates, but a high EQA sample frequency with higher error rates. CONCLUSIONS: Further research into the impact of introducing or changing services of EQA providers is needed to confirm the results found in this first of its kind study.

The versatility of external quality assessment for the surveillance of laboratory and in vitro diagnostic performance: SARS-CoV-2 viral genome detection in Austria.

OBJECTIVES: External quality assessment (EQA) schemes provide information on individual and general analytical performance of participating laboratories and test systems. The aim of this study was to investigate the use and performance of SARS-CoV-2 virus genome detection systems in Austrian laboratories and their preparedness to face challenges associated with the pandemic. METHODS: Seven samples were selected to evaluate performance and estimate variability of reported results. Notably, a dilution series was included in the panel as a measure of reproducibility and sensitivity. Several performance criteria were evaluated for individual participants as well as in the cohort of all participants. RESULTS: A total of 109 laboratories participated and used 134 platforms, including 67 different combinations of extraction and PCR platforms and corresponding reagents. There were no false positives and 10 (1.2%) false negative results, including nine in the weakly positive sample (Ct ∼35.9, ∼640 copies/mL). Twenty (22%) laboratories reported results of mutation detection. Twenty-five (19%) test systems included amplification of human RNA as evidence of proper sampling. The overall linearity of Ct values from individual test systems for the dilution series was good, but inter-assay variability was high. Both operator-related and systematic failures appear to have caused incorrect results. CONCLUSIONS: Beyond providing certification for participating laboratories, EQA provides the opportunity for participants to evaluate their performance against others so that they may improve operating procedures and test systems. Well-selected EQA samples offer additional inferences to be made about assay sensitivity and reproducibility, which have practical applications.

Prevalence of SARS-CoV-2 infection in patients presenting for intravitreal injection.

AIM: Due to the coronavirus disease 2019 (COVID-19) pandemic, nosocomial transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is of great concern to clinicians of all specialties. Currently there are no published data available on the prevalence of the infection in ophthalmology patients presenting for intravitreal injection (IVI). The purpose of this retrospective study was to estimate the prevalence of SARS-CoV­2 infection in patients presenting for IVI at our hospital. METHODS: Patients presenting for IVI in April 2020 at our hospital who had been screened for SARS-CoV­2 infection using nasopharyngeal and oropharyngeal specimen for real-time reverse transcription polymerase chain reaction analysis were included in a retrospective study. To assess the representativity of this sample for IVI patients, characteristics were compared with patients presenting for IVI during March-April 2019. RESULTS: The study included 279 patients and 319 historic control patients. Of 277 valid test results, one SARS-CoV­2 positive patient was found, resulting in a carrier rate of 0.36% with a 95% Clopper-Pearson confidence interval of 0.01-1.99%. No differences in sex (57.7% vs. 59.9% female, p = 0.650), age (77.63 ± 10.29 vs. 77.59 ± 10.94 years, p = 0.962), and region of residence were found between groups. CONCLUSION: The study provides an estimate for the prevalence of SARS-CoV­2 infection in asymptomatic patients presenting for IVI. While these data may be used as a baseline, further research is needed to assess the development of SARS-CoV­2 prevalence in this patient group in order to support risk assessment and infection prevention strategies.

Cardiovascular Adverse Reactions During Antipsychotic Treatment: Results of AMSP, A Drug Surveillance Program Between 1993 and 2013.

BACKGROUND: Cardiovascular diseases are still the leading cause of global mortality. Some antipsychotic agents can show severe cardiovascular side effects and are also associated with metabolic syndrome. METHODS: This observational study was based on data of AMSP (Arzneimittelsicherheit in der Psychiatrie), a multicenter drug surveillance program in Austria, Germany and Switzerland, that recorded severe drug reactions in psychiatric inpatients. RESULTS: A total of 404 009 inpatients were monitored between 1993 and 2013, whereas 291 510 were treated with antipsychotics either in combination or alone. There were 376 cases of severe cardiovascular adverse reactions reported in the given timespan, yielding a relative frequency of 0.13%. The study revealed that incidence rates of cardiovascular adverse reactions were highest during treatment with ziprasidone (0.35%), prothipendyl (0.32%), and clozapine (0.23%). The lowest rate of cardiovascular symptoms occurred during treatment with promethazine (0.03%) as well as with aripiprazole (0.06%). The most common clinical symptoms were orthostatic collapse and severe hypotonia, sinustachycardia, QTc prolongation, myocarditis, and different forms of arrhythmia. The dosage at the timepoint when severe cardiovascular events occurred was not higher in any of the given antipsychotics than in everyday clinical practice and was in average therapeutic ranges. In terms of subclasses of antipsychotics, no significant statistical difference was seen in the overall frequencies of adverse reactions cases, when first-generation high potency, first-generation low potency, and second-generation antipsychotics were compared. Thirty percent of adverse events among second-generation antipsychotics were induced by clozapine. CONCLUSIONS: Our findings on cardiovascular adverse reactions contribute to a better understanding of cardiovascular risk profiles of antipsychotic agents in inpatients.

OPTICAL COHERENCE TOMOGRAPHY BIOMARKERS TO DISTINGUISH DIABETIC MACULAR EDEMA FROM PSEUDOPHAKIC CYSTOID MACULAR EDEMA USING MACHINE LEARNING ALGORITHMS.

PURPOSE: In diabetic patients presenting with macular edema (ME) shortly after cataract surgery, identifying the underlying pathology can be challenging and influence management. Our aim was to develop a simple clinical classifier able to confirm a diabetic etiology using few spectral domain optical coherence tomography parameters. METHODS: We analyzed spectral domain optical coherence tomography data of 153 patients with either pseudophakic cystoid ME (n = 57), diabetic ME (n = 86), or "mixed" (n = 10). We used advanced machine learning algorithms to develop a predictive classifier using the smallest number of parameters. RESULTS: Most differentiating were the existence of hard exudates, hyperreflective foci, subretinal fluid, ME pattern, and the location of cysts within retinal layers. Using only 3 to 6 spectral domain optical coherence tomography parameters, we achieved a sensitivity of 94% to 98%, specificity of 94% to 95%, and an area under the curve of 0.937 to 0.987 (depending on the method) for confirming a diabetic etiology. A simple decision flowchart achieved a sensitivity of 96%, a specificity of 95%, and an area under the curve of 0.937. CONCLUSION: Confirming a diabetic etiology for edema in cases with uncertainty between diabetic cystoid ME and pseudophakic ME was possible using few spectral domain optical coherence tomography parameters with high accuracy. We propose a clinical decision flowchart for cases with uncertainty, which may support the decision for intravitreal injections rather than topical treatment.

The association of seminal leucocytes, interleukin-6 and interleukin-8 with sperm DNA fragmentation: A prospective study.

The effect of seminal leucocytes on sperm DNA integrity has been discussed controversially in literatures. Moreover, the studies investigating the in vivo effect of pro-inflammatory cytokines interleukin-6 and interleukin-8 on sperm DNA fragmentation are scarce and inconsistent. The association of standard sperm parameters with sperm DNA fragmentation is also a matter of ongoing discussion. Hence, the aims of this study were, first, to evaluate the effect of seminal leucocytes, interleukin-6 and interleukin-8 on sperm DNA integrity and, second, to examine whether standard semen parameters are associated with sperm DNA fragmentation. Seminal leucocytes, interleukin-6, interleukin-8 and standard semen parameters, including total sperm number, sperm concentration, progressive motility, nonprogressive motility, immotility and normal morphology, were determined in 134 consecutive men. The concentrations of seminal leucocytes, interleukin-6 and interleukin-8, did not correlate with sperm DNA fragmentation. In contrast, total sperm number, sperm concentration, progressive motility, nonprogressive motility and normal morphology exhibited significant inverse correlations with sperm DNA fragmentation. Immotile spermatozoa were directly correlated with sperm DNA fragmentation. In conclusion, seminal leucocytes, interleukin-6 and interleukin-8, are not associated with sperm DNA fragmentation. Poor standard semen parameters are significantly related to the high levels of sperm DNA fragmentation.

Progression of function and pain relief as indicators for returning to sports after arthroscopic isolated type II SLAP repair-a prospective study.

BACKGROUND: One of the currently used surgical techniques in isolated type II SLAP lesions is arthroscopic SLAP repair. Postoperatively, patients tend to suffer from a prolonged period of pain and are restricted in their sports activities for at least 6 months. The aim of this study was to prospectively evaluate the clinical outcome as well as the postoperative course of pain after arthroscopic type II SLAP repair. METHODS: Outcome measures were assessed using the Individual Relative Constant Score (CSindiv), the American Shoulder and Elbow Surgeons (ASES) Score, the Visual Analogue Scale (VAS), and the Short Form 36 (SF-36). Data were collected preoperatively, as well as at 3, 6, 12 and >24 months postoperatively. RESULTS: Eleven patients with an average age of 31.8 years (range: 22.8-49.8 years) underwent arthroscopic repair of isolated type II SLAP lesions. Mean follow-up time was 41.9 months (range: 36.1-48.4 months). 6 months after surgery, there was a statistically significant improvement of function according to the CSindiv (p = 0.004), the ASES Score (p = 0.006), and the SF-36 subscale "physical functioning" (p = 0.014) and a statistically significant decrease of pain according to the VAS (p = 0.007) and the SF-36 subscale "bodily pain" (p = 0.022) compared to preoperative levels. CONCLUSIONS: Arthroscopic repair of isolated type II SLAP lesions with suture anchors leads to a satisfactory functional outcome and return to pre-injury sports levels, with delayed, but significant pain relief observed 6 months after surgery. Thus, a return to sports should not be allowed earlier than 6 months after surgery, when patients have reached pain-free function and recovered strength. TRIAL REGISTRATION: Researchregistry1761 (UIN).

Drug-Induced Liver Injury during Antidepressant Treatment: Results of AMSP, a Drug Surveillance Program.

BACKGROUND: Drug-induced liver injury is a common cause of liver damage and the most frequent reason for withdrawal of a drug in the United States. The symptoms of drug-induced liver damage are extremely diverse, with some patients remaining asymptomatic. METHODS: This observational study is based on data of Arzneimittelsicherheit in der Psychiatrie, a multicenter drug surveillance program in German-speaking countries (Austria, Germany, and Switzerland) recording severe drug reactions in psychiatric inpatients. Of 184234 psychiatric inpatients treated with antidepressants between 1993 and 2011 in 80 psychiatric hospitals, 149 cases of drug-induced liver injury (0.08%) were reported. RESULTS: The study revealed that incidence rates of drug-induced liver injury were highest during treatment with mianserine (0.36%), agomelatine (0.33%), and clomipramine (0.23%). The lowest probability of drug-induced liver injury occurred during treatment with selective serotonin reuptake inhibitors ([0.03%), especially escitalopram [0.01%], citalopram [0.02%], and fluoxetine [0.02%]). The most common clinical symptoms were nausea, fatigue, loss of appetite, and abdominal pain. In contrast to previous findings, the dosage at the timepoint when DILI occurred was higher in 7 of 9 substances than the median overall dosage. Regarding liver enzymes, duloxetine and clomipramine were associated with increased glutamat-pyruvat-transaminase and glutamat-oxalat-transaminase values, while mirtazapine hardly increased enzyme values. By contrast, duloxetine performed best in terms of gamma-glutamyl-transferase values, and trimipramine, clomipramine, and venlafaxine performed worst. CONCLUSIONS: Our findings suggest that selective serotonin reuptake inhibitors are less likely than the other antidepressants, examined in this study, to precipitate drug-induced liver injury, especially in patients with preknown liver dysfunction.

SPECTRAL DOMAIN-OPTICAL COHERENCE TOMOGRAPHY IMAGE CONTRAST AND BACKGROUND COLOR SETTINGS INFLUENCE IDENTIFICATION OF RETINAL STRUCTURES.

PURPOSE: To evaluate image contrast and color setting on assessment of retinal structures and morphology in spectral-domain optical coherence tomography. METHODS: Two hundred and forty-eight Spectralis spectral-domain optical coherence tomography B-scans of 62 patients were analyzed by 4 readers. B-scans were extracted in 4 settings: W + N = white background with black image at normal contrast 9; W + H = white background with black image at maximum contrast 16; B + N = black background with white image at normal contrast 12; B + H = black background with white image at maximum contrast 16. Readers analyzed the images to identify morphologic features. Interreader correlation was calculated. Differences between Fleiss-kappa correlation coefficients were examined using bootstrap method. Any setting with significantly higher correlation coefficient was deemed superior for evaluating specific features. RESULTS: Correlation coefficients differed among settings. No single setting was superior for all respective spectral-domain optical coherence tomography parameters (P = 0.3773). Some variables showed no differences among settings. Hard exudates and subretinal fluid were best seen with B + H (κ = 0.46, P = 0.0237 and κ = 0.78, P = 0.002). Microaneurysms were best seen with W + N (κ = 0.56, P = 0.025). Vitreomacular interface, enhanced transmission signal, and epiretinal membrane were best identified using all color/contrast settings together (κ = 0.44, P = 0.042, κ = 0.57, P = 0.01, and κ = 0.62, P ≤ 0.0001). CONCLUSION: Contrast and background affect the evaluation of retinal structures on spectral-domain optical coherence tomography images. No single setting was superior for all features, though certain changes were best seen with specific settings.

Using self-drilling screws in volar plate osteosynthesis for distal radius fractures: a feasibility study.

BACKGROUND: Symptomatic extensor tendon irritation is a frequent complication in volar plate osteosynthesis of distal radius fractures. It is typically caused by dorsal screw protrusion and overdrilling of the dorsal cortex. The use of self-drilling locking screws (SDLS) could overcome both causes. The practical applicability of SDLS depends on two prerequisites: (1) the feasibility of preoperative distal screw length determination, and (2) sufficient primary biomechanical stability of SDLS compared to standard locking screws (SLS). METHODS: We first assessed the feasibility of preoperative screw length determination (1): Distal radius width, depth and distal screw lengths were measured in 38 human radii. Correlations between distal radius width and depth were assessed, a cluster analysis (Ward's method and squared Euclidean distance) for distal radius width conducted, and intra-cluster screw lengths analyzed (ANOVA). The biomechanical performance of SDLS (2) was assessed by comparison to SLS in a distal radius fracture model (AO-23 A3). 75 % distal screw length was chosen for both groups to simulate a worst-case scenario. Uniaxial compression tests were conducted to measure stiffness, elastic limit, maximum force and residual tilt. Statistics comprised of independent sample t-tests and a Bonferroni correction (p < 0.0125). RESULTS: (1) Distal radius width and depth showed a high correlation (R (2) = 0.79; p < 0.001). Three distal radius width clusters could be identified: small <34 mm; medium 34-36.9 mm; large >36.9 mm. ANOVA and Tukey post-hoc analysis revealed significantly different volar-dorsal depths (p < 0.05) for nearly all screws. (2) To assess biomechanical stability nine specimens were tested each; no significant differences were found between the SDLS and SLS groups. CONCLUSIONS: This feasibility study demonstrates that (1) distal radius width can be used as a predictor for distal screw length and (2) that SDLS provides mechanical stability equivalent to SLS. These results highlight the feasibility of applying SDLS screws in volar plate osteosynthesis at least in extraarticular fractures.

Multimodal Imaging of Cotton Wool Spots in Branch Retinal Vein Occlusion.

PURPOSE: To describe and follow cotton wool spots (CWS) in branch retinal vein occlusion (BRVO) using multimodal imaging. METHODS: In this prospective cohort study including 24 patients with new-onset BRVO, CWS were described and analyzed in color fundus photography (CF), spectral domain optical coherence tomography (SD-OCT), infrared (IR) and fluorescein angiography (FA) every 3 months for 3 years. The CWS area on SD-OCT and CF was evaluated using OCT-Tool-Kit software: CWS were marked in each single OCT B-scan and the software calculated the area by interpolation. RESULTS: 29 central CWS lesions were found. 100% of these CWS were visible on SD-OCT, 100% on FA and 86.2% on IR imaging, but only 65.5% on CF imaging. CWS were visible for 12.4 ± 7.5 months on SD-OCT, for 4.4 ± 3 months and 4.3 ± 3.4 months on CF and on IR, respectively, and for 17.5 ± 7.1 months on FA. The evaluated CWS area on SD-OCT was larger than on CF (0.26 ± 0.17 mm(2) vs. 0.13 ± 0.1 mm(2), p < 0.0001). The CWS area on SD-OCT and surrounding pathology such as intraretinal cysts, avascular zones and intraretinal hemorrhage were predictive for how long CWS remained visible (r(2) = 0.497, p < 0.002). CONCLUSIONS: The lifetime and presentation of CWS in BRVO seem comparable to other diseases. SD-OCT shows a higher sensitivity for detecting CWS compared to CF. The duration of visibility of CWS varies among different image modalities and depends on the surrounding pathology and the CWS size.

Follow-up of pediatric celiac disease: value of antibodies in predicting mucosal healing, a prospective cohort study.

BACKGROUND: In diagnosing celiac disease (CD), serological tests are highly valuable. However, their role in following up children with CD after prescription of a gluten-free diet is unclear. This study aimed to compare the performance of antibody tests in predicting small-intestinal mucosal status in diagnosis vs. follow-up of pediatric CD. METHODS: We conducted a prospective cohort study at a tertiary-care center. 148 children underwent esophohagogastroduodenoscopy with biopsies either for symptoms ± positive CD antibodies (group A; n = 95) or following up CD diagnosed ≥ 1 year before study enrollment (group B; n = 53). Using biopsy (Marsh ≥ 2) as the criterion standard, areas under ROC curves (AUCs) and likelihood-ratios were calculated to estimate the performance of antibody tests against tissue transglutaminase (TG2), deamidated gliadin peptide (DGP) and endomysium (EMA). RESULTS: AUCs were higher when tests were used for CD diagnosis vs. follow-up: 1 vs. 0.86 (P = 0.100) for TG2-IgA, 0.85 vs. 0.74 (P = 0.421) for TG2-IgG, 0.97 vs. 0.61 (P = 0.004) for DPG-IgA, and 0.99 vs. 0.88 (P = 0.053) for DPG-IgG, respectively. Empirical power was 85% for the DPG-IgA comparison, and on average 33% (range 13-43) for the non-significant comparisons. Among group B children, 88.7% showed mucosal healing (median 2.2 years after primary diagnosis). Only the negative likelihood-ratio of EMA was low enough (0.097) to effectively rule out persistent mucosal injury. However, out of 12 EMA-positive children with mucosal healing, 9 subsequently turned EMA-negative. CONCLUSIONS: Among the CD antibodies examined, negative EMA most reliably predict mucosal healing. In general, however, antibody tests, especially DPG-IgA, are of limited value in predicting the mucosal status in the early years post-diagnosis but may be sufficient after a longer period of time.

Differential diagnosis of macular edema of different pathophysiologic origins by spectral domain optical coherence tomography.

PURPOSE: To develop a classification approach based solely on spectral domain optical coherence tomography to differentiate macular edema (ME) of different disease entities and to determine underlying pathology. METHODS: A cross-sectional study including 153 participants: 27 with Irvine-Gass, 31 with uveitic ME, 24 with ME after branch retinal vein occlusion, 13 with central retinal vein occlusion, 44 with diabetic ME, and 14 controls. Spectral domain optical coherence tomography was graded according to a standardized reading protocol. Grading characteristics were: ME pattern in the central line (horizontal/vertical) and in volume scans, distribution of cysts in Early Treatment Diabetic Retinopathy Study grid, morphologic features, and quantitative parameters such as individual layer thickness. The parameters in a best-fitting multivariate model were evaluated for reliability to predict the underlying pathology using a leave-one-out crossover-validation analysis. To evaluate clinical reliability, two masked clinicians graded spectral domain optical coherence tomography images according to the assessed parameters. RESULTS: The best-fitting multivariate model revealed that microfoci, ME pattern in vertical line scan, and foveal retinal nerve fiber layer thickness are the best indicators of the underlying pathology of ME. Classification accuracy of this model was 96%, mean cross-validated test classification accuracy was 84% (r² = 0.95, P < 0.0001). Clinical relevance was examined with 2 independent readers, yielding classification accuracies of 86% in both cases. CONCLUSION: Macular edema demonstrates characteristic patterns, morphologic features, and layer thicknesses dependent on the underlying disease process. Diagnostic recognition of these features may allow clinical and automated disease identification based primarily on spectral domain optical coherence tomography analysis.

The effect of seminal pathogens on standard semen parameters, sperm kinematics and seminal inflammatory markers.

This study evaluated the effects of urogenital pathogens on standard semen parameters, sperm kinematics and host inflammatory response in a cohort of asymptomatic subfertile men. There were six groups based on the results of bacterial culture, including Ureaplasma urealyticum (U. Urealyticum) (n = 27), mixed comprising two or more pathogenic species (n = 28), Gardnerella Vaginalis (G. Vaginalis) (n = 15), gram-positive cocci and bacilli (g+cocci/bacilli) (n = 15), gram-negative bacilli (g-bacilli) (n = 10) and Chlamydia trachomatis (C. trachomatis) (n = 2). One control group (n = 20) and one leukocytospermic group (n = 10) were also included. Sperm quality parameters, seminal leukocytes and interleukin (IL)-6 of all groups, apart from C. trachomatis, were compared to the control group. Standard semen parameters were significantly worse in all groups except for that with g-bacilli. Progressive motility, total motility and normal sperm morphology demonstrated the most significant differences, when U. Urealyticum, leukocytospermia and mixed pathogens were detected in semen. Among sperm kinematics, the concentration of progressive motile sperm cells (CPMS), the percentage of progressive motile sperm cells (PPMS) and straightness (STR) were manifested significant declines in the presence of seminal pathogens. CPMS was affected in all groups except for G. vaginalis. Moreover, the presence of g+cocci/bacilli and g-bacilli were associated with increased seminal IL-6. Seminal leukocytes were elevated significantly only when g-bacilli were cultured in semen. We conclude that seminal pathogens can negatively affect sperm quality. The most negative effect is related to U. Urealyticum. Moreover, g+cocci/bacilli and g-bacilli can initiate an inflammatory response.

Broström ankle ligament repair augmented with suture tape : Results of magnetic resonance imaging evaluation.

BACKGROUND: The Broström procedure is an established procedure in cases of primary lateral ankle ligament repair (LALR). To improve postoperative stability an augmentation device, InternalBrace™ (Arthrex, Naples, FL) has been introduced. This study evaluates remodelling of the anterior talofibular ligament (ATFL) in patients undergoing a tape augmented Broström technique as well as clinical outcomes. METHODS: In this study 32 patients with chronic lateral ankle instability (CLAI) receiving augmented LALR were included. Clinical outcomes were evaluated at a one-time postoperative visit between 12 and 18 months. A 3 T magnetic resonance imaging (MRI) was done to evaluate the morphology of the ATFL. Statistical analysis was completed with the free software and environment R version 3.6.3 (Bell Laboratories, Murray Hill, NJ, USA) and P-values < 0.05 were considered statistically significant. RESULTS: The mean follow-up time was 15.3 ± 1.8 months with a return to sport time of 4.0 ± 2.4 months. The average AOFAS (American Orthopaedic Foot and Ankle Society Score) score was 94.4 ± 7.2, the FAOS (Foot and Ankle Outcome Score) demonstrated 87.3 ± 10.4 points and the FFI (Foot Function Index - 2 scores (pain and function score)) was 22.9 ± 20.1 and 15.4 ± 10.4, respectively. The MRI findings demonstrated an average length of the ATFL of 18.6 ± 4.3 mm and the width was 3.6 ± 0.9 mm. A clear differentiation between the ATFL and the augmentation device could be shown in 28 cases. The Fisher's exact test could not depict a significant correlation between the presence of a bone marrow edema and the tension of the augmentation device with a level of significance of α = 0.05. CONCLUSION: An anatomical healing tendency of the ligament repair and good integrity of the augmentation device could be shown based on MRI findings. The lateral ligament repair augmented with suture tape is an effective and safe procedure regarding surgical treatment in chronic lateral ankle instability producing good clinical outcome.

Benchmarking medical laboratory performance on a global scale.

Background and aims: Laboratory performance as a relative concept needs repetitive benchmarking for continuous improvement of laboratory procedures and medical processes. Benchmarking as such establishes reference levels as a basis for improvements efforts for healthcare institutions along the diagnosis cycle, with the patient at its center. But while this concept seems to be generally acknowledged in laboratory medicine, a lack of practical implementation hinders progress at a global level. The aim of this study was to examine the utility of a specific combination of indicators and survey-based data collection approach, and to establish a global benchmarking dataset of laboratory performance for decision makers in healthcare institutions. Methods: The survey consisted of 44 items relating to laboratory operations in general and three subscales identified in previous studies. A global sample of laboratories was approached by trained professionals. Results were analyzed with standard descriptive statistics and exploratory factor analysis. Dimensional reduction of specific items was performed using confirmatory factor analysis, resulting in individual laboratory scores for the three subscales of "Operational performance," "Integrated clinical care performance," and "Financial sustainability" for the high-level concept of laboratory performance. Results and conclusions: In total, 920 laboratories from 55 countries across the globe participated in the survey, of which 401 were government hospital laboratories, 296 private hospital laboratories, and 223 commercial laboratories. Relevant results include the need for digitalization and automation along the diagnosis cycle. Formal quality management systems (ISO 9001, ISO 15189 etc.) need to be adapted more broadly to increase patient safety. Monitoring of key performance indicators (KPIs) relating to healthcare performance was generally low (in the range of 10-30% of laboratories overall), and as a particularly salient result, only 19% of laboratories monitored KPIs relating to speeding up diagnosis and treatment. Altogether, this benchmark elucidates current practice and has the potential to guide improvement efforts and standardization in quality & safety for patients and employees alike as well as sustainability of healthcare systems around the globe.