Patient informed consent, ethical and legal considerations in the context of digital vulnerability with smart, cardiac implantable electronic devices.

Advancements in digitalisation with cardiac implantable electronic devices (CIEDs) allow patients opportunities for improved autonomy, quality of life, and a potential increase in life expectancy. However, with the digital and functional practicalities of CIEDs, there exists also cyber safety issues with transferring wireless information. If a digital network were to be hacked, a CIED patient could experience both the loss of sensitive data and the loss of functional control of the CIED due to an unwelcome party. Moreover, if a CIED patient were to become victim of a cyber attack, which resulted in a serious or lethal event, and if this information were to become public, the trust in healthcare would be impacted and legal consequences could result. A cyber attack therefore poses not only a direct threat to the patient's health but also the confidentiality, integrity, and availability of the CIED, and these cyber threats could be considered "patient-targeted threats." Informed consent is a key component of ethical care, legally concordant practice, and promoting patient-as-partner therapeutic relationships [1]. To date, there are no standardised guidelines for listing cybersecurity risks within the informed consent or for discussing them during the consent process. Providers are responsible for adhering to the ethical principles of autonomy, beneficence, non-maleficence, and justice, both in medical practice generally and the informed consent process specifically. At present, the decision to include cybersecurity risks is mainly left to the provider's discretion, who may also have limited cyber risk information. Without effective and in-depth communication about all possible cybersecurity risks during the consent process, CIED patients can be left unaware of the privacy and physical risks they possess by carrying such a device. Therefore, cyber risk factors should be covered within the patients' informed consent and reviewed on an ongoing basis as new risk information becomes available. By including cyber risk information in the informed consent process, patients are given the autonomy to make the best-informed decision.

Impact of dental prosthetic treatment and patients' expectations on the seven domains and four-dimensional scale of the Oral Health Impact Profile.

BACKGROUND: Recently, recommendations were given for a new scoring of the Oral Health Impact Profile (OHIP). The original seven domain structure should be replaced by a four-dimensional scale. OBJECTIVES: To investigate the effect of dental prosthetic treatment on the seven domains and the four-dimensional scale of the OHIP-G49/53 questionnaire. METHODS: Seventy four patients were grouped according their pre- and post-treatment situation and the type of treatment they received. Patients completed the OHIP-G49/53 questionnaire before prosthetic treatment (T0), and at 1 week (T1), 3 months (T2) and 6 months (T3) after treatment. Treatment effects on the seven domains and the four dimensions of the OHIP scale were analysed, and the oral health-related quality of life (OHRQoL) was measured. Patients' expectations of their prosthetic treatment were also evaluated. Data were analysed using two-way Mixed ANOVA, regression analysis, and Cronbach's alpha test with a level of significance of α ≤ .017. RESULTS: OHRQoL significantly improved following prosthetic treatment compared with baseline. The largest improvement was found between T0 and T1 evaluations (all p ≤ .001). Unlike the seven-domain scale, the four OHIP dimensions demonstrated further significant improvements across the T1/T2/T3 evaluations (all p ≤ .017). Different pre-treatment findings had different treatment effects on the four OHIP dimensions and seven OHIP domains. Patients' expectations were mainly fulfilled. CONCLUSION: Compared with the seven-domain scale, the four dimensions showed significant follow-up changes, suggesting the four dimensions are suitable for evaluating treatment effects up to 6 months. Clinically meaningful effects of dental prosthetic treatment can be sensitively measured using the four-dimensional OHIP scale.

Comprehensive Geriatric Assessment and Quality of Life Aspects in Patients with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).

To define frailty in older cancer patients, the aim of this study was to assess the geriatric status and quality of life (QoL) aspects in patients suffering from recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC) under palliative treatment. A comprehensive geriatric assessment (CGA) was performed on 21 r/m HNSCC patients at two defined assessments, and the QoL aspects and the impact of descriptive data were evaluated. The Kolmogorov-Smirnov test, Spearman's rho correlation, and two-way mixed ANOVA were used for statistical analysis. All patients were found to be "frail". Pain, fatigue, and the burden of illness were the highest-rated symptoms. Oral function and orofacial appearance were highly impaired. A significant impact of descriptive data on the CGA and QoL results was found (all p ≤ 0.05). Thus, the CGA results revealed high frailty, severe comorbidities, and high impairments in QoL aspects. The CGA and QoL results were negatively affected by the primary HNSCC treatment approach, the need for prosthetic treatment, and worse oral functional capacity. Therefore, frailty in r/m HNSCC patients seems to be multidimensional. The evaluation of the CGA and QoL aspects in r/m HNSCC patients can be recommended to detect special needs, organize aftercare, and improve the support for frail and vulnerable cancer patients to create a multidisciplinary treatment approach.

Oral-Health-Related Quality of Life in Patients with Medication-Related Osteonecrosis of the Jaw: A Prospective Clinical Study.

Medication-related osteonecrosis of the jaw (MRONJ) represents an adverse side effect of antiresorptive and antiangiogenic medications. It is associated with impaired quality of life, oral health, and oral function and can be classified into various stages. The purpose of this prospective clinical study is to evaluate the impact of stages I and II MRONJ on oral-health-related quality of life (OHRQoL) and related parameters. Patients' OHRQoL, satisfaction with life, oral discomfort, and oral health were assessed using the German version of the Oral Health Impact Profile (OHIP-G49), visual analog scales (VAS), and Satisfaction with Life Scale (SWLS) at baseline (T0), 10 days (T1), and 3 months after treatment (T2) in 36 patients. Data were analyzed using Kolmogorov-Smirnov test, two-way mixed ANOVAs, and follow-up Mann-Whitney U tests. The impact of treatment effects on the original seven OHIP domain structures and the recently introduced four-dimensional OHIP structure were evaluated using linear regression analysis. Thirty-six patients received surgical MRONJ treatment. Before treatment, patients' perceived OHRQoL, oral discomfort, oral health, and satisfaction with life were negatively affected by MRONJ. Surgical treatment significantly improved OHRQoL and related parameters (all p ≤ 0.012). This improvement was greater in patients with higher impairment at T0. OHRQoL and oral restrictions were still impaired after treatment in patients who needed prosthetic treatment. The four-dimensional structure revealed valuable information beyond the standard seven OHIP domains. Increased awareness of MRONJ risks and an interdisciplinary treatment approach for MRONJ patients are needed.

Emotional Reactivity, Emotion Regulation, and Regulatory Choice in Somatic Symptom Disorder.

OBJECTIVE: Despite the transdiagnostic importance of emotional dysregulation in psychopathology, the exact nature of emotional dysregulation in somatic symptom disorders (SSDs) is still unclear. The present study compared measures of emotional reactivity, emotion regulation (ER), and regulatory choice between n = 62 individuals with SSD ( Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition ) and n = 61 healthy participants. METHODS: Participants underwent two ER tasks, assessing a) efficacy of reappraisal and suppression, and 2) regulatory choice, while electrodermal activity and heart rate variability were recorded. In addition, self-reports (Emotion Reactivity Scale, Emotion Regulation Questionnaire, Difficulties in Emotion Regulation Scale) regarding habitual emotional reactions and regulation strategies were assessed. RESULTS: Individuals with SSD reported significantly higher trait emotional reactivity (Emotion Reactivity Scale; p < .001, d = 1.61), significantly more trait ER difficulties (Difficulties in Emotion Regulation Scale; p < .001, d = 1.62), and significantly lower reappraisal use in daily life (Emotion Regulation Questionnaire; p < .001, d = -0.75). On a behavioral and physiological levels, no significant group differences were found regarding emotional reactivity (subjective ratings of emotional stimuli in task 1, p values = .653-.667; electrodermal activity: p values = .224-.837), ER (task 1: p values = .077-.731; heart rate variability: p values = .522-.832), or regulatory choice (task 2: p = .380). Although individuals with SSD were equally effective in state ER (task 1), they perceived ER during the task as significantly more effortful ( p = .038, d = -0.38). CONCLUSIONS: Results suggest that dysregulated emotions might not result from lacking abilities in implementing ER effectively, but rather could arise from less frequent ER initiation because ER is perceived as more effortful.

Can Religiosity and Social Support Explain Effects of Trait Emotional Intelligence on Health-Related Quality of Life: A Cross-Cultural Study.

Religion and social support along with trait emotional intelligence (EI) help individuals to reduce stress caused by difficult situations. Their implications may vary across cultures in reference to predicting health-related quality of life (HRQoL). A convenience sample of N = 200 chronic heart failure (CHF) patients was recruited at cardiology centers in Germany (n = 100) and Pakistan (n = 100). Results indicated that trait-EI predicted better mental component of HRQoL in Pakistani and German CHF patients. Friends as social support appeared relevant for German patients only. Qualitative data indicate an internal locus of control in German as compared to Pakistani patients. Strengthening the beneficial role of social support in Pakistani patients is one example of how the current findings may inspire culture-specific treatment to empower patients dealing with the detrimental effects of CHF.

Impaired psychological well-being of healthcare workers in a German department of anesthesiology is independent of immediate SARS-CoV-2 exposure - a longitudinal observational study.

Background: The study aimed to assess the mental well-being of healthcare professionals at a German department of anesthesiology and critical care with a specialized ICU for treatment of COVID-19 patients during the first two peaks of the 2020 pandemic, and identifying risk and protective factors. Methods: A single-center longitudinal, online-based survey was conducted in healthcare workers from a department of anesthesiology and critical care in Bavaria, the most affected federal state in Germany at the time of assessment. Validated scores for depression, anxiety, somatic disorders, burnout, resilience, and self-management were used and complemented by questions about perceived COVID-19-related stressors. In parallel, patient characteristics in the ICU were collected. Results: 24 and 23 critically ill COVID-19 patients were treated during both observation periods in April/May and November/December 2020, respectively. 87.5% and 78.2% of patients had moderate to severe acute respiratory distress syndrome. From March 6, 2020 onwards, the hospital had switched to a command and control-based hospital incident command system (HICS) and increased work forces. Point prevalence of depression-like symptoms (13.6% and 12.8%) and burnout (21.6% and 17.4%) in the department's healthcare professionals was high. Exposure to SARS-CoV-2 did not increase psychological burden. Consequences of the lockdown were rated as highly distressing by a majority of all ICU personnel. High self-reported trait resilience was protective against signs of depression, generalized anxiety, and burnout. Conclusions: During the pandemic, healthcare professionals have been suffering from increased psychological distress compared to reference data for both the general population and ICU personnel. General effects of the lockdown appear more relevant than actual COVID-19 patient contact. High trait resilience has a protective effect, yet vulnerable individuals may require specific support. Prevention against potential after effects of the lockdown, and in particular measures allowing to avoid another lockdown, appear warranted.

Validation of the German-language version of the Liverpool Oral Rehabilitation Questionnaire version 3 and evaluation of oral-health-related quality of life among patients with squamous cell carcinoma of the head and neck.

The aim of this study was to translate the Liverpool Oral Rehabilitation Questionnaire version 3 (LORQv3) into German and validate this version in order to assess oral-health-related quality of life (OHRQoL) among head and neck cancer patients. This study was conducted at a German university clinic among patients who had completed therapy for squamous cell carcinoma of the head and neck (HNSCC). The original English-language LORQv3 was translated into German according to the forward-backward approach. Validity and reliability were evaluated using further questionnaires related to OHRQoL and psychological impairments. Subgroups were built with reference to oral rehabilitation status and type of cancer therapy. Furthermore, OHRQoL was evaluated. Test-retest reliability was assessed by weighted kappa with a 10-14 day interval. Data were analysed by using Spearman's correlation and the following tests: Shapiro-Wilk, Kruskal-Wallis, Mann-Whitney U and Cronbach's alpha. The level of significance was set at α = 0.05. Analysis of the LORQv3 evaluations revealed excellent Cronbach's alpha and high test-retest reliability. Construct validity were supported by the data. LORQv3 summary score and domains were significantly affected by status of oral rehabilitation (p = 0.003, p = 0.008, p = 0.024) and treatment approach (p < 0.001, p = 0.025, p = 0.035). The German version of the LORQv3 showed high reliability and validity and an impaired OHRQoL of HNSCC patients. It can therefore be recommended for the assessment of OHRQoL.

Maternal Vaginal Ureaplasma spp. Colonization in Early Pregnancy Is Associated with Adverse Short- and Long-Term Outcome of Very Preterm Infants.

Vaginal colonization with Ureaplasma (U.) spp. has been shown to be associated with adverse pregnancy outcome; however, data on neonatal outcome are scarce. The aim of the study was to investigate whether maternal vaginal colonization with U. spp. in early pregnancy represents a risk factor for adverse short- or long-term outcome of preterm infants. Previously, 4330 pregnant women were enrolled in an observational multicenter study, analyzing the association between vaginal U. spp. colonization and spontaneous preterm birth. U. spp. colonization was diagnosed via PCR analysis from vaginal swabs. For this study, data on short-term outcome were collected from medical records and long-term outcome was examined via Bayley Scales of Infant Development at 24 months adjusted age. Two-hundred-and-thirty-eight children were born <33 weeks gestational age. After exclusion due to asphyxia, malformations, and lost-to-follow-up, data on short-term and long-term outcome were available from 222 and 92 infants, respectively. Results show a significant association between vaginal U. spp. colonization and severe intraventricular hemorrhage (10.4% vs. 2.6%, p = 0.03), retinopathy of prematurity (21.7% vs. 10.3%, p = 0.03), and adverse psychomotor outcome (24.3% vs. 1.8%, OR 13.154, 95%CI 1.6,110.2, p = 0.005). The data suggest an association between vaginal U. spp. colonization in early pregnancy and adverse short- and long-term outcome of very preterm infants.

Isolation of Small Extracellular Vesicles from Human Sera.

Robust, well-characterized methods for purifying small extracellular vesicles (sEV) from blood are needed before their potential as disease biomarkers can be realized. Here, we compared isolation of sEV from serum by differential ultracentrifugation (DUC) and by exclusion chromatography using commercially available Exo-spin™ columns. We show that sEV can be purified by both methods but Exo-spin™ columns contain copious additional particles recorded by nanoparticle tracking analysis, invalidating its use for quantifying yields. DUC samples contained higher concentrations of exosome specific proteins CD9, CD63 and CD81 and electron microscopy confirmed that most particles in DUC preparations were sEV, whereas Exo-spin™ samples also contained copious co-purified plasma lipids. MACSPlex bead analysis identified multiple exosome surface proteins, with stronger signals in DUC samples, enabling detection of 21 of 37, compared to only 10 in Exo-spin™ samples. Nevertheless, the pattern of expression was consistent in both preparations, indicating that lipids do not interfere with bead-based technologies. Thus, both DUC and Exo-spin™ can be used to isolate sEV from human serum and what is most appropriate depends on the subsequent use of sEV. In summary, Exo-spin™ enables isolation of sEV from blood with vesicle populations similar to the ones recovered by DUC, but with lower concentrations.

Integrated and diurnal indices of maternal pregnancy cortisol in relation to sex-specific parasympathetic responsivity to stress in infants.

Maternal hypothalamic-pituitary-adrenal axis activity may prenatally program sex-specific stress-response pathways. We investigated associations between maternal cortisol during pregnancy and infant parasympathetic responsivity to stress among 204 mother-infant pairs. Cortisol indices included 3rd trimester hair cortisol, as well as diurnal slope and area under the curve, derived from saliva samples collected during pregnancy. Mother-infant dyads participated in the Repeated Still-Face Paradigm (SFP-R) at age 6 months. We calculated respiration-adjusted respiratory sinus arrhythmia (RSAc ), an indicator of parasympathetic activation, from infant respiration and cardiac activity measured during the SFP-R. We used multivariable linear mixed models to examine each cortisol index in relation to infant RSAc and investigated sex differences using cross-product terms. Diurnal cortisol indices were not associated with RSAc . There was no association between hair cortisol and baseline RSAc . However, hair cortisol was associated with sex-specific changes in RSAc over the SFP-R such that, among girls, parasympathetic withdrawal was reduced with increasing prenatal exposure to cortisol. Consistently higher levels of prenatal cortisol exposure may lead to dampened parasympathetic responsivity to stress during infancy, particularly among girls. Maternal hair cortisol may be particularly valuable for studying the effects of prenatal cortisol exposure on infant autonomic reactivity.

Cardiac sympathetic activation and parasympathetic withdrawal during psychosocial stress exposure in 6-month-old infants.

Infant autonomic reactivity to stress is a potential predictor of later life health complications, but research has not sufficiently examined sympathetic activity, controlled for effects of physical activity and respiration, or studied associations among autonomic adjustments, cardiac activity, and affect in infants. We studied 278 infants during the repeated Still-Face Paradigm, a standardized stressor, while monitoring cardiac activity (ECG) and respiratory pattern (respiratory inductance plethysmography). Video ratings of physical activity and affect were also performed. Respiratory sinus arrhythmia (RSA) and T-wave amplitude (TWA) served as noninvasive indicators of cardiac parasympathetic and sympathetic activity, respectively. Responses were compared between infants who completed two still-face exposures and those who terminated after one exposure due to visible distress. Findings, controlled for physical activity, showed robust reductions in respiration-adjusted RSA and TWA, with more tonic attenuation of TWA. Infants completing only one still-face trial showed more pronounced autonomic changes and less recovery from stress. They also showed elevated minute ventilation, suggesting hyperventilation. Both reductions in adjusted RSA and TWA contributed equally to heart rate changes and were associated with higher negative and lower positive affect. These associations were more robust in the group of distressed infants unable to complete both still-face trials. Thus, cardiac sympathetic activation and parasympathetic withdrawal are part of the infant stress response, beyond associated physical activity and respiration changes. Their association with cardiac chronotropy and affect increases as infants' distress level increases. This excess reactivity to social stress should be examined as a predictor of future cardiovascular disease.

Prospective study of nocebo effects related to symptoms of idiopathic environmental intolerance attributed to electromagnetic fields (IEI-EMF).

The exact causes of Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields (IEI-EMF, i.e., experience of somatic symptoms attributed to low-level electromagnetic fields) are still unknown. Psychological causation such as nocebo effects seem plausible. This study aimed to experimentally induce a nocebo effect for somatic symptom perception and examined whether it was reproducible after one week. We also examined whether these effects were associated with increased sympathetic activity and whether interoceptive accuracy (IAcc) moderated these relationships. Participants were recruited from the general population and instructed that electromagnetic exposure can enhance somatosensory perception. They participated twice in a cued exposure experiment with tactile stimulation and sham WiFi exposure in 50% of trials. The two sessions were scheduled one week apart (session 1: N = 65, session 2: N = 63). Before session 1, participants watched either a 6-min film on adverse health effects of EMF or a neutral film on trade of mobile phones. IAcc was assessed with the heartbeat detection paradigm. Electrodermal activity served as a measure of sympathetic activation. Evidence for a nocebo effect (i.e., increased self-reported intensity and aversiveness and electrodermal activity) during sham WiFi exposure was observed in both sessions. IAcc moderated the nocebo effect, depending on stimulus intensity. Contrary to previous findings, no difference emerged between the health-related EMF and the neutral films. Based on negative instructions, somatic perception and physiological responding can be altered. This is consistent with the assumption that IEI-EMF could be due to nocebo effects, suggesting an important role for psychological interventions.

Efficacy of a web-based intervention for improving psychosocial well-being in patients with implantable cardioverter-defibrillators: the randomized controlled ICD-FORUM trial.

AIMS: Anxiety, depression, and reduced quality of life (QoL) are common in patients with implantable cardioverter-defibrillators (ICDs). Treatment options are limited and insufficiently defined. We evaluated the efficacy of a web-based intervention (WBI) vs. usual care (UC) for improving psychosocial well-being in ICD patients with elevated psychosocial distress. METHODS AND RESULTS: This multicentre, randomized controlled trial (RCT) enrolled 118 ICD patients with increased anxiety or depression [≥6 points on either subscale of the Hospital Anxiety and Depression Scale (HADS)] or reduced QoL [≤16 points on the Satisfaction with Life Scale (SWLS)] from seven German sites (mean age 58.8 ± 11.3 years, 22% women). The primary outcome was a composite assessing change in heart-focused fear, depression, and mental QoL 6 weeks after randomization to WBI or UC, stratified for age, gender, and indication for ICD placement. Web-based intervention consisted of 6 weeks' access to a structured interactive web-based programme (group format) including self-help interventions based on cognitive behaviour therapy, a virtual self-help group, and on-demand support from a trained psychologist. Linear mixed-effects models analyses showed that the primary outcome was similar between groups (ηp2 = 0.001). Web-based intervention was superior to UC in change from pre-intervention to 6 weeks (overprotective support; P = 0.004, ηp2 = 0.036), pre-intervention to 1 year (depression, P = 0.004, ηp2 = 0.032; self-management, P = 0.03, ηp2 = 0.015; overprotective support; P = 0.02, ηp2 = 0.031), and 6 weeks to 1 year (depression, P = 0.02, ηp2 = 0.026; anxiety, P = 0.03, ηp2 = 0.022; mobilization of social support, P = 0.047, ηp2 = 0.018). CONCLUSION: Although the primary outcome was neutral, this is the first RCT showing that WBI can improve psychosocial well-being in ICD patients.

A cross-cultural comparison of the roles of emotional intelligence, metacognition, and negative coping for health-related quality of life in German versus Pakistani patients with chronic heart failure.

OBJECTIVES: Low emotional intelligence (EI) may predispose individuals to applying maladaptive coping strategies. This may maintain anxious worrying, which is highly prevalent in patients with chronic heart failure (CHF) and may affect mental (MCS) and physical component summaries (PCS) of health-related quality of life (HRQoL). DESIGN: The current study is a cross-sectional and cross-cultural survey. METHODS: N = 200 outpatients with CHF were recruited at cardiology institutes in Germany and Pakistan and assessed with self-report questionnaires. RESULTS: Path analysis (χ2 (4) = 7.59, p = .11, GFI = .99) revealed that the expected associations between low EI and lower SF-36 MCS and PCS of HRQoL were fully mediated by negative metacognition and maladaptive coping in the Pakistani sample (p's ≤ .05). The German sample applied different maladaptive coping strategies, which also led to lower MCS and PCS scores, but did not mediate a direct positive effect of EI on HRQoL. CONCLUSION: The current findings support culture-independent validity of the metacognitive model but also reveal major cultural differences regarding the application and effect of specific maladaptive coping strategies. This has important implications for caregivers in a cross-cultural context and highlights the need for culture-specific tailoring of psychosocial interventions. Statement of contribution What is already known on this subject? Worry, an integral component of generalized anxiety disorder (GAD) and highly comorbid in chronic heart failure (CHF) patients, contributes to anxiety and resulting stress as evident from metacognitive model of GAD. In addition, previous literature has also established the protective role of emotional intelligence (EI) against stress, thus maintaining quality of life. What does this study add? Cross-cultural (Pakistan vs. Germany) validation of the metacognitive model of GAD. Supportive evidence for the metacognitive model in patients with CHF. Mediation of maladaptive metacognitions and negative coping in the relationship of low trait EI and low health-related quality of life.

Vaginal Ureaplasma parvum serovars and spontaneous preterm birth.

BACKGROUND: Ureaplasma species (spp) are the bacteria most often isolated from the amniotic cavity of women with preterm labor or preterm premature rupture of membranes; thus, the link between intrauterine Ureaplasma spp infection and adverse pregnancy outcome clearly is established. However, because vaginal Ureaplasma spp colonization is very common in pregnant women, the reason that these microorganisms cause ascending infections in some cases but remain asymptomatic in most pregnancies is not clear. Previous studies suggested an association between vaginal colonization with Ureaplasma parvum as opposed to U urealyticum and preterm delivery. However, because of the high frequency of vaginal Ureaplasma spp colonization during pregnancy, additional risk factors are needed to select a group of women who might benefit from treatment. OBJECTIVE: To further identify pregnant women who are at increased risk for preterm delivery, the aim of the present study was to investigate U parvum serovar-specific pathogenicity in a large clinical cohort. STUDY DESIGN: We serotyped 1316 samples that were positive for U parvum using a high-resolution melt polymerase chain reaction assay, and results were correlated with pregnancy outcome. RESULTS: Within U parvum positive samples, serovar 3 was the most common isolate (43.3%), followed by serovar 6 (31.4%) and serovar 1 (25.2%). There was a significantly increased risk for spontaneous preterm birth at very low (<32 weeks gestation; P<.005) and extremely low (<28 weeks gestation; P<.005) gestational age in the group with vaginal U parvum serovar 3 colonization compared with the control group of pregnant women who tested negative for vaginal Ureaplasma spp colonization. This association was found for neither serovar 1 nor serovar 6. The combination of vaginal U parvum serovar 3 colonization and diagnosis of bacterial vaginosis in early pregnancy or a history of preterm birth further increased the risk for adverse pregnancy outcome. CONCLUSION: Colonization with U parvum serovar 3, but not serovar 1 or serovar 6, in early pregnancy is associated with preterm delivery at very and extremely low gestational age. The combination of U parvum serovar 3 colonization and a history of preterm birth or bacterial vaginosis further increases the risk for spontaneous preterm birth at low gestational age and may define a target group for therapeutic intervention studies.

Neural mechanisms of training an auditory event-related potential task in a brain-computer interface context.

Effective use of brain-computer interfaces (BCIs) typically requires training. Improved understanding of the neural mechanisms underlying BCI training will facilitate optimisation of BCIs. The current study examined the neural mechanisms related to training for electroencephalography (EEG)-based communication with an auditory event-related potential (ERP) BCI. Neural mechanisms of training in 10 healthy volunteers were assessed with functional magnetic resonance imaging (fMRI) during an auditory ERP-based BCI task before (t1) and after (t5) three ERP-BCI training sessions outside the fMRI scanner (t2, t3, and t4). Attended stimuli were contrasted with ignored stimuli in the first-level fMRI data analysis (t1 and t5); the training effect was verified using the EEG data (t2-t4); and brain activation was contrasted before and after training in the second-level fMRI data analysis (t1 vs. t5). Training increased the communication speed from 2.9 bits/min (t2) to 4 bits/min (t4). Strong activation was found in the putamen, supplementary motor area (SMA), and superior temporal gyrus (STG) associated with attention to the stimuli. Training led to decreased activation in the superior frontal gyrus and stronger haemodynamic rebound in the STG and supramarginal gyrus. The neural mechanisms of ERP-BCI training indicate improved stimulus perception and reduced mental workload. The ERP task used in the current study showed overlapping activations with a motor imagery based BCI task from a previous study on the neural mechanisms of BCI training in the SMA and putamen. This suggests commonalities between the neural mechanisms of training for both BCI paradigms.

First Trimester Vaginal Ureaplasma Biovar Colonization and Preterm Birth: Results of a Prospective Multicenter Study.

BACKGROUND: While there is a proven association of upper genital tract Ureaplasma infection during pregnancy with adverse pregnancy outcome, the effect of vaginal Ureaplasma colonization on preterm delivery has been controversially debated. OBJECTIVES: We hypothesized that women with isolation of vaginal U. parvum but not U. urealyticum are at increased risk for spontaneous preterm birth (SPB) compared to women with negative results. METHODS: A vaginal swab taken between 12 and 14 weeks of gestation was analyzed for the presence of Ureaplasma biovars by PCR in 4,330 pregnant women. RESULTS: Of the study cohort, 37% were positive for U. parvum, 5.9% for U. urealyticum, and 3.1% for both. The rates of SPB were 10.4% (OR 1.7, 95% CI 1.3, 2.2, p < 0.001) and 8.9% (OR 1.4, 95% CI 0.9, 2.3, p = 0.193) in the groups with isolation of U. parvum and U. urealyticum, respectively, compared to 6.4% in the group with negative PCR results. Multiple logistic regression and interaction analyses showed that vaginal colonization with U. parvum but not U. urealyticum was a statistically significant risk factor for SPB (adjusted OR 1.6, 95% CI 1.2, 2.1, p < 0.001), independent of other risk factors such as bacterial vaginosis and history of SPB. CONCLUSION: Our study demonstrates a statistically significant and independent association between first-trimester vaginal colonization with U. parvum and subsequent SPB.

Anxious anticipation and pain: the influence of instructed vs conditioned threat on pain.

Negative emotions such as anxiety enhance pain perception. However, certain threat characteristics are discussed to have different or even divergent effects on pain (hypoalgesia vs hyperalgesia). In order to investigate the neurobiological basis of different threats, we compared the impact of conditioned threat (CT) vs instructed threat (IT) on pain using fMRI. In two groups, participants underwent either Pavlovian threat conditioning or an instructed threat procedure. Afterwards, in an identical test phase participants watched the same visual cues from the previous phase indicating potential threat or safety, and received painful thermal stimulation. In the test phase, pain ratings were increased in both groups under threat. Group comparisons show elevated responses in amygdala and hippocampus for pain under threat in the CT group, and higher activation of the mid-cingulate gyrus (MCC) in the IT group. Psychophysiological interaction analyses in CT demonstrated elevated connectivity of the amygdala and the insula for the comparison of pain under threat vs safety. In IT, the same comparison revealed elevated functional connectivity of the MCC and the insula. The results suggest a similar pain augmenting effect of CT and IT, which, however, seems to rely on different networks mediating the impact of threat on pain.

Overprotective social support leads to increased cardiovascular and subjective stress reactivity.

OBJECTIVE: Self-determination theory suggests that autonomy-enhancing social support helps individuals to perceive stressors as challenging rather than stressing. Overprotective support may reduce stress in the short-run but undermines autonomy, thus hampering stress-coping in the long run, particularly when social support is terminated. METHOD: Heartrate, blood-pressure and ratings were examined in N=44 undergraduate students receiving autonomy support (calculation steps) or overprotection (solutions) from a close friend or no support for solving arithmetic tasks as well as during a subsequent stress-challenge (solving arithmetic tasks alone). RESULTS: Overprotection resulted in increased heartrate, diastolic blood-pressure, stress ratings, and decreased subjective control during stress-challenge. Autonomy support did not lead to unfavorable stress responding. CONCLUSION: The current findings are in line with assumptions derived from self-determination theory and indicate that autonomy support can help to prevent stress. Overprotection does not buffer stress and is associated with increased stress when discontinued.