Longitudinal assessment of real-world patient adherence: a 12-month electronic patient-reported outcomes follow-up of women with early breast cancer undergoing treatment.

BACKGROUND: Electronic patient-reported outcomes (ePROs) assess patients' health status and quality of life, improving patient care and treatment effects, yet little is known about their use and adherence in routine patient care. AIMS: We evaluated the adherence of invasive breast cancer and ductal carcinoma in situ (DCIS) patients to ePROs follow-up and whether specific patient characteristics are related to longitudinal non-adherence. METHODS: Since November 2016, the Breast Center at Charité - Universitätsmedizin Berlin has implemented an ongoing prospective PRO routine program, requiring patients to complete ePROs assessments and consent to email-based follow-up in the first 12 months after therapy starts. Frequencies and summary statistics are presented. Multiple logistic regression models were performed to determine an association between patient characteristics and non-adherence. RESULTS: Out of 578 patients, 239 patients (41.3%, 95%CI: 37.3-45.5%) completed baseline assessment and all five ePROs follow-up during the first 12 months after therapy. On average, above 70% of those patients responded to the ePROs follow-up assessment. Adherence to the ePROs follow-up was higher during the COVID-19 pandemic than in the time periods before (47.4% (111/234) vs. 33.6% (71/211)). Factors associated with longitudinal non-adherence were younger age, a higher number of comorbidities, no chemotherapy, and a low physical functioning score in the EORTC QLQ-C30 at baseline. CONCLUSIONS: The study reveals moderate adherence to 12-month ePROs follow-up assessments in invasive early breast cancer and DCIS patients, with response rates ranging from 60 to 80%. Emphasizing the benefits for young patients and those with high disease burdens might further increase adherence.

Imaging of the brain-heart axis: prognostic value in a European setting.

BACKGROUND AND AIMS: Increasing data suggest that stress-related neural activity (SNA) is associated with subsequent major adverse cardiovascular events (MACE) and may represent a therapeutic target. Current evidence is exclusively based on populations from the U.S. and Asia where limited information about cardiovascular disease risk was available. This study sought to investigate whether SNA imaging has clinical value in a well-characterized cohort of cardiovascular patients in Europe. METHODS: In this single-centre study, a total of 963 patients (mean age 58.4 ± 16.1 years, 40.7% female) with known cardiovascular status, ranging from 'at-risk' to manifest disease, and without active cancer underwent 2-[18F]fluoro-2-deoxy-D-glucose positron emission tomography/computed tomography between 1 January 2005 and 31 August 2019. Stress-related neural activity was assessed with validated methods and relations between SNA and MACE (non-fatal stroke, non-fatal myocardial infarction, coronary revascularization, and cardiovascular death) or all-cause mortality by time-to-event analysis. RESULTS: Over a maximum follow-up of 17 years, 118 individuals (12.3%) experienced MACE, and 270 (28.0%) died. In univariate analyses, SNA significantly correlated with an increased risk of MACE (sub-distribution hazard ratio 1.52, 95% CI 1.05-2.19; P = .026) or death (hazard ratio 2.49, 95% CI 1.96-3.17; P < .001). In multivariable analyses, the association between SNA imaging and MACE was lost when details of the cardiovascular status were added to the models. Conversely, the relationship between SNA imaging and all-cause mortality persisted after multivariable adjustments. CONCLUSIONS: In a European patient cohort where cardiovascular status is known, SNA imaging is a robust and independent predictor of all-cause mortality, but its prognostic value for MACE is less evident. Further studies should define specific patient populations that might profit from SNA imaging.

Statistical analysis plan for the PRO B study: open-label, superiority randomised controlled trial of alarm-based patient-reported outcome monitoring in patients with metastatic breast cancer.

BACKGROUND: With an increasing collection of patient-reported outcomes (PROs) to measure health-related quality of life (HRQoL) in oncological patients, there is still a lack of standardised strategies on how to interpret and use these data in patient care. Prior research has shown support for the use of digital PRO monitoring together with alarm systems to notify clinicians when the PRO values are deteriorating. This system has demonstrated advantages in improving HRQoL and increasing survival rates among oncology patients. Hence, we designed the PRO B study, a superiority multi-centre randomised controlled trial, to investigate the effects of alarm-based monitoring in metastatic breast cancer patients in Germany. The study protocol for the PRO B study was published in September 2021, and this manuscript describes a formal statistical analysis plan (SAP) for the PRO B study to improve the transparency and quality of this trial. METHODS AND DESIGN: The trial aimed to recruit 1000 patients with metastatic breast cancer. However, as of the completion of recruitment on June 15, 2023, we have successfully enrolled 924 patients from 52 breast cancer centres. Patients were 1:1 stratified randomised to the intervention and control groups. App-based PRO questionnaires are sent weekly to the intervention group and every 3 months to the control group. Only patients in the intervention group trigger an alarm if their PRO scores deteriorate, and they are subsequently contacted by the local care team within 48 h. The primary outcome is the fatigue score at 6 months, and secondary outcomes are other HRQoL and overall survival. Evaluation of the superiority of the intervention will be done using a linear mixed model with random intercepts for study centres. CONCLUSION: This detailed SAP defines the main components of the statistical analysis for the PRO B study to assist the statistician and prevent bias in selecting analysis and reporting findings. Version 1 of the SAP was finalised on January 18, 2024. TRIAL REGISTRATION: DRKS (German Clinical Trials Register) DRKS00024015 . Registered on February 15, 2021.

Reducing trainee mistakes. Better performance with changing to a high-fidelity simulation system?

BACKGROUND: Postpartum hemorrhage is a significant cause of both maternal morbidity and mortality worldwide and is increasing in incidence. This study aimed to assess improvement and identify shortcomings in trainee performance in different simulation systems in the management of postpartum hemorrhage. OBJECTIVE: To perform a pilot study evaluating and comparing high- and low-fidelity simulation models, assessing improvement in repeated performance with high-fidelity mode and identifying mistakes made assessed using Objective Structured Assessment of Technical Skills and thereby exploring what aspects of emergency management of postpartum hemorrhage should be prioritized in teaching settings and assessing what simulation setup is most effective in achieving competence. STUDY DESIGN: This was a prospective randomized, single-blinded, single-institution trial in a population of 17 junior obstetrical trainees at the Charité University Hospital Obstetric Simulation Center in Berlin. Trainees were randomized into 2 groups, with either initial low-fidelity simulation or high-fidelity simulation, followed by repeated assessment of performance, using the high-fidelity model simulation system. Individual simulation sessions were video-recorded and transcribed, and the timing of interventions was documented. Strandardized Objective Structured Assessment of Technical Skills forms were used as a checklist for performance. RESULTS: There was a statistically significant general improvement in performance (P=.02; 24.7-27.2 of 31.0 points; average of 8.7%) in the second cycle of simulation assessment and a statistically significant training effect (P=.043; 24.4-28.4 of 31.0 points; average of 12.9%) in the group that underwent repeat simulation assessment from the initial low-fidelity system to the high-fidelity system compared with the group using the same high-fidelity setup (P=.276; 25.0-25.8 of 31.0; average of 2.4%). CONCLUSION: There was an improvement in the performance when trainees underwent a repeated cycle of simulation assessment changing from a low-fidelity system to a high-fidelity system. Simulation assessment can identify mistakes and learning gaps that are important for obstetrical trainees. This study found that trainees make the same mistakes, regardless of which simulation model was initially used.

Subtype-Specific Survival of Young Women with Breast Cancer and Its Interaction with the Germline BRCA Status.

Data are scarce on the role of pathogenic germline variants in BRCA1 and BRCA2 (gBRCAm) in subtype-specific survival in young women who develop breast cancer under the age of 40. This retrospective, real-world cohort study assessed the distant disease-free survival (DDFS) and overall survival (OS) of young women diagnosed with breast cancer between 2008 and 2019 while taking into consideration the interaction of clinical subtypes and the gBRCA status. Among 473 women, HR+/Her2- was the most common subtype (49.0%), followed by TNBC (31.3%), HR+/Her2+ (13.7%), and Her2+/HR- (5.9%). The gBRCA status was known for 319 cases (gBRCAwt (wild-type - without pathogenic variants in BRCA1 or BRCA2): 204, gBRCA1m: 83, gBRCA2m: 31, 1 patient with both). The distribution of clinical subtypes varied depending on the gBRCA status (p < 0.001). In survival analysis with a median follow-up of 43 months, the unadjusted DDFS and OS were worse for gBRCAwt TNBC compared to both HR+ subtypes, but not for gBRCAm TNBC patients. T-stage, nodal involvement, and the gBRCA status were identified as significant for survival in TNBC. In TNBC, gBRCAm was associated with better DDFS and OS than gBRCAwt (5-year DDFS 81.4% vs. 54.3%, p = 0.012 and 5-year OS 96.7% vs. 62.7%, p < 0.001). In contrast, in HR+/Her2- patients, gBRCAm patients showed a tendency for worse survival, though not statistically significant. Subtype-specific survival in young women with breast cancer needs to be evaluated in interaction with the gBRCA status. For TNBC, gBRCAm is of favorable prognostic value for overall survival, while patients with gBRCAwt TNBC need to be considered to have the highest risk for adverse survival outcomes.

Impact of sex and gender on post-COVID-19 syndrome, Switzerland, 2020.

BackgroundWomen are overrepresented among individuals with post-acute sequelae of SARS-CoV-2 infection (PASC). Biological (sex) as well as sociocultural (gender) differences between women and men might account for this imbalance, yet their impact on PASC is unknown.AimWe assessed the impact of sex and gender on PASC in a Swiss population.MethodOur multicentre prospective cohort study included 2,856 (46% women, mean age 44.2 ± 16.8 years) outpatients and hospitalised patients with PCR-confirmed SARS-CoV-2 infection.ResultsAmong those who remained outpatients during their first infection, women reported persisting symptoms more often than men (40.5% vs 25.5% of men; p < 0.001). This sex difference was absent in hospitalised patients. In a crude analysis, both female biological sex (RR = 1.59; 95% CI: 1.41-1.79; p < 0.001) and a score summarising gendered sociocultural variables (RR = 1.05; 95% CI: 1.03-1.07; p < 0.001) were significantly associated with PASC. Following multivariable adjustment, biological female sex (RR = 0.96; 95% CI: 0.74-1.25; p = 0.763) was outperformed by feminine gender-related factors such as a higher stress level (RR = 1.04; 95% CI: 1.01-1.06; p = 0.003), lower education (RR = 1.16; 95% CI: 1.03-1.30; p = 0.011), being female and living alone (RR = 1.91; 95% CI: 1.29-2.83; p = 0.001) or being male and earning the highest income in the household (RR = 0.76; 95% CI: 0.60-0.97; p = 0.030).ConclusionSpecific sociocultural parameters that differ in prevalence between women and men, or imply a unique risk for women, are predictors of PASC and may explain, at least in part, the higher incidence of PASC in women. Once patients are hospitalised during acute infection, sex differences in PASC are no longer evident.

The value of non-enhanced MRI in the evaluation of patients with suspected idiopathic inflammatory myopathy.

INTRODUCTION/AIMS: The performance of magnetic resonance imaging (MRI) for diagnosing suspected idiopathic inflammatory myopathy (IIM) remains controversial. Furthermore, the role of contrast-enhanced magnetic resonance imaging (CE-MRI) sequences is unclear. The aim of this study was to evaluate the sensitivity and specificity of a non-enhanced magnetic resonance imaging (NE-MRI) protocol compared to a CE-MRI protocol in adult patients with confirmed IIM. METHODS: This study retrospectively enrolled patients with suspected IIM who underwent MRI of the upper thigh between 2008 and 2020. The protocol consisted of a T1-weighted (T1w) sequence, a turbo inversion recovery magnitude (TIRM) sequence and a contrast-enhanced T1-weighted sequence (CE-T1w). After randomly stratifying patients into a group with only the T1w and TIRM sequences available and another group with additional availability of CE-T1w, three blinded readers assessed the presence of IIM based on characteristic imaging features. Confirmation of the diagnosis was determined based on the 2017 ACR/EULAR criteria. RESULTS: Of the 80 patients (mean age 49.0 ± 21.1 years; 42 female, 38 male) included, 54 (67.5%) had a positive diagnosis of IIM. Cumulated sensitivity and specificity for MRI to detect IIM was 87.1% and 83.3% in the NE-MRI group versus 87.0% and 63.0% in the CE-MRI group. The group differences for sensitivity and specificity were non-significant for each of the three readers, respectively (p ≥ .081). DISCUSSION: NE-MRI detects suspected IIM with high diagnostic accuracy and performs equivalently to CE-MRI. Therefore, it may be appropriate to omit the use of contrast agents in MRI scans performed for suspected IIM.

Plasma NGAL levels in stable kidney transplant recipients and the risk of allograft loss.

BACKGROUND: The objective of this study was to investigate the utility of neutrophil gelatinase-associated lipocalin (NGAL) and calprotectin (CPT) to predict long-term graft survival in stable kidney transplant recipients (KTR). METHODS: A total of 709 stable outpatient KTR were enrolled >2 months post-transplant. The utility of plasma and urinary NGAL (pNGAL, uNGAL) and plasma and urinary CPT at enrollment to predict death-censored graft loss was evaluated during a 58-month follow-up. RESULTS: Among biomarkers, pNGAL showed the best predictive ability for graft loss and was the only biomarker with an area under the curve (AUC) > 0.7 for graft loss within 5 years. Patients with graft loss within 5 years (n = 49) had a median pNGAL of 304 [interquartile range (IQR) 235-358] versus 182 (IQR 128-246) ng/mL with surviving grafts (P < .001). Time-dependent receiver operating characteristic analyses at 58 months indicated an AUC for pNGAL of 0.795, serum creatinine-based Chronic Kidney Disease Epidemiology Collaboration estimated glomerular filtration rate (eGFR) had an AUC of 0.866. pNGAL added to a model based on conventional risk factors for graft loss with death as competing risk (age, transplant age, presence of donor-specific antibodies, presence of proteinuria, history of delayed graft function) had a strong independent association with graft loss {subdistribution hazard ratio (sHR) for binary log-transformed pNGAL [log2(pNGAL)] 3.4, 95% confidence interval (CI) 2.24-5.15, P < .0001}. This association was substantially attenuated when eGFR was added to the model [sHR for log2(pNGAL) 1.63, 95% CI 0.92-2.88, P = .095]. Category-free net reclassification improvement of a risk model including log2(pNGAL) in addition to conventional risk factors and eGFR was 54.3% (95% CI 9.2%-99.3%) but C-statistic did not improve significantly. CONCLUSIONS: pNGAL was an independent predictor of renal allograft loss in stable KTR from one transplant center but did not show consistent added value when compared with baseline predictors including the conventional marker eGFR. Future studies in larger cohorts are warranted.

Depressive symptoms and anti-N-methyl-D-aspartate-receptor GluN1 antibody seropositivity in the PROSpective cohort with incident stroke.

Background: Anti-NMDA-receptor GluN1 antibodies (NMDAR1-abs) are present in an autoimmune encephalitis with severe neuropsychiatric symptoms. We aimed to estimate the impact of serum NMDAR1-abs on depressive symptoms years after first-ever ischemic stroke (IS). Methods: Data were used from the PROSpective Cohort with Incident Stroke-Berlin (PROSCIS-B; NCT01363856). Serum NMDAR1-abs (IgM/IgA/IgG) were measured within 7 days after IS using cell-based assays. We defined seropositivity as titers ≥1:10, thereof low titers as ≤1:100 and high titers as >1:100. We used the Center for Epidemiological Studies-Depression (CES-D) scale to measure depressive symptoms at year one, two and three following IS. We calculated crude and confounder adjusted weighted generalized linear models to quantify the impact of NMDAR1-abs on CES-D assessed at three annual time-points. Results: NMDAR1-abs were measured in 583 PROSCIS-B IS patients (mean age = 67 [SD = 13]; 42%female; median NIHSS = 2 [IQR = 1-4]) of whom 76 (13%; IgM: n = 49/IgA: n = 43/IgG: n = 2) were seropositive, 55 (9%) with low and 21 (4%) with high titers. CES-D regarded over all follow-up time-points was higher in seropositive patients (ßcrude = 2.56 [95%CI = -0.34 to 5.45]; ßadjusted = 2.26 [95%CI = -0.68 to 5.20]) and effects were highest in patients with high titer (low titers: ßcrude = 1.42 [95%CI = -1.79 to 4.62], ßadjusted = 0.53 [95%CI = -2.47 to 3.54]; high titers: ßcrude = 5.85 [95%CI = 0.20 to 11.50]; ßadjusted = 7.20 [95%CI = 0.98 to 13.43]). Conclusion: Patients with serum NMDAR1-abs (predominantly IgM&IgA) suffer more severe depressive symptoms after mild-to-moderate IS compared to NMDAR1-abs seronegative patients.

Advanced muscle imaging in adolescent elite rowers utilizing diffusion tensor imaging: Association of imaging findings with stroke typology.

PURPOSE: Muscular overuse injuries are a common health issue in elite athletes. Changes in the muscular microenvironment can be depicted by Diffusion Tensor Imaging (DTI). We hypothesize that the biomechanics of different stroke typologies plays a role in muscle injury and tested our hypothesis by magnetic resonance imaging (MRI) examination of the lumbar spine muscles of adolescent rowers utilizing DTI. METHODS AND MATERIALS: Twenty-two male elite rowers (12 sweep, 10 scull rowers) with a mean age of 15.8 ± 1.2 years underwent 3-Tesla MRI of the lumbar spine 6 hours after cessation of training. Apparent diffusion coefficient (ADC) and fractional anisotropy (FA) were calculated for the erector spinae and multifidus muscle. Student's t-test was used to test differences of DTI parameters between sweep and scull rowers and a Pearson correlation was utilized to correlate the parameters to training volume. RESULTS: ADC values in the erector spinae and multifidus muscle were significantly higher (p = 0.039) and FA values significantly lower (p < 0.001) in sweep rowers compared to scull rowers. There was no significant association between DTI parameters and training volume (r ≤ -0.459, p ≥ 0.074). CONCLUSIONS: Our DTI results show that lumbar spine muscle diffusivity is higher in sweep rowers than in scull rowers. Altered muscle diffusivity is suggestive of microscopic tissue disruption and might be attributable to biomechanical differences between stroke typologies.

Low back pain in adolescent rowers: Association to muscle changes detected by magnetic resonance imaging.

Adult elite rowers are at risk of developing low back pain (LBP). However, LBP data on adolescent elite rowers is currently insufficient. Therefore, the aim of this study was to assess LBP prevalence, LBP intensity and training characteristics in male adolescent elite rowers and a healthy control group. Twenty rowers (mean age 15.8 ± 1.2 years) and a non-athletic control group matched by age and gender (n = 13) were prospectively enrolled and underwent LBP assessment with a validated questionnaire and magnetic resonance imaging (MRI) of the lumbar spine muscles, which included a T2-mapping sequence. From the quantitative image data, T2 relaxation times were calculated. The prevalence of LBP in the last 24 hours and 3 months in the rowing group was 55.0% and 85.0%, respectively, compared to 23.1% and 30.8% in the control group (p < 0.001). Rowers had significantly longer T2 relaxation times of the paraspinal muscles compared to controls (p ≤ 0.041). LBP intensity was associated with longer T2 relaxation times (p < 0.001). Adolescent rowers had a higher prevalence of LBP compared to an age-matched control group. The observed increase in T2 relaxation might be explained by muscle soreness due to strenuous exercise, which is correlated with short-term pain intensity.

Undiagnosed uterine anomalies revealed by breech on ultrasound prior to external cephalic version - A chance to take a closer look.

OBJECTIVE: Uterine anomalies (UA) occur in up to 6.7% of women. Breech is eight times more likely to occur with UA which may not be diagnosed prior to pregnancy and may only be found in the third trimester with breech. The objective of the study is to assess the prevalence of both already known and newly sonographically diagnosed UA in breech from 36 weeks of gestation and its impact on external cephalic version (ECV), delivery options and perinatal outcomes. STUDY DESIGN: We recruited 469 women with breech at 36 weeks of gestation over a 2-year period at the Charité University Hospital, Berlin. Ultrasound examination was performed to rule out UA. Patients with known and newly 'de novo' diagnosed anomalies were identified and delivery options and perinatal outcomes analyzed. RESULTS: The 'de novo' diagnosis of UA at 36-37 weeks of pregnancy with breech was found to be significantly higher compared to the diagnosis prior to pregnancy with 4.5% vs 1.5% (p < 0.001 and odds ratio 4 with 95% confidence interval 2.12-7.69). Anomalies found included 53.6% bicornis unicollis, 39.3% subseptus, 3.6% unicornis and 3.6% didelphys. A trial of vaginal breech delivery was successful in 55.5% of cases when attempted. There were no successful ECVs. CONCLUSION: Breech is a marker for uterine malformation. Diagnosis of UA with breech can be up to four times improved with focused ultrasound screening in pregnancy even from 36 weeks of gestation prior to ECV to identify missed anomalies. Timely diagnosis aids antenatal care and delivery planning. Importantly, definitive diagnosis and treatment can be planned postpartum to improve outcomes in future pregnancies. ECV plays a limited role in selected cases.

Robot-Assisted Laparoscopic Prostatectomy Experience and Pathological Quality: Are They Always Linked?

Objective: We investigated whether pathological outcomes improved with experience and surgeon generation after robot-assisted laparoscopic prostatectomy (RALP). Materials and Methods: The study included 1338 patients who underwent RALP between February 2010 and April 2020. We created learning curves for pelvic lymph node dissection (PLND), number of lymph nodes (LNs) removed, and positive surgical margin (PSM) after adjustment for confounders. We compared the outcomes between the first and second generation of surgeons in regression models. Results: The learning curve regarding PLND indications showed a significant increase with experience for the first generation, whereas the second generation had a learning curve that remained flat at a higher level (92.3%) and significantly better than the first generation (p < 0.001). Similarly, the number of LN removed showed a significant increase with experience in both generations, but the overall median number of LN removed was significantly higher in the second generation compared with the first generation (12 vs 10, p < 0.001). However, the learning curve for PSM remained flat at ∼20% after adjustment and did not show improvement with experience in both generations of surgeons (p = 0.794). Conclusions: Surgeons showed improvement with experience and education with RALP with respect to the indications for PLND and number of LNs removed. However, there was no improvement over time and generations for PSM. Experience based solely on the number of patients operated on is not an intrinsic factor in the pathological quality of RALP. Factors other than experience may also play a role in oncologic improvement.

Associations among navigational support and health care utilization and costs in patients with advanced cancer: An analysis based on administrative health insurance data.

BACKGROUND: Fragmented and complex healthcare systems make it difficult to provide continuity of care for patients with advanced cancer near the end of life. Nurse-based cross-sectoral navigation support has the potential to increase patients' quality of life. The objective of this paper was to evaluate associations between navigation support and health care utilization, and the associated costs of care. METHODS: The evaluation is based on claims data from 37 statutory health insurance funds. Non-randomized recruitment of the intervention group (IG) took place between 2018 and 2019 in four German hospitals. The comparison group (CG) was defined ex post. It comprises nonparticipating clients of the involved health insurance funds matched on age, gender, and diagnosis in a 1:4 ratio to the IG. Healthcare resource utilization was compared using incident rate ratios (IRRs) based on negative binomial regression models. Linear mixed models were performed to compare differences in lengths of hospital stays and costs between groups. RESULTS: A total of 717 patients were included (IG: 149, CG: 568). IG patients showed shorter average lengths of hospital stays (IG: 11 days [95% CI: 10, 13] vs. CG: 15 days [95% CI: 14, 16], p < 0.001). In the IG, 21% fewer medications were prescribed and there were on average 15% fewer outpatient doctor contacts per month. Average billed costs in the IG were 23% lower than in the CG (IG: 6754 EUR [95% CI: 5702, 8000] vs. CG: 8816 EUR [95% CI: 8153, 9533], p < 0.001). CONCLUSIONS: The intervention was associated with decreased costs mainly as a result of a non-intended navigation effect. The social care nurses had navigated patients within the hospital early, needs-oriented and effectively but interpreted their function less cross-sectorally. Linkage of hospital-based navigators with the outpatient care sector needs further exploration.

Assessment of high-risk human papillomavirus infections and associated cervical dysplasia in HIV-positive pregnant women in Germany: a prospective cross-sectional two-centre study.

PURPOSE: Invasive cervical cancer (ICC) is associated in nearly 100% with persistent high-risk Human Papillomavirus (HR-HPV) infection. ICC is still one of the leading causes for cancer mortality in women worldwide. The immunosuppressive influence of Human Immunodeficiency Virus (HIV) and the immunocompromised period of pregnancy due to tolerance induction against the hemiallogeneic fetus, are generally risk factors for acquisition and persistence of HR-HPV infections and their progression to precancerous lesions and HPV-associated carcinoma. METHODS: Overall, 81 pregnant women living with HIV (WLWH) were included. A medical history questionnaire was used to record clinical and HIV data. Participants received cervicovaginal cytological smear, colposcopy and HPV testing. HPV test was performed using BSGP5+/6+ PCR with Luminex read-out. The HR-HPV genotypes 16, 18, 31, 33, 45, 52, 58 were additionally grouped together as high-high-risk HPV (HHR-HPV) for the purpose of risk-adapted analysis. RESULTS: HR-HPV prevalence was 45.7%. Multiple HPV infections were detected in 27.2% of participants, of whom all had at least one HR-HPV genotype included. HR-HPV16 and HR-HPV52 were the most prevalent genotypes and found when high squamous intraepithelial lesion (HSIL) was detected by cytology. HIV viral load of ≥ 50 copies/ml was associated with higher prevalence of HR-HPV infections. Whereas, CD4 T cells < 350/µl showed association with occurrence of multiple HPV infections. Time since HIV diagnosis seemed to impact HPV prevalence. CONCLUSION: Pregnant WLWH require particularly attentive and extended HPV-, colposcopical- and cytological screening, whereby clinical and HIV-related risk factors should be taken into account.

Depression, anxiety and stress in women with breech pregnancy compared to women with cephalic presentation-a cross-sectional study.

PURPOSE: This study aims to evaluate the level of psychological distress for women with breech compared to cephalic presentation. We hypothesized, that women with breech presentation have higher levels of depression, stress and anxiety. Secondary objectives were to analyze potential demographic risk factors and comorbidity of psychological distress in breech pregnancy. METHODS: The breech study group was formed by 379 women with breech presentation. A sample of 128 women with cephalic presentation was recruited during routine clinical care. Depression, anxiety and stress symptoms were ascertained by means of the Depression-Anxiety-Stress-Score (DASS)-21 questionnaire. Categorial data was analyzed with Chi-square or exact test, continuous data with unpaired t test or Mann-Whitney U test. Demographic risk factors were identified using a binary logistic regression model. RESULTS: Prevalence of psychological distress among women with breech was not higher compared to those of other pregnant women. Symptomatic depression, anxiety and stress affected 5.8%, 14.5% and 11.9% of women with breech, respectively. Decreasing age was identified as a risk factor for anxiety (p = 0.006). Multiparity increased risk for depression (p = 0.001), for anxiety (p = 0.026) and for perinatal stress (p = 0.010). More than 80% of women with depressive symptoms had comorbidities of psychological distress. CONCLUSIONS: Breech presentation compared to cephalic presentation was not associated with higher levels of psychological distress. However, breech pregnancies are affected by symptoms of potential mental disorder. Multiparous women and younger women may need additional support and would benefit from a standardized screening tool for the assessment of perinatal psychological distress. CLINICAL TRIAL REGISTRATION: Ethical approval (EA2/241/18) was granted by the Ethics Commission of the Charité University Hospital on the 23.01.2019 (ClinicalTrials.gov Identifier: NCT03827226).

Tablets as an Option for Telemedicine-Evaluation of Diagnostic Performance and Efficiency in Intracranial Arterial Aneurysm Detection.

Purpose: To evaluate a commercially available mobile device for the highly specialized task of detection of intracranial arterial aneurysm in telemedicine. Methods: Six radiologists with three different levels of experience retrospectively interpreted 60 computed tomography (CT) angiographies for the presence of intracranial arterial aneurysm, among them 30 cases with confirmed positive findings. Each radiologist reviewed the angiography datasets twice: once on a dedicated medical-grade workstation and on a commercially available mobile consumer-grade tablet with an interval of 3 months. Diagnostic performance, reading efficiency and subjective scorings including diagnostic confidence were analyzed and compared. Results: Diagnostic performance was comparable on both devices regardless of readers' experience, and no significant differences in sensitivity (66-87.5%) and specificity (79.4-87%) were found. Results obtained with tablets and medical workstations were also comparable in terms of subjective assessment across all reader groups. Conclusions: There was no significant difference between tablet and workstation readings of angiography datasets for the presence of intracranial arterial aneurysm. Sensitivity, specificity, efficiency and subjective scorings were similar with the two devices for all three reader groups. While medical workstations are 10 times more expensive, tablets allow higher mobility especially for radiologists on call.

Examining the Feasibility of an Application-Based Patient-Reported Outcome Monitoring for Breast Cancer Patients: A Pretest for the PRO B Study.

In preparation for the PRO B study which aims to examine the effects of an app-based intensified patient-reported outcome (PRO) monitoring for metastatic breast cancer patients, prior assessment of its feasibility was carried out. Sixteen breast cancer patients visiting the breast cancer unit at Charité were recruited and downloaded an app connected to an ePRO system. They received electronic questionnaires on two occasions (baseline and the following week) and were subsequently contacted for a semi-structured phone interview for evaluation. Eleven participants answered at least one questionnaire. Some participants did not receive any or only a part of the questionnaires due to technical problems with the app. Participants who completed the evaluation questionnaire (n = 6) were overall satisfied with the weekly PRO questionnaire. All interviewed (n = 11) participants thought it was feasible to answer the PRO questionnaires on a weekly basis for one year, as planned in the PRO B study. The pretest revealed a need for major technical adjustments to the app because push notifications about the receipt of new questionnaires were not displayed on some smartphone models. Due to the low number of participants, generalization of the findings is limited to our specific context and study. Nevertheless, we could conclude that if technical aspects of the app were improved, the PRO B study could be implemented as planned. The ePRO questionnaire was considered feasible and adequate from the patients' perspectives.

Serum anti-NMDA-receptor antibodies and cognitive function after ischemic stroke (PROSCIS-B).

OBJECTIVE: We aimed to investigate whether serum anti-N-methyl-D-aspartate-receptor GluN1 (previously NR1) antibody (NMDAR1-abs) seropositivity impacts cognitive function (CF) in the long term following ischemic stroke. METHODS: Data were used from the PROSpective Cohort with Incident Stroke-Berlin. NMDAR1-abs (IgM/IgA/IgG) were measured with cell-based assays from serum obtained within 7 days after the first-ever stroke. Seropositivity was defined as titers ≥ 1:10, low titers as ≤ 1:100 and high titers as > 1:100. We assessed CF at 1, 2 and 3 years after stroke with the Telephone Interview for Cognitive Status-modified (TICS-m) and used crude and propensity score adjusted inverse probability weighted generalized linear models to estimate the impact of NMDAR1-abs serostatus on TICS-m. RESULTS: Data on NMDAR1-abs (median day of sampling = 4[IQR = 2-5]) were available in 583/621 PROSCIS-B patients (39% female; median NIHSS = 2[IQR = 1-4]; median MMSE = 28[IQR:26-30]), of whom 76(13%) were seropositive (IgM: n = 48/IgA: n = 43/IgG: n = 2). Any NMDAR1-abs seropositivity had no impact on TICS-m compared to seronegative patients (ßcrude = 0.69[95%CI = - 0.84 to 2.23]; ßadjusted = 0.65[95%CI = - 1.00 to 2.30]). Patients with low titers scored better on TICS-m compared to seronegative patients (ßcrude = 2.33[95%CI = 0.76 to 3.91]; ßadjusted = 2.47[95%CI = 0.75 to 4.19]); in contrast, patients with high titers scored lower on TICS-m (ßcrude =  -2.82[95%CI = - 4.90 to - 0.74], ßadjusted = - 2.96[95%CI = - 5.13 to - 0.80]), compared to seronegative patients. CONCLUSION: In our study, NMDAR1-abs seropositivity did not affect CF over 3 years after a first mild to moderate ischemic stroke. CF differed according to NMDAR1-abs serum titer, with patients with high NMDAR1-abs titers having a less favorable cognitive outcome compared to seronegative patients.