Expert opinion on the use of transvaginal sonography for presurgical staging and classification of endometriosis.

Gynecological ultrasonography plays a central role in the management of endometriosis. The rapid technical development as well as the currently increasing evidence for non-invasive diagnostic methods require an updated compilation of recommendations for the use of ultrasound in the management of endometriosis. The present work aims to highlight the accuracy of sonography for diagnosing and classifying endometriosis and will formulate the present list of key messages and recommendations. This paper aims to demonstrate the accuracy of TVS in the diagnosis and classification of endometriosis and to discuss the clinical applications and consequences of TVS findings for indication, surgical planning and assessment of associated risk factors. (1) Sophisticated ultrasound is the primary imaging modality recommended for suspected endometriosis. The examination procedure should be performed according to the IDEA Consensus. (2) Surgical intervention to confirm the diagnosis alone is not recommended. A preoperative imaging procedure with TVS and/or MRI is strongly recommended. (3) Ultrasound examination does not allow the definitive exclusion of endometriosis. (4) The examination is primarily transvaginal and should always be combined with a speculum and a bimanual examination. (5) Additional transabdominal ultrasonography may enhance the accuracy of the examination in case of extra pelvic disease, extensive findings or limited transvaginal access. (6) Sonographic assessment of both kidneys is mandatory when deep endometriosis (DE) and endometrioma are suspected. (7) Endometriomas are well defined by sonographic criteria. When evaluating the ovaries, the use of IOTA criteria is recommended. (8) The description of sonographic findings of deep endometriosis should be systematically recorded and performed using IDEA terminology. (9) Adenomyosis uteri has sonographically well-defined criteria (MUSA) that allow for detection with high sensitivity and specificity. MRI is not superior to differentiated skilled ultrasonography. (10) Classification of the extent of findings should be done according to the #Enzian classification. The current data situation proves the best possible prediction of the intraoperative situs of endometriosis (exclusive peritoneum) for the non-invasive application of the #Enzian classification. (11) Transvaginal sonographic examination by an experienced examiner is not inferior to MRI diagnostics regarding sensitivity and specificity in the prediction of the extent of deep endometriosis. (12) The major advantage of non-invasive imaging and classification of endometriosis is the differentiated planning or possible avoidance of surgical interventions. The recommendations represent the opinion of experts in the field of non-invasive and invasive diagnostics as well as therapy of endometriosis. They were developed with the participation of the following national and international societies: DEGUM, ÖGUM, SGUM, SEF, AGEM/DGGG, and EEL.

Ensembles of data-efficient vision transformers as a new paradigm for automated classification in ecology.

Monitoring biodiversity is paramount to manage and protect natural resources. Collecting images of organisms over large temporal or spatial scales is a promising practice to monitor the biodiversity of natural ecosystems, providing large amounts of data with minimal interference with the environment. Deep learning models are currently used to automate classification of organisms into taxonomic units. However, imprecision in these classifiers introduces a measurement noise that is difficult to control and can significantly hinder the analysis and interpretation of data. We overcome this limitation through ensembles of Data-efficient image Transformers (DeiTs), which not only are easy to train and implement, but also significantly outperform the previous state of the art (SOTA). We validate our results on ten ecological imaging datasets of diverse origin, ranging from plankton to birds. On all the datasets, we achieve a new SOTA, with a reduction of the error with respect to the previous SOTA ranging from 29.35% to 100.00%, and often achieving performances very close to perfect classification. Ensembles of DeiTs perform better not because of superior single-model performances but rather due to smaller overlaps in the predictions by independent models and lower top-1 probabilities. This increases the benefit of ensembling, especially when using geometric averages to combine individual learners. While we only test our approach on biodiversity image datasets, our approach is generic and can be applied to any kind of images.

Physiological stress response patterns during a blood donation.

BACKGROUND: Donating blood is associated with increased psychological stress. This study investigates whether a blood donation induces physiological stress and if response patterns differ by gender, donation experience and non-acute stress. STUDY DESIGN AND METHODS: In 372 donors, physiological stress [blood pressure, pulse rate, pulse rate variability (PRV)] was measured at seven moments during routine donation. PRV was assessed using time domain [root mean square of successive differences (RMSSD)] and frequency domain [high frequency (HF) and low frequency (LF) power] parameters. Non-acute stress was assessed by questionnaire. Shape and significance of time course patterns were assessed by fitting multilevel models for each stress measure and comparing men and women, first-time and experienced donors, and donors with high and low levels of non-acute stress. RESULTS: Significant response patterns were found for all stress measures, where levels of systolic blood pressure (F(1,1315) = 24·2, P < 0·001), RMSSD (F(1,1315) = 24·2, P < 0·001), LF (F(1,1627) = 14·1, P < 0·001) and HF (F(1,1624) = 34·0, P < 0·001) increased towards needle insertion and then decreased to values lower than when arriving at the donation centre. Diastolic blood pressure (F(1,1326) = 50·9, P < 0·001) increased and pulse rate (F(1,1393) = 507·4, P < 0·001) showed a U-shaped curve. Significant group effects were found, that is, higher systolic blood pressure/pulse rate in women; higher pulse rate in first-time donors; higher RMSSD at arrival and from screening until leaving in first-time donors; and higher LF and HF in first-time donors. CONCLUSION: This study shows an increase in physiological stress related to needle insertion, followed by a decrease when leaving the donation centre. Some group effects were also found.

Reasons to end the donor career: a quantitative study among stopped blood donors in the Netherlands.

BACKGROUND AND OBJECTIVES: Previous work has studied barriers to donating blood or plasma among current, lapsed and non-donors. Still, it remains unclear why donors stop donating and end their donor career voluntarily. A thorough understanding of why donors stop is necessary to develop more effective retention strategies and manage the decline in whole-blood donors. METHODS: An online questionnaire that contained questions about reasons to stop donation was sent out to 7098 Dutch whole-blood donors who deregistered from the donor pool in 2015 but who were not permanently deferred for medical reasons (response: N = 2490, 35%). RESULTS: The final sample consisted of 1865 stopped blood donors. Of the stopped blood donors, 28·4% reported that negative physical experiences were (partly) the reason to stop. This stopping reason was more often reported by women than men, those aged 19-33 years compared to older groups and those who had donated five times or less compared to those with more donations. Inconvenient opening times (26·1%) was a stopping reason more frequently reported by men compared to women, those aged 34-50 years compared to their younger and older counterparts and those who had donated more than five times. CONCLUSIONS: We found that the stopping reasons for blood donors are dependent on gender, age and the number of donations. Stopping reasons differ substantially from barriers experienced by current, lapsed and non-donors. More research on preventing negative physical experiences and implementing more flexible opening hours are advised.

Psychological and hormonal stress response patterns during a blood donation.

BACKGROUND AND OBJECTIVES: Donating blood has been associated with increased stress responses, with scarce evidence indicating that levels of psychological and hormonal stress are higher pre-donation than post-donation. We investigated whether a blood donation induces psychological and/or hormonal stress during the course of a blood donation, and whether responses differed between men and women, first-time and experienced donors and donors with high or low non-acute stress. MATERIALS AND METHODS: In 363 donors, psychological (donation-stress and arousal) and hormonal (cortisol) stress were measured by questionnaire and salivary sample at seven key moments during a routine donation. Non-acute stress was assessed by a questionnaire. Repeated measurement analyses were performed, using the last measurement (leaving the donation center) as reference value. RESULTS: Levels of donation-stress, arousal and cortisol were significantly higher during donation than when leaving the donation center. When compared with men, women reported higher levels of donation-stress and cortisol in the first part of the visit. When compared with first-time donors, experienced donors reported lower levels of donation-stress during the first part of the visit, and higher levels of arousal but less reactivity throughout the visit. When compared to donors high on non-acute stress, donors low on non-acute stress reported lower levels of donation-stress during the first part of the visit, and showed less cortisol reactivity throughout the visit. CONCLUSION: Donating blood influences psychological and hormonal stress response patterns. The response patterns differ between women and men, first-time and experienced donors and between donors high and low on non-acute stress.

Blood donor show behaviour after an invitation to donate: The influence of collection site factors.

BACKGROUND AND OBJECTIVES: Show behaviour after invitation to donate varies considerably across donors. More insight into this variation is important for blood banks in achieving stable stocks. This study examined individual factors determining intended show behaviour. Most importantly, however, this study is the first study to account for variation in donor behaviour across different collection sites. MATERIALS AND METHODS: We applied a multilevel approach to data from Donor InSight, including 11 889 donors from 257 fixed and mobile collection sites in the Netherlands. The aim of the multilevel models was to account for variance at two levels, that is donors and collection sites. We estimated the likelihood of showing after invitation based on individual predictors, including demographics, donation history and attitude. At the collection site level, we included satisfaction with the blood bank aggregated from individual responses by donors who donate at this site, opening hours and collection site type, that is fixed/mobile. RESULTS: Most importantly, show behaviour varied considerably across collection sites and depended on characteristics of these sites. Moreover, women, older and more experienced donors had higher odds of showing after invitation than men, younger and less experienced donors. Donors higher on warm glow, self-efficacy and donor identity more likely showed after an invitation. Higher aggregate satisfaction and donating at fixed collection sites increased the odds of show. CONCLUSION: In addition to individual factors, collection site characteristics are important in explaining variation in donor show behaviour, thus presenting clues for blood bank policies and interventions to improve donor show.

Negative experiences and pre-donation blood pressure: the role of attitude and anxiety.

BACKGROUND/OBJECTIVES: Negative experiences (NEs) have been shown to result in an increased stress response, as indicated by blood pressure, at the subsequent donation. This response might be influenced by how the donor rates the donation in terms of importance and pleasantness [affective attitude (AA)/cognitive attitude (CA)] or by anxiety about donating blood. We investigated the effect of AA/CA/anxiety on the impact of NEs on pre-donation blood pressure (pd-BP) in the subsequent donation. MATERIALS/METHODS: pd-BP at visit 3 was compared between donors with and without a history of NEs during or after their first two visits (visit 1: medical check, visit 2: first donation). The effect of AA/CA/anxiety (measured 1 month prior to visit 1 on a 7-point scale) on visit 3 pd-BP was explored using linear regression and interaction analyses. Analyses were stratified for gender, age and pd-BP at visit 1, which were taken into account as confounders. RESULTS: In 1106 first-time blood donors (70% female), 632 donors (57% of total) indicated an NE at their first donation. Mean scores for AA/CA/anxiety were 5·2/6·5/2·2 (men without NE), 4·8/6·3/3·0 (men with NE), 5·2/6·6/2·6 (women without NE) and 4·8/6·6/3·2 (women with NE). No significant associations were found for NE and pd-BP at visit 3 after adjusting for confounding. Of 48 interaction effects, four were significant, but effects were small and inconsistent. CONCLUSION: In donors who had had negative experiences during their first donation, anxiety and attitude to donation did not influence their pre-donation blood pressure at their subsequent visit.

Prenatal Risk Calculation (PRC) 3.0: An Extended DoE-Based First-Trimester Screening Algorithm Allowing For Early Blood Sampling.

AIM: Both previous versions of the German PRC algorithm developed by our group for routine first-trimester screening relied on the assumption that maternal blood sampling and fetal ultrasonography are performed at the same visit of a pregnant women. In this paper we present an extension of our method allowing also for constellations where this synchronization is abandoned through preponing blood sampling to dates before 11 weeks of gestation. METHODS: In contrast to the directly measured concentrations of the serum parameters PAPP-A and free ß-hCG, the logarithmically transformed values could be shown to admit the construction of reference bands covering the whole range from 16 to 84 mm CRL [corresponding to 63 to 98 days of gestation]. Prior to determining reference limits from which the DoEs for each individual patient had to be calculated, the log concentrations of all PAPP-A and free ß-hCG values were transformed once more using the calibration approach established in 1 for the elimination of the influence of maternal weight. RESULTS: Although that part of the database which was available for estimating the reference bands for blood sampling times prior to 11 weeks of gestation was comparatively sparse (898 out of 186 215 pregnancies with euploid outcome), the key statistical characteristics of the extended risk-calculation procedure turned out to be very satisfactory. Using the same cutoff value of 1:150 for the posterior risks of trisomy 21 and 13/18, the overall FPR (false positive rate) for diagnosing a T21 was found to be 3.42%. The corresponding DTR (detection rate) was obtained to be 86.8% and thus exceeded the DTR attained by PRC 2.0 for trisomy 21. For trisomies 13 and 18, the proportions of patients with calculated posterior risks exceeding the cutoff value of 1:150 were obtained to be 1.60% (=FPR) and 86.4% (=DTR). CONCLUSION: Transforming the measured concentrations of PAPP-A and free ß-hCG to the logarithmic scale allows one to extend the DoE-based algorithm developed by the FMF Germany for diagnosing trisomies 21 and 13/18 in such a way that it can be applied to constellations where blood sampling is done before 11 weeks of gestation.

Is Transducer Hygiene sufficient when Vaginal Probes are used in the Clinical Routine?

Vaginal ultrasound probes are semi-critical Group A medical products which must be disinfected following the manufacturer's instructions after every patient examination. According to the "Essential Requirements for Medical Devices (Directive 93/42/EEC, Annex I, paragraph 13)" the manufacturer's instructions for use for reusable products must contain suitable instructions for preparation processes. This presumes both an effective and material-compatible method. Evidence of effectiveness must be validated.In the Editorial in issue 1 Ultraschall in der Medizin/European Journal of Ultrasound 2005 we discussed the topic of transducer hygiene and stated that proper handling and cleaning as well as disinfection of probes in daily use are indispensable. This applies particularly to vaginal ultrasound probes routinely used in gynecological and obstetrical clinics, gynecological practices as well as IVF centers Normally the probe used in a transvaginal ultrasound examination is covered with a latex protective cover (with CE marking) which contains a certain amount of ultrasound gel. After the examination, the cover is removed and disposed of, and the gel is removed from the transducer. Since handling of the probe, ultrasound gel and cover can result in smear infections and cross-contamination with various pathogens (e. g. MRSA, HBV, HCV, HIV, herpes papilloma and cytomegalic viruses), after the protective cover is removed, the probe must be cleaned and subjected to disinfection with a bactericidal, fungicidal and virucidal effect. This is especially important in the event the cover ruptures during the vaginal examination, and the probe comes into direct contact with vaginal secretions or blood. The same likewise applies if the sterile protective cover is perforated during a follicular puncture. Usually special bactericidal, levurocidal and virucidal wipes or special submersion disinfection methods are available for disinfecting the vaginal ultrasound probes 11. Using special virucidal wipes on the probes is considered low-level disinfection. Primarily quaternary ammonia compounds are employed for this procedure. This method is easily applicable, has good cleaning characteristics, is effective against HPV and has high skin tolerance. However, it has the disadvantage of not removing all microorganisms during the disinfection process. Immersion procedures are high-level disinfection methods during which the transducer head is dipped in a special fluid for a certain amount of time. The disinfectants used for this include e. g. preparations based on glutaraldehyde or succinic aldehyde. However, in practice immersion disinfection has a number of disadvantages 13: 1. The procedure cannot be validated. 2. The probe permanently attached to the device must be placed in a separate holder and disinfected for at least 15 minutes. This is impracticable in routine operations in a clinic, outpatient facility or practice with a high number of examinations. 3. After this disinfection method, the probe has to be thoroughly rinsed with potable or higher-quality water in order to remove remnants of allergenic or locally toxic substances. 4. Frequently examinations take place in small interior areas with poor ventilation, thus under some circumstances posing an inhalant-related health hazard. 5. The required virucidal effect is frequently not achieved within 15 minutes 13. Furthermore, extended probe contact with liquid disinfecting agents in the long run results in increased wear of the transducer head membrane.Therefore it was interesting to note that in 2009 a fully-automatic disinfection system for ultrasound probes was introduced to the market (Trophon(EPR). This product, developed in Australia, promised relatively rapid high-level disinfection (HLD). During this software-controlled, mechanical disinfection procedure, the entire ultrasound probe (transducer head and handle) is placed in a sealed disinfection chamber, then hydrogen peroxide (H2O2) is discharged as an anti-microbial aerosol into the closed chamber.  The ultra-fine mist wets the entire surface of the probe with H2O2, thereby achieving high-level disinfection of the entire ultrasound probe. At the end of the process, a catalytic decomposition system breaks down the H2O2 into environmentally-friendly oxygen and water. When the chamber is opened, the probe is dry and ready for immediate use. The fully-automatic device was designed as a table unit to be placed directly next to the ultrasound equipment so that the probe does not need to be disconnected from the base unit. The entire disinfection process lasts 7 minutes: 2 minutes for the application and 5 minutes to remove the aerosol residue. In a validation study using carrier tests, Heeg and Gauer in 2014 showed that this procedure genuinely achieved HLD of ultrasound probes within 7 minutes, thus making it suitable for daily clinical routine. The procedure fulfills all requirements for HLD based on the medical device classification according to the legally-prescribed recommendation of the Commission for Hospital Hygiene and Prevention of Infection and the Federal Institute for Drugs and Medical Products (KRINKO/BfArM) in Germany. In the USA, this method was approved by the FDA as well as the leading probe manufacturers, and bears the testing certificate of the German Society for Hospital Hygiene (DGKH).All in all, it should be stated that the sole use of a latex protective cover when using a vaginal probe does not meet the necessary standard of care required for the provision of semi-critical medical products according to the joint recommendation of the German Federal Institute for Drugs and Medical Products (BfArM) and Commission for Hospital Hygiene and Prevention of Infection of the Robert Koch Institute, and constitutes a contravention of necessary patient and user protections. Use of the protective cover does not rule out smear infections and cross-contamination; therefore after each examination, the probe, after removal of the cover, must undergo disinfection measures providing bactericidal, fungicidal and virucidal effects. Since the transducer handle also poses a significant risk of transmission of germs, this component must likewise be sufficiently disinfected. In the event of perforation or rupture of the latex cover, thus resulting in the probe coming into contact with vaginal secretions or blood, the probe must be not only cleaned, but effectively disinfected with a virucide as well. It should also be noted that infection by bacteria and viruses can be caused not only by a contaminated probe, but by the ultrasound gel as well. According to studies by Heeg and Gauer 15, Buescher et al. as well as Ryndock et al., the fully automatic HLD system operated with hydrogen peroxide is currently the only validated system proven to provide HLD of ultrasound probes in a 7-minute cycle, thus suitable for application in the daily routine. Likewise it can also be presumed that this procedure also offers good material compatibility.

Quality Requirements for the early Fetal Ultrasound Assessment at 11-13+6 Weeks of Gestation (DEGUM Levels II and III).

The early fetal ultrasound assessment at 11 - 13(+6) weeks of gestation remains the cornerstone of care despite the progress in diagnosing fetal chromosomal defects using cell-free fetal DNA (cffDNA) from the maternal circulation. The measurement of nuchal translucency (NT) allows the risk calculation for the fetal trisomies 21, 18 and 13 but also gives information on those fetal chromosomal defects which are at present unable to be detected using cffDNA. Nuchal translucency is the only auditable parameter at 11 - 13(+6) weeks and gives thus information on the quality of the first trimester anomaly scan. In addition it gives indirect information on the risks for fetal defects and for cardiac anomalies. Also the chances for a healthy live baby can be estimated. As experience with first trimester anomaly scanning increases, and the resolution of the ultrasound equipment has increased substantially, more and more details of the fetal anatomy become accessible at the first trimester scan. Therefore fetal anatomical defects and complex anomalies have become amenable to examination in the first trimester. This guideline describes compulsory and optional parameters for investigation at the first trimester scan and outlines a structured method of examining a first trimester fetus at 11 - 13(+6) weeks of gestation.

Perceived blood transfusion safety: a cross-European comparison.

BACKGROUND AND OBJECTIVES: During the past decades, blood transfusions have become an ever safer clinical procedure in developed countries. Extensive donor screening together with improved infectious disease testing has led to a minimization of risks for transfusion recipients. Still, the general public perceives the process of blood transfusion as risky. MATERIALS AND METHODS: This study tested variation in perceived transfusion safety across countries and explained it with individual and country factors. We examined whether individual demographic and macro-level factors (i.e. Human Development Index and Power Distance Index) explain variation within and across European countries. We applied multilevel models to 2009 Eurobarometer data collected in 26 countries (N = 20 874). RESULTS: Results were largely in line with expectations derived from risk perception and power and status difference theories. Generally, women, older adults, the lower educated and those earning lower incomes perceived heightened risk. Most of the variation across Europe was explained by the Human Development Index. Risk perception regarding blood transfusions was lower in countries with higher Human Development Indices, that is countries with higher average education, life expectancy and Gross Domestic Product. CONCLUSION: This study provides new insights of how risk perception regarding blood transfusions is shaped within and across Europe. Both individual demographic factors and country characteristics play a role.

Detection of Fetal Corpus Callosum Abnormalities by Means of 3D Ultrasound.

PURPOSE: The objective of this study was to prenatally detect corpus callosum pathologies such as agenesis, partial agenesis, hypo- and hyperplasia and enhanced echogenicity. MATERIALS AND METHODS: Between 2009 and 2013 detailed 3D ultrasound examinations of the fetal corpus callosum were carried out as part of a level III examination for fetal anomalies. All scans were performed using Voluson E8 equipment (GE, Zipf, Austria) with a 5 - 8 MHz 3D transabdominal and 5 - 9 MHz 3D transvaginal transducer. All cases were evaluated for the following variables: inner, outer and curved length of the corpus callosum, height of the different segments of the corpus callosum and the corpus callosum area. All parameters were compared with normal growth charts. In all cases of suspected corpus callosum anomaly direct and indirect signs for corpus callosum agenesis and associated malformations were observed. RESULTS: 31 fetuses with pathological corpus callosum were diagnosed with 3D ultrasound. Gestational age at the time of diagnosis ranged from 20 to 38 weeks. 12 cases showed agenesis, 11 cases partial agenesis, 5 cases hypoplasia, 2 cases a combination of partial hyper- and hypoplasia and one case a lipoma of the corpus callosum. In corpus callosum underdevelopment, the more affected parts were the body and splenium. Associated anomalies were present in 25 of the 31 cases (80.6%) of corpus callosum pathologies. CONCLUSION: 3D neurosonography serves as an excellent tool to precisely demonstrate the pathological development of the fetal corpus callosum. By correlating the measures with the function of each affected corpus callosum segment, we can try to get a vague prediction of the neurological prognosis.