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In the present study, language development of Dutch children with a cochlear implant (CI) in a bilingual educational setting and Flemish children with a CI in a dominantly monolingual educational setting is compared. In addition, we compared the development of spoken language with the development of sign language in Dutch children. Eighteen children with a CI participated in the study: six Dutch children older than 18 months at implantation and 12 Flemish children, of whom seven were younger than 18 months at implantation and five were older than 18 months. Tests were administered on auditory perception, speech intelligibility, spoken language and sign language (Dutch children). Five assessments were made to monitor language development of the children: a pre-test before implantation and four post-tests at six, 12, 24 and 36 months after implantation. In general, Flemish children showed more progress in spoken language development than Dutch children. Moreover, earlier implanted Flemish children showed more progress than later implanted Flemish children. This applies to auditory perception, speech intelligibility and spoken language. Whereas spoken language of Dutch children improved in the course of time, the development of sign language in Dutch children did not show any progress. Despite possible alternative explanations, such as better residual aided hearing before implantation or more professional support, it is plausible that the differences are partly caused by the linguistic environment. The lack of progress in development of sign language might be explained by the decreasing use of sign language by parents after implantation. (Contains 1 table and 5 figures.)

This article presents the results of an exploratory study into the effects of School Self-Evaluation (SSE) used by eight Education Inspectorates in seven European countries. This study reveals that in the countries where SSE is strongly incorporated into the school inspection system, there is a rather substantial degree of steering by the Inspectorate with respect to the form and content of the SSE; it also tends to be both oriented towards improvement and accountability (England, Scotland, the Netherlands and Northern Ireland). On the other hand, in countries where SSE holds a moderate or weak position in the school inspection structure, the degree of steering varies from open (Hesse, Denmark) to pre-structured (Belgium, Lower Saxony) and is more improvement-oriented.

Germany, Belgium and the Netherlands were hit by extreme precipitation and flooding in July 2021. This brief communication provides an overview of the impacts to large-scale critical infrastructure systems and how recovery has progressed. The results show that Germany and Belgium were particularly affected, with many infrastructure assets severely damaged or completely destroyed. Impacts range from completely destroyed bridges and sewage systems, to severely damaged schools and hospitals. We find that (large-scale) risk assessments, often focused on larger (river) flood events, do not find these local, but severe, impacts due to critical infrastructure failures. This may be the result of limited availability of validation material. As such, this brief communication not only will help to better understand how critical infrastructure can be affected by flooding, but also can be used as validation material for future flood risk assessments. [ABSTRACT FROM AUTHOR]

Study Question: Does endometrial scratching in women with one failed IVF/ICSI treatment affect the chance of a live birth of the subsequent fresh IVF/ICSI cycle?Summary Answer: In this study, 4.6% more live births were observed in the scratch group, with a likely certainty range between -0.7% and +9.9%.What Is Known Already: Since the first suggestion that endometrial scratching might improve embryo implantation during IVF/ICSI, many clinical trials have been conducted. However, due to limitations in sample size and study quality, it remains unclear whether endometrial scratching improves IVF/ICSI outcomes.Study Design, Size, Duration: The SCRaTCH trial was a non-blinded randomised controlled trial in women with one unsuccessful IVF/ICSI cycle and assessed whether a single endometrial scratch using an endometrial biopsy catheter would lead to a higher live birth rate after the subsequent IVF/ICSI treatment compared to no scratch. The study took place in 8 academic and 24 general hospitals. Participants were randomised between January 2016 and July 2018 by a web-based randomisation programme. Secondary outcomes included cumulative 12-month ongoing pregnancy leading to live birth rate.Participants/materials, Setting, Methods: Women with one previous failed IVF/ICSI treatment and planning a second fresh IVF/ICSI treatment were eligible. In total, 933 participants out of 1065 eligibles were included (participation rate 88%).Main Results and the Role Of Chance: After the fresh transfer, 4.6% more live births were observed in the scratch compared to control group (110/465 versus 88/461, respectively, risk ratio (RR) 1.24 [95% CI 0.96-1.59]). These data are consistent with a true difference of between -0.7% and +9.9% (95% CI), indicating that while the largest proportion of the 95% CI is positive, scratching could have no or even a small negative effect. Biochemical pregnancy loss and miscarriage rate did not differ between the two groups: in the scratch group 27/153 biochemical pregnancy losses and 14/126 miscarriages occurred, while this was 19/130 and 17/111 for the control group (RR 1.21 (95% CI 0.71-2.07) and RR 0.73 (95% CI 0.38-1.40), respectively). After 12 months of follow-up, 5.1% more live births were observed in the scratch group (202/467 versus 178/466), of which the true difference most likely lies between -1.2% and +11.4% (95% CI).Limitations, Reasons For Caution: This study was not blinded. Knowledge of allocation may have been an incentive for participants allocated to the scratch group to continue treatment in situations where they may otherwise have cancelled or stopped. In addition, this study was powered to detect a difference in live birth rate of 9%.Wider Implications Of the Findings: The results of this study are an incentive for further assessment of the efficacy and clinical implications of endometrial scratching. If a true effect exists, it may be smaller than previously anticipated or may be limited to specific groups of women undergoing IVF/ICSI. Studying this will require larger sample sizes, which will be provided by the ongoing international individual participant data-analysis (PROSPERO CRD42017079120). At present, endometrial scratching should not be performed outside of clinical trials.Study Funding/competing Interest(s): This study was funded by ZonMW, the Dutch organisation for funding healthcare research. J.S.E. Laven reports grants and personal fees from AnshLabs (Webster, Tx, USA), Ferring (Hoofddorp, The Netherlands) and Ministry of Health (CIBG, The Hague, The Netherlands) outside the submitted work. A.E.P. Cantineau reports 'other' from Ferring BV, personal fees from Up to date Hyperthecosis, 'other' from Theramex BV, outside the submitted work. E.R. Groenewoud reports grants from Titus Health Care during the conduct of the study. A.M. van Heusden reports personal fees from Merck Serono, personal fees from Ferring, personal fees from Goodlife, outside the submitted work. F.J.M. Broekmans reports personal fees as Member of the external advisory board for Ferring BV, The Netherlands, personal fees as Member of the external advisory board for Merck Serono, The Netherlands, personal fees as Member of the external advisory for Gedeon Richter, Belgium, personal fees from Educational activities for Ferring BV, The Netherlands, grants from Research support grant Merck Serono, grants from Research support grant Ferring, personal fees from Advisory and consultancy work Roche, outside the submitted work. C.B. Lambalk reports grants from Ferring, grants from Merck, grants from Guerbet, outside the submitted work.Trial Registration Number: Registered in the Netherlands Trial Register (NL5193/NTR 5342).Trial Registration Date: 31 July 2015.Date Of First Patient’s Enrolment: 26 January 2016. [ABSTRACT FROM AUTHOR]

In this study, we investigated the reliability and validity of three self-report questionnaires measuring the early emotional bond between a mother and her newborn infant: the Maternal Postpartum Attachment Scale (MPAS), the Postpartum Bonding Questionnaire (PBQ) and the Mother-to-Infant Bonding Scale (MIBS). In a monocentric prospective observational cohort study, 263 mothers completed the MPAS, the PBQ and the MIBS at 8-12 and at 20-25 weeks postpartum. The participants also completed measures of mental health and, during their pregnancy, measures of recalled parental bonding, adult romantic attachment, antenatal attachment and social desirability. In our study, the internal reliabilities of the PBQ and the MPAS were high at 8-12 weeks postpartum but dropped significantly at 20-25 weeks postpartum. Moderately strong correlations between the scales of the PBQ, the MPAS and the MIBS supported their construct validity. Further, weak correlations were found with social desirability and adult attachment representations, whereas moderate correlations were found with antenatal feelings of attachment and antenatal attitudes to motherhood. Finally, maternal feelings of bonding were also moderately associated with maternal mood. Overall, our findings suggest that the MPAS, the PBQ and the MIBS provide a reliable and valid indication of the early emotional tie between a woman and her newborn infant. [ABSTRACT FROM AUTHOR]

This paper describes some results of a large experimental programme on unsteady flow through the rotor of a transonic turbine stage in the large Compression Tube Turbine Facility at the von Karman Institute for Fluid Dynamics. The tests were carried out as part of a Brite EURAM project. The test programme covered the investigation of the effects of a variation in the rotational speed of the rotor, the axial stator–rotor distance and the stator trailing-edge coolant flow ejection. The paper aims at presenting the measurements of the relative inlet total pressure and the rotor blade surface pressure at rotor mid-span. [ABSTRACT FROM AUTHOR]

In this paper we formulate a dynamic model expressing the human life table data by using the first- passage-time theory for a stochastic process. The model is derived analytically and then is applied to the mortality data in Belgium and France. A stochastic simulation is also performed for the `health state function' proposed and the related stochastic paths. Furthermore the implications of the proposed model and the results derived for pension funds and option theory are discussed. [ABSTRACT FROM AUTHOR]

Objective: To analyze the correlation between the neural telemetry response thresholds obtained by the conventional method (ART) and the new method offered by the software Maestro 7.0 (AutoART). Method: Auditory response telemetry (ART) measurements were performed intraoperatively by ART and AutoART. Data regarding the presence of electrical compound action potential (eCAP) in both methods and the correlation between the threshold values were analyzed. Both methods use the same pulse duration,but the stimulation rate and number of iterations differ. Average thresholds were calculated for the apical (electrodes 1 to 4), medial (5 to 8) and basal region (9 to 12). Auto ART was always the first method of recording eCAP. ART thresholds were converted and comparison with t test was analyzed in the same unit (qu). Results: Measures were recorded in nine surgeries, six with the Flex28 device, two with the FlexSoft and one the Flex19. All surgeries resulted in complete insertion and normal of impedances of all electrodes. In seven surgeries, the number of electrodes that presented presence of neural responses with conventional ART was equal to the number of present responses obtained with AutoART. In one surgery, we observed presence of neural responses in 75% of the electrodes with AutoART, and absent response with conventional ART. In another surgery, responses were found in 80% of the electrodes tested in AutoART and 100% in ART. We found statistical differences between AutoART and ART mean thresholds in all measures. Conclusions: AutoART is an effective and faster way of measuring neural responses. However, the thresholds obtained through AutoNRT were significantly higher than the thresholds obtained by ART. We believe that the difference in thresholds may be due to the diferences in the number of iterations, the stimulation rate or because autoART was always the first of the measurements. We will continue to collect data randomizing the order of the evaluations. [ABSTRACT FROM AUTHOR]

Background & Objective: Biofilm-related infections caused by the colonization of bacteria on silicone medical devices are on the rise. The unexpected postoperative infection can be prevented sustained release of antibiotics in the surgical field. The purpose of this study was to evaluate the efficacy of sustained release of antibiotic by nanofibrous mat in preventing the formation of ciprofloxacin- resistant Pseudomonas aeruginosa (CRPA) biofilm on a silicone component of cochlear implant or postoperative infection. Materials and Methods: We fabricated a biocompatible and biodegradable piperacillin-tazobactam (PT)-eluting electrospun poly(e-caprolactone) (PCL)-polyethylene oxide (PEO)-PT-PCL nanofibrous mat. The release of PT was assessed in vitro by spectrophotometry and the antibacterial effect was evaluated by inhibition zone test and biofilm formation test. Antibiofilm effect was assessed by scanning electron microscopic analysis and examinined of the dead/live stains with confocal microscopy. Results: In the SEM image, the PCL fibers in the outer layer were homogenously uniform in diameter (2.5 ± 0.4 mm) with a highly porous mesh structure that is used in controlling drug release. The PT in the PEO fibrous mat was distributed consistently over the whole region of the fibrous mat. The diameter of the electrospun PEO/PT fibers was about 310 x 15 nm. The release profile of the PT in the multi-layered fibrous mat revealed that about 90% of the PT was rapidly released (initial burst) in less than 1 h from the PCL/PEO/PT/PCL nanofiber mat at 37xC. However, for the remaining 10% of PT, the release was slightly deterred over 7 days. A wide zone of inhibition (more than 3x 3 cm) was identified around the upper 3 round discs of the PCL/(PEO/PT)/PCL nanofiber mat. We found that PT was released at a constant level for 7 days. PT-eluting nanofibrous mat prevented the formation of CRPA biofilm on the silicone surface, in vitro. . Colony counts of the controls were significantly higher than those from the silicone sheet with the PCL/PEO/PT/PCL nanofiber mat (p < 0.0001). Live and dead bacteria show green and red fluorescence, respectively. The control silicone sheet biofilm showed green fluorescence for live cell densities; in contrast, the study group silicone sheet showed a robust red fluorescence for dead cell densities. Scanning electron microscopy showed a robust CRPA biofilm in the control group. On the other hand, there was no CRPA biofilm formation in the silicone sheet with PCL/ PEO/PT/ PCL nanofiber mat group. Conclusion: From these results, it can be concluded that the PT-eluting nanofiber mat may be a promising method for the prevention of CRPA biofilm formation and consequent infections. [ABSTRACT FROM AUTHOR]

Background and Objectives : Idiopathic sudden sensorineural hearing loss(ISSNHR) is defined as a rapid decline in hearing for 3 days or less affecting 3 or more frequencies by 30dB or more without any identifiable causes. Hearing outcomes and prognostic factors of ISSNHL were investigated in patients who underwent com¬bined intratympanic and systemic steroid therapy. Materials and Methods : This study was performed by retrospective chart review. Clinical outcomes and prognostic factors (age, sex, hearing threshold, type of audiogram, vertigo, tinnitus, social and medical history) were evaluated in 147 patients who received intratympanic steroid plus systemic steroid therapy. Results : Complete hearing recovery was achieved in 36.7% (n=54) of the patients, partial recovery in 12.9% (n=19), slight recovery in 12.3% (n=18), and total recovery in 61.9% (n=91). Age was identified as an independent, negative prognostic factor for hearing recovery. The re¬covery rates of the down sloping and profound types were poorer than those of the up sloping type as determined by audiogram. Conclusion : The results of this study suggest that the combined treatment of intratympanic and systemic steroids for ISSNHL results in high hearing recovery rates, and that the down-sloping and profound types of audiogram patterns and age are negative prognostic fac¬tors. [ABSTRACT FROM AUTHOR]

Background & Objective : To date, percutaneous bone anchored hearing aids has been used for treatment of hearing- impaired patients with satisfactory hearing outcome. However, percutaneous abutment has concerning problems such as hygine, adverse soft tissue reaction and biofilm formation. Transcutaneous BAHA attract was developed for prevention of complications by skin penetrating abutment. To assess surgical, audiological benefits, and quality of life, in bone-achored hearing device users ( transcutaneous cochlear BAHA attract 5). Materials and method : It is a retrospective evaluation of sixteen patients fitted unilaterally by single surgeon. Patients assessed with audiometric measurements and application of Glasgow Benefit Inventory(GBI) and Korean Version-Profile of Hearing Aid Benefit(K-PHAB). Results : All surgery was done by typical C-shape incision under local anesthetics except one case. The implant was used with 4 mm length except two children with 3 mm length due to cortical bone thickness. Skin reduction was performed in 13 patients except three patient. The patients were divided two type; single side deafness or sensorineural hearing loss (n=12), mixed or conductive hearing loss (n=4). The seroma was complicated after operation in one patient with wafarin user. The seroma was released by conventional dressing. The barovac drain was used for the other patients for prevention of seroma after surgery. There was no wound healing problem. The BAHA attract device was attached 6 or 8 weeks post-surgery. With the device, sound-field pure-tone audiometry results revealed an increase gain in all frequencies. However, KPHAB and GBI showed polarized results because of the inconvenience the patients experience in their daily lives. Conclusions : The surgery was relatively simple and can be local anesthesia except children. Transcutaneous BAHA attract device can provide good hearing benefit and subjective satisfaction, but sufficient consideration is needed to select for operating patient. [ABSTRACT FROM AUTHOR]

Introduction: The results of cochlear implant (CI) is individual but in everyday listening situations, the combination of reverberation, background noise and speaker distance results in poor listening conditions and the impact is even greater for the hearing impaired. The Roger system is an adaptive multichannel remote microphone technology with a digital modulation that is indicate for use in difficult communications. Objective: The purpose of the study is to evaluate the benefits of the Roger system in CI users. Method: It is a prospective cross-sectional study in which 13 adults post-lingual deafness, Medel recipients were randomly chosen. For the evaluation of the benefit of the Roger system, the participant was positioned in the center of a room with eight speakers, with reverberation time (T60) measured at 429.40ms. Words or sentences recognition was evaluated at zero azimuth at one meter of the subject's head at 65 dB SPL, and the multi-talker babble noise was presented in the other speakers at 55 dB SPL. The contribution of Roger to reverberant environments was evaluated in silence (S0) and Roger's contribution to noise in 2 positioning situations (S0N0-signal and noise at zero azimuth and S0N315-signal at zero azimuth and noise at all directions). The difficulty of the speech material was chosen according to the performance in the silence. The percentage of correct answers in each test was compared between the test situations. Results: Roger's contribution to reverberant environments was identified in 46% of patients with a 26% improvement in performance. Roger's contribution to noise with zero azimuth positioning was identified in 30% of patients with a 9% improvement in performance. Roger's contribution to noise from all directions was identified in 61% of patients with a 20% improvement in performance. Conclusion: The Roger system contributed to speech recognition in reverberant environments and when noise is surrounding. [ABSTRACT FROM AUTHOR]

Introduction: Cochlear Implantation (CI) under Local Anaesthetic (LA) is an option for those patients who are deemed at a higher risk for a General Anaesthetic (GA). It is felt by some that GA in the elderly can affect cognitive function. Patient selection, counselling and planning is pivotal to ensure good outcome and experience. Methods: With the selected patients particular attention is paid to communication during the surgery. Selection of the correct font for the custom-made cue cards enables appropriate interaction. Usual surgical preparation including facial nerve monitoring is performed. Local anaesthesia (Levobupivacaine 5mg/ml) is infiltrated into the appropriate neural pathways to ensure maximum effect. Lignocaine is used by infiltration/topically in the middle ear. Sedation is avoided but prophylactic antibiotics, Dexamethasone, anti--emetics and fluids are administered. One important feature is to ensure that any drill irrigation fluid is at body temperature to avoid caloric effects and to minimise suction. A simple questionnaire about the patients' experience is recorded. Results: Fourteen patients with age range of 26 to 93 years (Mean 76.3) have successfully undergone CI under LA. Operative time is no different from GA and no procedure was abandoned nor complications noted. One patient was discharged the same day, the others the following day after completion of antibiotics. Implantation in one pregnant female was successfully achieved prior to delivery to enable early bonding. 100% of the patients indicated in the questionnaire that they were satisfied with the anaesthetic care and would have the same anaesthetic again. Conclusions: CI surgery under LA is safe and well tolerated. Careful patient selection and counselling is required. Further comparative study to investigate cognitive impact of GA versus LA would be of future interest. [ABSTRACT FROM AUTHOR]

Objectives :Cochlear implantation (CI) under local anaesthetic (LA) has become established practice for many implant teams when considering certain cohorts of patients (e.g. elderly, co-morbidity). However, there is a paucity of information available regarding patient experience that can be used in the pre-operative period. We aim to discuss our series and demonstrate qualitative information about patient experience of CI under LA at the Yorkshire Auditory Implant Service (YAIS). Methods: Chart review of all patients who received a CI under LA at YAIS. Data to include demographics, co-morbidities and physiological parameters were recorded and used to calculate P-POSSUM (Portsmouth Physiological and Operative Severity Score for the enumeration of Mortality and Morbidity) scores. The Iowa Satisfaction with Anaesthesia Scale (ISAS) questionnaire was distributed to all patients who received CI under LA and responses were subsequently analysed. Results: Fourteen patients received CI under LA at YAIS. Male to female ratio was 9:5. The mean age was 77.5 years (range 26 to 93). The mean P-POSSUM mortality and morbidity for this cohort was 1.9% and 28.6% respectively. The average ISAS score was +2.05 (where range of -3 is completely dissatisfied and +3 is completely satisfied). Conclusion: Our study has shown patients to have a favourable experience with implantation using LA. The data regarding validated patient experience obtained from this work can be used to help counsel patients that may be offered CI under LA in the future. [ABSTRACT FROM AUTHOR]

Early discussion on palliative care with patients with advanced, progressive or terminal disease is difficult regardless patient's life expectancy. In Belgium, a Royal Decree sets the criteria to identify patients with palliative needs. For that purpose, the Palliative Care Indicators Tool (PICT) is proposed. This 3-step identification tool designed for physicians begins with the so-called surprise question, «Would you be surprised if your patient died in the next 6 to 12 months?». The second and third steps examine the fragility and incurability criteria, respectively. The surprise question intends to encourage the clinician to trust his/her intuition and to promote a reflection on patient's needs. The PICT facilitates communication between caregivers. Also, it makes possible early thinking about advanced care planning. Hence, it allows patients to receive palliative care in due time. In this paper, after reviewing the background of the surprise question, we shall examine the benefits and limitations of the surprise question.

Progress of medical knowledge pushed the limits of medicine. This raises major ethical issues. The Belgian lawmaker, concerned to ensure the observance of Human Rights, attempted to regulate some of these issues. It remains essential to listen to the patient and to respect his/her will. Likewise, defining therapeutic goals based on patient's values and priorities is crucial until the end of patient's life.

Study Question: Does endometrial scratching in women with one failed IVF/ICSI treatment affect the chance of a live birth of the subsequent fresh IVF/ICSI cycle?, Summary Answer: In this study, 4.6% more live births were observed in the scratch group, with a likely certainty range between -0.7% and +9.9%., What Is Known Already: Since the first suggestion that endometrial scratching might improve embryo implantation during IVF/ICSI, many clinical trials have been conducted. However, due to limitations in sample size and study quality, it remains unclear whether endometrial scratching improves IVF/ICSI outcomes., Study Design, Size, Duration: The SCRaTCH trial was a non-blinded randomised controlled trial in women with one unsuccessful IVF/ICSI cycle and assessed whether a single endometrial scratch using an endometrial biopsy catheter would lead to a higher live birth rate after the subsequent IVF/ICSI treatment compared to no scratch. The study took place in 8 academic and 24 general hospitals. Participants were randomised between January 2016 and July 2018 by a web-based randomisation programme. Secondary outcomes included cumulative 12-month ongoing pregnancy leading to live birth rate., Participants/materials, Setting, Methods: Women with one previous failed IVF/ICSI treatment and planning a second fresh IVF/ICSI treatment were eligible. In total, 933 participants out of 1065 eligibles were included (participation rate 88%)., Main Results and the Role of Chance: After the fresh transfer, 4.6% more live births were observed in the scratch compared to control group (110/465 versus 88/461, respectively, risk ratio (RR) 1.24 [95% CI 0.96-1.59]). These data are consistent with a true difference of between -0.7% and +9.9% (95% CI), indicating that while the largest proportion of the 95% CI is positive, scratching could have no or even a small negative effect. Biochemical pregnancy loss and miscarriage rate did not differ between the two groups: in the scratch group 27/153 biochemical pregnancy losses and 14/126 miscarriages occurred, while this was 19/130 and 17/111 for the control group (RR 1.21 (95% CI 0.71-2.07) and RR 0.73 (95% CI 0.38-1.40), respectively). After 12 months of follow-up, 5.1% more live births were observed in the scratch group (202/467 versus 178/466), of which the true difference most likely lies between -1.2% and +11.4% (95% CI)., Limitations, Reasons for Caution: This study was not blinded. Knowledge of allocation may have been an incentive for participants allocated to the scratch group to continue treatment in situations where they may otherwise have cancelled or stopped. In addition, this study was powered to detect a difference in live birth rate of 9%., Wider Implications of the Findings: The results of this study are an incentive for further assessment of the efficacy and clinical implications of endometrial scratching. If a true effect exists, it may be smaller than previously anticipated or may be limited to specific groups of women undergoing IVF/ICSI. Studying this will require larger sample sizes, which will be provided by the ongoing international individual participant data-analysis (PROSPERO CRD42017079120). At present, endometrial scratching should not be performed outside of clinical trials., Study Funding/competing Interest(s): This study was funded by ZonMW, the Dutch organisation for funding healthcare research. J.S.E. Laven reports grants and personal fees from AnshLabs (Webster, Tx, USA), Ferring (Hoofddorp, The Netherlands) and Ministry of Health (CIBG, The Hague, The Netherlands) outside the submitted work. A.E.P. Cantineau reports 'other' from Ferring BV, personal fees from Up to date Hyperthecosis, 'other' from Theramex BV, outside the submitted work. E.R. Groenewoud reports grants from Titus Health Care during the conduct of the study. A.M. van Heusden reports personal fees from Merck Serono, personal fees from Ferring, personal fees from Goodlife, outside the submitted work. F.J.M. Broekmans reports personal fees as Member of the external advisory board for Ferring BV, The Netherlands, personal fees as Member of the external advisory board for Merck Serono, The Netherlands, personal fees as Member of the external advisory for Gedeon Richter, Belgium, personal fees from Educational activities for Ferring BV, The Netherlands, grants from Research support grant Merck Serono, grants from Research support grant Ferring, personal fees from Advisory and consultancy work Roche, outside the submitted work. C.B. Lambalk reports grants from Ferring, grants from Merck, grants from Guerbet, outside the submitted work., Trial Registration Number: Registered in the Netherlands Trial Register (NL5193/NTR 5342)., Trial Registration Date: 31 July 2015., Date of First Patient’s Enrolment: 26 January 2016., (© The Author(s) 2020. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.)

Objectives: The aim of the study was to test the antiviral efficacy of a triple nucleoside reverse transcriptase inhibitor (NRTI) regimen, with potential beneficial metabolic effects, as maintenance therapy after induction with dual NRTIs and a boosted protease inhibitor (PI)., Methods: An open-label, noninferiority study was carried out. Antiretroviral therapy (ART)-naïve patients with CD4 count ≤ 350 cells/μL and HIV-1 RNA >30000 copies/mL (n=207) were treated with zidovudine/lamivudine and lopinavir/ritonavir. After achieving HIV-1 RNA <50 copies/mL on two consecutive occasions between weeks 12 and 24 after baseline, 120 patients (baseline: median HIV-1 RNA 5.19 log10 copies/mL; median CD4 count 180 cells/μL) were randomized to receive abacavir/lamivudine/zidovudine (ABC/3TC/ZDV) (n=61) or to continue the PI-based ART (n=59)., Results: For the proportions of patients (intention-to-treat; missing=failure) with HIV-1 RNA <400 copies/mL (PI group, 66%; ABC/3TC/ZDV group, 71%) and <50 copies/mL (PI group, 63%; ABC/3TC/ZDV group, 62%) at 96 weeks, switching to ABC/3TC/ZDV was noninferior compared with continuing the PI regimen; the difference in failure rate (ABC/3TC/ZDV minus PI) was -4.4 percentage points [95% confidence interval (CI) -21.0 to +12.3 percentage points] and +0.4 percentage points (95% CI -16.9 to +17.7 percentage points), respectively. In the per protocol analysis, the difference in virological failure for HIV-1 RNA >400 copies/mL (0 of 39 patients in the PI group and two of 45 patients in the NRTI group) and for HIV-1 RNA >50 copies/mL (two of 39 and three of 45 patients, respectively) was +4.4 percentage points (95% CI -2.1 to +11.0 percentage points) and +1.5 percentage points (95% CI -8.6 to +11.7 percentage points), respectively, also showing noninferiority. Serum lipids significantly improved in the NRTI group, but not in the PI arm., Conclusions: A single-class NRTI regimen after successful induction with standard ART had similar antiviral efficacy compared to continuation of a PI-based regimen at 96 weeks after baseline, with improved serum lipids., (© 2014 British HIV Association.)

Background: Hazelnut (Corylus avellana) allergy exhibits age and geographically distinct sensitization patterns that have not yet been fully resolved., Objective: To study sensitization to Cor a 11 in different age groups of hazelnut-allergic patients and infants with atopic dermatitis (AD) sensitized to hazelnut in a birch-endemic region., Methods: Sera from 80 hazelnut-allergic patients, 33 infants under 1 year of age with AD (24 sensitized and 9 not sensitized to hazelnut), 32 healthy control individuals, and 29 birch pollen-allergic but hazelnut-tolerant individuals were tested for immunoglobulin (Ig) E reactivity to Cor a 11 by ImmunoCAP. IgE reactivity to Cor a 1.01, Cor a 1.04, Cor a 8, and Cor a 9 was studied by ISAC microarray., Results: Forty patients (22 preschool children, 10 schoolchildren, and 8 adults) with systemic reactions on consumption of hazelnut were sensitized to Cor a 11 (respective rates of 36%, 40%, and 12.5%). Forty patients (6 preschool children, 10 schoolchildren, and 24 adults) reported oral allergy syndrome but only 2 of them (of preschool age) were sensitized to Cor a 11. Two (8%) of the AD infants sensitized to hazelnut showed IgE reactivity to Cor a 11. This reactivity was not observed in any of the AD infants without sensitization to hazelnut, in any of the birch-pollen allergic patients without hazelnut allergy, or in any of the healthy control individuals., Conclusion: Sensitization to Cor a 11 in a birch-endemic region is predominantly found in children with severe hazelnut allergy, a finding that is consistent with observations concerning sensitization to Cor a 9.

In this study, we investigated the reliability and validity of three self-report questionnaires measuring the early emotional bond between a mother and her newborn infant: the Maternal Postpartum Attachment Scale (MPAS), the Postpartum Bonding Questionnaire (PBQ) and the Mother-to-Infant Bonding Scale (MIBS). In a monocentric prospective observational cohort study, 263 mothers completed the MPAS, the PBQ and the MIBS at 8-12 and at 20-25 weeks postpartum. The participants also completed measures of mental health and, during their pregnancy, measures of recalled parental bonding, adult romantic attachment, antenatal attachment and social desirability. In our study, the internal reliabilities of the PBQ and the MPAS were high at 8-12 weeks postpartum but dropped significantly at 20-25 weeks postpartum. Moderately strong correlations between the scales of the PBQ, the MPAS and the MIBS supported their construct validity. Further, weak correlations were found with social desirability and adult attachment representations, whereas moderate correlations were found with antenatal feelings of attachment and antenatal attitudes to motherhood. Finally, maternal feelings of bonding were also moderately associated with maternal mood. Overall, our findings suggest that the MPAS, the PBQ and the MIBS provide a reliable and valid indication of the early emotional tie between a woman and her newborn infant.

In this study, we investigated the psychometric qualities of the Dutch version of the Maternal Antenatal Attachment Scale (MAAS). In a monocentric prospective observational cohort study, 403 expectant mothers completed a booklet with questionnaires in the first (T1), second (T2), and third (T3) pregnancy trimesters. In addition to the MAAS (T1-T3), the following measures were used: the Marlowe-Crowne Social Desirability Scale (T1), the Parental Bonding Inventory (T1), the Relationship Questionnaire (T1) the Facilitator scale and the Regulator scale (T3), the Edinburgh Postnatal Depression Scale (T1-T3) and the Pregnancy Related Anxiety Questionnaire (T1-T3). In this study, the mean of the MAAS scales increased as the pregnancy progressed. Good internal reliabilities were found for the Total MAAS scale, the Quality subscale and the Preoccupation subscale. Small-to-moderate correlations were found with social desirability, maternal orientation, parental care and adult attachment. Maternal mood was weakly associated with the quality but not with the intensity of the maternal attachment feelings. Overall, our findings suggest that the Dutch version of the Maternal Antenatal Attachment Scale is a reliable and valid measure of the early emotional tie between a pregnant woman and her unborn child.

Objective: To evaluate reliability and validity of the Dutch translated Aberdeen Varicose Vein Questionnaire (AVVQ) for measuring health related quality of life (HR-QOL) in patients with venous disease in the lower limb., Methods: The AVVQ consists of 13 questions related varicose veins. This study assessed feasibility, reliability and validity of the Dutch translated AVVQ in a sample of 145 patients with venous disease of the leg. Test and retest of the Dutch translated AVVQ were performed within a 2 week interval., Results: There was a high test (99%) and retest (97%) response. Feasibility; AVVQ showed few missing answers (0.6%) and non-unique answers (0.2%). Regarding internal consistency; Cronbach's alpha exceeded 0.7 indicating a high level of concordance between the AVVQ questions (alpha=0.76). Test-retest reliability; Spearman's rho showed a significant strong association between test and retest scores (rho=0.87). Discriminative validity; AVVQ score was able to differentiate between subgroups of patients with different severity of venous disease according to the CEAP classification (Mann-Whitney U test, p<0.01)., Conclusions: This study supports applications of the Dutch AVVQ in HR-QOL measurement in patients with venous disease in the Netherlands and the Flemish speaking part of Belgium.

Objective: To determine the value of health-related quality of life (HRQoL) to predict change in disability status in patients with multiple sclerosis (MS)., Methods: Over a 5-year period, data were collected on HRQoL (Medical Outcomes Study Short Form-36 Health Survey) and disability status (Expanded Disability Status Scale) from a heterogeneous group of 81 Dutch-speaking patients with MS., Results: Multivariate logistic regression analysis showed that HRQoL in the domains of Physical Functioning and Role-Physical Functioning is a significant predictor of change in disability status., Conclusions: A patient's subjectively perceived health-related quality of life may not be only a clinically and psychosocially meaningful outcome per se but may also be a predictor of objective outcomes such as change in disability status over a substantial period of time.

Background: It is well recognised that natural rubber latex allergy can be associated with serological cross-reactivity to plant allergens, especially tropical fruits and Ficus. In contrast, data on the frequency and clinical value of specific IgE antibodies against these allergens remain rare. In addition, little is known about the prevalence and diagnostic value of specific IgE antibodies to classical inhalant and animal allergens in NRL allergic patients., Objective: The purpose of this study was to investigate the prevalence, the sensitivity, and the specificity of these different specific IgE antibodies in patients suffering from NRL allergy., Methods: Serum samples of 42 NRL allergic adults were investigated. All had a history of NRL allergy confirmed by a positive skin test for latex and a positive latex-specific IgE. Samples were analysed for IgE antibodies against 9 plant food allergens (avocado, banana, chestnut, fig, kiwi, papaya, peanut, pineapple and tomato) and Ficus benjamina. A specific IgE quantification for 3 animal food allergens (codfish, cow's milk, egg's white) and 8 common inhalant allergens (Dermatophagoïdes pteronyssinus, birch pollen, timothy grass pollen, mugwort pollen, cat and dog epithelium, Aspergillus fumigatus and Cladosporium herbarum) was also performed. Because double blind placebo-controlled challenges could not be considered, for ethical reasons, patient's food allergy or immediate hypersensitivity for Ficus and inhalant allergens was documented by a standardised questionnaire. Diagnosis of atopy was based on a relevant history and the presence of a specific IgE antibody to at least one classical inhalant allergen. For some IgE determinations presence or absence of cross-reactivity was investigated by CAP-inhibition tests., Results: A specific IgE antibody to at least one of the investigated inhalant and animal food allergens was found in respectively 76% and 12% of the serum samples. A plant food-specific IgE antibody was observed in 88% of the serum samples, most frequently to papaya (71%) and least frequently to kiwi (17%). Twenty-nine percent of the serum samples contained Ficus-IgE. According to the questionnaire and the threshold of 0.35 kUa/L, sensitivity of the plant food IgE antibodies varied between 0% for papaya and 73% for avocado. Specificity varied between 28% for papaya and 91% for kiwi. For Ficus-IgE sensitivity was 20% and specificity 70%., Conclusions: For inhalant and animal food allergens sensitivity and specificity of the IgE quantification correlated generally well with the values obtained in non-NRL allergic adults. Determination of specific IgE to the investigated plant foods and Ficus was not always a sensitive neither a specific test to establish the clinical diagnosis of this allergy.

Objective: The aim of this study was to evaluate the relative frequencies of sensitisation to four common inhalant allergens in two atopic populations suffering from asthma and/or rhinitis. One had been studied in the period of 1975 till 1979, and a second population was evaluated between 1992 and 1995., Data Sources: At both time periods patients with inhalant allergy and visiting our outpatient clinic were included. Quantification of IgE to Dermatophagoides pteronyssinus, birch, timothy grass, and mugwort was performed via the Phadebas RAST technique (Pharmacia, Brussels, Belgium)., Results: In patients suffering from respiratory allergy the frequency of birch pollen sensitisation significantly increased from 13% in the period 1975-1979 to 34% in the period 1992-1995. In contrast, the frequency of house dust mite, timothy grass pollen, and mugwort pollen sensitisation remained almost unchanged. The increase was not associated with an increase in the birch pollen count., Conclusion: Birch pollen hypersensitivity has almost tripled among atopic subjects during the last 2 decades. The exact mechanisms for this increase remain to be evaluated.

The Disability and Impact Profile (DIP) is used for the measurement of quality of life in multiple sclerosis (MS) patients. Data from 211 persons with definite MS from Belgium, Denmark and the Netherlands were used to address three questions. To what extent do the impairment ratings and their complementary weighted scores share common variance? What is the factor structure of the weighted scores? To what extent do disease-related information and information from psychological questionnaires offer concurrent validity for the factors? Correlations between impairment ratings and the weighted item scores were high; for most items the complementary ratings of impact do not supplement information provided by impairment ratings. The DIP weighted scores can be represented to some extent by three independent dimensions: a motor (skeletal movement) or displacement ability factor, a factor relating to sensory-cognitive intactness and a psychological well-being factor. A two-factor solution provides a first factor identical to that of the three-factor solution and a second factor representing psychological well-being. The two factors correlate well with instruments measuring disability and with satisfaction versus emotional distress. Provisional scales based on the factors were constructed.

Seventy-three Dutch and Flemish patients with definite multiple sclerosis (MS) were assessed by means of the Disability and Impact Profile (DIP), which is a 2 x 39 item, self-administered questionnaire with parallel questions about disabilities and their importance for or impact on the patient, resulting in a profile of weighted scores. It was designed as a tool for clinical assessment of quality of life (QoL) domains in MS patients. Group data showed more than 50% loss on weighted scores for "walk", "clean home", "work" and "worry about deterioration". In individual patients a median of 7 (range 0-23) major disruptions of quality of life (MD-QoL: loss on weighted score more than 50%) was found. Prevalence of MD-QoL in more than 10% of the patients was found for as many as 31 disabilities and > 50% for 3 ("clean home", "work" and "worry about deterioration"). Results in the MS group were compared with available data from 25 patients with rheumatoid arthritis (RA) and 25 patients with a spinal cord lesion (SCl). Weighted scores of "read", "memory" and "concentration" were significantly lower in the MS group than in the RA and SCl groups. Significantly lower weighted scores in both the MS and RA groups were found for "worry about deterioration", "physical endurance", "clean home", "work", "see" and "write". In conclusion, major disruptions in many domains of QoL were found in MS patients. Weighted score profiles for MS were in accordance with clinical manifestations. Unlike Kurtzke's Extended Disability Status Scale, DIP assesses a wide range of potentially MS-affected human activities, and also takes into account the subjective perception of disabilities.

Public health is in crisis. Apart from temporary factors, this crisis could have also its origin in theoretical and conceptual insufficiencies relative to the definition of this scientific domain. Organisational and institutional conditions needed for the strengthening of public health are discussed in relation with the localization of its production sites, taking into account the needed synthesis or consensus to reach and in view of the larger and valuable intellectual traditions to which it belongs. The crisis of public health is only part of a crisis of medicine and of our modern societies.

A random cross-sectional sample of 198 residents was taken from a convenience sample of 20 Flemish, community-based nursing homes for the aged. Twenty trained interviewers reviewed the medication list of these residents and interviewed the nurses responsible for their daily care to assess their activities of daily living (ADL) and cognitive status. Direct interview was possible of 128 residents (65%); communication with the other 70 residents was impossible because of dementia (55 patients) or communication problems, such as aphasia and deafness (15 patients). An average of 4.5 different medicines was mentioned on the medication lists of the 198 residents. Drug use increases with age but stabilises after the age of 80 y. Medicines are ordered from local community pharmacies and are delivered to the ward rooms in original drug dispensing packs. The nursing staff is responsible for distribution inside the institution. Nursing personnel read the inserts of the medicines given to 98% of the residents and keep the inserts of 77% in the nursing office. Only 11% of the residents maintained some autonomy in ordering, keeping and taking their medication, although 42% were evaluated by the nurses as functionally and cognitively fit. Only 4% of the 128 residents able to respond to an interview had a notion of the potential adverse effects of their medication; the two most important sources of information about medicines mentioned by those residents were the general practitioner and the nursing personnel; 4% mentioned relatives and friends, or the pharmacist, as information sources.

We designed an 84-item questionnaire to determine the attitude of the Belgian public toward package inserts (PI) for medication information, written in technical language and intended for health professionals, within an original drug-dispensing distribution system. There were 398 respondents to this general public survey, based on a 0.05 percent selection from election registers of the districts of Gent and Liège. Eighty-nine percent of the respondents read the PI, focusing their attention principally on adverse effects (88 percent), dosage and dosing guidelines (85 percent), contraindications (82 percent), indications (79 percent), and medication shelf-life (76 percent). Compliance (83 percent), reassurance (57 percent), increased knowledge about the medication (50 percent), and decision to take the medicine (31 percent) were among the respondents' motives for reading the PI. Most respondents considered the PI information useful and complete, but difficult to remember and understand. Readers further criticized its legibility and poor graphic illustration. The PI was seen as a supplementary source of information, instrumental to the physician-pharmacist-patient relationship, without the power to overrule the physician's or pharmacist's instructions. Some respondents reported that the PI made them afraid to use the medication. Expectations for the ideal PI were contradictory and can only be met with a never-optimal compromise between comprehensiveness and conciseness.

In Belgium, all dispensed drugs are provided with package inserts. Traditional physician-orientated inserts are gradually being replaced by patient package inserts (PPIs). The present survey is focused on the use of inserts for antihypertensive drugs and their impact on the reported occurrence and attribution of adverse drug reactions (ADRs). A group of 28 general practitioners (GPs) from the Flemish part of Belgium collected data from 702 hypertensive patients. Each participating GP submitted a consecutive sample of his patients to an interview in the Spring 1989, when 25% of the antihypertensive specialties carried a PPI-version. 1049 prescriptions for antihypertensive drugs had been dispensed. Two thirds of the patients, mostly those with a higher educational level, had read the package inserts. PPIs accounted for 16% of the inserts, and they had not been read significantly more than the traditional inserts. Reporting by the patients of possible drug-related health problems (spontaneously + after having heard the items on a check-list) was not affected by reading the insert or by the type of insert. However, the PPI did bring about spontaneous reporting, especially by patients with a low educational level. Attribution of at least one health problem to the medication was not affected by reading in itself but by the type of insert. Attribution was higher when the patient had received a PPI, except in the case of highly educated patients. Spontaneous reporting and attribution of health problems to the medications prescribed was found more frequently among patients with higher education, who did not seem to need a PPI to recognize problems as being drug-related.

In a homosexual communication centre in Antwerp 196 homosexual men were screened for seromarkers of syphilis, hepatitis A (HAV), hepatitis B (HBV) and cytomegalovirus (CMV). A comparison group consisted of 118 heterosexual men attending a venereal disease clinic in Antwerp. Treponemal antibodies were found in 7.1% of homosexual men, of whom half gave no history of past or present infection. Anti HAV was present in 43.3%, HBV seromarkers in 34.4%, and CMV antibodies in 71.2% of homosexual men. Hepatitis B surface antigen (HBsAg) was detected in eight homosexual men, but not in the heterosexual control group. Prevalence rates of infections other than HAV were significantly higher in homosexual men than in heterosexual men. Answers to a questionnaire were used to evaluate risk factors for different diseases, which were: duration of active homosexuality for all infections, promiscuity (greater than or equal to 10 partners in the past six months) for syphilis and hepatitis B, and anal intercourse for hepatitis B. Visiting saunas and travelling for sexual contacts also indicated a higher risk for STD, but were an indirect expression of promiscuity.

Over a 12 year period in 230 patients mitral valve replacement was performed using the model 6120 Starr-Edwards prosthesis. Operative mortality was 6.5%, mean follow-up of the operative survivors was 3.9 years. Estimated late survival rate was 80% at 5 years and 73% at 12 years. 38% of late deaths were considered valve-related. Under routine anticoagulation thromboembolism occurred at a rate of 4.7% per patient-year with a fatal thromboembolic incidence of 1.4% per patient-year. In comparison with data available on other currently used prosthetic valves it appears that the rates of valve-related complications are quite similar, with the 6120 Starr-Edwards model being subject to the longest follow-up.

After a short note on terminology, in this review article a survey is given of former and existing initiatives concerning the Patient Package Insert (PPI) in the USA and in Western Europe, with emphasis on the situation in Belgium. Arguments in favour of and against the PPIs are given, based upon the literature. The need for drug information for the general public is illustrated by a number of studies. Content and presentation of the PPI as a source of drug information are discussed. Studies on the impact of PPIs on satisfaction, knowledge, compliance, adverse drug reactions emotions, risk/benefit-decisions etc. are reviewed. Finally, attention is drawn to remaining problems and to the needs for further research.

The results of surgery in 21 patients with I.H.S.S. are reported. Dyspnea, angina pectoris and syncope were the most common symptoms in decreasing frequency. Before the operation, 5 patients were in New York Heart Association's functional class II, 10 in class III and 6 in class IV. The mean resting peak systolic pressure gradient was 66 mm Hg in 20 patients and mean left ventricular end-diastolic pressure was 14 mm Hg in 19 patients. The ventriculoseptomyectomy accomplished through a transaortic approach is the procedure of choice. The operative mortality rate was 14% (3 of 21 patients). There were 2 late deaths from congestive heart failure. Any sudden death did not occur. The remaining 16 patients have been followed up for a mean of 75 months (range 12 months to 11 years), 11 patients are in functional class I, 4 in class II and 1 in class III. Complete left-bundle-branch block occurred in 3 patients. Our study with a long post-operative follow-up period, documents that surgery results in good to excellent alleviation of symptoms in survivors. The elevated pre-operative left ventricular end-diastolic pressure has a significantly poor prognosis. We currently recommend surgery for the symptomatic patients who have not responded to medical therapy, not late in the symptomatic course of the disease.

A study during a five-year period has been conducted on the incidence of ischaemic heart disease (IHD) among two cohorts of Belgian employees who were free of IHD at entry. As regards the final outcome these incidences differ significantly. The chief difference between the two cohorts is their systolic blood pressure. These pressure differences may be attributed to differences in the level of work pressure. The increased work pressure in Cohort I might account, through stress, for the greater incidence of sudden death or myocardial infarction.