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Introduction of a nationwide first-trimester anomaly scan in the Dutch national screening program
Full text linkBackground: A significant proportion of major fetal structural anomalies can be detected in the first trimester by ultrasound examination. However, the test performance of the first-trimester anomaly scan performed in a low-risk population as part of a nationwide prenatal screening program is unknown. Potential benefits of the first-trimester anomaly scan include early detection of fetal anomalies, providing parents with more time for reproductive decision-making. Objective: To investigate the uptake, test performance, and time to a final prenatal diagnosis after referral. Study Design: A nationwide implementation study was conducted in the Netherlands (November 2021−November 2022). The FTAS was performed between 12+3 and 14+3 weeks of gestation by certified sonographers using a standard protocol. Women were referred to a tertiary care center if anomalies were suspected. Uptake, test performance, and time to a final prenatal diagnosis (days between referral and date of final diagnosis/prognosis for reproductive decision-making) were determined. Test performance was calculated for first-trimester major congenital anomalies, such as anencephaly and holoprosencephaly and all diagnosed anomalies <24 weeks of gestation. Results: The first-trimester anomaly scan uptake was 74.9% (129,704/173,129). In 1.0% (1313/129,704), an anomaly was suspected, of which 54.9% (n=721) had abnormal findings on the detailed first-trimester diagnostic scan and 44.6% (n=586) showed normal results. In 0.5% (n=6), intrauterine fetal death occurred. In the total group of 721 cases with abnormal findings, 332 structural anomalies, 117 genetic anomalies, 82 other findings (abnormal fetal biometry, sonomarkers, placental/umbilical cord anomaly, an-/oligohydramnios), and 189 cases with transient findings (defined as ultrasound findings which resolved <24 weeks of gestation) were found, with 1 case having an unknown outcome. 0.9% (n=1164) of all cases with a normal first-trimester anomaly scan were diagnosed with a fetal anomaly in the second trimester. Test performance included a sensitivity of 84.6% (126/149) for first-trimester major congenital anomalies and 31.6% (537/1701) for all types of anomalies. Specificity for all anomalies was 99.2% (98,055/98,830); positive predictive value 40.9% (537/1312); negative predictive value 98.8% (98,055/99,219); positive likelihood ratio 40.3; negative likelihood ratio 0.7; false positive rate 0.8% (775/98,830), and false negative rate 68.4% (1164/1701). The median time to diagnosis for structural anomalies was 20 days (6–43 days; median gestational age 16+3), for genetic anomalies 17 days (8.5–27.5 days; median gestational age 15+6 weeks), and for first-trimester major congenital anomalies 9 days (5–22 days; median gestational age 14+6 weeks). Conclusion: The performance of a newly introduced nationwide first-trimester anomaly scan in a low-risk population showed a high sensitivity for first-trimester major congenital anomalies and a lower sensitivity for all anomalies combined. The program was accompanied by a referral rate of 1.0%, of which 59.1% involved cases where anomalies were either not confirmed or resolved before 24 weeks gestation. Timing of diagnosis was around 16 weeks of gestation for referred cases. To evaluate the balance between benefits and potential harm of the first-trimester anomaly scan within a nationwide prenatal screening program, it is essential to assess the effectiveness of the program over time and to consider the perspectives of both women and their partners, as well as healthcare professionals
Examining the psychometric properties of the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 among young urban South African women
Full text linkBackground: Valid, reliable, and easy-to-administer scales are crucial for identifying mental health conditions, especially in LMICs where such scales tend not to be validated. This study aims to address this gap by investigating the psychometric properties and factorial structure of the PHQ-9 and GAD-7 in a sample of young women in Soweto, South Africa. Methods: The PHQ-9 and GAD-7 were administered to 6028 women aged 18–28 years old. Cronbach's alpha, Mokken scale analysis, and Confirmatory Factor Analysis were used to provide support for the internal consistency and construct validity of these scales. Results: Both scales demonstrated good internal consistency (α = 0.81 for PHQ-9 and α = 0.84 for GAD-7). Internal consistency reliability was further supported by positive inter-item correlations and item-by-scale correlations for all items on both measures. CFA of the PHQ-9 and GAD-7 showed a reasonable fit for the 1-factor model and 2-factor models (depression and anxiety with somatic and cognitive subtypes). Limitations: This study was limited to young African women in urban Soweto who were proficient in English, which may affect generalizability. Differences in language or cultural context may impact the accuracy and applicability of these scales to other African populations. Conclusion: The PHQ-9 and GAD-7 are valid and reliable for identifying psychological distress in the studied population. Despite showing good psychometric properties, further diagnostic assessment is needed to confirm clinical diagnoses. The scales are useful for identifying those at risk but not a substitute for comprehensive diagnostic evaluations
Feasibility of telementoring during robot-assisted minimally invasive esophagectomy
No full textIntroduction: Telementoring could increase the quality, reduce the time, and increase cost efficiency of the proctoring program for robot-assisted minimally invasive esophagectomy (RAMIE). However, feasibility is unclear as no studies assessed telementoring for RAMIE. Methods: The feasibility of telementoring was assessed during the thoracic part of RAMIE procedures in three high-volume centers. RAMIEs were performed by trained surgeons, proctored by two experts. The primary outcome was the impact of the technology on conveying and understanding instructions. Results: Between December 2021 and December 2022, nine RAMIE procedures were proctored using telementoring. Overall quality of the telementoring technique was scored good to excellent (median score: good). The vast majority of the 24 proctor instructions were conveyed and understood fluently (n = 21, 96%). Most proctor instructions were aimed at improving surgical exposure (n = 9, 38%). The major point of criticism was the use of the audio as the communication through the headset of the performing surgeon was not accessible by the complete team. Discussion: Telementoring is deemed feasible for proctoring trained RAMIE surgeons after onsite proctoring. Technical improvements with regard to audio technology are warranted for broad implementation, especially in earlier training settings. The role of telementoring in the training pathway of learning surgeons needs clinical validation
National consensus on a new resectability classification for perihilar cholangiocarcinoma - A modified Delphi method
Full text linkBackground: Currently, no practical definition of potentially resectable, borderline or unresectable perihilar cholangiocarcinoma (pCCA) is available. Aim of this study was to define criteria to categorize patients for use in a future neoadjuvant or induction therapy study. Method: Using the modified DELPHI method, hepatobiliary surgeons from all tertiary referral centers in the Netherlands were invited to participate in this study. During five online meetings, predefined factors determining resectability and additional factors regarding surgical resectability and operability were discussed. Results: The five online meetings resulted in 52 statements. After two surveys, consensus was reached in 63% of the questions. The main consensus included a definition regarding potential resectability. 1) Clearly resectable: no vascular involvement (≤90°) of the future liver remnant (FLR) and expected feasibility of radical biliary resection. 2) Clearly unresectable: non-reconstructable venous and/or arterial involvement of the FLR or no feasible radical biliary resection. 3) Borderline resectable: all patients between clearly resectable and clearly unresectable disease. Conclusion: This DELPHI study resulted in a practical and applicable resectability, or more accurate, an explorability classification, which can be used to categorize patients for use in future neoadjuvant therapy studies
Vaccination and clozapine use: a systematic review and an analysis of the VAERS database
No full textIn the context of COVID-19 concerns related to the potential interactions between clozapine and vaccination arose. With the ultimate goal of deriving recommendations for clinical practice, we systematically reviewed the current evidence regarding altered vaccine effectiveness in clozapine-treated patients and safety aspects of vaccination, such as haematological changes and the impact of vaccines on clozapine blood levels, in clozapine-treated patients. A systematic PRISMA-conform literature search of four databases (PubMed, PsycINFO, EMBASE and Cochrane Library) complemented by a case-by-case analysis of the Vaccine Adverse Event Reporting System (VAERS) database was performed. We then systematically appraised the joint evidence and tried to derive recommendations for clinical practice. 14 records were included in this analysis. These records consisted of 5 original articles and 9 case reports. Among the original articles, two studies provided data on the association between clozapine use and antibody responses to vaccination, both indicating that clozapine use in schizophrenia may be associated with reduced levels of immunoglobulins. Additionally, three studies examined vaccine safety in clozapine-treated patients, with no clinically significant adverse effects directly attributable to the interplay between vaccinations and clozapine. VAERS Analysis encompassed 137 reports and showed no consistent evidence of an increased risk for clozapine blood level increases or adverse events. We found no evidence indicating that clozapine impairs the effectiveness of vaccines. Moreover, no serious safety concerns seem to apply when patients on clozapine are receiving vaccines. However, it is crucial to acknowledge that data on the interaction between clozapine and vaccines remain limited
‘This form could give me the courage to address otherwise undiscussed topics’: student reasons for (not) impacting their feedback environment
Full text linkStudents are increasingly expected to take up proactive roles in feedback processes. While most feedback research focuses on asking, receiving, and engaging with feedback, some suggest that students must also proactively shape their feedback environment. This study explored graduate life science master’s students’ first impressions of a dialogue prompt, which aimed to support them in proactively starting a dialogue with their supervisor on several aspects of the feedback environment during their research internship. We used a survey to explore reasons for (not) wanting to use the dialogue prompt and to what extent individual and interpersonal variables could explain these. An exploratory factor analysis uncovered three factors. Aided by qualitative analysis, these were interpreted as underlying reasons for (not) wanting to use the dialogue prompt. ‘Barriers of Use’ represents potential barriers hindering the prompt’s use, ‘Practical Use’ represents the prompt’s usefulness in addressing practical topics, and ‘Critical Voicing Use’ in addressing critical topics. Multiple regression examining individual and interpersonal variables only showed one significant association, suggesting that students who are positive about the prompt’s Practical Use also tend to believe that feedback, in general, is useful for achieving goals. We discuss our findings in relation to students’ proactivity and responsibility
Timing of information presentation matters: Effects on secondary school students' cognition, motivation and emotion in game-based learning
Full text linkAbstract: Learning with games requires two types of information, namely domain-specific information and game-specific information. Presenting these two types of information together with gameplay may pose a heavy demand on cognitive resources. This study investigates how timing of information presentation affects cognition (ie, mental effort and performance), motivation (ie, achievement goals) and emotion (ie, achievement emotions). Participants were secondary school students (N = 145). Participants participated in a 2 × 2 factorial experiment with two factors—timing of domain-specific information presentation and timing of game-specific information presentation, either before or during gameplay. We measured mental effort, chemistry knowledge, time on task, achievement goals and achievement emotions. Multiple regression and robust regression revealed that presenting domain-specific information before gameplay promoted higher approach goals, higher avoidance goals and more enjoyment than presenting it during gameplay. There was no difference between presenting game-specific information before gameplay and during gameplay except for performance-avoidance goals. We conclude that timing of information presentation affects motivational and emotional processes and outcomes and that students feel more motivated and enjoyed when domain-specific information is presented before learning than during learning. Educators may change the timing of domain-specific information presentation accordingly. Practitioner notes What is already known about this topic Well-designed game-based learning can increase learning. Game-based learning needs effective instructional design features. What this paper adds One instructional design feature, timing of information presentation, affects motivation and emotion in game-based learning. Students feel more motivated and enjoyed when domain-specific information is presented before learning than during learning. This study is one of the first to focus on cognitive, motivational and emotional processes and outcomes, and their interconnections. Implications for practice and policy Educators would do well to present domain-specific information before learning than during learning. Researchers on instructional design features should attend to all cognitive, motivational and emotional processes and outcomes instead of just one or two
Exploring the contribution of genetic variants to high sunitinib exposure in patients with cancer
Full text linkAims: Sunitinib exhibits considerable interindividual variability in exposure. While the target total plasma concentration of sunitinib and its active metabolite is 50–87.5 ng/mL for the intermittent dosing schedule, ~10–21% of patients experience higher exposures (>87.5 ng/mL), correlated with an increased risk for toxicity. Previous research identified single nucleotide variants (SNVs) in genes from the sunitinib pharmacokinetic pathway to be associated with efficacy and toxicity. However, significant interindividual variability in exposure remains unexplained. Our aim was to identify genetic variants associated with supratherapeutic exposure of sunitinib. Methods: This was a genome-wide association study. Cases were identified during routine therapeutic drug monitoring and consisted of patients with dose-normalized sunitinib plasma concentrations >87.5 ng/mL (intermittent dosing) or >75 ng/mL (continuous dosing). Controls were sampled from the historical cohort EuroTARGET who tolerated the standard dose of 50 mg in an intermittent schedule. SNVs were tested for an association with sunitinib exposure. A P-value ≤5 × 10−8 was considered significant and a P-value between 5 × 10−8 and 5 × 10−6 was considered suggestive. Results: Sixty-nine cases and 345 controls were included for association analysis. One SNV (rs6923761), located on the gene glucagon-like peptide 1 receptor, was significantly associated with increased sunitinib exposure (P = 7.86 × 10−19). Twelve SNVs were suggestive for an association with sunitinib exposure (P ≤ 5 × 10−6). Conclusions: While rs6923761 is associated with high sunitinib exposure, the underlying mechanism is not yet clarified and warrants further investigation. [Corrections made on 23 September 2024, after first online publication: In the preceding sentence, identifier rs6923671 has been changed to rs6923761 in this version.] We could not confirm the earlier found associations between SNVs in candidate genes involved in the pharmacokinetic pathway of sunitinib and its efficacy and toxicity
Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage: The Role of the Complement and Innate Immune System
Full text linkSpecific inflammatory pathways are important in the development of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage. Understanding the specific pathways of inflammation may be critical for finding new treatments. Evidence is accumulating that innate inflammatory cells and proteins play a more important role than cells of the adaptive inflammatory system. In this work, we review the evidence from clinical and preclinical data regarding which cells of the immune system play a role in DCI with particular emphasis on the bone-marrow-derived cells monocytes and neutrophils and the brain parenchymal microglia. In addition, we will review the evidence that complement proteins, a non-cellular part of the innate immune system, play a role in the development of DCI
