[Maternal bonding and infant attachment in women with and without social phobia]. / Unterschiede in der Mutter-Kind-Bindung bei Frauen mit und ohne Soziale Phobie.

Objective: To examine the association of maternal social phobia with maternal bonding and infant attachment in a prospective-longitudinal study (MARI study, N = 306). Method: A subsample of 46 women with and without lifetime social phobia (Composite International Diagnostic Interview for Women, CIDI-V) and their infants was investigated. Mothers reported antenatal and postnatal bonding (MAAS, MPAS). Infants' attachment classifications/behavior were observed in the strange situation test at 16 months after delivery. Results: The rate of insecure attachment was higher in infants of mothers with social phobia (45.4 % vs. 33.3 %), and infants needed significantly more time to reconnect with their mothers during reunion in the strange situation (U = 160.0, p = .019). There were no group differences with regard to maternal bonding during pregnancy (t = -.151, p = .881) and after delivery (t = .408, p = .685) and resistant (U = 262.5, p = .969), avoidant (U = 311.5, p = .258) as well as contact-keeping behaviors (U = 224.0, p = .373) of the infant in the strange situation. Conclusions: Mothers with social phobia may transmit their inhibited behavioral disposition to their infants or fail to encourage their infants to interact with other people. Mothers with social phobia should be informed about the possible link of maternal avoidance behavior with adverse infant development and should be provided with information on treatment options.

[Safety data of the new, reduced-dose influenza vaccine FluArt after its first season on the market]. / Az új, csökkentett dózisú, hazai gyártású influenzavakcina (FluArt) forgalomba hozatalát követo elso szezonjának biztonságossági vizsgálata.

INTRODUCTION: The currently licensed seasonal influenza vaccines contain split, subunit or whole virions, typically in amounts of 15 µg hemagglutinin per virus strain for adult and up to 60 µg in elderly patients. AIM: The present study reports safety data of the newly licensed, reduced dose vaccine with 6 µg of hemagglutinin per strain produced by Fluart (Hungary) after its first season on the market. The main objective of enhanced safety surveillance was to detect a potential increase in reactogenicity and allergic events that is intrinsic to the product in near real-time in the earliest vaccinated cohorts. METHOD: The study methods were based on the Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU by the European Medicines Agency. STATISTICS: We used the Fisher exact test with 95% confidence intervals. RESULTS: We studied 587 patients and detected a total 24 adverse events, all of which have already been known during the licensing studies of the present vaccine. The frequencies of the adverse events were not different from what had been seen with the previously licensed 15 µg vaccine. CONCLUSIONS: Based on the results, the authors conclude that the new, reduced dose vaccine FluArt is safe and tolerable. Orv Hetil. 2017; 158(49): 1953-1959.

[Development of criteria for the prospective assessment of the need for updating guideline recommendations: The AGIL criteria]. / Entwicklung von Kriterien für die prospektive Einschätzung des Aktualisierungsbedarfs von Leitlinienempfehlungen: AGIL-Kriterien.

BACKGROUND: Evidence-based guideline and vaccination recommendations should continuously be updated to appropriately support health care decisions. However, resources for updating guidelines are often limited. The aim of this project was to develop a list of criteria for the prospective assessment of the need for updating individual guideline or vaccination recommendations, which can be applied from the time a guideline or guideline update is finalised. METHODS: In this article we describe the development of the AGIL criteria (Assessment of Guidelines for Updating Recommendations). The AGIL criteria were developed by experienced scientists and experts in the field of guideline development in a multi-step process. The five steps included: 1) development of an initial list of criteria by the project team; 2) online survey of guideline experts on the initial version of the criteria list; 3) revision of the criteria list based on the results of the online survey; 4) workshop on the criteria list at the EbM Congress 2023; 5) creation of version 1.0 of the AGIL criteria based on the workshop results. RESULTS: The initial list included the following three criteria: 1) relevance of the question 2) availability of new relevant evidence, and 3) impact of potentially new evidence. The response rate of the online survey for fully completed questionnaires was 31.0% (N=195; 630 guideline experts were contacted by email). For 90.3% (n=176) of the respondents, the criteria list included all essential aspects for assessing the need for updating guideline recommendations. More than three quarters of respondents rated the importance of the three criteria as "very important" or "important" (criteria 1-3: 75.3%, 86.1%, 85.2%) and - with the exception of criterion 1 - comprehensibility as "very comprehensible" or "comprehensible" (criteria 1-3: 58.4%, 75.9%, 78.5%). The results of the online survey and the workshop generally confirmed the three criteria with their two sub-questions. The incorporation of all feedback resulted in the AGIL criteria (version 1.0), recapping: 1) relevance of the question regarding a) PICO components and b) other factors, e.g. epidemiological aspects; 2) availability of new evidence a) on health-related benefits and harms and b) on other decision factors, e.g. feasibility, acceptability; 3) impact of new evidence a) on the certainty of evidence on which the recommendation is based and b) on the present recommendation, e.g. DISCUSSION: The moderate response rate of the online survey may have limited its representativeness. Nevertheless, we consider the response rate to be satisfactory in this research context. The inclusion of many experts in the online survey and the EbM Congress workshop is a strength of the project and supports the quality of the results. CONCLUSIONS: The AGIL criteria provide a structured guidance for the prospective assessment of the need for updating individual guideline recommendations and other evidence-based recommendations. The implementation and evaluation of the AGIL criteria 1.0 in a field test is planned.

[Normative data on clinical neuropsychological tests in Hungary II.] / Klinikai neuropszichológiai tesztek magyarországi normatív adatai II.

INTRODUCTION: One basis of clinical neuropsychology is the application of objective, standardized measurements. Several internationally widespread measurements of memory and learning do not have normative data of the Hungarian population, hence it is crucial to provide a basis for future reference. OBJECTIVE: The purpose of this study was to provide normative data about neuropsychological instruments measuring executive functions, memory and verbal learning skills in relation to demographic factors. METHOD: Rey Auditory Verbal Learning Test (RAVLT), Montreal Cognitive Assessment (MoCA) and Prospective and Retrospective Memory Questionnaire (PRMQ) were administered to an adult, Hungarian representative sample (age, sex, education). RESULTS: Higher educated participants performed better on PRMQ, MoCA and RAVLT. Participants with primary education were identified as a risk group for poor verbal learning skills, executive functions and they committed more memory errors. Age had no significant effect on the results of PRMQ, while on MoCA and RAVLT a significant decline in performance was observed with the passage of lifetime. Females performed better in immediate and delayed recall on RAVLT. CONCLUSION: Application of the presented neuropsychological tests is recommended in clinical practice and scientific research as well. The presented normative data could be a valuable reference point for future studies and practical application, furthermore a basis for early identification of neurocognitive deficits. Orv Hetil. 2023; 164(16) 618-629.

Premenstrual syndrome and premenstrual dysphoric disorder / Premenstruális szindróma és premenstruális dysphoriás zavar

Premenstrual syndrome (PMS) is one of the most common problems for women of reproductive age. The physical, mental and behavioural symptoms recur during the luteal phase of the cycle in daily life and cause a deterioration in the quality of life, affecting the patient's social, work and family relationships. Symptoms typically disappear spontaneously within a few days after the onset of menstruation. The onset and severity of PMS are determined by the cyclical functioning of the hypothalamic-pituitary-ovarian axis and the combined presence of other physiological (e.g., chronobiological and circadian) and psychological stressors, which interact with each other. The diagnosis of PMS and premenstrual dysphoric disorder (PMDD) is based on the following criteria, as recommended by the International Society for Premenstrual Disorders (ISPMD): in PMS, the woman has 1-4 symptoms, which may be physical, behavioural or affective/psychological, or at least five symptoms, which may be physical or behavioural. However, if a woman has 5 or more symptoms, and one of these is affective (e.g., irritability, mood swings, anger) in addition to physical or behavioural symptoms, a more accurate diagnosis of PMDD can be made. Since, in addition to the general and gynecological history, the prospective scales (e.g., Prospective record of the impact and severity of menstrual symptoms - PRISM; Daily record of severity of problems - DRSP) completed daily by the physician are helpful in confirming the diagnosis of PMS and PMDD, it is important to take into account the severity of symptoms, the woman's plans for conception or contraceptive needs, her other associated medical conditions, her response to previous treatment methods, and her history of other medical conditions when formulating a treatment plan. Therapeutic options include regular aerobic exercise, stress relief, cognitive behavioural therapy, drug treatments (selective serotonin reuptake inhibitors - SSRIs, combined oral estrogen-progestin contraceptives - COCs, GnRH agonists), -depending on the severity of PMS and PMDD.

[Patient-oriented multicentre research in surgery: the Surgical Trial Network (CHIR-Net)]. / Patientenorientierte chirurgische Forschung im Verbund - Das Chirurgische Studiennetzwerk CHIR-Net.

BACKGROUND: Patient-oriented clinical research in surgery requires prospective randomised multicentre trials (mRCTs) to generate valid evidence. In order to conduct high quality mRCTs, a network of surgical clinical trial centres is necessary. METHODS: The Surgical Trial Network (CHIR-Net), which is funded by the German Federal Ministry of Education and Research (BMBF), was established as a structure of surgical regional centres. Currently, the CHIR-Net comprises 12 regional surgical centres with their associated clinical partner hospitals. The major aim of this network is to generate patient-relevant surgical questions of high clinical impact and to answer these questions in high-quality prospective randomised multicentre trials with well-trained study personnel. RESULTS: Since 2006 32 mRCTs have been initiated in the CHIR-Net. Twelve surgical regional centres - in cooperation with 333 German and European hospitals - have recruited more than 7,500 patients. More than 80 surgeons have successfully completed the CHIR-Net educational curriculum for young surgeons. CONCLUSIONS: The CHIR-Net has successfully established a national clinical trial network to investigate surgical questions in randomised multicentre clinical trials. A nationwide research infrastructure, including university and non-university hospitals as well as the associated clinical coordination centres (KKS), was created to ensure patient-oriented surgical clinical research in a network at the highest methodological level thus implementing evidence-based medicine in daily surgical practice.