Thesis Chapters by Angeliki Koukoura
Deception detection studies have become a trending topic over the past 34 years. Lie detection se... more Deception detection studies have become a trending topic over the past 34 years. Lie detection seems to have moral, ethical, methodological, clinical, and legal implications. Although researchers have studied the P300 (P3) Event-Related Potential (ERP) component towards an understanding of the phenomenon extensively, deception remains a well-hidden cognitive process. The basic set-up of most of the deception detection studies contains a mock-crime scenario and the use of a Concealed Information Test (CIT). The same design requires a deceptive response from the participants. Towards this direction, the present study employed a fundamental research question via examining if meaningful stimuli can modulate the P300 component compared to target & irrelevant stimuli in guilty participants. The aim of the present study was: a) to check if a non-deceptive design could produce similar results to previous ERP-based deception detection studies, and b) to raise interest concerning the set-up of the experimental design of previous applications. In line with the literature, and with no deceptive behavior, P3 results revealed similar patterns and statistical significance. The unexpected findings of Early Posterior Negativity (EPN) and P100 (P1) provide a new index to be further explored in future deception detection studies. While the present results should not be taken as a new index for deception, they appoint a new path against the phenomenon. Future research suggestions are also addressed.
Η εργασία που ακολουθεί επιχειρεί να ανασυνθέσει την ζωή και το έργο του πατέρα της ψυχανάλυσης, ... more Η εργασία που ακολουθεί επιχειρεί να ανασυνθέσει την ζωή και το έργο του πατέρα της ψυχανάλυσης, Sigmund Freud. Επιχειρείται μια σύντομη ανασκόπηση των βασικών στοιχείων που συγκροτούν μια τόσο σπουδαία φυσιογνωμία σαν και αυτή του πρώτου μεγάλου ψυχαναλυτή. Η ανασκόπηση αυτή φιλοδοξεί να δημιουργήσει μια πιο σαφή εικόνα για την προσωπικότητα του Freud, αλλά και για την συστηματική εργασία του στους τομείς της ψυχιατρικής και της ψυχανάλυσης, την οποία και εδραίωσε. Ο Freud αποτελεί, δίχως αμφιβολία, από τα πρώτα κιόλας χρόνια της καριέρας του έως και τις μέρες μας, μια πολυσυζητημένη φιγούρα στον κλάδο της ψυχιατρικής, έχοντας στο ενεργητικό του πολλά άρθρα, βιβλία, μελέτες άμεσα σχετιζόμενα με τα προσωπικά του ενδιαφέροντα που εκτείνονταν, κυρίως, στο χώρο των νευρώσεων. Τα παραπάνω στοιχεία σχετικά με την καθοριστική συμβολή του Freud, σε συνδυασμό με το ερευνητικό ενδιαφέρον της γράφουσας για την ιστορία της ψυχιατρικής, αλλά και της ψυχανάλυσης, οδήγησαν στη συγγραφή της παρούσας εργασίας. Η εργασία αυτή, λοιπόν, προτίθεται να καταστήσει, με έναν τρόπο λιτό, περισσότερο κατανοητό, το έργο που μας κληροδότησε ο Freud.
Drafts by Angeliki Koukoura
Ποιες είναι οι σωματικές και ψυχολογικές ενδείξεις στα σεξουαλικά κακοποιημένα παιδιά;
Ποιοι είναι οι ατομικοί παράγοντες κινδύνου που οδηγούν στην εκδήλωση παραβατικής συμπεριφοράς στ... more Ποιοι είναι οι ατομικοί παράγοντες κινδύνου που οδηγούν στην εκδήλωση παραβατικής συμπεριφοράς στους ανηλίκους;
Πώς τα σύνδρομα παραληρητικής παραγνώρισης συνδέονται με την εκδήλωση παραβατικής / εγκληματικής ... more Πώς τα σύνδρομα παραληρητικής παραγνώρισης συνδέονται με την εκδήλωση παραβατικής / εγκληματικής συμπεριφοράς;
Διαταραχές προσωπικότητας που εμφανίζονται συχνότερα σε άτομα που έχουν διαπράξει έγκλημα.
Οι δυο κυρίαρχες κατευθύνσεις της ψυχολογικής προσέγγισης στη μελέτη της εγκληματικής συμπεριφοράς.
Το συγκεκριμένο έγγραφο αποτελεί μια σύντομη εργασία που δίνει πληροφορίες σχετικά με τον τρόπο π... more Το συγκεκριμένο έγγραφο αποτελεί μια σύντομη εργασία που δίνει πληροφορίες σχετικά με τον τρόπο που οφείλει να συντάσσεται η οποιαδήποτε ψυχιατρική πραγματογνωμοσύνη βάσει του Ελληνικού Ποινικού Κώδικα και του ιατρικού απορρήτου.
Papers by Angeliki Koukoura
International Journal of Digital Health, 2023
The use of real-world evidence (RWE) to support international regulatory decision-making is refle... more The use of real-world evidence (RWE) to support international regulatory decision-making is reflected in the growing number of regulatory frameworks and guidelines published by Competent Authorities and international initiatives that accept real-world data (RWD) sources. RWD can be obtained from a range of sources, including electronic health/medical records, pharmacy and insurance claims, patient-reported outcomes, product and disease registries, biobanks, and observational studies. However, the availability of RWD sources depends on the processes/systems implemented by regional healthcare systems, which are limited by the potential of inconsistent data collection, heterogeneity of clinical practices, and an overall lack of standardization. As the analysis of RWD/RWE primarily evaluates association rather than causation, it is still often viewed as a supplement to, rather than a replacement of, data that derives from controlled environments, such as Randomized Controlled Trials (RCT). Despite this, RWE may still be used to support the assessment of safety and effectiveness in regulatory submissions and can facilitate regulatory decisions (including reimbursement) by providing long-term data on safety and performance that could not otherwise be collected during the limited duration of a RCT. However, available RWE frameworks reveal serious challenges to the use of RWE for the support of the assessment of safety and effectiveness, due to biases in data collection, lack of randomization, quality of data collection, and generalizability of results and endpoints. Patient privacy and the need to ensure confidentiality also hinders regulatory stakeholders from establishing and implementing concrete regulations. This is because the collection and management of RWD must be used in accordance with national, and often conflicting, laws on data protection and information governance. This article summarizes all currently available RWE frameworks and discusses potential solutions for future harmonization and cross-stakeholder collaborations. Such harmonization and collaboration will boost the integration of RWE, not only in the post-approval stages of a medicine’s lifecycle but also in the development and lifelong post-market surveillance of medical devices (MDs).
Medical Devices: Evidence and Research, 2022
Preference testing is a valuable source of information that can be provided by both healthcare pr... more Preference testing is a valuable source of information that can be provided by both healthcare professionals (HCPs) and patients (users). It can be used to improve the design and development of medical devices by feeding into device usability and, ultimately, risk management. Furthermore, it can aid with selecting the most appropriate clinical endpoints to be used in the clinical evaluation of a device and increase patient engagement by incorporating patient-relevant outcomes. Preference testing is widely conducted in the food industry but is not widespread in the medical field due to limited guidelines and a lack of regulatory framework. As such, manufacturers may be unaware of the benefits of preference testing and fail to take full advantage of it, or conversely, may use inappropriate methodology and/or analyses and consequently fail to collect meaningful data. In this position paper, we aim to highlight the benefits and uses of preference testing, along with potential methods that could be used for preference testing of medical devices. A key step towards the wider implementation of preference testing in medical devices is for the publication of international standards and guidelines for the collection, assessment, and implementation of preference data into the life cycle of a medical device.
Organ donation in the US and Europe: The supply vs demand imbalance
Organ donation and transplantation remain the best and most cost-effective clinical solution for ... more Organ donation and transplantation remain the best and most cost-effective clinical solution for end-stage organ failure. Several agencies across the US and Europe provide legislative, regulatory, and humanitarian services to generate smoother applications in all transplantation processes and donor-recipient relationships. US and European statistics present nine types of grafts, with kidneys being the most transplanted organ worldwide. However, organ shortage, religion, underrepresented minority groups, difficulties in obtaining consent, lack of understanding, and general ethical concerns present challenging barriers to organ donation, reflecting the complexity of graft procurement and allocation. Breaking down these barriers to reduce the organ-supply imbalance requires an appropriate multifaceted approach. Some of the key areas include increasing the potential donor pool and consent rates, apt organ allocation, and improving organ health. Additionally, suitable policies and standa...
Biomarker Insights, 2021
Companion diagnostics (CDx) hail promise of improving the drug development process and precision ... more Companion diagnostics (CDx) hail promise of improving the drug development process and precision medicine. However, there are various challenges involved in the clinical development and regulation of CDx, which are considered high-risk in vitro diagnostic medical devices given the role they play in therapeutic decision-making and the complications they may introduce with respect to their sensitivity and specificity. The European Union (E.U.) is currently in the process of bringing into effect in vitro Diagnostic Medical Devices Regulation (IVDR). The new Regulation is introducing a wide range of stringent requirements for scientific validity, analytical and clinical performance, as well as on post-market surveillance activities throughout the lifetime of in vitro diagnostics (IVD). Compliance with General Safety and Performance Requirements (GSPRs) adopts a risk-based approach, which is also the case for the new classification system. This changing regulatory framework has an impact on all stakeholders involved in the IVD Industry, including Authorized Representatives, Distributors, Importers, Notified Bodies, and Reference Laboratories and is expected to have a significant effect on the development of new CDx.
Biomarker Insights, 2021
Companion diagnostics (CDx) hail promise of improving the drug development process and precision ... more Companion diagnostics (CDx) hail promise of improving the drug development process and precision medicine. However, there are various challenges involved in the clinical development and regulation of CDx, which are considered high-risk in vitro diagnostic medical devices given the role they play in therapeutic decision-making and the complications they may introduce with respect to their sensitivity and specificity. The European Union (E.U.) is currently in the process of bringing into effect in vitro Diagnostic Medical Devices Regulation (IVDR). The new Regulation is introducing a wide range of stringent requirements for scientific validity, analytical and clinical performance, as well as on post-market surveillance activities throughout the lifetime of in vitro diagnostics (IVD). Compliance with General Safety and Performance Requirements (GSPRs) adopts a risk-based approach, which is also the case for the new classification system. This changing regulatory framework has an impact on all stakeholders involved in the IVD Industry, including Authorized Representatives, Distributors, Importers, Notified Bodies, and Reference Laboratories and is expected to have a significant effect on the development of new CDx.
Organ donation in the US and Europe: The supply vs demand imbalance, 2020
a r t i c l e i n f o Available online xxxx Keywords: Organ donation Organ donor Organ transplant... more a r t i c l e i n f o Available online xxxx Keywords: Organ donation Organ donor Organ transplant Donation after brain death Donation after circulatory death Organ shortage Organ donation and transplantation remain the best and most cost-effective clinical solution for end-stage organ failure. Several agencies across the US and Europe provide legislative, regulatory, and humanitarian services to generate smoother applications in all transplantation processes and donor-recipient relationships. US and European statistics present nine types of grafts, with kidneys being the most transplanted organ worldwide. However, organ shortage, religion, underrepresented minority groups, difficulties in obtaining consent, lack of understanding, and general ethical concerns present challenging barriers to organ donation, reflecting the complexity of graft procurement and allocation. Breaking down these barriers to reduce the organ-supply imbalance requires an appropriate multifaceted approach. Some of the key areas include increasing the potential donor pool and consent rates, apt organ allocation, and improving organ health. Additionally, suitable policies and standardized guidelines for both donors and recipients, alongside educational initiatives, are needed to ensure patient safety and global awareness. Looking forward, novel and effective research plans and initiatives are needed if we are to avoid a colossal supply-demand gap.
Human Factors Engineering (HFE) principles were initially implemented in safety-related procedure... more Human Factors Engineering (HFE) principles were initially implemented in safety-related procedures in aviation and other high-risk industries to minimize human error-related risks. The introduction of HFE in healthcare aims not to eliminate the 'human factor,' but rather to enable 'engineering' to redesign clinical settings to become resilient to unanticipated events related to operational and/or safety shortcomings. Given the complexity of the Operating Room (OR) and the socio-technico-cognitive activities that occur during a surgical operation, HFE needs to consider a wide spectrum of Surgical Flow Disruptions (SFD), such as miscommunications, fatigue, workload, physical layout of the site etc. The increase of fully automated/computer-assisted surgical systems into everyday surgical practice highlights the need for specialized technical skills and a subsequent change in mind-set and intraoperative decision-making. The complexity of the modern OR calls out for incorporation of a culture safety also illustrated by the close interaction of Usability Engineering (UE) and Risk Management (RM) throughout the lifecycle of a medical system and by Regulations currently in force. This article discusses the practical parameters of HFE incorporation into surgical practice and aims to highlight how this holistic redefinition of OR settings promotes patient and medical staff safety through mitigation of error-prone processes.
The growing number of emerging medical technologies and sophistication of modern medical devices ... more The growing number of emerging medical technologies and sophistication of modern medical devices (MDs) that improve both survival and quality of life indexes are often challenged by alarming cases of vigilance data cover-up and lack of sufficient pre-and post-authorization controls. Combining Quality with Risk Management processes and implementing them as early as possible in the design of MDs has proven to be an effective strategy to minimize residual risk. This article aims to discuss how the design of MDs interacts with their safety profile and how this dipole of intended performance and safety may be supported by Human Factors Engineering (HFE) throughout the Total Product Life-Cycle (TPLC) of an MD in order to capitalize on medical technologies without exposing users and patients to unnecessary risks.
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Thesis Chapters by Angeliki Koukoura
Drafts by Angeliki Koukoura
Papers by Angeliki Koukoura