<- Home <- Arhive <- Vol. 26, Issue 4, December 2018



Rom J Leg Med26(4)429-436(2018)
DOI:10.4323/rjlm.2018.429
© Romanian Society of Legal Medicine


Preventing malpractice and medical litigation in digestive interventional endoscopy by the use of empirical models for the informed consent

E. Toader, G. G. Balan, G. Constantinescu, D. B. Iliescu


Abstract: Informed consent contributed to universal assurance of patient self determination. Patients have the right to be fully informed about their health status and therefore they may refuse and stop any medical intervention. The importance and role of the informed consent should be seen also as a factor promoting quality in healthcare and therefore preventing medical litigation and malpractice. The aim of our study is to provide empirical models for informed consent in interventional endoscopy as such empirical models could contribute to a higher level of quality healthcare assurance and subsequently a lower index of medical litigation and malpractice claims in endoscopy. Methods. All the data used in investigation was collected from available sources and therefore rely on a mini-review of the literature. The literature was screened by searching for a set of keywords in various medical databases in September 2018. The analysis of the literature allows obtaining empirical models that need to be confirmed by various alternative hypotheses, namely logical interconnections between various social dimensions in need of an inter-party regulation clause. Results and discussions. Empirical modeling includes various circumstances like emergency endoscopy, therapeutic endoscopy in children, follow-up procedures after therapeutic endoscopy, unexpected findings and intra-procedural need for special care, therapeutic ERCP and infection control in patients with biliary obstruction in need for endoscopic stenting, diagnostic EUS and the need for fine needle aspiration and fine needle biopsy, withdrawal of consent and advanced decisions to refuse treatment or waiver consent, tissue sampling during endoscopy, media documentation of the procedure, live-endoscopy settings, or trainees participating at the procedure. Referring to such models is surely not exhaustive but should be applied by practitioners when the case allows it. Nevertheless, general principles of informed consenting should always be applied. Conclusion. The models developed are characterized by validation and sustainability and using such models may strengthen the idea that proper informed consent models could play an important role in the quality and safety assurance of interventional digestive endoscopy procedures therefore lowering the overall prevalence of medical litigation and malpractice.
Keywords: malpractice, gastrointestinal endoscopy, self determination, autonomy, model.



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