Informed Consent: Legal Obligation or Cornerstone of the Care Relationship?

The topic of informed consent has become increasingly important in recent decades, both in the ethical-deontological field and as a duty of law. The review covered all sentences issued by the 13th section of the Civil Court of Rome during the period January 2016-December 2020. During this period, 156 judgments were found in which a breach of consent was required; in 24 of these, specific liability was proven, and the corresponding compensation liquidated. Moreover, 80% of the cases concerned the lack of information provided. The most involved branches were those related to surgical areas: general surgery, plastic surgery and aesthetic medicine and orthopaedics. The total amount of compensation paid was EUR 287,144.59. The research carried out has highlighted how, in a broad jurisprudential context, the damage caused by the violation of the right related to informed consent is considered, and how it impacts on the economic compensation of damages. Additionally, it showed that the areas most affected by the information deficit are those related to the performance of surgical activities, which are characterized by greater invasiveness and a higher risk of adverse events. The data reported underline the exigency to consider informed consent not as a mere documentary allegation but as an essential moment in the construction of a valid therapeutic alliance, which is also useful for avoiding unnecessary litigation that is becoming increasingly burdensome for healthcare systems all over the world.

Medico-Legal Aspects of Hospital-Acquired Infections: 5-Years of Judgements of the Civil Court of Rome.

INTRODUCTION: Healthcare-associated infections (HAIs) represent a risk to patients' health, as well as being an issue of worldwide relevance in terms of public health and increased healthcare costs. The occurrence of a complication causally related to the development of an infection contracted during a hospital stay, or in any event during a healthcare activity, may represent a source of liability for the healthcare facility itself and, therefore, lead to compensation for the injured patient. The aim of this research is to analyze the phenomenon of professional liability related to HAIs, to emphasize its economic and juridical aspects and, at the same time, highlight the clinical-managerial issues deserving attention, in order to guarantee the safety of care for patients. METHODS: The retrospective review concerned all the judgments regarding HAIs drawn up by the Judges of the Civil Court of Rome, published between January 2016 and December 2020. RESULTS: In the five-year period considered, 140 verdicts were issued in which the liability for which compensation was sought was related to the occurrence of healthcare-related infections. Convictions were recognized in 62.8%. The most involved branches were those related to the surgical areas: orthopedics, heart surgery, and general surgery. The three most frequently isolated organisms were Staphylococcus aureus, Pseudomonas aeruginosa, and Klebsiella pneumoniae. The total amount of compensation paid was EUR 21.243.184,43. CONCLUSIONS: The study showed how the analysis of the juridical and medico legal aspects of HAIs may represent not only a helpful tool for healthcare performance assessment, but also a data source usable in clinical risk management and in the implementation of patient safety.