Informed consent and biological agents in rheumatology and internal medicine.

BACKGROUND: The need for highly effective therapies in rheumatologic diseases has led to the widespread and growing use of a heterogeneous class of molecules called biological agents. The increasing experience with biological agents has raised concerns about safety and efficacy issues that need to be discussed in the informed consent acquisition process. METHODS: The authors performed a review of the literature on biological agents focusing on their most important characteristics concerning the informed consent procedures. RESULTS: No studies specifically addressed the issue of informed consent in patients receiving biological agents. Several studies reported data about off-label use of biological agents usually with no obvious attention to informed consent shortcomings. CONCLUSION: The reported association between biological agents and serious infections or malignancies, including reactivation of latent tuberculosis, needs specific disclosure in informed consent acquisition, together with information about the possible efficacy in clinical contexts often characterized by resistance to previous treatments. Ethical and clinical issues bound to the need for experimenting with new agents with potentially serious adverse effects deserve specific attention. Studies aimed at evaluating mental capacity to consent in subjects receiving biological agents are required.

Antipsychotic Polypharmacy and High-Dose Antipsychotic Regimens in the Residential Italian Forensic Psychiatric Population (REMS).

Few data exist regarding treatment with antipsychotics in forensic psychiatric patient populations with high social dangerousness. We performed a secondary analysis of 681 patients treated with at least one antipsychotic, extracted from a 1-year observational retrospective study, conducted on 730 patients treated in the Italian Residencies for Execution of Security Measures (REMS) (96.4% of the REMS population). We aimed at investigating antipsychotic polypharmacy (prescription of two or more concomitant antipsychotics) and high dose/very high-dose antipsychotics, as well as the possible factors associated with such therapeutic regimens. High dose/very high-dose antipsychotics were defined as a prescribed daily dose to WHO-defined daily dose ratio greater than 1.5 or 3.0, respectively. Binary logistic regression analysis was used in three models to test possible predictors of antipsychotic polypharmacy, high-dose antipsychotics, and very high-dose antipsychotic prescription. Antipsychotic polypharmacy resulted in n = 308 (45.2%) of the patients, n = 346 (50.8%) received high-dose antipsychotics, and n = 96 (14.1%) very high-dose antipsychotics. The multivariate analysis disclosed an association between antipsychotic polypharmacy and male gender (odds ratio (OR): 2.75 and 95% CI: 1.34-5.65), long-acting injectable (LAI) antipsychotic prescription (OR: 2.62 and 95% CI: 1.84-3.74), and aggressive behavior in REMS (OR: 1.63 and 95% CI: 1.13-2.36). High-dose antipsychotics were also associated with male gender (OR: 2.01 and 95% CI: 1.02-3.95), LAI antipsychotic prescription (OR: 2.78 and 95% CI: 1.95-3.97), and aggressive behavior in REMS (OR: 1.63 and 95% CI: 1.12-2.36). The use of antipsychotic polypharmacy and high-dose antipsychotics is frequent in the REMS population. These results might depend on regulatory and organizational aspects of the REMS system, including variability in structures, lack of a common model of care, and lack of stratified therapeutic security.

Improving Healthcare Workers' Adherence to Surgical Safety Checklist: The Impact of a Short Training.

BACKGROUND: Although surgery is essential in healthcare, a significant number of patients suffer unfair harm while undergoing surgery. Many of these originate from failures in non-technical aspects, especially communication among operators. A surgical safety checklist is a simple tool that helps to reduce surgical adverse events, but even if it is fast to fill out, its compilation is often neglected by the healthcare workers because of unprepared cultural background. The present study aims to value the efficacy of a free intervention, such as a short training about risk management and safety checklist, to improve checklist adherence. METHODS: In March 2019, the medical and nursing staff of the General Surgical Unit attended a two-lesson theoretical training concerning surgical safety and risk management tools such as the surgical safety checklist. The authors compared the completeness of the surgical checklists after and before the training, considering the same period (2 months) for both groups. RESULT: The surgical safety checklists were present in 198 cases (70.97%) before the intervention and 231 cases (96.25%) after that. After the training, the compilation adherence increased for every different type of healthcare worker of the unit (surgeons, nurses, anesthetists, and scrab nurses). Furthermore, a longer hospitalization was associated with a higher surgical checklist adherence by the operators. CONCLUSIONS: The results showed that a free and simple intervention, such as a two-lesson training, significantly stimulated the correct use of the surgical safety checklist. Moreover, the checklist adherence increased even for the operators who did not attend the training, maybe because of the positive influence of the colleagues' positive behaviors. As the results were promising with only two theoretical lessons, much more can be done to build a new safety culture in healthcare.

Incident Reporting System in an Italian University Hospital: A New Tool for Improving Patient Safety.

Clinical risk management constitutes a central element in the healthcare systems in relation to the reverberation that it establishes, and as regards the optimization of clinical outcomes for the patient. The starting point for a right clinical risk management is represented by the identification of non-conforming results. The aim of the study is to carry out a systematic analysis of all data received in the first three years of adoption of a reporting system, revealing the strengths and weaknesses. The results emerged showed an increasing trend in the number of total records. Notably, 86.0% of the records came from the medical category. Moreover, 41.0% of the records reported the possible preventive measures that could have averted the event and in 30% of the reports are hints to be put in place to avoid the repetition of the events. The second experimental phase is categorizing the events reported. Implementing the reporting system, it would guarantee a virtuous cycle of learning, training and reallocation of resources. By sensitizing health workers to a correct use of the incident reporting system, it could become a virtuous error learning system. All this would lead to a reduction in litigation and an implementation of the therapeutic doctor-patient alliance.

The relationship between alexithymia and circulating cytokine levels in subjects undergoing upper endoscopy.

OBJECTIVE: Despite emerging evidence suggesting a link between alexithymia and immune function, previous studies yielded contrasting results. The proposed link between alexithymia and immune function remains controversial as does the role, in this relationship, of anxiety, depression and subjective stress. The aim of the study is to investigate the possible association between alexithymia and circulating levels of cytokines in subjects awaiting an upper endoscopy, a stressful procedure, controlling for anxiety levels, depression and subjective stress. METHODS: Participants were recruited from among consecutive patients referred for routine diagnostic upper endoscopy. All participants completed the Toronto Alexithymia Scale (TAS-20), the Hospital Anxiety and Depression Scale, and the Stress-related Vulnerability Scale. Serum levels of IL-1ß, IL-4, IL-6, IL-10, TNF-α and IFN-γ were measured by ELISA. RESULTS: Of the 90 subjects initially approached, 68 completed the study. The TAS-20 identified 22 alexithymic and 36 non-alexithymic patients. ELISA detected significantly lower IL-4 and IL-6 concentrations in alexithymic than in non-alexithymic patients. According to multiple linear regression analysis, alexithymia predicted low IL-4 and IL-6 levels in the sample overall, independently of stress, anxiety, depression and other possible confounders. No between-group differences were found in serum levels of IFN-γ, IL-1ß, and TNF-α. CONCLUSION: These findings argue against an isolated shift towards pro-inflammatory or anti-inflammatory mediators and suggest that circulating cytokine profiles differ in alexithymic and non-alexithymic subjects.