High-Fidelity simulation-based program improves flow state scale in the perinatal team.

BACKGROUND: We aimed to evaluate the degree of realism and involvement, stress management and awareness of performance improvement in practitioners taking part in high fidelity simulation (HFS) training program for delivery room (DR) management, by means of a self-report test such as flow state scale (FSS). METHODS: This is an observational pretest-test study. Between March 2016 and May 2019, fourty-three practitioners (physicians, midwives, nurses) grouped in multidisciplinary teams were admitted to our training High Fidelity Simulation center. In a time-period of 1 month, practitioners attended two HFS courses (model 1, 2) focusing on DR management and resuscitation maneuvers. FSS test was administred at the end of M1 and M2 course, respectively. RESULTS: FSS scale items such as unambiguous feed-back, loss of self consciousness and loss of time reality, merging of action and awareness significantly improved (P < 0.05, for all) between M1 and M2. CONCLUSIONS: The present results showing the high level of practitioner involvement during DR management-based HFS courses support the usefulness of HFS as a trustworthy tool for improving the awareness of practitioner performances and feed-back. The data open the way to the usefulness of FSS as a trustworthy tool for the evaluation of the efficacy of training programs in a multidisciplinary team.

Administration of the vasopressin analog desmopressin for the management of bleeding in rectal cancer patients: results of a phase I/II trial.

Purpose The vasopressin analog desmopressin (dDAVP) is known to increase plasma levels of hemostatic factors, and preclinical studies in colorectal cancer models have demonstrated that it hampers tumor vascularization and metastatic progression. We evaluated safety and preliminary efficacy of dDAVP in rectal cancer patients with bleeding, before receiving specific oncologic treatment with surgery, chemotherapy and/or radiotherapy. Methods Patients with rectal cancer having moderate or severe rectal bleeding were enrolled in an open-label, dose-finding trial. Intravenous infusions of dDAVP were administered during two consecutive days in doses from 0.25 to 2.0 µg/kg, using single or twice daily regimen. Bleeding was graded using a score based on the Chutkan scale and tumor perfusion was evaluated by dynamic contrast-enhanced magnetic resonance imaging. Results The trial accrued a total of 32 patients. Dose-limiting toxicity occurred in patients receiving 1 µg/kg or higher. The most prominent treatment-related severe adverse event was hyponatremia. Most patients receiving the maximum tolerated dose of 0.5 µg/kg showed at least a partial hemostatic response and 58% developed a complete response with absence of bleeding at day 4 and/or at the last follow-up at day 14. Tumor perfusion was decreased in two-thirds of patients after dDAVP treatment. Conclusions dDAVP appeared as a promising hemostatic agent in rectal cancer patients with bleeding. Randomized clinical trials to confirm its effectiveness are warranted.Clinical trial registration www.clinicaltrials.gov NCT01623206.

A phase II dose-escalation trial of perioperative desmopressin (1-desamino-8-d-arginine vasopressin) in breast cancer patients.

Desmopressin (dDAVP) is a well-known peptide analog of the antidiuretic hormone vasopressin, used to prevent excessive bleeding during surgical procedures. dDAVP increases hemostatic mediators, such as the von Willebrand factor (vWF), recently considered a key element in resistance to metastasis. Studies in mouse models and veterinary trials in dogs with locally-advanced mammary tumors demonstrated that high doses of perioperative dDAVP inhibited lymph node and early blood-borne metastasis and significantly prolonged survival. We conducted a phase II dose-escalation trial in patients with breast cancer, administering a lyophilized formulation of dDAVP by intravenous infusion in saline, 30-60 min before and 24 h after surgical resection. Primary endpoints were safety and tolerability, as well as selection of the best dose for cancer surgery. Secondary endpoints included surgical bleeding, plasma levels of vWF, and circulating tumor cells (CTCs) as measured by quantitative PCR of cytokeratin-19 transcripts. Only 2 of a total of 20 patients experienced reversible adverse events, including hyponatremia (grade 4) and hypersensitivity reaction (grade 2). Reactions were adequately managed by slowing the infusion rate. A reduced intraoperative bleeding was noted with increasing doses of dDAVP. Treatment was associated with higher vWF plasma levels and a postoperative drop in CTC counts. At the highest dose level evaluated (2 µg/kg) dDAVP appeared safe when administered in two slow infusions of 1 µg/kg, before and after surgery. Clinical trials to establish the effectiveness of adjunctive perioperative dDAVP therapy are warranted. This trial is registered on www.clinicaltrials.gov (NCT01606072).

The phenomenological dimension of meaning: words, vowels, phonemes as ways to sing the world, to celebrate the world, and to live it.

This is commentary on Cornejo's Intersubjectivity as co-phenomenology: from the holism to the being-in-the-world-with-others, co-phenomenology, in which meaning is defined as a construal of phenomenological experience, it is not an individual creation, but rather an intersubjective one. In this paper the basic question is how language expresses the world and things and, consequently, what vision of the world is expressed by language and what relationship it creates with the real. Language is a set of differences between signs and meanings. It lives for and by this constant aspiration to say the inexpressible, to capture the elusive. Language tries to express the driving inner movement of the real through references and interlacing, by multiplying the relational threads of meanings. For example, the phonetic gesture performs for the speaker and his listener a certain structuring of experience, a certain modulation of existence. This is a communicative dimension in which meaning is always a process. It is the situation of co-feeling between subjects, in which understanding is achieved, as defined by Cornejo in his essay.

The communicative experience: between inexpressible and elusive.

This is a commentary on Cornejo's "Intersubjectivity as co-phenomenology: from the holism to the being-in-the-world-with-others," co-phenomenology, in which meaning is defined as a construal of phenomenological experience, not an individual creation, but rather an intersubjective one. In this paper the basic question is how language expresses the world and things and, consequently, what vision of the world is expressed by language and what relationship it creates with the real. Language lives for and by this constant aspiration to say the inexpressible and it tries to express the driving inner movement of the real through references and interlacing, by multiplying the relational threads of meanings. For example, the phonetic gesture performs for the speaker and his listener a certain structuring of experience, a certain modulation of existence. This is a communicative dimension in which meaning is always a process. It is the situation of co-feeling between subjects, in which understanding is achieved, as defined by Cornejo in his essay. Words, vowels, phonemes from this analysis are not only the conceptual and the final sense of words, but also their emotional sense, are ways to sing the world and they represent the emotional essence.