Psychological distress and oral chemotherapy: a pilot study.

12nonemixedL. Bergui; GHIGGIA, ADA; CAVALLO, Federica; FERRERO, Simone; SCALDAFERRI, matilde; SCIORSCI, elisa; CATTEL, Francesco; TESIO, VALENTINA; ROMEO, ANNUNZIATA; VALINOTTI, GIULIA; TORTA, Riccardo; CASTELLI, LorysL., Bergui; Ghiggia, Ada; Cavallo, Federica; Ferrero, Simone; Scaldaferri, Matilde; Sciorsci, Elisa; Cattel, Francesco; Tesio, Valentina; Romeo, Annunziata; Valinotti, Giulia; Torta, Riccardo; Castelli, Lory

Developing and piloting a communication assessment tool assessing patient perspectives on communication with pharmacists (CAT-Pharm)

Background: Effective communication strategies in health care help to enhance patient empowerment and improve clinical outcomes. Objective: Adapt the original Communication Assessment (CAT) instrument for the pharmacist profession (CAT-Pharm) and to test its validity and reliability in two different settings. Setting: Five hospital pharmacies in Italy and five community pharmacies in Malta. Method: Pilot study involving a standardized multi-step process adhering to internationally accepted and recommended guidelines. Corrections and adjustments to the translation addressed linguistic factors and cultural components. CAT-Pharm, compared to the original CAT, maintained 10 out of the 14 items: one was slightly modified; three were changed to better fit the pharmacist role; one was added. Main outcome measure: CAT-Pharm development and testing its practicality to Assess patient perceptions of pharmacists’ interpersonal and communication skills. Results CAT-Pharm was tested on 97 patients in the Italian setting and 150 patients in the Maltese setting to assess the practicality of the tool and its usefulness in investigating gaps and priorities for improving pharmacist-patient communication. Results: Show reliability and internal validity of the CAT-Pharm tool. The analysis of patient perceptions of communication with the pharmacist in Italy indicated differences from that in Malta. The different settings provided insight into the utility of CAT-Pharm. Conclusion: This study provided a valid and reliable tool that could be applied to assess patient perception of the pharmacist's communication abilities

Safety of Rapid Daratumumab Infusion: A Retrospective, Multicenter, Real-Life Analysis on 134 Patients With Multiple Myeloma

Background: The anti-CD38 monoclonal antibody daratumumab is the backbone of most anti-multiple myeloma (MM) regimens. To mitigate the risk of infusion-related reactions (IRRs), intravenous daratumumab administration requires 7 hours for the first infusion and 3.5-4 hours thereafter, thus making daratumumab-containing regimens burdensome for patients and health care resources. Preliminary data suggest that a rapid (90-minute) infusion of daratumumab is safe and does not increase IRRs. The rapid schedule was adopted by our centers since 2019. Methods: We conducted an observational multi-center, real-life study to assess the safety of rapid daratumumab infusion protocol from the third administration in relapsed MM patients receiving daratumumab alone or in combination with lenalidomide-dexamethasone or bortezomib-dexamethasone. The primary endpoint was the safety of the rapid infusion protocol, particularly in terms of IRRs. Results: A total of 134 MM patients were enrolled. IRRs occurred in 7 (5%) patients and were mostly mild (6/7 of grade 1-2), with only 1 patient experiencing a grade 3 IRR. Due to the IRRs, 5 (3.7%) patients discontinued the rapid infusions and resumed daratumumab at the standard infusion rate, while 1 patient permanently discontinued daratumumab. In 4/7 patients (57%), IRRs occurred while resuming rapid daratumumab infusions after a temporary interruption (2-4 months). No other adverse event was considered related to the rapid infusion protocol. Conclusions: Our findings confirmed the safety of rapid daratumumab infusions starting from the third administration. In case of prolonged daratumumab interruption, it is advisable to resume infusions at the standard rate (3.5 hours) before switching to the rapid infusion

Safety and pharmacokinetics of motesanib in combination with gemcitabine for the treatment of patients with solid tumours

The aim of this open-label phase 1b study was to assess the safety and pharmacokinetics of motesanib in combination with gemcitabine in patients with advanced solid tumours. Eligible patients with histologically or cytologically documented solid tumours or lymphoma were enroled in three sequential, dose-escalating cohorts to receive motesanib 50 mg once daily (QD), 75 mg two times daily (BID), or 125 mg QD in combination with gemcitabine (1000 mg m−2). The primary end point was the incidence of dose-limiting toxicities (DLTs). Twenty-six patients were enroled and received motesanib and gemcitabine. No DLTs occurred. The 75 mg BID cohort was discontinued early; therefore, 125 mg QD was the maximum target dose. Sixteen patients (62%) experienced motesanib-related adverse events, most commonly lethargy (n=6), diarrhoea (n=4), fatigue (n=3), headache (n=3), and nausea (n=3). The pharmacokinetics of motesanib and of gemcitabine were not markedly affected after combination therapy. The objective response rate was 4% (1 of 26), and 27% (7 of 26) of patients achieved stable disease. In conclusion, treatment with motesanib plus gemcitabine was well tolerated, with adverse event and pharmacokinetic profiles similar to that observed in monotherapy studies

Liposomal Packaging Generates Wnt Protein with In Vivo Biological Activity

Wnt signals exercise strong cell-biological and regenerative effects of considerable therapeutic value. There are, however, no specific Wnt agonists and no method for in vivo delivery of purified Wnt proteins. Wnts contain lipid adducts that are required for activity and we exploited this lipophilicity by packaging purified Wnt3a protein into lipid vesicles. Rather than being encapsulated, Wnts are tethered to the liposomal surface, where they enhance and sustain Wnt signaling in vitro. Molecules that effectively antagonize soluble Wnt3a protein but are ineffective against the Wnt3a signal presented by a cell in a paracrine or autocrine manner are also unable to block liposomal Wnt3a activity, suggesting that liposomal packaging mimics the biological state of active Wnts. When delivered subcutaneously, Wnt3a liposomes induce hair follicle neogenesis, demonstrating their robust biological activity in a regenerative context

The psychometric properties of the subscales of the GHQ-28 in a multi-ethnic maternal sample: results from the Born in Bradford cohort

Background: Poor maternal mental health can impact on children’s development and wellbeing; however, there is concern about the comparability of screening instruments administered to women of diverse ethnic origin. Methods: We used confirmatory factor analysis (CFA) and exploratory factor analysis (EFA) to examine the subscale structure of the GHQ-28 in an ethnically diverse community cohort of pregnant women in the UK (N = 5,089). We defined five groups according to ethnicity and language of administration, and also conducted a CFA between four groups of 1,095 women who completed the GHQ-28 both during and after pregnancy. Results: After item reduction, 17 of the 28 items were considered to relate to the same four underlying concepts in each group; however, there was variation in the response to individual items by women of different ethnic origin and this rendered between group comparisons problematic. The EFA revealed that these measurement difficulties might be related to variation in the underlying concepts being measured by the factors. Conclusions: We found little evidence to recommend the use of the GHQ-28 subscales in routine clinical or epidemiological assessment of maternal women in populations of diverse ethnicity

Symmetry in temporal logic model checking

Temporal logic model checking involves checking the state-space of a model of a system to determine whether errors can occur in the system. Often this involves checking symmetrically equivalent areas of the state-space. The use of symmetry reduction to increase the efficiency of model checking has inspired a wealth of activity in the area of model checking research. We provide a survey of the associated literature