Communication, understanding and engagement of patients with pancreatic cancer at time of diagnosis.

BACKGROUND: Objectives: To investigate communication clarity and understanding at the time of pancreatic adenocarcinoma (PDAC) diagnosis and whether they can influence patient engagement and compliance. METHODS: Consecutive PDAC patients were enrolled at the time of diagnosis after obtaining informed consent in a single-center study. The patients completed a validated scale (PHE-s®), and the understanding rate was assessed using standardized tools. Patient compliance was evaluated, and the correlation between the PHE-s®, understanding, and compliance was calculated. RESULTS: Thirty patients were enrolled (15 female) with a mean age 64.4, 13 were metastatic. The mean visit time was 31 min, being longer if visiting doctor was an oncologist (p = 0.002). The engagement level was high in 70% of the patients, and all but one were compliant. The analysis of doctor-patient interactions showed a median of 121 conversational turns for doctors, 75 for patients, and 20 for caregivers (p < 0.0001), and the median percentage of speaking time was 77% for doctors, 13% for patients, and 2% for caregivers (p < 0.0001). Female caregivers spent more time speaking than did male caregivers (median 11.6% vs. 1.3%; p = 0.06). There were 290 instances of problematic understanding, most of which occurred during the taking of patients' personal medical history for doctors, while for patients and caregivers, these occurred mainly during the discussion of diagnosis/treatment (p < 0.0001). In a multivariable analysis, only origin from central or southern Italy was associated with high engagement (p = 0.0087). CONCLUSION: In this first attempt to measure clarity of communication and engagement in patients with PDAC, typical features of conversation and problematic understanding emerged, which deserves further investigation.

Effectiveness of patients' involvement in a medical and nursing pain education programme: a protocol for an open-label randomised controlled trial including qualitative data.

INTRODUCTION: Pain is a multidimensional experience that varies among individuals and has a significant impact on their health. A biopsychosocial approach is recommended for effective pain management; however, health professionals' education is weak on this issue. Patient involvement is a promising didactic methodology in developing a more holistic perspective, however there is a lack of reliable evidence on this topic. The aim of the present study is to evaluate the effectiveness of patient involvement in pain education in undergraduate medicine and nursing students. METHODS AND ANALYSIS: An open-label randomised controlled trial including qualitative data will be conducted. After an introductory lesson, each student will be randomly assigned to the intervention group, which includes an educational session conducted by a patient-partner along with an educator, or to the control group in which the session is exclusively conducted by an educator. Both sessions will be carried out according to the Case-Based Learning approach. Primary outcomes will be students' knowledge, attitudes, opinions and beliefs about pain management, whereas the secondary outcome will be students' satisfaction. The Pain Knowledge and Attitudes (PAK) and Chronic Pain Myth Scale (CPMS) will be administered preintervention and postintervention to measure primary outcomes. Students' satisfaction will be measured by a questionnaire at the end of the session. Two focus groups will be conducted to evaluate non-quantifiable aspects of learning. ETHICS AND DISSEMINATION: The protocol of this study was approved by the independent Area Vasta Emilia Nord ethics committee.Adherence to The Declaration of Helsinki and Good Clinical Practice will ensure that the rights, safety and well-being of the participants in the study are safeguarded, as well as data reliability. The results will be disseminated through scientific publications and used to improve the educational offer. A version of the anonymised data set will be released for public access. TRIAL REGISTRATION: Trial was not registered on ClinicalTrials.gov as the interventions being compared only concern educational programmes and the outcomes considered do not refer to any clinical dimension.

"Strada Facendo" a Series of Group Meetings with Parents of Children and Youths with Disabilities.

The article describes the psychological support offered to parents of disabled children/youths through the structuring of mutual self-help meetings. The therapeutic approach, which is based on the principles of the Family Centered Care (FCC), has an experiential character. These meetings are especially important as they took place after a long period of forced distancing, due to the Covid 19 pandemic. We can see how this type of path fully responds to the needs of these parents and how it can be strategic for strengthening their capacity for resilience in the daily struggle for the quality of life of their children.

A Community-Based Participatory Framework to Co-Develop Patient Education Materials (PEMs) for Rare Diseases: A Model Transferable across Diseases.

At least 50% of chronic disease patients don't follow their care plans, leading to lower health outcomes and higher medical costs. Providing Patient Education Materials (PEMs) to individuals living with a disease can help to overcome these problems. PEMs are especially beneficial for people suffering from multisystemic and underrecognized diseases, such as rare diseases. Congenital disorders of glycosylation (CDG) are ultra-rare diseases, where a need was identified for PEMs in plain language that can clearly explain complex information. Community involvement in the design of PEMs is extremely important for diseases whose needs are underserved, such as rare diseases; however, attempts to involve lay and professional stakeholders are lacking. This paper presents a community-based participatory framework to co-create PEMs for CDG, that is transferable to other diseases. A literature review and questionnaire were performed, and only four articles describing the development of PEMS for rare diseases have been found, which demonstrates a lack of standardized approaches. The framework and PEMs were co-developed with CDG families and will be crucial in increasing health literacy and empowering families. We will close a gap in the creation of PEMs for CDG by delivering these resources in lay language in several languages.

Affective Disorders in Complex Disabilities: Strategies Empowerment for Improving the Lifestyle of the Disabled Person.

The concept of physical and intellectual disability has experienced a series of changes and evolutions over time with regard to approach, classification and rehabilitation-therapeutic programs, since it contemplates a heterogeneous clinical phenomenology in terms of severity, complexity, pervasiveness and severity of the diagnosis. The significant repercussions on the quality of life mean that a comprehensive approach is required with attention to the physical, social, emotional, sensory and cognitive profile, and that there is a need for the adoption of classification systems and assessment tools that are different and in some ways pioneering, so as to guarantee the surpassing of the concept of disability as a "mere defect" physical and/or impairment and/or loss of psychological, physiological or anatomical function (Holden & Gitlesen 2003, Linden 2017, WHO 2001). It is exactly in contemplation of a bio-psycho-social model, that the International Classification of Functioning, Disability and Health (ICF) arises, which possesses a neutral position with respect to etiology and a complementarity with the ICD-10 classification (WHO 2001), since it allows the functional diagnosis (i.e. a specialized analytical description of the potential and deficits in relation to the pathology) proposing a detailed analysis of the possible social consequences of disability by evaluating the residual capacities and measuring the "social skills" (WHO 2001).

The Double Framing Effect of Emotive Metaphors in Argumentation.

In argumentation, metaphors are often considered as ambiguous or deceptive uses of language leading to fallacies of reasoning. However, they can also provide useful insights into creative argumentation, leading to genuinely new knowledge. Metaphors entail a framing effect that implicitly provides a specific perspective to interpret the world, guiding reasoning and evaluation of arguments. In the same vein, emotions could be in sharp contrast with proper reasoning, but they can also be cognitive processes of affective framing, influencing our reasoning and behavior in different meaningful ways. Thus, a double (metaphorical and affective) framing effect might influence argumentation in the case of emotive metaphors, such as "Poverty is a disease" or "Your boss is a dictator," where specific "emotive words" (disease, dictator) are used as vehicles. We present and discuss the results of two experimental studies designed to explore the role of emotive metaphors in argumentation. The studies investigated whether and to what extent the detection of a fallacious argument is influenced by the presence of a conventional vs. novel emotive metaphor. Participants evaluated a series of verbal arguments containing either "non-emotive" or "emotive" (positive or negative) metaphors as middle terms that "bridge" the premises of the argument. The results show that the affective coherence of the metaphor's vehicle and topic plays a crucial role in participants' reasoning style, leading to global heuristic vs. local analytical interpretive processes in the interplay of the metaphorical and the affective framing effects.

Misunderstandings in ART Triadic Interactions: A Qualitative Comparison of First and Follow-Up Visits.

BACKGROUND: Misunderstandings in medical interactions can compromise the quality of communication and affect self-management, especially in complex interactions like those in the assisted reproductive technology (ART) field. This study aimed to detect and describe misunderstandings in ART triadic visits. We compared first and follow-up visits for frequency, type, speakers, and topics leading to misunderstandings. METHODS: We purposively sampled 20 triadic interactions from a corpus of 85 visits. We used a previously developed coding scheme to detect different types of misunderstandings (i.e., with strong, acceptable, and weak evidence). We analyzed also the different topics leading to strong misunderstandings (direct expressions of lack of understanding, pragmatic alternative understandings, semantic alternative understandings) to provide insights about the contents of the consultation that may need particular attention and care. FINDINGS: We detected an overall number of 1078 misunderstandings in the 20 selected visits. First visits contained almost two-third of the misunderstandings (n = 680, 63%). First visits were particularly rich in misunderstandings with acceptable evidence (e.g., clarifications and checks for understanding), compared to follow-up visits. In first visits, doctors' turns more frequently than couples' turns contained misunderstandings, while in follow-up visits it was the other way around. Looking at the couple, the majority of the misunderstandings were expressed by the woman (n = 241, 22%) rather than by the man (n = 194, 18%). However, when weighting for their number of turns, 9% of the men's turns included an expression of misunderstanding, compared to the 7% of the women's turns. Finally, more than half of the misunderstandings with strong evidence were about history-taking and treatment-related topics, and while the history-taking ones were particularly frequent in first visits the treatment-related ones were more present in follow-up visits. DISCUSSION: Findings indicate that first visits may deserve particular attention to avoid misunderstandings, as they are the moment where a shared understanding can be harder to reach. In particular, misunderstandings happening in first visits seem mostly related to physicians having to reconstruct the clinical history of patients, while those in the follow-up visits seem to reflect residual and unsolved doubts from the couple, especially concerning treatments.

Coding Problematic Understanding in Patient-provider Interactions.

This article proposes a coding scheme for identifying and assessing linguistic evidence of problematic understanding in health-care provider communication with patients affected by type 2 diabetes mellitus. Drawing on the existing literature in pragmatics and linguistics, the scheme is grounded on the distinctions between the different types of linguistic evidence of the occurrence of a misunderstanding or a problematic understanding, divided into three levels (stronger, acceptable and weak) based on their probative force. The application of the scheme is illustrated through a pilot study, conducted on an Italian corpus of 46 transcripts of videotaped consultations between six health-care providers and 13 patients affected by diabetes mellitus type 2. The most frequent types of linguistic evidence of problematic understanding were the categories of "acceptable" (amounting to 58% of the total) and the "strong" evidence (35%). Patients' problematic understanding was detected to occur significantly more frequently than health-care providers. Providers were also found to be significantly more aware of possible misunderstandings, tending to verify more frequently the correctness of their own interpretations. This pilot study represents a first step in the process of developing a productive evidence-based tool for detecting problematic understanding, which can be used for implementing linguistic strategies for helping prevent the risk of misunderstandings in health-care communication. Our findings show that misunderstandings are widespread between patients and that some linguistic strategies may be more effective than others in preventing the risk of misunderstandings, suggesting possible directions of research for improving health-care providers' communicative skills.

Evaluation of the Quality of Rehabilitation Treatment in Neurodevelopmental Disorder.

Complex disability is very difficult to manage. It usually subtends very serious clinical pictures, because it affect several body systems, or because it is associated with intellectual disability and behavioral disorders. Often affected patients are unable to communicate their basic needs. All these factors combine to make the management of these patients very complex, and those who care for them realize how important it is to find a way to detect their state and to identify their potential capabilities. Developing appropriate rehabilitation programs for these patients requires additional effort and an assessment capacity that is as objective as possible. Few scales cited in the literature are capable of evaluating these aspects in patients with complex disabilities, among them the Barthel Index (Mahoney & Barthel 1965) and the Vineland Adaptive Behavior scale II (Sparrow et al. 2005). The majority of these scales often tend to depict the data regarding the disease to a degree of severity that precludes adequate individual rehabilitation program development. There is a dire need for a more appropriate instrument, an observational grid that is capable of identifying the potential of this patient population and evaluate the effectiveness of rehabilitation interventions provided. The aim of the study is to evaluate the efficacy of rehabilitation interventions in a group of patients with IQ <32 (determined by the Vineland II scale) using an evaluation tool created ad hoc called D-Rubrics, designed with the intent to identify "micro-differences" between baseline (T0) and post-rehabilitation (T1). The goal is part of a more long term-term objective which involves developing an effective assessment tool for patients with complex disabilities. Such an assessment tool should be practical, easy to administer and useful in both clinical and research settings.

[Inhibitors of PCSK9]. / Inhibiteurs de la PCSK9.

Observational data show a consistent association between elevated low density lipoproteins (LDL-C) and cardiovascular disease (CVD). Reduction of LDL-C reduces the risk of CVD as has been shown by many trials. Statins are currently the most effective drugs for lowering LDL-C, but can present side effects which might limit the prescribed dosage and prevent patients from reaching the recommended LDL levels. Although treated with statins important residual cardiovascular event risk remains in patients in primary and secondary prevention for CVD. The discovery of protein convertase subtilisin kexin 9 antibodies is a very promising new hypolipidemic treatment and the aim of this review is to explain their mechanism of action and to discuss safety and efficacy results of some phase III studies.

Les données d'observation montrent une association cohérente entre une élévation des lipoprotéines de basse densité (LDL-C) et les maladies cardiovasculaires (MCV). Les statines sont actuellement les médicaments les plus efficaces pour abaisser le LDL-C, mais elles peuvent présenter des effets secondaires qui pourraient limiter les patients d'atteindre les niveaux de LDL-C recommandés. Bien que traités par les statines, un important risque résiduel d'événement cardiovasculaire reste chez les patients en préventions primaire et secondaire. La découverte des anticorps contre la protéase convertase subtilisine / kexine 9 est un nouveau traitement antilipémique très prometteur et le but de cet examen est d'expliquer leur mécanisme d'action et de discuter les données de sécurité et d'efficacité de quelques études de phase III.

mHealth for diabetes support: a systematic review of apps available on the Italian market.

mHealth is an expanding field of research and experimentation, concerned with the potentialities of mobile applications as tools to enhance patients' abilities in the management of chronic conditions. We present a systematic review of mHealth applications available on the Italian market and for the Italian speakers in order to assess their reported usability and functions. The review shows that there are rather few products on offer and the ones that are available display weak educational components, do not seem to be based on solid theoretical models of behavior change or decision making, and do not seem to be intended as devices to be integrated in the ecology of the doctor-patient relationship.

PCSK9 inhibitors: an overview on a new promising lipid-lowering therapy.

Atherosclerosis is characterized by cholesterol deposition in the arterial intima, with subsequent plaque formation and arterial disease. Low-density lipoprotein cholesterol (LDL-C) plays the most important role in the atherogenesis process, which is the substrate of cardiovascular disease and is the leading cause of death worldwide. Several studies show that a strict control of risk factors, particularly the reduction of LDL-C levels, is a cornerstone in primary and secondary prevention of coronary heart disease. Statins are currently the most effective drugs for lowering LDL-C, but the discovery of proprotein convertase subtilisin kexin 9 (PCSK9) has opened up new therapeutic options in lipid management. PCSK9 reduces LDL-receptors' recycling resulting in a decrease of LDL-C receptors on the surface of hepatocytes and an increase of LDL-C levels in plasma. Obviously, inhibition of PCSK9 has been associated with an increase of LDL-C receptors with subsequent lowering of plasma levels of LDL-C. The clinical development of monoclonal antibodies against PCSK9 has been achieved through phase I and II studies, and nowadays there are many ongoing phase III trials with promising preliminary results. The aim of this review is to update the evidence for PCSK9 monoclonal antibodies, such as evolocumab, alirocumab and bococizumab, in LDL-C management and to discuss their therapeutic perspectives based on the most recent clinical studies, with attention to side-effects.

Sustained improvement in left ventricular function after bone marrow derived cell therapy in patients with acute ST elevation myocardial infarction. A 5-year follow-up from the Stem Cell Transplantation in Ischaemic Myocardium Study.

BACKGROUND: Intracoronary injection of autologous bone marrow-derived mononucleated cells (BM-MNC) may improve LV function shortly after acute ST elevation myocardial infarction (STEMI), but little is known about the long-term durability of the treatment effect. METHODS: In a single-centre trial a total of 60 patients with acute anterior STEMI, successful reperfusion therapy and a left ventricular ejection fraction (LVEF) of <50% were screened for the study. 23 patients were actively treated with intracoronary infusion of BM-MNC within a median of 3 days. The open-label control group consisted of 19 patients who did not consent to undergo BM-MNC treatment but agreed to undergo regular clinical and echocardiographic follow-up for up to 5 years after AMI. RESULTS: Whereas at 4 months there was no significant difference between the increase in LVEF in the BM-MNC group and the control group (+7.0%, 95%CI 3.6; 10.4) vs. +3.9%, 95%CI -2.1; 10), the absolute increase at 5 years remained stable in the BM-MNC but not in the control group (+7.95%, 95%CI 3.5; 12.4 vs. -0.5%, 95%CI -5.4; 4.4; p for interaction between groups = 0.035). DISCUSSION: In this single-centre, open-labelled study, intracoronary administration of BM-MNC is feasible and safe in the short term. It is also associated with sustained improvement of left ventricular function in patients with acute myocardial infarction, encouraging phase III studies to examine the potential BM-MNC effect on clinical outcome.

The predictive value of stable precursor fragments of vasoactive peptides in patients with chronic heart failure: data from the GISSI-heart failure (GISSI-HF) trial.

AIMS: Though various neurohormonal systems are concurrently activated during heart failure (HF), their biological effectors are not always easy to measure due to their short life in vivo, instability in biological samples, or very low concentrations. We measured the plasma concentrations of four stable precursor fragments of neurohormonal systems in patients with chronic HF and evaluated their relationship with outcome. METHODS AND RESULTS: This study was performed in 1237 patients with chronic and stable HF enrolled in the GISSI-heart failure trial (GISSI-HF). The following four precursor fragments, mid-regional pro-atrial natriuretic peptide (MR-proANP), mid-regional pro-adrenomedullin (MR-proADM), C-terminal pro-endothelin-1 (CT-proET-1) and C-terminal pro-vasopressin (CT-proAVP or copeptin), were measured at randomization and after 3 months. Baseline concentrations were independent predictors of clinical outcome (median follow-up 3.9 years). The addition of MR-proANP improved net reclassification for mortality when added to multivariable models based on clinical risk factors alone [net reclassification improvement (NRI) = 0.12, P = 0.0007] or together with NT-proBNP (NRI = 0.06, P = 0.01). Changes in MR-proANP concentrations were related to mortality [HR (95% CI) 1.38 (0.99-1.93), P = 0.0614 and 1.58 (1.13-2.21), P = 0.0078 in the middle and highest vs. lowest tertiles], while changes in the other markers were not. CONCLUSION: In patients with chronic and stable HF enrolled in a multicentre, randomized, clinical trial, measurement of stable precursor fragments of vasoactive peptides provided prognostic information independent of natriuretic peptides which are currently the best biomarkers for risk stratification.

Prevalence and prognostic value of elevated urinary albumin excretion in patients with chronic heart failure: data from the GISSI-Heart Failure trial.

BACKGROUND: Increased urinary excretion of albumin is an early sign of kidney damage and a risk factor for progressive cardiovascular and renal diseases and heart failure. There is, however, only limited information on the prevalence and prognostic role of urinary albumin excretion in patients with established chronic heart failure. METHODS AND RESULTS: A total of 2131 patients enrolled in 76 sites participating in the GISSI-Heart Failure trial provided a first morning spot sample of urine at any of the clinical visits scheduled in the trial to calculate the urinary albumin-to-creatinine ratio. The relation between log-transformed urinary albumin-to-creatinine ratio and all-cause mortality (428 deaths, time from urine collection to event or censoring) was evaluated with Cox multivariable models adjusted for all significant risk factors at the time of urine collection, in the study population, and in patients without diabetes or hypertension. Almost 75% of the patients had normal urinary albumin excretion, but 19.9% had microalbuminuria (30 to 299 mg/g creatinine) and 5.4% had overt albuminuria (>or=300 mg/g). There was a progressive, significant increase in the adjusted rate of mortality in the study population (hazard ratio, 1.12; 95% CI, 1.05 to 1.18 per 1-U increase of log(urinary albumin-to-creatinine ratio), P=0.0002) and in the subgroup of patients without diabetes or hypertension. Randomized treatments (n-3 polyunsaturated fatty acids or rosuvastatin) had no major impact on albumin excretion. CONCLUSIONS: Independently of diabetes, hypertension, or renal function, elevated albumin excretion is a powerful prognostic marker in patients with chronic heart failure.

Comparison of brain natriuretic peptide plasma levels versus logistic EuroSCORE in predicting in-hospital and late postoperative mortality in patients undergoing aortic valve replacement for symptomatic aortic stenosis.

The accuracy of the logistic EuroSCORE (logES), a widely used risk prediction algorithm for cardiac surgery including aortic valve surgery, usually overestimates observed perioperative mortality. Elevated brain natriuretic peptide (BNP) in symptomatic patients with aortic stenosis (AS) is associated with a poor short-term outcome after aortic valve replacement. We aimed to compare BNP with the logES for predicting short- and long-term outcome in symptomatic patients with severe AS undergoing aortic valve replacement. We prospectively studied 144 consecutive patients referred for aortic valve replacement (42% women, 73 +/- 9 years, mean aortic gradient 51 +/- 18 mm Hg, and left ventricular ejection fraction 61 +/- 11%) undergoing either isolated aortic valve replacement (58%) or combined to bypass grafting. Both plasma BNP and logES was estimated before surgery. The median BNP plasma level and logES were 157 pg/ml (interquartile range [IQR] 61 to 440) and 6.6% (IQR 4.2 to 12.2), respectively. The perioperative mortality was 6% and the overall mortality by the end of the study was 13%. Patients with logES >10.1% (upper tertile) had a higher risk of dying over time (hazard ratio [HR] 2.86, p = 0.037), as had patients with BNP >312 pg/ml (HR 9.01, p <0.001). Discrimination (based on C statistic) and model performance (based on Akaike information criterion) were better for BNP than for logES. At the bivariable analysis, only BNP was an independent predictor of death (HR 8.2, p = 0.002). Preoperative BNP was even more accurate than logES in predicting outcome. In conclusion, in symptomatic patients with severe AS, high preoperative BNP plasma level and high logES confirm their predicting value for short- and long-term outcome.