Hemostatic Profile and Serological Response of Patients with Immune Thrombotic Thrombocytopenic Purpura after Receiving BNT162b2 Vaccine: A Prospective Study.

INTRODUCTION: Coronavirus disease is a clinical challenge for patients with autoimmune conditions. Patients affected by immune thrombotic thrombocytopenic purpura (iTTP) are particularly vulnerable to SARS-CoV-2 infection. Protecting these patients with vaccination is therefore mandatory, although concerns may exist on a possible increased thrombotic risk or risk of disease relapse after vaccine exposure. So far, there is no information on serological response and hemostatic activation in iTTP patients after SARS-CoV-2 vaccination. MATERIALS AND METHODS: In this study, in April 2021, we enrolled iTTP patients in clinical remission and on regular outpatient follow-up to receive the first and second dose BNT162b2 vaccine as a part of a prospective trial aimed at monitoring for 6 months after vaccination the occurrence of subclinical laboratory signs of clotting activation, as well as overt thrombotic complications or disease relapse. The seroconversion response was monitored in parallel. The results were compared with those of control non-iTTP subjects. RESULTS: A moderate decrease of ADAMTS-13 activity was recorded at 3 and 6 months in five patients with normal values at baseline, while an ADAMTS-13 relapse occurred at 6 months in one patient. Abnormalities in the endothelium activation biomarkers postvaccination were observed in iTTP patients compared with controls. The immunological response to vaccine was overall positive. No clinical iTTP relapses or thrombotic events manifested in the 6 month-follow-up after vaccination. CONCLUSION: The results of this study are in favor of efficacy and safety of mRNA vaccines in patients with iTTP, and highlight the importance of long-term monitoring of iTTP patients.

Baseline characteristics of COVID-19 Italian patients admitted to Desio Hospital, Lombardy: a retrospective study.

The correlation of clinical, radiological and laboratory findings of patients at admission in the Emergency Department (ED) with clinical severity and risk of mortality was investigated. Adult coronavirus disease 2019 (COVID-19) patients hospitalized in March 2020 in Desio Hospital, Lombardy, were retrospectively included in the study, and categorized in terms of disease severity and adverse outcome. Out of the 175 patients enrolled, 79% presented one or more comorbidities, with cardiovascular disease being the most frequent (62%). More than half of the patients showed lymphocytopenia and 20% thrombocytopenia. The patients in the severe group presented higher absolute neutrophil count (ANC), C-reactive protein (CRP), AST, LDH, procalcitonin (PCT) and BUN values compared to the non-severe group (p < .05). Increased odds of mortality associated with older age (OR = 22.43; 95% CI 5.22-96.27), partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FIO2) ratio < 200 (OR = 4.97; 95% CI 1.55-15.84), clinical severity (OR = 21.32; 95% CI 2.27-200.13), creatinine > 106.08 µmol/L (OR = 2.87; 95% CI 1.04-7.92) and creatine kinase > 2.90 µkat/L (OR = 3.80; 95% CI 1.31-10.9) were observed on admission (p < .05). The above findings may contribute to identify early risk factors of poor prognosis, and to select the most appropriate management for patients.

Evaluation of a Mobile Phone-Based Intervention to Increase Parents' Knowledge About the Measles-Mumps-Rubella Vaccination and Their Psychological Empowerment: Mixed-Method Approach.

BACKGROUND: There is mixed evidence on the effectiveness of vaccination-related interventions. A major limitation of most intervention studies is that they do not apply randomized controlled trials (RCTs), the method that, over the last 2 decades, has increasingly been considered as the only method to provide proof of the effectiveness of an intervention and, consequently, as the most important instrument in deciding whether to adopt an intervention or not. This study, however, holds that methods other than RCTs also can produce meaningful results. OBJECTIVE: The aim of this study was to evaluate 2 mobile phone-based interventions aimed at increasing parents' knowledge of the measles-mumps-rubella (MMR) vaccination (through elements of gamification) and their psychological empowerment (through the use of narratives), respectively. The 2 interventions were part of an RCT. METHODS: We conducted 2 studies with the RCT participants: a Web-based survey aimed at assessing their rating of the tool regarding a number of qualities such as usability and usefulness (N=140), and qualitative telephonic interviews to explore participants' experiences with the app (N=60). RESULTS: The results of the survey showed that participants receiving the knowledge intervention (alone or together with the empowerment intervention) liked the app significantly better compared with the group that only received the empowerment intervention (F2,137=15.335; P<.001). Parents who were exposed to the empowerment intervention complained that they did not receive useful information but were only invited to make an informed, autonomous MMR vaccination decision. CONCLUSIONS: The results suggest that efforts to empower patients should always be accompanied by the provision of factual information. Using a narrative format that promotes parents' identification can be an appropriate strategy, but it should be employed together with the presentation of more points of views and notions regarding, for instance, the risks and benefits of the vaccination at the same time. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number 30768813; http://www.isrctn.com/ ISRCTN30768813 (Archived by WebCite at http://www.webcitation.org/6xOQSJ3w8).

Effectiveness of a smartphone app to increase parents' knowledge and empowerment in the MMR vaccination decision: A randomized controlled trial.

Researchers are trying to build evidence for mhealth effectiveness in various fields. However, no evidence yet is showing the effectiveness of mhealth on parents' attitudes and behavior with regard to recommended vaccination of their children. The aim of this study was to look into the effects of 2 smartphone-based interventions targeting MMR vaccination knowledge and psychological empowerment respectively. The interventions used gamification features and videos in combination with text messages. We conducted a 2x2 between-subject factorial randomized controlled trial (absence/presence of knowledge intervention X absence/presence of empowerment intervention) with parents of young children in Italy. We randomly allocated 201 eligible participants to one of the 4 conditions. Data were collected by questionnaires at baseline and posttest. Primary outcomes were MMR vaccination knowledge, psychological empowerment, risk perception, and preferred decisional role; secondary outcomes included MMR vaccination intention, attitude, confidence, and recommendation intention. A significant gain in vaccination knowledge was reported by all experimental groups compared with the control (F(3,179) = 48.58, p < .000), while only those receiving both interventions reported a significant increase in their psychological empowerment (t(179) = -2.79, p = .006). Participants receiving the intervention targeting knowledge reported significantly higher intention to vaccinate (t(179) = 2.111; p = .03) and higher confidence in the decision (t(179) = 2.76; p = .006) compared with the control group. Parent-centered, gamified mobile interventions aimed at providing parents with vaccination-related information can be used to increase their knowledge, their intention to vaccinate as well as their confidence in the vaccination decision.

What are parents' perspectives on psychological empowerment in the MMR vaccination decision? A focus group study.

OBJECTIVES: Most developed countries do not have compulsory immunisation requirements, but instead issue recommendations. Although parents are expected to make an informed, autonomous (ie, empowered) decision regarding their children's vaccinations, there is no evidence about how parents' interpret this demand nor on the latitude of their decision-making. The goal of this study is to gain insights from parents residing in a low measles-mumps-rubella (MMR) uptake area on what constitutes feelings of empowerment in the decision they have to make on their child's MMR vaccination. DESIGN: A qualitative study employing focus group interviews. SETTING: 11 vaccination centres and hospitals in the Province of Trento, Italy. PARTICIPANTS: 24 mothers and 4 fathers of children for whom the MMR vaccination decision was still pending participated in 6 focus groups. RESULTS: Autonomy and competence were salient themes in relation to empowerment, and were further connected with beliefs regarding legal responsibility and ethics of freedom concerning the decision, parents' relationship with the paediatrician (trust), feelings of relevance of the decision and related stress, and seeking, avoidance, or fear of vaccination-related information. Competence was interpreted as medical knowledge and information-seeking skills, but it was also related to the extent parents perceived the paediatrician to be competent. CONCLUSIONS: Since parents' interpretation of empowerment goes beyond mere perceptions of being informed and autonomous and differs across individuals, it is important that this construct be correctly interpreted and implemented by best practice, for instance by explicitly adopting a relational conception of autonomy. Knowing whether parents want to make an empowered decision and what their information and autonomy needs are might help health professionals adapt their communication about immunisation, and promote parental perception of making an informed, autonomous decision.

Intentional and Unintentional Medication Non-Adherence in Hypertension: The Role of Health Literacy, Empowerment and Medication Beliefs.

BACKGROUND: Medication non-adherence is a major public health issue, creating obstacles to effective treatment of hypertension. Examining the underlying factors of deliberate and non-deliberate non-adherence is crucial to address this problem. Thus, the goal of the present study is to assess the socio-demographic, clinical and psychological determinants of intentional and unintentional non-adherence. DESIGN AND METHODS: A cross-sectional survey was conducted between March, 2015 and April, 2016. The sample consisted of hypertension patients holding at least one medical prescription (N=109). Measurements assessed patients' medication adherence, health literacy, empowerment, self-efficacy, medication beliefs, and patients' acceptance of their doctor's advice, socio-demographic and clinical characteristics. RESULTS: Patients who occasionally engaged in either intentional or unintentional non-adherence reported to have lower adherence selfefficacy, higher medication concern beliefs, lower meaningfulness scores and were less likely to accept the doctor's treatment recommendations. Patients who occasionally engaged in unintentional nonadherence were younger and had experienced more side effects compared to completely adherent patients. Adherence self-efficacy was a mediator of the effect of health literacy on patients' medication adherence and acceptance of the doctor's advice was a covariate. CONCLUSIONS: Regarding the research implications, health literacy and adherence self-efficacy should be assessed simultaneously when investigating the factors of non-adherence. Regarding the practical implications, adherence could be increased if physicians i) doublecheck whether their patients accept the treatment advice given and ii) if they address patients' concerns about medications. These steps could be especially important for patients characterized with lower self-efficacy, as they are more likely to engage in occasional nonadherence.

Effects of gender and executive function on visuospatial working memory in adult obsessive-compulsive disorder.

Visuospatial working memory (VSWM) is the ability of the brain to transiently store and manipulate visual information. VSWM deficiencies have been reported in obsessive-compulsive disorder (OCD), but not consistently, perhaps due to variability in task design and clinical patient factors. To explore this variability, this study assessed effects of the design factors task difficulty and executive organizational strategy and of the clinical factors gender, OCD symptom dimension, and duration of illness on VSWM in OCD. The CANTAB spatial working memory, spatial recognition memory, delayed matching to sample, and stop signal tasks were administered to 42 adult OCD patients and 42 age- and sex-matched healthy controls. Aims were to detect a possible VSWM deficit in the OCD sample, to evaluate influences of the above task and patient factors, to determine the specificity of the deficit to the visuospatial subdomain, and to examine effects of sustained attention as potential neurocognitive confound. We confirmed previous findings of a VSWM deficit in OCD that was more severe for greater memory load (task difficulty) and that was affected by task strategy (executive function). We failed to demonstrate significant deficits in neighboring or confounding neurocognitive subdomains (visual object recognition or visual object short-term memory, sustained attention). Notably, the VSWM deficit was only significant for female patients, adding to evidence for sexual dimorphism in OCD. Again as in prior work, more severe OCD symptoms in the symmetry dimension (but no other dimension) significantly negatively impacted VSWM. Duration of illness had no significant effect on VSWM. VSWM deficits in OCD appear more severe with higher task load and may be mediated through poor task strategy. Such deficits may present mainly in female patients and in (male and female) patients with symmetry symptoms.

Evaluating effect of symptoms heterogeneity on decision-making ability in obsessive-compulsive disorder.

AIMS: Despite having a univocal definition, obsessive-compulsive disorder (OCD) shows a remarkably phenotypic heterogeneity. The published reports show impaired decision-making in OCD patients, using tasks such as the Iowa Gambling Task (IGT). We wanted to verify the hypothesis of an IGT worse performance in a large sample of OCD patients and healthy control (HC) subjects and to examine the relation between neuropsychological performance in IGT and the OCD symptoms heterogeneity. METHODS: Binary data from the Yale-Brown Obsessive Compulsive Scale collected on a large sample of OCD patients were analyzed using a multidimensional item response theory model to explore the underlying structure of data, thus revealing latent factors. Factor scores were categorized into quartiles. Then, for each factor, we identified patients respectively with the highest versus lowest score. We evaluated whether symptom dimensions affect the probability of a correct answer over time generalized, during IGT performance, fitting a generalized linear mixed model. RESULTS: We found a general deficit in ambiguous decision-making in OCD compared to HC. Moreover, our findings suggested that OCD symptoms heterogeneity affects decision-making learning abilities during IGT. In fact, while 'Symmetry' and 'Washing' patients showed a learning curve during the task, other subgroups did not. CONCLUSIONS: Our study confirmed previous findings suggesting that OCD is characterized by a deficit in decision-making under uncertainty. Moreover, our study gave evidence about biological specificity for each symptom dimension in OCD. Data were discussed in the context of the somatic marker hypothesis, which was hypothesized to be reduced in OCD patients.

Smoking, physical activity and respiratory irregularities in patients with panic disorder.

BACKGROUND: In the past decades different evidences suggested a relationship between panic disorder (PD) and respiration, among which the presence of different respiratory irregularities at rest in PD patients. It has been hypothesized that PD could be characterized by a dysfunction of those areas involved in the central control of respiration. The aim of the present study was to elucidate possible differences in breath-by-breath respiratory function at rest between a sample of PD patients with agoraphobia and healthy controls (HC), with particular attention to smoking and physical activity as possible relevant factors in the understanding of respiratory dynamics in PD. METHODS: Respiratory physiology was assessed in 32 PD patients and 24 HC. Respiratory rate (RR), tidal volume (VT), minute ventilation (VE), and end-tidal CO2 (pCO2) have been assessed. RESULTS: A significant diagnosis-by-smoking interaction was found for mean RR and VT. Mean pCO2 was significantly higher in active than in sedentary patients. Anxiety state did not account for the results. CONCLUSIONS: Our findings suggest an abnormal regulation of the respiratory system as a key mechanism in PD. In future studies it should be useful t o stratify data taking into account level and intensity of physical activity and smoking behaviour, as well as to consider the cardiac profile and the effect of those variables able to modulate the homeostatic brain functioning. .

Low baseline startle in anorexia nervosa patients.

This study examined baseline startle magnitude, using eye blink response and skin conductance response in anorexia nervosa patients. Twenty female in-patients with anorexia nervosa and an equal number of female healthy controls were tested. Baseline startle response was assessed during blank screens while four startling loud sounds (a 116 dB, 1s, 250 Hz tone) were delivered with a time interval ranging from 35 to 55 s. It was investigated if BMI and state anxiety correlated with physiological responses. The clinical sample showed a lower baseline startle reflex measured with both indices, than healthy controls. Across the whole sample, a single regression model partially explained the relationship between BMI and baseline skin conductance response.

Executive functioning in anorexia nervosa patients and their unaffected relatives.

Formal genetic studies suggested a substantial genetic influence for anorexia nervosa (AN), but currently results are inconsistent. The use of the neurocognitive endophenotype approach may facilitate our understanding of the AN pathophysiology. We investigated decision-making, set-shifting and planning in AN patients (n=29) and their unaffected relatives (n=29) compared to healthy probands (n=29) and their relatives (n=29). The Iowa Gambling Task (IGT), the Tower of Hanoi (ToH) and the Wisconsin Card Sorting Test (WCST) were administered. Concordance rates and heritability indices were also calculated in probands/relatives. Impaired performance on the IGT and the WCST were found in both AN probands and their relatives, although planning appeared to be preserved. The IGT heritability index suggested the presence of genetic effects that influence this measure. No evidence for genetic effects was found for the WCST. The results suggest the presence of a shared dysfunctional executive profile in women with AN and their unaffected relatives, characterized by deficient decision-making and set-shifting. Concordance analysis strongly suggests that these impairments aggregate in AN families, supporting the hypothesis that they may constitute biological markers for AN. Decision-making impairment presents a moderate heritability, suggesting that decision-making may be a candidate endophenotype for AN.

Motor inhibition and cognitive flexibility in eating disorder subtypes.

Anorexia Nervosa (AN) and Bulimia Nervosa (BN) are complex Eating Disorders (EDs). Even if are considered two different diagnostic categories, they share clinical relevant characteristics. The evaluation of neurocognitive functions, using standardized neuropsychological assessment, could be a interesting approach to better understand differences and similarities between diagnostic categories and clinical subtypes in EDs thus improving our knowledge of the pathophisiology of EDs spectrum. This study explored cognitive flexibility and motor inhibition in patients with AN considering both Restricter and Binge/Purge subtypes, patients with BN and healthy comparisons subjects (HC). Intra-Extra Dimentional Set shifting Test and Stop Signal Task, selected from CANTAB battery, were administered to analyzed set-shifting and motor inhibition respectively. AN patients showed a deficient motor inhibition compared to HC, while no evidence for impaired motor inhibition was found in BN patients; a significant relationship between commission errors in the Stop Signal Task and attentional impulsiveness was found. Moreover, no difference in set-shifting abilities was found comparing all clinician groups and HC. So our results indicated no cognitive impairment in these two cognitive functions in BN patients, while AN and BN showed different performances in motor inhibition. A similar cognitive profile was found in other obsessive compulsive spectrum disorders. Finally, the paper suggests a new interactive approach for the study of cognitive profile in psychiatric disorders; it might be more useful since it is more closely related to the executive functions complexity.