Verbal descriptors of the frequency of side effects: implementation of EMA recommendations in patient information leaflets in Poland.

BACKGROUND: The European Medicines Agency (EMA) recommends a description of drug side effects based on the frequency format and the associated verbal description. Although the recommendations refer to English-speaking countries, in several non-English-speaking states, official authorities have accepted the proposed recommendations on how the patient information leaflets should be designed for descriptions of side effect frequencies. OBJECTIVE: The aim of the study was to examine how manufacturers of authorized medicines in Poland implement the EMA recommendations regarding the verbal descriptors of the frequency of side effects. METHODS: A qualitative study. As a first step, we identified which of the 150 pharmaceutical companies operating in Poland had the largest market share. Then, five manufacturers were selected at random from the list of the top 15 drug manufacturers in Poland by market share of the pharmaceutical sector. Lists of medicinal products authorized for marketing in Poland were downloaded from manufacturers' websites, and then five products from each manufacturer were selected based on random sampling. The study included only prescription medicines and excluded over-the-counter medicines and dietary supplements from the sample. Subsequently, for each of the 25 drugs, relevant patient information leaflets were obtained from the manufacturers' websites. We evaluated how information on the frequency of side effects was provided in each leaflet, including the use of EMA-recommended terms (verbal descriptors such as 'very common,' 'common,' 'uncommon,' 'rare' and 'very rare') and additional notes explaining their meanings. RESULTS: For all manufacturers, word labels of the frequencies of side effects selected for the study were the same, but the additional notes explaining their meanings were different. There were various explanations of how to understand verbal descriptors of the frequency of side effects not only across different manufacturers but also across different medicines from one manufacturer. CONCLUSIONS: There is no single standard in the Polish pharmaceutical industry for implementing the EMA recommendations into the written information about the frequency of side effects. The observed differences for an explanation of how to understand a given verbal term do not favor a uniform interpretation of the verbal frequency labels meaning by patients.

Mindreading and metacognition patterns in patients with borderline personality disorder: experimental study.

Current psychopathology attempts to understand personality disorders in relation to deficits in higher cognition such as mindreading and metacognition. Deficits in mindreading are usually related to limitations in or a complete lack of the capacity to understand and attribute mental states to others, while impairments in metacognition concern dysfunctional control and monitoring of one's own processes. The present study investigated dysfunctional higher cognition in the population of patients with borderline personality disorder (BPD) by analyzing the accuracy of metacognitive judgments in a mindreading task [reading the mind in the eyes Test (RMET)] and a subsequent metacognitive task based on self-report scales: a confidence rating scale (CR) versus a post-decision wagering scale (PDW). It turned out that people from the BPD group scored lower in the RMET. However, both groups had the same levels of confidence on the PDW scale when giving incorrect answers in the RMET test. As initially hypothesized, individuals with BPD overestimated their confidence in incorrect answers, regardless of the type of metacognitive scales used. The present findings indicate that BPD individuals show dysfunctional patterns between instances of mindreading and metacognition.

A new approach to the prevention of nursing care rationing: Cross-sectional study on positive orientation.

AIMS: To assess the effects of nurses' life satisfaction and life orientation on the level of nursing care rationing. BACKGROUND: Best practice within human resource management argues that striving for a positive orientation within the workforce may create a friendly work environment that could promote the employee's development and job satisfaction in a health care organisation. METHODS: A total of 547 nurses were enrolled and assessed using three self-report scales: the Basel Extent of Rationing of Nursing Care-R (BERCA-R), the Satisfaction with Life Scale (SWLS) and the Life Orientation Test (LOT-R). Then, the data were submitted into bivariate analyses. RESULTS: More pessimistic nurses with low and moderate levels of life satisfaction, and those with a neutral life orientation, presented with significantly higher BERCA-R scores than those who were more optimistic and who had high levels of life satisfaction. CONCLUSIONS: Nursing care rationing depends on psychological factors of life satisfaction and life orientation. Low levels of satisfaction with life and a more pessimistic life orientation negatively contribute towards a higher prevalence of nursing care rationing. IMPLICATIONS FOR NURSING MANAGEMENT: Nursing management policies, including intervention management, should consider ensuring positive orientation is in place to increase job satisfaction and optimism in health care workers.

Blindness of intentions and metacognitive deficits during moral judgements in schizophrenia.

BACKGROUND: Previous research has shown that moral judgments are affected by social cognitive abilities, such as theory of mind (ToM). This study examines how information about an actor's beliefs and the consequences of their actions affect the moral evaluation of the character's behavior in social events. Our research builds upon previous studies, which have shown that these factors contribute differently to moral judgments made by both adults and young children. OBJECTIVES: This study aimed to explore how participants with schizophrenia and healthy controls read stories about social situations in the context of moral judgments. MATERIAL AND METHODS: The study used the research procedure that included 4 variants of 16 scenarios describing social situations, and thus comprising 64 stories. After each story, participants evaluated their confidence level on a 4-point scale. To assess delusional beliefs, the Polish adaptation of the Peters Delusion Inventory (PDI) questionnaire and the Paranoia Checklist (PCh) were used. Respondents completed these questionnaires after completing the scenario test procedure. RESULTS: In social situations, patients with paranoid schizophrenia were found to evaluate actions of protagonists who attempted to harm another person more leniently than when it was an accident. Conversely, healthy individuals judged those actors who expressed intentions to hurt another person significantly more harshly than in an accident situation. Metacognition measures show that paranoid schizophrenia patients make moral judgments with high confidence, despite being based on an incorrect reading of the other person's intentions. CONCLUSIONS: The study indicates that ToM has a significant impact on the moral judgment of others. Decreased moral cognition can result from both positive and negative symptoms. Deficits related to metacognition can also sustain such cognitive distortions.

Application of machine learning in predicting frailty syndrome in patients with heart failure.

Prevention and diagnosis of frailty syndrome (FS) in patients with heart failure (HF) require innovative systems to help medical personnel tailor and optimize their treatment and care. Traditional methods of diagnosing FS in patients could be more satisfactory. Healthcare personnel in clinical settings use a combination of tests and self-reporting to diagnose patients and those at risk of frailty, which is time-consuming and costly. Modern medicine uses artificial intelligence (AI) to study the physical and psychosocial domains of frailty in cardiac patients with HF. This paper aims to present the potential of using the AI approach, emphasizing machine learning (ML) in predicting frailty in patients with HF. Our team reviewed the literature on ML applications for FS and reviewed frailty measurements applied to modern clinical practice. Our approach analysis resulted in recommendations of ML algorithms for predicting frailty in patients. We also present the exemplary application of ML for FS in patients with HF based on the Tilburg Frailty Indicator (TFI) questionnaire, taking into account psychosocial variables.

The perception of visual emotion: comparing different measures of awareness.

Here, we explore the sensitivity of different awareness scales in revealing conscious reports on visual emotion perception. Participants were exposed to a backward masking task involving fearful faces and asked to rate their conscious awareness in perceiving emotion in facial expression using three different subjective measures: confidence ratings (CRs), with the conventional taxonomy of certainty, the perceptual awareness scale (PAS), through which participants categorize "raw" visual experience, and post-decision wagering (PDW), which involves economic categorization. Our results show that the CR measure was the most exhaustive and the most graded. In contrast, the PAS and PDW measures suggested instead that consciousness of emotional stimuli is dichotomous. Possible explanations of the inconsistency were discussed. Finally, our results also indicate that PDW biases awareness ratings by enhancing first-order accuracy of emotion perception. This effect was possibly a result of higher motivation induced by monetary incentives.

Importance analysis of psychosociological variables in frailty syndrome in heart failure patients using machine learning approach.

The prevention and diagnosis of frailty syndrome (FS) in cardiac patients requires innovative systems to support medical personnel, patient adherence, and self-care behavior. To do so, modern medicine uses a supervised machine learning approach (ML) to study the psychosocial domains of frailty in cardiac patients with heart failure (HF). This study aimed to determine the absolute and relative diagnostic importance of the individual components of the Tilburg Frailty Indicator (TFI) questionnaire in patients with HF. An exploratory analysis was performed using machine learning algorithms and the permutation method to determine the absolute importance of frailty components in HF. Based on the TFI data, which contain physical and psychosocial components, machine learning models were built based on three algorithms: a decision tree, a random decision forest, and the AdaBoost Models classifier. The absolute weights were used to make pairwise comparisons between the variables and obtain relative diagnostic importance. The analysis of HF patients' responses showed that the psychological variable TFI20 diagnosing low mood was more diagnostically important than the variables from the physical domain: lack of strength in the hands and physical fatigue. The psychological variable TFI21 linked with agitation and irritability was diagnostically more important than all three physical variables considered: walking difficulties, lack of hand strength, and physical fatigue. In the case of the two remaining variables from the psychological domain (TFI19, TFI22), and for all variables from the social domain, the results do not allow for the rejection of the null hypothesis. From a long-term perspective, the ML based frailty approach can support healthcare professionals, including psychologists and social workers, in drawing their attention to the non-physical origins of HF.

Heart Failure Care: Testing Dyadic Dynamics Using the Actor-Partner Interdependence Model (APIM)-A Scoping Review.

Self-care behaviors are essential for the effective treatment of heart failure (HF), and poor self-care may lead to adverse clinical events in patients with HF. A growing body of literature addresses the need to analyze the characteristics of both patient and caregiver since they are in mutual, long-term interaction, and their reactions to events are dependent on each other. One of the most common approaches for analyzing data on HF self-care dyads is the Actor-Partner Interdependence Model (APIM). The purpose of this study was to conduct a scoping review to answer the following question: what did we learn from HF dyadic studies based on the APIM approach? Medline, Academic Search Ultimate, and CINAHL Complete databases were searched, using the terms "dyad," "dyadic," and "heart failure," for studies published between 2009 and April 2021. Fifteen studies were reviewed from a pool of 106 papers. Studies using the APIM approach revealed interrelated patient and caregiver characteristics that influence self-care and explain many complex dyadic behaviors. Our analysis provided evidence that (1) APIM is a useful analytical approach; (2) a family-oriented approach can improve the functioning of a patient with HF; and (3) social support from caregivers significantly enhances patients' adaptation to illness.

Digital health and modern technologies applied in patients with heart failure: Can we support patients' psychosocial well-being?

Despite advances in the treatment of heart failure (HF), the physical symptoms and stress of the disease continue to negatively impact patients' health outcomes. Technology now offers promising ways to integrate personalized support from health care professionals via a variety of platforms. Digital health technology solutions using mobile devices or those that allow remote patient monitoring are potentially more cost effective and may replace in-person interaction. Notably, digital health methods may not only improve clinical outcomes but may also improve the psycho-social status of HF patients. Using digital health to address biopsychosocial variables, including elements of the person and their context is valuable when considering chronic illness and HF in particular, given the multiple, cross-level factors affecting chronic illness clinical management needed for HF self-care.

Physical, Psychological and Social Frailty Are Predictive of Heart Failure: A Cross-Sectional Study.

BACKGROUND: Little is known about frailty among patients hospitalized with heart failure (HF). To date, the limited information on frailty in HF is based on a unidimensional view of frailty, in which only physical aspects are considered when determining frailty. The aims of this study were to study different dimensions of frailty (physical, psychological and social) in patients with HF and the effect of different dimensions of frailty on the incidence of heart failure. METHODS: The study used a cross-sectional design and included 965 patients hospitalized for heart failure and 164 healthy controls. HF was defined according to the ESC guidelines. The Tilburg Frailty Indicator (TFI) was used to assess frailty. Probit regression analyses and chi-square statistics were used to examine associations between the occurrence of heart failure and TFI domains of frailty. RESULTS: Patients diagnosed with frailty were 15.3% more likely to develop HF compared to those not diagnosed with frailty (p < 0.001). An increase in physical, psychological and social frailty corresponded to an increased risk of HF of 2.9% (p < 0.001), 4.4% (p < 0.001) and 6.6% (p < 0.001), respectively. CONCLUSIONS: We found evidence of the association between different dimensions of frailty and incidence of HF.

Cognition and Frailty in Patients With Heart Failure: A Systematic Review of the Association Between Frailty and Cognitive Impairment.

Background/Aim: Pathological processes associated with aging increase the risk of cognitive deficits. Frailty syndrome may significantly accelerate these pathological processes in elderly patients with heart failure. The objective of this review was to better understand the association between frailty syndrome and co-occurring cognitive decline in patients with heart failure. Methods: We conducted a systematic review based on PubMed/MEDLINE, Scopus, EMBASE, and CINAHL as databases. The search followed the method described by Webb and Roe. For inclusions, the studies were selected employing cross-sectional and longitudinal designs. The included studies had to evaluate frailty syndrome and cognitive impairments among participants with heart failure. As we were interested in older adults, the search was limited to individuals >65 years of age. The search was limited to primary research articles written in English published since the year 2000. Results: Of the 1,245 studies retrieved by the systematic review, 8 relevant studies were enclosed for the full-text review. Our review revealed that most studies of patients with HF demonstrated evidence of an association between greater frailty and cognitive impairment. In particular, six studies reported evidence for the significant association between higher levels of frailty and cognitive impairment in patients with heart failure. The remaining two studies failed to find an association between frailty and cognitive impairment. Conclusions: The development of frailty and cognitive impairment in heart failure is particularly important because this cardiovascular disease is a common cause of both morbidity and mortality in the world. The results of this review fill the existing gap in the literature related to the identification of clinical factors linked with frailty syndrome that contribute to cognitive impairment in patients with a diagnosis of heart failure. The prevalence of overlapping frailty and cognitive impairment in patients with heart failure, therefore, necessitates a routine assessment of these components in the care of patients with cardiovascular disease.

Measurement of Unwanted Thought Suppression Strategies with the Thought Control Questionnaire in the General Polish Population: A Confirmatory Factor Analysis and Validation.

INTRODUCTION: Although psychological studies have suggested both the desired and paradoxical effects of unwanted thought suppression, we still know little about this mechanism. It has been proposed that individual differences in using specific strategies to suppress intrusions explain why contradictory effects of suppression are observed. The main aims of the study were to investigate the factor structure of the Polish version of Thought Control Questionnaire (TCQ) and verify whether this structure corresponds to the original version of the TCQ measurement. METHODS: Using the TCQ, which is a 30-item self-report measure, this research investigated individual thought control strategies to suppress intrusive thoughts in the general population. We used parallel analysis and theoretical interpretability to investigate the most appropriate factor structure of the inventory. To examine the validity of the Polish version of TCQ the correlational analysis of TCQ factors with other psychometric scales: Beck Depression Inventory, The State-Trait Anxiety Inventory and The Metacognitions Questionnaire. The internal consistency of the TCQ subscales was also assessed by calculating the Cronbach's alpha reliability coefficients for each factor. RESULTS: The resulting five-factor solution explained 51.86% of the total variance. The Polish version of TCQ consisted of five subscales yielding satisfactory reliability values: 1) Punishment (α = 0.725); 2) Distraction (α = 0.688); 3) Social Control (α = 0.780); 4) Worry (α = 0.788; 5) Re-appraisal (α = 0.70). CONCLUSION: The five-factor solution was convergent with the dimensions that appeared in the original TCQ version and were observed in the most TCQ adaptations in various countries. Our findings support the psychological construct of thought-control strategies measured by TCQ and prove the satisfactory reliability of this self-report measure within a Polish population.

Readiness for Discharge from Hospital after Myocardial Infarction: A Cross-Sectional Study.

Myocardial infarction (MI) is a common cause of cardiovascular deaths. Education of patients with myocardial infarctions essential to prevent further cardiovascular events and reduce the risk of mortality. The study aimed to evaluate the associations between patients' readiness for hospital discharge after myocardial infarction, acceptance of illness, social, demographic, and clinical factors. The study used a cross-sectional design and included 102 patients, who were hospitalized for myocardial infarction after percutaneous coronary intervention (PCI). Two questionnaires were used: The Readiness for Hospital Discharge After Myocardial Infarction Scale (RHD-MIS) and Acceptance of Illness Scale (AIS). Low readiness characterized nearly half of patients (47.06%), 27.45% of patients showed an intermediate level of readiness, while 25.49% of patients had high readiness. Readiness for hospital discharge was higher among younger patients, respondents living in relationships, living with a family, with tertiary or secondary education, and professionally active. Acceptance of illness was higher among male patients, respondents living in relationships, and family, with secondary education and professionally active. The AIS score positively correlated with readiness for hospital discharge.

Acceptance of the disease and sexual functions of patients with heart failure.

BACKGROUND: Sexual activity is an important element of quality of life for many individuals suffering from heart failure. AIMS: The study investigated the influence of disease acceptance on sexual function in a population of male patients with chronic heart failure. METHODS: The study included 80 patients with chronic heart failure (mean age 63.3±9.2 years) who filled in the Mell-Krat Scale questionnaire to evaluate sexual needs and reactions. We also used the International Index of Erection Function (IIEF-5) inventory and the Acceptance of Illness Scale (AIS). RESULTS: The study showed that the acceptance of the illness was positively associated with all of the Mell-Krat components such as sexual need, F = (3.27), frequency of intercourse, F = (2.46), position and technique, F = (1.88). Also, according to the IIEF-5 questionnaire, 84.42% of respondents had erectile dysfunction. Taken together these indicated that psychological adjustments such as acceptance of disease increase quality of all aspects of sexual functions in heart failure patients, including their erectile functions. CONCLUSIONS: Our findings suggest that psychological adjustments to feelings of loss associated with the onset of heart failure disease is the important determinant of quality of sexual life among male adults. Our research implicates that effects of AIS on sexual functioning give reasonable information to tailor sexual counselling for males suffering from heart failure.

Absence of advantageous wagering does not mean that awareness is fully abolished.

Post-decision wagering (Persaud, McLeod, & Cowey, 2007) has been proposed as a method of demonstrating that perception can occur without conscious awareness. When wagering is independent from above-chance performance there is evidence of a lack of awareness of the correctness of the first-order discriminations. However, there are reasons to believe that the contingency analysis conducted by Persaud and colleagues failed to measure "the zero accuracy-wagering criterion". The author shows that a Pearson chi-square test employed by Persaud and colleagues is unable to accommodate the hypothesis of partial independence between accuracy and advantageous wagering. On the contrary, the problem of "the zero accuracy-wagering criterion" is best conducted with log-linear models. Moreover, log-linear analysis suggests that absence of advantageous wagering is not sufficient evidence for a lack of conscious awareness. In the case of the blindsight study, there was compelling evidence that the patient GY was partially aware of having information about the correctness of his decisions.

Polish version of the White Bear Suppression Inventory (WBSI) by Wegner and Zanakos: factor analysis and reliability. / Skala tlumienia mysli ­ polska wersja kwestionariusza WBSI (White Bear Suppression Inventory) Wegnera i Zanakos: analiza czynnikowa i rzetelnosc skali.

OBJECTIVES: The main aim of this study was to adapt a Polish version of the White Bear Suppression Inventory (WBSI), originally created by Wegner and Zanakos (1994) to measure chronic suppression. METHODS: The Polish version of the WBSI was prepared following the back-translation procedure. The scale was administered to 246 individuals from general population. Then, factor structure analysis of the WBSI was conducted. Finally, reliability analysis of the Polish version of the WBSI and its two sub-scales was done. RESULTS: The Polish version of the WBSI yielded satisfactory psychometric properties. The results from the explanatory factor analysis indicated a two-factor structure of the WBSI inventory including factorsof 'suppression' and 'intrusions'. The psychological measures with both factors as well as measures based on the total WBSI scores show very high reliability. CONCLUSIONS: The reliability of the Polish version of the WBSI is comparable to the original version. The analysis allowed us to identify a new subscale that may represent the experience of intrusions. The Polish version of the WBSI is characterized by good psychometric properties and may be used to assess intrusions and suppression.

Monetary Incentives Increase Metacognitive Confidence in Source Memory Performance in Patients With Schizophrenia.

BACKGROUND: Contemporary psychiatric research focuses its attention on the patient's dysfunction of metacognition in relation to the basic cognitive processes of mental activity. The current study investigated dysfunctional metacognition in relation to self-monitoring of memory in patients diagnosed with schizophrenia. Dysfunctions in metacognition were examined by focusing on two types of metacognitive measures: post-decision wagering (PDW) scale and confidence ratings (CR) scale (CR). OBJECTIVES: The research employed an action-memory task that required patients with schizophrenia (N = 39) and healthy controls (N = 50) to evaluate their metacognition by categorizing self-monitoring actions (imagined vs. performed actions) either with PDW or CR. It was hypothesized that metacognition in self-monitoring activity in patients diagnosed with schizophrenia is improved by imaginary monetary incentives. MATERIAL AND METHODS: To test this hypothesis, participants were asked to memorize actions either performed or imagined during the first phase of the experiment. The second phase was to identify previous actions as performed, imagined or new, and then to express confidence using two measures of metacognition (CR or PDW scales) that were randomly allocated to participants. RESULTS: Our study showed reduced performance in the action memory task for patients with schizophrenia, although there were no group differences in confidence measures when assessing self-monitoring actions. In particular, irrespective of the diagnosis, no differences in confidence measures for correct responses were found in the case of the PDW and CR scales. We also observed that metacognitive judgements were more accurate for incorrect responses when both groups used monetary incentives to reveal their metacognition. CONCLUSIONS: Our findings suggest that monetary incentives improve accuracy of metacognition among both patients and healthy controls. This accuracy-enhancing effect of monetary incentives on metacognition was possibly a result of motivational processes, including aversion to loss. The paper discusses the potential application of PDW in therapeutic metacognitive training for patients with schizophrenia.

Assessment of Frailty and Occurrence of Anxiety and Depression in Elderly Patients with Atrial Fibrillation.

PURPOSE: Atrial fibrillation (AF) is the most common cardiac arrhythmia, and its incidence increases with age. The elderly population is commonly affected by frailty syndrome (FS). FS syndrome along with anxiety and depressive symptoms are prevalent among elderly patients with AF. It is unclear whether depression contributes to AF or vice versa. The purpose of this study was to assess correlations between FS and the occurrence of anxiety and depression symptoms in a group of elderly patients with AF. PATIENTS AND METHODS: This cross-sectional study included 100 elderly patients (69 females, 31 males, mean age: 70.27 years) with AF. Standardized research instruments were used including the Tilburg Frailty Indicator (TFI) to assess FS, and two questionnaires to assess depression including the Geriatric Depression Scale (GDS), and the Hospital Anxiety Depression Scale (HADS). RESULTS: Mild FS was found in 38% and moderate FS in 29% of patients. Based on GDS scores, depression symptoms were found in 51% of patients' sample. Based on HADS scores, 20% of patients were found to have anxiety symptoms, and 28% revealed depression symptoms. Single-factor analysis demonstrated a significant positive correlation between HADS anxiety symptoms (r=0.492), HADS depression symptoms (r=0.696), and GDS score (r=0.673) on the one hand, and overall TFI frailty score on the other. Multiple-factor analysis identified overall GDS score, education, and lack of bleeding as significant independent predictors of TFI scores (p<0.05). CONCLUSION: FS is common in the population of elderly patients with AF. We found evidence for the association between symptoms of anxiety and depression and the incidence of FS in this group of patients. Due to the risk of consequences which may in part be irreversible, screening for FS is recommended.

Emotional see-saw affects rationality of decision-making: Evidence for metacognitive impairments.

This research investigated the cognitive mechanisms that underlie impairments in human reasoning triggered by the emotional see-saw technique. It has previously been stated that such manipulation is effective as it presumably induces a mindless state and cognitive deficits in compliant individuals. Based on the dual-system architecture of reasoning (system 2) and affective decision-making (system 1), we challenged the previous theoretical account by indicating that the main source of compliance is impairment of the meta-reasoning system when rapid affective changes occur. To examine this hypothesis, we manipulated affective feelings (system 1 processing) by violating participants' expectations regarding reward and performance in a go/no-go task in which individuals were to inhibit their responses to earn money. Aside from the go/no-go performance, we measured rationality (meta-reasoning system 2) in decision-making by asking participants to comply with a nonsensical request. We found that participants who were exposed to meta-reasoning impairments due to the emotional see-saw phenomenon exhibited mindless behavior.