Effects of electroconvulsive therapy on cortical thickness in depression: a systematic review.

OBJECTIVE: Electroconvulsive therapy (ECT) is one of the most studied and validated available treatments for severe or treatment-resistant depression. However, little is known about the neural mechanisms underlying ECT. This systematic review aims to critically review all structural magnetic resonance imaging studies investigating longitudinal cortical thickness (CT) changes after ECT in patients with unipolar or bipolar depression. METHODS: We performed a search on PubMed, Medline, and Embase to identify all available studies published before April 20, 2023. A total of 10 studies were included. RESULTS: The investigations showed widespread increases in CT after ECT in depressed patients, involving mainly the temporal, insular, and frontal regions. In five studies, CT increases in a non-overlapping set of brain areas correlated with the clinical efficacy of ECT. The small sample size, heterogeneity in terms of populations, comorbidities, and ECT protocols, and the lack of a control group in some investigations limit the generalisability of the results. CONCLUSIONS: Our findings support the idea that ECT can increase CT in patients with unipolar and bipolar depression. It remains unclear whether these changes are related to the clinical response. Future larger studies with longer follow-up are warranted to thoroughly address the potential role of CT as a biomarker of clinical response after ECT.

Depressive symptom complexes of community-dwelling older adults: a latent network model.

Late-life depression has multiple, heterogeneous clinical presentations. The aim of the study was to identify higher-order homogeneous clinical features (symptom complexes), while accounting for their potential causal interactions within the network approach to psychopathology. We analyzed cross-sectional data from community-dwelling adults aged 65-85 years recruited by the European MentDis_ICF65+ study (n = 2623, mean age 74, 49% females). The severity of 33 depressive symptoms was derived from the age-adapted Composite International Diagnostic Interview. Symptom complexes were identified using multiple detection algorithms for symptom networks, and their fit to data was assessed with latent network models (LNMs) in exploratory and confirmatory analyses. Sensitivity analyses included the Partial Correlation Likelihood Test (PCLT) to investigate the data-generating structure. Depressive symptoms were organized by the Walktrap algorithm into eight symptom complexes, namely sadness/hopelessness, anhedonia/lack of energy, anxiety/irritability, self-reproach, disturbed sleep, agitation/increased appetite, concentration/decision making, and thoughts of death. An LNM adequately fit the distribution of individual symptoms' data in the population. The model suggested the presence of reciprocal interactions between the symptom complexes of sadness and anxiety, concentration and self-reproach and between self-reproach and thoughts of death. Results of the PCLT confirmed that symptom complex data were more likely generated by a network, rather than a latent-variable structure. In conclusion, late-life depressive symptoms are organized into eight interacting symptom complexes. Identification of the symptom complexes of late-life depression may streamline clinical assessment, provide targets for personalization of treatment, and aid the search for biomarkers and for predictors of outcomes of late-life depression.

Poor sleep quality may contribute to dysfunctional illness perception, physical and emotional distress in hospitalised patients: results of a national survey of the Italian Society of Consultation-Liaison Psychiatry.

Distress associated with physical illness is a well-known risk factor for adverse illness course in general hospitals. Understanding the factors contributing to it should be a priority and among them dysfunctional illness perception and poor sleep quality may contribute to it. As poor sleep quality is recognised as a major risk factor for health problems, we aimed to study its association with illness perception and levels of distress during hospitalisation. This cross-sectional study included a consecutive series of 409 individuals who were hospitalised in medical and surgical units of different hospitals located throughout the Italian national territory and required an assessment for psychopathological conditions. Sleep quality was assessed with the Pittsburgh (Sleep Quality Index), emotional and physical distress with the Edmonton Symptom Assessment System (ESAS), and illness perception with the Brief Illness Perception Questionnaire (BIPQ). Differences between groups, correlations and mediations analyses were computed. Patients with poor sleep quality were more frequently females, with psychiatric comorbidity, with higher scores in the ESAS and BIPQ. Poor sleep quality was related to dysfunctional illness perception, and to both emotional and physical distress. In particular, by affecting cognitive components of illness perception, poor sleep quality may, directly and indirectly, predict high levels of distress during hospitalisation. Poor sleep quality may affect >70% of hospitalised patients and may favour dysfunctional illness perception and emotional/physical distress.Assessing and treating sleep problems in hospitalised patients should be included in the routine of hospitalised patients.

Violence Against Physicians in the Workplace: Trends, Causes, Consequences, and Strategies for Intervention.

PURPOSE: Violence against healthcare professionals has become an emergency in many countries. Literature in this area has mainly focused on nurses while there are less studies on physicians, whose alterations in mental health and burnout have been linked to higher rates of medical errors and poorer quality of care. We summarized peer-reviewed literature and examined the epidemiology, main causes, consequences, and areas of intervention associated with workplace violence perpetrated against physicians. RECENT FINDINGS: We performed a review utilizing several databases, by including the most relevant studies in full journal articles investigating the problem. Workplace violence against doctors is a widespread phenomenon, present all over the world and related to a number of variables, including individual, socio-cultural, and contextual variables. During the COVID-19 pandemic, incidence of violence has increased. Data also show the possible consequences in physicians' deterioration of quality of life, burnout, and traumatic stress which are linked to physical and mental health problems, which, in a domino effect, fall on patients' quality of care. Violence against doctors is an urgent global problem with consequences on an individual and societal level. This review highlights the need to undertake initiatives aimed at enhancing understanding, prevention, and management of workplace violence in healthcare settings.

Machine Learning and Non-Affective Psychosis: Identification, Differential Diagnosis, and Treatment.

PURPOSE OF REVIEW: This review will cover the most relevant findings on the use of machine learning (ML) techniques in the field of non-affective psychosis, by summarizing the studies published in the last three years focusing on illness detection and treatment. RECENT FINDINGS: Multiple ML tools that include mostly supervised approaches such as support vector machine, gradient boosting, and random forest showed promising results by applying these algorithms to various sources of data: socio-demographic information, EEG, language, digital content, blood biomarkers, neuroimaging, and electronic health records. However, the overall performance, in the binary classification case, varied from 0.49, which is to be considered very low (i.e., noise), to over 0.90. These results are fully justified by different factors, some of which may be attributable to the preprocessing of the data, the wide variety of the data, and the a-priori setting of hyperparameters. One of the main limitations of the field is the lack of stratification of results based on biological sex, given that psychosis presents differently in men and women; hence, the necessity to tailor identification tools and data analytic strategies. Timely identification and appropriate treatment are key factors in reducing the consequences of psychotic disorders. In recent years, the emergence of new analytical tools based on artificial intelligence such as supervised ML approaches showed promises as a potential breakthrough in this field. However, ML applications in everyday practice are still in its infancy.

The Italian validation of the Death and Dying Distress Scale.

OBJECTIVES: Death anxiety (DA), a condition characterized by fear, angst, or panic related to the awareness of one's own death, is commonly observed in advanced cancer patients. The aim of this study was to examine the psychometric properties of the Italian version of the Death and Dying Distress Scale (DADDS-IT) in a sample of patients with advanced cancer. METHODS: The sample included 200 Italian advanced cancer patients meeting eligibility criteria to access palliative care. Patients' levels of DA were assessed by using the DADDS-IT, while the levels of depression, anxiety, demoralization, spiritual well-being, and symptom burden were assessed using the Patient Health Questionnaire-9, the Generalized Anxiety Disorder-7, the Demoralization Scale, the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale, and the Edmonton Symptom Assessment System, respectively; Karnofsky Performance Status was used to measure functional impairment. Confirmatory factor analyses (CFA) of previous structures and exploratory factor analyses (EFA) were conducted. RESULTS: CFA revealed that none of the previous structures adequately fitted data from our sample. EFA revealed a 4-factor model comprising Finitude (α = 0.91), Regret (α = 0.86), Dying (α = 0.88), and Relational Burden (α = 0.73), accounting for the 77.1% of the variance. Dying subscore was higher in hospice patients than in those recruited in medical wards. SIGNIFICANCE OF RESULTS: The present study provides further evidence that DA is a condition that deserves attention and that DADDS-IT shows good psychometric properties to support its use in research and clinical settings.

Reflecting on meaning in an existential-reorientation group psychotherapy approach for cancer patients: A qualitative thematic analysis.

OBJECTIVE: The objectives of this study were to evaluate, in the Italian cultural context, breast cancer patients' main meaning themes related to the experience of the disease, on the one side, and to be part of an existentially oriented group intervention, on the other. METHOD: A short reorientation-existential (RET) group intervention, structured by using some tools and background from cognitive analytic therapy (CAT) and based on the meaning-centered psychotherapy (MCP) existential framework, was delivered to 29 breast cancer patients. The sessions were audio-recorded and transcribed verbatim, with the narratives from reflective exercises (meaning of the journey cancer, meaning of the journey of intervention) uploaded to computer software NVivo 11. Analysis of the transcripts emerged from reflective exercises on the personal meaning of cancer and the letters of meaning (goodbye letter) written by the patients to express the meaning of their experience in the group was conducted through the interpretative phenomenological analysis (IPA) framework. RESULTS: Four superordinate themes were identified in the exercise meaning of the experience of cancer, namely "sense of stigma and loneliness (the foreigner)," "guilt (unjust guilt and anticipatory guilt)," "reconsidering one's own life and nostalgia," and "rebirth (a new life, life after life)." Three superordinate themes were found in the meaning of the group experience in the letters, namely "togetherness and gratitude," "legacy," and "acceptance." SIGNIFICANCE OF RESULTS: The study confirmed that a short group intervention, based on the existentially oriented framework and delivered in a public clinical healthcare setting, was enriched by focusing on the personal meaning of cancer. Some themes, such as loneliness, nostalgia, and rebirth, emerged during reflection giving, in written letters to participants, the sense of the group therapeutic experience.

The Impact of COVID-19 Lockdowns in a Sample of Outpatients in a Mental Health Department of a Metropolitan Hospital in Milan.

Background and Objectives: Italy was the first country in Europe to face the coronavirus 2019 (COVID-19) pandemic and its consequences, which led to two phases of severe restrictions for its population. This study aims to estimate the connections between the trauma of the COVID-19 emergency and the clinical features of a sample of outpatients in a Milan Community Mental Health setting, comparing the first (April 2020) and second lockdowns (November 2020). Materials and Methods: The sample included 116 consecutive outpatients recruited in April 2020 and 116 in November 2020. The subjects were evaluated with Clinical Global Impression Severity (CGI-S), Brief Psychiatric Rating Scale (BPRS-18), and Impact of Event Scale-Revised (IES-R). Results: The IES-R identified 47.4% participants in April and 50% in November with clinical scores over the cut-off. The network analysis of BPRS-18 and IES-R depicted the connection among different symptoms; in April, Unusual Thought Content, Anxiety, and Somatic Concern represented the most central items, and the strongest connections were found between Uncooperativeness and Hostility, Blunted Affect and Emotional Withdrawal, and IES-Intrusion and IES-Arousal. In the November group, the most central items were represented by Conceptual Disorganization and Emotional Withdrawal, whereas the strongest connections were found between IES-Arousal and IES-Intrusion, Excitement and Grandiosity, and Unusual Thought Content and Conceptual Disorganization. Conclusions: Our findings show continued high distress levels and increased psychological burdens during the second phase of restrictions; this could be described as "pandemic fatigue", a general psychological weariness due to pandemic-related restrictions, as well as a lack of motivation to comply with them. As mental health professionals, our mission during these difficult times has been to keep community psychiatry services accessible, with particular regard to vulnerable and marginalized populations.

Knowledge about risk factors for cancer and cancer risk behavior among patients with severe mental illness.

OBJECTIVE: To examine knowledge about, perception of and current risk factors for cancer, among patients with severe mental illness (SMI) and to compare these variables with patients without SMI. METHODS: A series of patients affected by SMI (i.e., schizophrenia spectrum disorders, bipolar disorders and severe personality disorders) and a matched (gender, age) control group of primary care attenders were assessed, by using an ad hoc semi-structured interview and a short true/false 17-item questionnaire, about family history of cancer, cancer risk-related lifestyles, personal perception and knowledge of risk for cancer. RESULTS: Patients with SMI (n = 185, mainly schizophrenia spectrum disorders, 48%, and mood disorders, 33%) significantly differed from primary care attenders (n = 173) for: lower participation to occult stool blood screening test, Pap smear test and mammography; higher prevalence of current and past smoking habits; lower awareness towards their own physical symptoms and their perception of risks for cancer; lower physical exercise practicing; lower knowledge about risk factors for cancer (e.g. familiarity for cancer, smoke-habits, breast and uterine cancer). CONCLUSIONS: Patients suffering from SMI had higher at-risk behavior for cancer and showed fewer concerns and less knowledge about risk for cancer than primary care attendees. These findings can guide to implement screening for cancer (e.g., Pap test, blood) and to design evidence-based interventions to reduce cancer risk (e.g., educational and behavioral change for smoking cessation, dietary habits) among patients with SMI.

Hostility in cancer patients as an underexplored facet of distress.

OBJECTIVE: In the present study, we aimed to assess hostility and to examine its association with formal psychiatric diagnosis, coping, cancer worries, and quality of life in cancer patients. METHODS: The World Health Organization (WHO) Composite International Diagnostic Interview (CIDI) to make an ICD-10 (International Classification of Disease) psychiatric diagnosis was applied to 516 cancer outpatients. The patients also completed the Brief Symptom Inventory-53 to assess hostility (BSI-HOS), and the Mini-Mental Adjustment to cancer scale (Mini-MAC). A subset of patients completed the Cancer Worries Inventory (CWI), the Openness Scale, and the Quality of Life Index. RESULTS: By analyzing the distribution of the responses 25% of the patients had moderate and 11% high levels of hostility, with about 20% being BSI-HOS "cases." Hostility was higher in patients with a formal ICD-10 psychiatric diagnosis (mainly major depression, other depressive disorders, anxiety disorders) than patients without ICD-10 diagnosis. However, about 25% of ICD-10-non cases also had moderate-to-high hostility levels. Hostility was associated with Mini-MAC hopelessness and anxious preoccupation, poorer quality of life, worries (mainly problems sin interpersonal relationships), and inability to openly discuss these problems within the family. CONCLUSIONS: Hostility and its components should be considered as dimensions to be more carefully explored in screening for distress in cancer clinical settings for its implications in negatively impacting on quality of life, coping and relationships with the family, and possibly the health care system.

Mortality from cancer in people with severe mental disorders in Emilia Romagna Region, Italy.

OBJECTIVE: To examine cancer-related mortality in patients with severe mental disorders (SMI) in the Emilia Romagna (ER) Region, Northern Italy, during the period 2008-2017 and compare it with the regional population. METHODS: We used the ER Regional Mental Health Registry identifying all patients aged ≥18 years who had received an ICD-9CM system diagnosis of SMI (i.e., schizophrenia or other functional psychosis, mania, or bipolar affective disorders) during a 10-year period (2008-2017). Information on deaths (date and causes of death) were retrieved through the Regional Cause of Death Registry. Comparisons were made with the deaths and cause of deaths of the regional population over the same period. RESULTS: Amongst 12,385 patients suffering from SMI (64.1% schizophrenia spectrum and 36.9% bipolar spectrum disorders), 24% (range 21%-29%) died of cancer. In comparison with the general regional population, the mortality for cancer was about 50% higher among patients with SMI, irrespective if affected by schizophrenia or bipolar disorders. As for the site-specific cancers, significant excesses were reported for stomach, central nervous system, respiratory, and pancreas cancer with a variability according to psychiatric diagnosis and gender. CONCLUSIONS: Patients suffering from SMI had higher mortality risk than the regional population with some differences according to cancer type, gender, and psychiatric diagnosis. Proper cancer preventive and treatment interventions, including more effective risk modification strategies (e.g., smoking cessation, dietary habits) and screening for cancer, should be part of the agenda of all mental health departments in conjunction with other health care organizations, including psycho-oncology.

Aggressive Behavior and Psychiatric Inpatients: a Narrative Review of the Literature with a Focus on the European Experience.

PURPOSE OF REVIEW: We summarized peer-reviewed literature on aggressive episodes perpetrated by adult patients admitted to general hospital units, especially psychiatry or emergency services. We examined the main factors associated with aggressive behaviors in the hospital setting, with a special focus on the European experience. RECENT FINDINGS: A number of variables, including individual, historical, and contextual variables, are significant risk factors for aggression among hospitalized people. Drug abuse can be considered a trans-dimensional variable which deserves particular attention. Although mental health disorders represent a significant component in the risk of aggression, there are many factors including drug abuse, past history of physically aggressive behavior, childhood abuse, social and cultural patterns, relational factors, and contextual variables that can increase the risk of overt aggressive behavior in the general hospital. This review highlights the need to undertake initiatives aimed to enhance understanding, prevention, and management of violence in general hospital settings across Europe.

Insomnia, Fatigue, and Depression: Theoretical and Clinical Implications of a Self-reinforcing Feedback Loop in Cancer.

Introduction: Insomnia is emerging as a modifiable major risk factor for mental and physical problems, including cancer, and it may contribute to cancer-related fatigue and depression. Since both fatigue and depression may favor insomnia as well, we may hypothesize a self-reinforcing feedback loop among these factors in cancer. Methods: With the aim of discussing this hypothesis, PubMed, PsycINFO, and Embase electronic databases were searched for literature published according to the PRISMA method with several combinations of terms such as "insomnia" and "cancer" and "fatigue" and "depression". On this basis, we conducted a narrative review about theoretical aspects of insomnia in the context of cancer and about its role in cancer-related fatigue and depression. Results: Twenty-one papers were selected according to inclusion/exclusion criteria. Insomnia is frequent in cancer, and it is associated with cancer-related comorbid conditions such as emotional distress, depressive symptoms, and cancer-related fatigue. The hyperactivation of stress and inflammatory systems, which sustain insomnia, may contribute to cancer-related depression and fatigue. A deleterious feedback loop may be created, and it may perpetuate not only insomnia but also these cancer-related comorbid conditions. Conclusion: Although the understanding of the causal relationship between insomnia/ depression/fatigue in individuals with cancer is limited, we may hypothesize that these symptoms can exacerbate and maintain each other. When insomnia is established in cancer, it may lead to a vicious cycle with fatigue and depression and may contribute to adverse cancer outcomes. Interventions targeting insomnia could provide a promising approach not only for insomnia but also for cancer-related symptoms among cancer patients.

Association between Type-D Personality and Affective (Anxiety, Depression, Post-traumatic Stress) Symptoms and Maladaptive Coping in Breast Cancer Patients: A Longitudinal Study.

Background: Type-D (distressed) personality has not been prospectively explored for its association with psychosocial distress symptoms in breast cancer patients. Objective: The objective of the study was to test the hypothesis that Type-D personality can be associated with psychosocial distress variables in cancer over a 2-point period (6 month-follow-up). Aims: The aim of the study was to analyze the role of Type-D personality in relation to anxiety, depression, post-traumatic stress symptoms, general distress, and maladaptive coping among cancer patients. Methods: 145 breast cancer patients were assessed within 6 months from diagnosis (T0) and again 6 months later (T1). The Type-D personality Scale, the Hospital Anxiety and Depression Scale, Depression subscale (HAD-D), the Brief Symptom Inventory (BSI-18) Anxiety subscale, the Distress Thermometer (DT), the Post-traumatic Symptoms (PTS) Impact of Event Scale (IES), and the Mini Mental Adjustment to Cancer (Mini-MAC) Anxious Preoccupation and Hopelessness scales were individually administered at T0 and T1. Results: One-quarter of cancer patients met the criteria for Type-D personality, which was stable over the follow-up time. The two main constructs of Type-D personality, namely social inhibition (SI) and negative affectivity (NA), were related to anxiety, depression, PTS, BSI-general distress and maladaptive coping (Mini-MAC anxious preoccupation and hopelessness). In regression analysis, Type-D SI was the most significant factor associated with the above-mentioned psychosocial variables, both at T0 and T1. Conclusion: Likewise other medical disorders (especially cardiology), Type-D personality has been confirmed to be a construct significantly related to psychosocial distress conditions and maladaptive coping that are usually part of assessment and intervention in cancer care. More attention to personality issues is important in oncology.

Quality of life, level of functioning, and its relationship with mental and physical disorders in the elderly: results from the MentDis_ICF65+ study.

BACKGROUND: An ageing population worldwide needs to investigate quality of life (QoL) and level of functioning (LoF) in the elderly and its associated variables. We aimed to study the relationship between Quality of Life (QoL) and Level of Functioning (LoF) in an elderly population in Europe. METHOD: As part of the Ment_Dis65+ European Project, 3142 community-dwelling adults aged 65-84 years in six countries were assessed by using the adaptation for the elderly of the Composite International Diagnostic Interview (CIDI65+) to provide psychiatric diagnosis according to the International Classification of Diseases (10th edition) (ICD-10 Classification of Mental and Behavioural Disorders). Socio-demographic and clinical interviews, and two self-report tools, the World Health Organization QoL assessment (WHO QoL BREF), to assess QoL, and the WHO Disability Assessment Schedule -II (WHODAS-II), to assess LoF, were also administered. RESULTS: Most subjects reported good levels of QoL (56.6%) and self-rated health (62%), with no or mild disability (58.8%). There was a linear decrease of the QoL and the LoF by increase of age. Elderly with ICD-10 mental disorder (e.g. somatoform, affective and anxiety disorders) had poorer QoL and lower LoF. There were a number of predictors of lower levels of QoL and disability, including both socio-demographic variables (e.g. male gender, increase in age, poor financial situation, retirement, reduced number of close significant others), ICD-10 psychiatric diagnosis (mainly anxiety, somatoform disorders) and presence of medical disorders (mainly heart and respiratory diseases). CONCLUSIONS: The study indicates that QoL and LoF were quite acceptable in European elderly people. A series of variables, including psychiatric and somatic disorders, as well as socio-demographic factor influenced in a negative way both QoL and LoF. More specific links between mental health, social and health services dedicated to this segment of the population, should be implemented in order to provide better care for elderly people with conditions impacting their QoL and functioning.

Italian Validation of the Screen for Cognitive Impairment in Psychiatry.

Cognitive impairments have profound implications for the management of severe mental disorders; however, they are rarely assessed in everyday clinical practice due to constraints in time, resource and expertise. Novel and short instruments, such as the Screen for Cognitive Impairment in Psychiatry (SCIP), which overcome such limitations are greatly needed. The study aims to assess the validity and reliability, among healthy subjects, of the Italian translation of the SCIP, a brief, accessible tool to detect cognitive impairments among individuals suffering from mental disorders, as the first step to validate the instrument in clinical settings. One-hundred and twenty healthy subjects completed two of the three alternative forms of the SCIP. Cronbach Alpha (0.70) supported the reliability of the SCIP scores. Correlation coefficients supported the test-retest reliability of the tool. Learning effects were observed despite the use of alternative forms. Factor analysis indicated a two-factor solution explaining 55.4% of the total variance: the first factor ("memory") loading for VLT-I and VLT-D and less for WMT; the second factor ("executive function") loading for VFT and PST and less for WMT. The study proved the validity and reliability of the Italian version of the SCIP as a reliable and simple instrument to screen for cognitive impairment in the general population.

Traditional versus progressive robot-assisted gait training in people with multiple sclerosis and severe gait disability: study protocol for the PROGR-EX randomised controlled trial.

Gait disorders are the most frequent symptoms associated to multiple sclerosis (MS). Robot-assisted gait training (RAGT) in people with MS (PwMS) has been proposed as a possible effective treatment option for severe motor disability without significant superiority when compared to intensive overground gait training (OGT). Furthermore, RAGT at high intensity may enhance fatigue and spasticity. This study aims to evaluate the effects of a low-intensity RAGT at progressively increasing intensity compared to conventional RAGT and OGT in PwMS and moderate to severe walking impairment. 24 PwMS will be recruited and assigned to one of the three treatment groups: low-intensity RAGT at progressively increasing intensity, conventional RAGT and OGT. All participants will receive 3-weekly treatment sessions of 3 hours each for 4 weeks. In the first 2 hours of treatment, all participants will receive a rehabilitation programme based on stretching exercises, muscle strengthening and educational interventions. During the last hour, subjects will undergo specific gait training according to the assignment group. Outcomes will be assessed before and after treatment and at 3-month follow-up. The primary outcome is walking speed. Secondary outcomes include mobility and balance, psychological measures, muscle oxygen consumption, electrical and haemodynamic brain activity, urinary biomarkers, usability, and acceptability of robotic devices for motor rehabilitation. The results of this study will provide a safe, affordable and non-operator-dependent, intervention for PwMS. Results in terms of functional, psychological, neurophysiological and biological outcomes will confirm our hypothesis. The study's trial registration number: NCT06381440.

Dapaglifozin on Albuminuria in Chronic Kidney Disease Patients with FabrY Disease: The DEFY Study Design and Protocol.

Fabry disease (FD) is a rare genetic disorder caused by a deficiency in the α-galactosidase A enzyme, which results in the globotriaosylceramide accumulation in many organs, including the kidneys. Nephropathy is a major FD complication that can progress to end-stage renal disease if not treated early. Although enzyme replacement therapy and chaperone therapy are effective, other treatments such as ACE inhibitors and angiotensin receptor blockers can also provide nephroprotective effects when renal damage is also established. Recently, SGLT2 inhibitors have been approved as innovative drugs for treating chronic kidney disease. Thus, we plan a multicenter observational prospective cohort study to assess the effect of Dapagliflozin, a SGLT2 inhibitor, in FD patients with chronic kidney disease (CKD) stages 1-3. The objectives are to evaluate the effect of Dapagliflozin primarily on albuminuria and secondarily on kidney disease progression and clinical FD stability. Thirdly, any association between SGT2i and cardiac pathology, exercise capacity, kidney and inflammatory biomarkers, quality of life, and psychosocial factors will also be evaluated. The inclusion criteria are age ≥ 18; CKD stages 1-3; and albuminuria despite stable treatment with ERT/Migalastat and ACEi/ARB. The exclusion criteria are immunosuppressive therapy, type 1 diabetes, eGFR < 30 mL/min/1.73 m2, and recurrent UTIs. Baseline, 12-month, and 24-month visits will be scheduled to collect demographic, clinical, biochemical, and urinary data. Additionally, an exercise capacity and psychosocial assessment will be performed. The study could provide new insights into using SGLT2 inhibitors for treating kidney manifestations in Fabry disease.

Psychosocial determinants of healthcare use costs in kidney transplant recipients.

Introduction: Psychosocial factors frequently occur in kidney transplant recipients (KTRs), leading to behavioral alterations and reduced therapeutic adherence. However, the burden of psychosocial disorders on costs for KTRs is unknown. The aim of the study is to identify predictors of healthcare costs due to hospital admissions and emergency department access in KTRs. Methods: This is a longitudinal observational study conducted on KTRs aged >18 years, excluding patients with an insufficient level of autonomy and cognitive disorder. KTRs underwent psychosocial assessment via two interviews, namely the Mini-International Neuropsychiatric Interview 6.0 (MINI 6.0) and the Diagnostic Criteria for Psychosomatic Research Interview (DCPR) and via the Edmonton Symptom Assessment System Revised (ESAS-R) scale, a self-administrated questionnaire. Sociodemographic data and healthcare costs for hospital admissions and emergency department access were collected in the 2016-2021 period. Psychosocial determinants were as follows: (1) ESAS-R psychological and physical score; (2) symptomatic clusters determined by DCPR (illness behavior cluster, somatization cluster, and personological cluster); and (3) ICD diagnosis of adjustment disorder, anxiety disorder, and mood disorder. A multivariate regression model was used to test the association between psychosocial determinants and total healthcare costs. Results: A total of 134 KTRs were enrolled, of whom 90 (67%) were men with a mean age of 56 years. A preliminary analysis of healthcare costs highlighted that higher healthcare costs are correlated with worse outcomes and death (p < 0.001). Somatization clusters (p = 0.020) and mood disorder (p < 0.001) were positively associated with costs due to total healthcare costs. Conclusions: This study showed somatization and mood disorders could predict costs for hospital admissions and emergency department access and be possible risk factors for poor outcomes, including death, in KTRs.