Mood Disorder Questionnaire Positivity in Systemic Lupus Erythematosus and Other Chronic Diseases including Screen Bipolar Disorders or Rhythm and Energy Dysregulation Syndromes (DYMERS).

Introduction: This study explores the issue of paper-and-pencil screening tests for bipolar disorder, often leading to false positives. It discusses hypotheses that connect MDQ positivity with sleep disorders, a decline in health-related quality of life, and the impact of the COVID-19 pandemic on mood disorders. The study proposes that MDQ identifies a "Dysregulation of Mood, Energy, and Social Rhythms Syndrome" (DYMERS), indicating a stress-related condition. It aims to investigate the association between MDQ positivity and systemic lupus erythematosus (SLE) in comparison to other chronic disorders. Methods: This case-control study, conducted from April 2019 to February 2020, investigated MDQ positivity in patients with SLE. Ethical approvals were obtained, and statistical analysis was used for data assessment. Results: This is a case-controlled study where MDQ positivity was significantly higher in systemic lupus erythematosus cases than controls. The analysis compared gender, age, and the presence of depressive episodes between MDQ-positive and MDQ-negative cases, revealing some differences but no significant variations. Interestingly, no association with high prednisone or biologics use was observed. The frequency of MDQ positivity in systemic lupus erythematosus was compared to other chronic pathologies, revealing varying associations with each condition. Conclusion: This study reveals a high rate of (MDQ) positivity in systemic lupus erythematosus (SLE), associated with the risk of bipolar disorder in SLE. Notable discrepancies in MDQ positivity risk factors between SLE and bipolar disorder are observed. The study emphasizes the ability of MDQ to identify a distinct syndrome characterized by rhythm dysregulation, posing a risk for bipolar disorder and other disorders.

A Virtual Reality Cognitive Stimulation Program as an Effective Tool Against Residual/Prodromal Depressive Symptoms in Bipolar Disorders.

Background: Bipolar disorder (BD) is a severe psychiatric illness characterized by a chronic course and recurrent episodes, including residual depressive symptoms even during euthymic phases. These symptoms, although not meeting criteria for a depressive episode, are linked to relapse risk and impaired social functioning. This study aims to assess whether Virtual Reality Cognitive Remediation Training reduces depressive symptoms below the clinical threshold in individuals with BD. Methods: This post hoc analysis focuses on the secondary outcome (PHQ9) of a randomized-controlled trial. Participants were recruited from the Center of Liaison Psychiatry and Psychosomatics in Italy. The experimental group received Virtual Reality Cognitive Remediation, while the control group received standard treatment Results: Data from 39 individuals in the experimental group and 25 in the control group were analyzed. A greater reduction in PHQ-9 scores (>9) was observed in the experimental group (71.8% to 48.7%) compared to the control group. Significant improvements in total PHQ-9 scores and specific symptoms were noted in the experimental group compared to the control group. Conclusions: The study highlights the significant impact of virtual reality intervention on reducing depressive symptoms in bipolar disorder. This promising outcome underscores the potential preventive role of cognitive stimulation in relapse prevention. The intervention could offer valuable benefits for both treatment and prevention strategies in bipolar disorder.

Prevalence and Risk by Age and Sex of Sleep Dysregulation and Depressive Episodes in Bipolar and Depressive Disorders in a Community Survey in Sardinia, Italy.

Background/Objectives: Sleep disturbances often accompany mood disorders and persistent insomnia after mood symptoms have resolved may be a marker of poor outcome. The association between sleep symptoms and mood disorders seems to change with age and sex. This study aims to assess the frequency of depressive episodes and sleep disorders in the general population through an agile screening questionnaire and to evaluate the association of depressive episodes and sleep symptoms by sex and age categories. Methods: 774 women and 728 men from Sardinia aged > 16 years old were enrolled. The Patient Health Questionnaire (PHQ-9) was administered through a computer-assisted telephonic interview. Results: The frequency of depressive episodes was double in women (10.6% vs. 4.4%; p < 0.0001), with the highest values in women > 75 yo (17.4%). The frequency of sleep dysregulation was double in women (18.7% vs. 9.6%; p < 0.0001), with the highest values in women > 75 yo (35.9%) and the lowest in the group of men > 75 yo. The group of young males showed the lowest frequency of depressive episodes (1.4%) and a frequency of sleep dysregulation (9.1%) similar to that of the other groups of age and sex. Sleep dysregulation without depressive episodes presented a higher distribution in the elderly, both in males (20.7%) and in females (18.5%). No significative differences were found across sex and age groups in the distribution of depressive episodes without sleep dysregulation. Conclusions: The use of an agile screener such as PHQ9 in the general population and/or in populations at risk can be a valuable tool in finding those individuals in whom sleep dysregulation may represent an early warning signal, one that may be thoroughly evaluated to identify and treat possible sleep disorders early.

Reliability and Factor Structure of the Well-Being and Respect for Human Rights Questionnaire in Measuring Caregivers' Perception.

Background: This study has investigated perceptions of respect for users' rights among informal caregivers in mental healthcare settings, aligning with the guidelines outlined in the United Nations Convention on the Rights of Persons with Disabilities (CRPD) and the World Health Organization QualityRights initiative. The study has employed the questionnaire on Well-being at Work and Respect for Human Rights (WWRR) among informal caregivers and tested whether the questionnaire's factor structure among informal caregivers aligns with that of users and health workers. We have hypothesized that informal caregivers prioritize users' needs and rights over the care context's climate. Methods: This was a cross-sectional study. The "Well-being at Work and Respect for Human Rights" questionnaire was distributed to 100 caregivers in 4 territorial mental health facilities in Sardinia, Italy. Confirmatory Factor Analysis (CFA) was utilized to assess the participants' responses. Results: Participants reported high satisfaction with their relatives' treatment, perceiving a high level of respect for human rights among users and healthcare professionals. However, they highlighted insufficient resources for services, particularly the need for additional staff. CFA revealed that a scale with the first five items demonstrated good reliability, convergent validity, and discrimination. Mean scores indicated high satisfaction and perception of respect for human rights across the sample, with no significant differences by age or gender. Conclusion: Satisfaction with users' rights is closely correlated with other factors comprising the notion of organizational well-being within a healthcare service.

Improving Quality of Life in Bipolar Disorders with an Immersive Virtual Reality Remediation Training Randomized Controlled Trial (RCT).

Background: Health-related quality of life (H-QoL) is a critical measure in bipolar disorder (BD). Recent trials using virtual reality (VR) have shown potential in improving H-QoL. However, VR's effect on the H-QoL of people with BD needs to be further explored. Methods: This study involved a secondary analysis of a feasibility randomized controlled trial, focusing on "quality of life". Participants (aged 18-75) diagnosed with bipolar disorder were randomized into two groups. The experimental group used the CEREBRUM VR app, while the control group received the usual care. Quality of life was assessed using the Short-Form Health Survey (SF-12). Results: A total of 39 individuals in the experimental group and 25 in the control group represent the final samples. The results showed a greater improvement in the SF-12 total score in the experimental group (8.7%) compared to the control group (F = 66.851 p < 0.0001), specifically in the dimension of physical activity limitation, emotional impact, concentration, pain, calmness, energy levels, discouragement, and social activities. Conclusions: This study demonstrated an improvement in QoL for individuals with BD following a VR intervention. As a feasibility study, this secondary outcome needs to be confirmed by further phase III studies. If confirmed, VR could offer valuable rehabilitation tools and insights into the pathogenesis and treatment of BD.

Depression during the COVID pandemic in La Manouba Governorate, Tunisia: A community survey.

BACKGROUND: It is difficult to quantify the impact of the COVID-19 pandemic on mental health as many community surveys have limited quality, rely on screening tests to measure mental health conditions and distress, and often use convenience samples. Moreover, robust surveys come mainly from high-income countries. AIM: To measure the prevalence of depressive disorders with onset during the pandemic in a community of a Lower-Middle-income country (LMIC)-Tunisia. METHODS: Clinical semi-structured face-to-face interviews were carried out during the pandemic (September-December 2021) by medical doctors among a representative sample of the general population in the governorate of La Manouba, Tunisia. Psychiatric diagnoses were established according to DSM-IV. RESULTS: The prevalence of Major Depressive Disorder (MDD) started or recurred after the pandemic was 5.66%. The factors associated with MDD were loss of job and considerably diminished income due to the pandemic (OR = 2.1, 95% CI [1.5, 2.9]) and the perception of having the family's financial situation below the Tunisian average (OR = 2.3, 95% CI [1.7, 3.2]). Female sex, marital status as separated/divorced, and having a COVID-19 infection were associated with MDD only in the overall sample and urban areas, but not in rural areas. Age and having loved ones who passed away due to COVID-19 were not associated with MDD. CONCLUSION: In Tunisia, the pandemic seems to have increased the risk of depression in people experiencing a precarious financial situation, also due to the pre-existing economic crisis. Specific local level factors, such as not establishing a rigid lockdown for an extended period, may have protected young people and allowed for better mourning in families suffering the loss of a loved one.

The Impact on Anxiety Symptoms of an Immersive Virtual Reality Remediation Program in Bipolar Disorders: A Randomized Clinical Trial.

Background: The objective of this work is to investigate the effectiveness of a cognitive remediation intervention on anxiety symptoms in people with bipolar disorder and the therapeutic effect on people whose anxiety symptoms were above the threshold for a screener and whose comorbidity could be identified as an anxiety disorder. Methods: The experimental intervention included 24 sessions (around 45 min each), two for each week over three months. The entire program was inspired by user-centered rehabilitation principles in a recovery-oriented perspective and an approach to bipolar disorder in an evolutionary and non-discriminating vision. The primary outcomes measure the score of the Zung Self-Rating Anxiety Scale (SAS), hypothesizing a higher decrease in the experimental group than in the control group. The survey has been conducted per the CONSORT guidelines for feasibility studies. Results: We evaluate a decrease in the overall SAS score from T0 to T1 to be higher in the experimental group compared to the control group, indicating an improvement in anxiety symptoms (p < 0.0001). Conclusions: The study suggests that virtual reality could have a role in treating anxiety symptoms and disorders in young adults with bipolar disorders or anxiety symptoms in people with hyperactivity and novelty-seeking behaviorsunder stress and high risk for bipolar disorder.

Improving Social and Personal Rhythm Dysregulation in Young and Old Adults with Bipolar Disorder: Post-Hoc Analysis of a Feasibility Randomized Controlled Trial Using Virtual Reality-Based Intervention.

Introduction: Rehabilitative interventions employing technology play a crucial role in bipolar disorder (BD) treatment. The study aims to appraise the virtual reality (VR)-based cognitive remediation (CR) and the interpersonal rhythm approaches to treatment outcomes of BD across different age groups. Methods: Post-hoc analysis of a 12-week randomizedcontrolled cross-over feasibility trial involving people with mood disorders (BD, DSM-IV) aged 18-75 years old: thirty-nine exposed to the experimental VR-based CR vs 25 waiting list controls. People with BD relapse, epilepsy or severe eye diseases (due to the potential VR risks exposure) were excluded. Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) was used to measure the outcome. Results: Cases and controls did not statistically significantly differ in age and sex distributions. Personal rhythm scores improved over the study follow-up in the experimental vs the control group (APC = 8.7%; F = 111.9; p < 0.0001), both in young (18-45 years) (APC = 5.5%; F = 70.46; p < 0.0001) and, to a lesser extent, older (>46 years) adults (APC = 10.5%; F = 12.110; p = 0.002). Conclusions: This study observed improved synchronization of personal and social rhythms in individuals with BD after a virtual reality cognitive remediation intervention, particularly in social activity, daily activities, and chronotype, with greater benefits in the younger population.

Heart Rate Variability Biofeedback Efficacy on Fatigue and Energy Levels in Fibromyalgia: A Secondary Analysis of RCT NCT0412183.

Background: Fibromyalgia syndrome (FMs) is a chronic condition characterized by widespread musculoskeletal pain and a range of complex symptoms, with chronic fatigue being a central feature significantly impacting daily life. The aim of this study was to analyze the secondary outcomes, specifically those related to perceived energy and fatigue symptoms in a randomized controlled trial (RCT) assessing the efficacy of heart rate variability biofeedback (HRV-BF) as an adjunctive treatment for FMs. Methods: Sixty-four FMs patients were randomly assigned to either receive 10 HRV-BF training sessions alongside standard pharmacological therapy (experimental group) or standard therapy alone for 10 weeks (control group). For this secondary analysis, potential improvements in specific items were evaluated regarding perceived energy (Item 10 of the Short-Form Health Survey), the ability to walk and climb stairs (Item 7 and Item 11 of the Fibromyalgia Impact Questionnaire, respectively), and the impact of pain on movement ability (Item 17 of the Bodily and Emotional Perception of Pain). Results: The experimental group demonstrated an improvement in the perception of energy, the ability to walk, and the impact of pain on movement ability. However, the same improvement was not observed in the ability to climb stairs. Conclusions: Fatigue assessment has emerged as a crucial factor for evaluating treatment efficacy in FMs and related conditions linked to altered energy levels, such as bipolar depression, and can offer valuable insights for precisely guiding HRV-BF treatments. ClinicalTrials.gov with code: NCT04121832.

An e-Health Psychoeducation Program for Managing the Mental Health of People with Bipolar Disorder during the COVID-19 Pandemic: A Randomized Controlled Study.

Background: Social rhythm dysregulation has been identified as a determining factor in bipolar disorder (BD) relapses. It directly impacts individuals' quality of life (QoL). This study aims to present preliminary data on the efficacy of an e-health psychoeducational intervention for BD for improving clinical outcomes. Methods: This study used an open-label, crossover, randomized controlled trial design. The inclusion criteria consisted of a BD diagnosis, affiliation with the Consultation Psychiatry and Psychosomatic Center at the University Hospital in Cagliari, Italy, age over 18, and the obtaining of informed consent. Anxiety and depressive symptoms, QoL, and social and biological rhythms were measured using standardized instruments validated in Italian. Results: A total of 36 individuals were included in the experimental group (EG) and 18 in the control group (CG). The final sample consisted of 25 in the EG and 14 in the CG. A statistically significant improvement in QoL was found in the EG post-treatment (p = 0.011). Significant correlations were found between QoL and the dysregulation of biorhythms in the EG at T0 (p = 0.0048) and T1 (p = 0.0014). Conclusions: This study shows that, during extreme distress, an e-health group psychoeducation intervention for people with BD could significantly improve the perception of QoL. The results must be confirmed by studies conducted with larger-sized samples.

The long-term adherence following the end of Community Treatment Order: A systematic review.

BACKGROUND: The community treatment order (CTO) is designed to deliver mental healthcare in the community and has been introduced in around 75 jurisdictions worldwide. It constitutes a legal obligation in which individuals with severe mental illness must adhere to out-of-hospital treatment plans. Despite intense criticism and the debated nature of published evidence, it has emerged as a clinical and policy response to frequent hospital readmissions and to enhance adherence in cases where there is refusal of pharmacological treatments. This systematic review outlines findings on CTO long-term adherence, after mandatory outpatient treatment has ended, in studies that include people with psychiatric disorders. METHOD: Following PRISMA guidelines, we performed a review of published articles from PubMed, PsycINFO, EMBASE, and CINAHL up to January 15, 2023. We included studies that assessed adherence after CTO ends. The study is registered with PROSPERO number CRD42022360879. RESULTS: Six independent studies analyzing the main indicators of long adherence: engagement with services and medication adherence, were included. The average methodological quality of the studies included is fair. Long-term adherence was assessed over a period ranging from 11 to 28 months. Only two studies reported a statistically significant improvement. Regarding the remaining studies, no positive correlation was observed, except for certain subgroup samples, while in one study, medication adherence decreased. CONCLUSION: Scientific evidence supporting the hypothesis that CTO has a positive role on long-term adherence post-obligation is currently not sufficient. Given the importance of modern recovery-oriented approaches and the coercive nature of compulsory outpatient treatment, it is necessary that future studies ensure the role of CTO in effectively promoting adherence.

The efficacy of heart rate variability biofeedback training on sleep disorders and impact of fibromyalgia: Results of a phase II randomized controlled trial.

OBJECTIVE: Fibromyalgia syndrome (FMs) is a chronic, musculoskeletal pain disorder characterized by sleep disturbances, fatigue, and cognitive dysfunction. Heart rate variability biofeedback (HRV-BF) aiming to improve self-regulation and strengthen the parasympathetic nervous system has been shown to be effective in several pain syndromes, but its efficacy in FMs has not been adequately investigated. This Phase II trial aimed to assess the feasibility and preliminary measurement of the improvement induced by HRV-BF in FMs. METHODS: Sixty-four patients with FMs were recruited. Patients were randomly assigned to either the experimental group (EG) or the control group (CG). The EG received 10 HRV-BF training sessions in addition to pharmacological standard therapy. The CG received standard therapies for 10 weeks. The FMs impact on daily life, sleep regularity, sense of coherence, depression symptoms and pain has been assessed as primary outcomes, quality of life as secondary. RESULT: 23 (71.9%) of EG patients completed the intervention and 20 (62.5%) of the CG were re-evaluated at time T1. No side effects were reported. It was not found any statistical differences between groups over time in primary and secondary outcomes. CONCLUSIONS: The HRV-BF intervention did not demonstrate efficacy in both primary and secondary outcomes. However, it is quite feasible in terms of drop-out rate and side effects. Further studies with larger sample sizes are needed to determine its actual efficacy. CLINICALTRIALS: gov with code: NCT04121832.

The Stability of Social and Behavioral Rhythms and Unexpected Low Rate of Relevant Depressive Symptoms in Old Adults during the COVID-19 Pandemic.

Background: The disruption of social rhythms was found to be associated with depressive disorders during the COVID-19 pandemic; lower rates of these disorders were surprisingly found in old adults. The present study aims to verify the stability of social rhythms during lockdown in a sample of elderly people. Methods: Controlled cohort study (secondary analyses) of a previous randomized-controlled trial with the first evaluation in April 2019 (T0) and then 48 weeks later (T1) during the lockdown. The regulation of social and behavioral rhythms was measured through the Brief Social Rhythms Scale (BSRS); the Patient Health Questionnaire-9 (PHQ9) was adopted to detect relevant depressive symptoms. Results: 93 elderlies (73.36 ± 4.97 years old, 50.5% females) were evaluated at T0 and T1. Neither the total score of BSRS nor any of the 10 items showed a statistically significant difference comparing the two survey periods. The frequency of relevant depressive symptoms was 5.3% at T0 and 6.4% at T1 (OR = 0.8, CI95% 0.2-24). Conclusions: Among elderlies who did not show an increased risk of depression during the lockdown, social and behavioral rhythms remained exceptionally stable during the same period. Considering previous evidence about rhythms dysregulation preceding depression, their stability may be considered a factor of resilience.

Quality of Life in Systemic Lupus Erythematosus and Other Chronic Diseases: Highlighting the Amplified Impact of Depressive Episodes.

BACKGROUND: Extensive research has explored SLE's impact on health-related quality of life (H-QoL), especially its connection with mental wellbeing. Recent evidence indicates that depressive syndromes significantly affect H-QoL in SLE. This study aims to quantify SLE's impact on H-QoL, accounting for comorbid depressive episodes through case-control studies. METHODS: A case-control study was conducted with SLE patients (meeting the ACR/EULAR 2019 criteria of age ≥ 18). The control group was chosen from a community database. H-QoL was measured with the SF-12 questionnaire, and PHQ-9 was used to assess depressive episodes. RESULTS: SLE significantly worsened H-QoL with an attributable burden of 5.37 ± 4.46. When compared to other chronic diseases, only multiple sclerosis had a worse impact on H-QoL. Major depressive episodes had a significant impact on SLE patients' H-QoL, with an attributable burden of 9.43 ± 5.10, similar to its impact on solid cancers but greater than its impact on other diseases. CONCLUSIONS: SLE has a comparable impact on QoL to serious chronic disorders. Concomitant depressive episodes notably worsened SLE patients' QoL, exceeding other conditions, similar to solid tumors. This underscores the significance of addressing mood disorders in SLE patients. Given the influence of mood disorders on SLE outcomes, early identification and treatment are crucial.

Why is it Important to Assess and Treat Alexithymia in the Cardiologic Field? An Overview of the Literature.

Background: Alexithymia has been found to be associated with several somatic illnesses, such as cardiovascular, indicating that it might be a risk factor for early death in the long-term course of post-myocardial infarction. From the cardiology perspective, the aim was to collect current evidence about the relationship between alexithymia and somatic illness. Methods: The literature was synthesized and summarized in a narrative format. The literature search was carried out in PubMed. Pertinent studies published in the last 50 years written in English were included and organized by three main topics ("The relation between alexithymia and somatic illness from the cardiology perspective"; "How do assess alexithymia?"; "Treating alexithymia") to be discussed. Results: High alexithymia is a dimensional trait that affects around 10% of the general population and up to 55% of people with essential hypertension. Also, the link between alexithymia and cardiovascular activity has been pointed out. There are several validated tools to assess alexithymia, as well as treatment options. Conclusion: Knowledge about the main features of alexithymia, as well as its assessment and treatment, can promote a multifactorial approach to the primary, secondary, and tertiary prevention of cardiac diseases.

Alexithymia for cardiologists: a clinical approach to the patient.

Alexithymia literally meaning 'no words for emotions' is a term used in mental health settings to describe people who have difficulties in identifying and verbalizing their emotional states. There is evidence in the literature that this personality trait may influence negatively the illness behavior when an acute coronary event occurs. In fact, people with high alexithymia are more likely to experience wrong appraisal and interpretation of symptoms, and because of their difficulty in describing feelings to others, they can be poor in reporting symptoms at the first consultation with a physician. This behavioral pattern (alexithymic) may put patients with acute myocardial infarction at higher risk for delayed medical care. Here, we aim to present an overview of alexithymia from the perspective of the clinical cardiologist, with a focus on the definition, clinical recognition, and potential impact on cardiovascular health.

Respects of human rights and perception of quality of care, the users' point of view comparing mental health and other health facilities in a region of Italy.

This work is part of a research project that aims to measure organisational well-being, human rights respect and quality of care in mental health services in Sardinia, Italy, country that has replaced long-stay psychiatric hospitals with community mental health services. Previous contributions have seen Italian health professionals and users as the most satisfied and optimistic about the quality of the mental health care provided and the respect they offer for service users' rights. Our aim is to confirm these findings by comparing experiences of users of mental health services with those of other care services in the same region. Our findings indicate that mental health services users show higher level of satisfaction for care and higher perception of users' human rights respect compared to non-mental health facilities users. They also have greater satisfaction with organisational aspects of services and they are more convinced that the health professionals rights are respected. In contrast, they are less satisfied with the resources available for care centres than other users and require more professional psychosocial support. We want to allow future comparisons to other regions on quality assessment through the perception of users and worker on respect for standards and human rights.

A Recovery-Oriented Program for People with Bipolar Disorder through Virtual Reality-Based Cognitive Remediation: Results of a Feasibility Randomized Clinical Trial.

BACKGROUND: Cognitive impairment is a frequent consequence of bipolar disorder (BD) that is difficult to prevent and treat. In addition, the quality of the preliminary evidence on the treatment of BD through Cognitive Remediation (CR) with traditional methods is poor. This study aims to evaluate the feasibility of a CR intervention with fully immersive Virtual Reality (VR) as an additional treatment for BD and offers preliminary data on its efficacy. METHODS: Feasibility randomized controlled cross-over clinical study, with experimental condition lasting three months, crossed between two groups. Experimental condition: CR fully immersive VR recovery-oriented program plus conventional care; Control condition: conventional care. The control group began the experimental condition after a three months period of conventional care (waiting list). After the randomization of 50 people with BD diagnosis, the final sample consists of 39 participants in the experimental condition and 25 in the control condition because of dropouts. RESULTS: Acceptability and tolerability of the intervention were good. Compared to the waitlist group, the experimental group reported a significant improvement regarding cognitive functions (memory: p = 0.003; attention: p = 0.002, verbal fluency: p = 0.010, executive function: p = 0.003), depressive symptoms (p = 0.030), emotional awareness (p = 0.007) and biological rhythms (p = 0.029). CONCLUSIONS: The results are preliminary and cannot be considered exhaustive due to the small sample size. However, the evidence of efficacy, together with the good acceptability of the intervention, is of interest. These results suggest the need to conduct studies with larger samples that can confirm this data. TRIAL REGISTRATION: ClinicalTrialsgov NCT05070065, registered in September 2021.

The Effects of Tyrosine Kinase Inhibitors (TKIs) in Monotherapy and with Add-on Treatments on Health-related Quality of Life of People with Chronic Myeloid Leukemia: A Systematic Review of Randomized-Controlled Trials.

Background: The era of establishing tyrosine kinase inhibitors (TKIs) in the treatment of chronic myeloid leukemia (CML) changed the outcome and the course of this life-threatening malignancy. People suffering from CML have now a better prognosis and a longer life expectancy due to the development of TKIs, even if it requires long-term, often lifelong, treatments that are nonetheless associated with improved Health-related Quality of life (HRQoL). However, data on the effects of TKIs on HRQoL are not always systematic; sometimes the data have been obtained by studies different from RCTs, or without a clear definition of what HRQoL is. The main purpose of this systematic review is to summarize all randomized-controlled trials (RCTs) including HRQoL as main or secondary outcome in patients with CML treated with TKIs or with TKIs plus an add-on treatment. Methods: A systematic review has been conducted by searching the relevant papers in PubMed/Medline and Web of Science with the following keywords: "quality of life" OR "health-related quality of life" OR "QoL" OR "HRQoL" OR "H-QoL" AND "chronic myeloid leukemia". Interval was set from January 2000 to December 2020. Results: 40 papers were identified through the search. Out of them, 7 RCTs were included. All the studies used standardized measures to assess HRQoL, even not always specific for CML. 5 RCTs randomized subjects to 2 or 3 arms to evaluate the effects of TKIs of the first, second and third generation in monotherapy. 2 RCTs randomized subjects to TKI therapy plus an add-on treatment versus TKI therapy as usual. The results of all these trials were examined and discussed. Conclusion: All the included RCTs pointed out significant findings regarding the positive effects of TKIs on HRQoL of people with CML, both when they were used in monotherapy or, notably, with an add-on treatment to enhance TKIs effects.

The perception of professionals and users of the quality of care and respect for human rights in four outpatient care facilities of an Italian hospital during the Covid-19 pandemic.

Background: During the Covid-19 pandemic, delays in providing medical services, dissatisfaction, criticism toward health workers (HW) and the risk of burnout of HW in Italy have been documented. No studies have contrasted the point of view of HW and users on the quality of care and respect for human rights in health facilities. Objective: To compare the perception of users of their satisfaction with the care provided with the perception of HW of their satisfaction with work as well as the perception of the respect of HW "s and users" human rights. Methods: The "Well-Being at work and respect for human rights questionnaire" (WWRR) was administered on a sample of users (142) and HW (154) in four outpatient health care facilities of a hospital in Sardinia, Italy. Results: Users showed higher scores than HW on their satisfaction with the care received (p < 0.0001), the perception of respect for their human rights (p < 0.0001), and availability of resources for care (p < 0.0001). The HW scores were higher than 50% of the maximum in all items, but a relatively low score was reported on the HW's satisfaction of the resources and the respect for their rights. Conclusion: The satisfaction for care and respect for human rights in the outpatient health services was higher than expected. The relatively low score by the HWs in relation to the satisfaction with the resources and perception of respect for their human rights could be a wake-up call. The study does not involve emergency rooms, wards, or Covid units.