New interferon-free therapies on HCV+ chronic hepatitis: Overcoming psychiatric side effects in a real world setting

2016 ◽  
Vol 33 (S1) ◽  
pp. S392-S393
Author(s):  
M. Moneglia ◽  
A. Santangelo ◽  
A. Ballerini ◽  
V. Ricca ◽  
A.L. Zignego
Keyword(s):  
Chronic Hepatitis ◽  
Side Effects ◽  
Real World ◽  
General Health ◽  
Second Generation ◽  
Psychiatric Symptoms ◽  
Sf 36 ◽  
Significant Difference ◽  
Patient Reported ◽  
Psychiatric Side Effects

IntroductionInterferon-alpha (IFNα) was the backbone therapy for HCV+ related chronic hepatitis (CH-C). However, it was associated with significant neuropsychiatric side effects and impaired health-related quality of life. Second Generation IFNα-free direct-acting antiviral agents (DAAs) seem to be associated with fewer side effects, better tolerability, high efficacy rates and better patient reported outcomes (PROs) [Younoussi, 2014].AimsTo describe the neuropsychiatric symptoms and PROs during Second Generation DAAs plus ribavirin oral treatment in a group of CH-C real world patients.MethodsNineteen CH-C outpatients, scheduled for IFNα-free treatment, were assessed at enrolment (T0), at 4 (T1) and at 12 (T2) weeks, the end of treatment, by means of MDRS, HAM-D, HAM-A, MRS, Y-BOCS and SF-36. A pharmacological therapy, based on clinical evidence, was provided at psychiatric symptoms onset.ResultsDuring the treatment, we didn’t report any worsening in the administred psychometric scales. Furthermore, we observed a general improvement at week 12 (T2), statistically significant only for MRS (P < 0.05). Any statistically significant difference was found for SF-36 mean scores comparing T0, T1 and T2. However, SF-36 cluster analysis showed between T0 and T2 a meaningful and significant rise of global health clusters “General health perceptions” (P < 0.05), “Change in overall health status” (P < 0.001) and a significant impairment in cluster “Emotional role functioning” (P < 0.05).ConclusionsOur real world data are consistent with trial setting results [Younoussi, 2014]. Contrary to previous IFNα-based therapy, new regimens don’t seem to be associated with psychiatric side effects and suggest an immediate gain in general health PROs over the treatment period.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Second generation direct-acting antiviral (DAAs) Treatment on HCV+ patients: Patient reported outcomes (PROs) and psychiatric symptoms in a real world setting sample

2017 ◽  
Vol 41 (S1) ◽  
pp. S316-S317
Author(s):  
M. Moneglia ◽  
A. Santangelo ◽  
I. Burian ◽  
L. Gragnani ◽  
F. Elisa ◽  
...  
Keyword(s):  
Side Effects ◽  
Real World ◽  
Psychiatric Symptoms ◽  
Neuropsychiatric Symptoms ◽  
Multivariate Logistic Regression Analysis ◽  
Psychiatric History ◽  
Sample Mean ◽  
Sf 36 ◽  
Significant Difference ◽  
Patient Reported

IntroductionAnti-HCV treatments are moving away from interferon-alpha towards DAAs, associated with fewer side effects, better tolerability, and better PROs.AimsTo describe neuropsychiatric symptoms and PROs during DAAs treatment in a group of HCV+ patients.MethodsForty outpatients, scheduled for DAAs treatment, were assessed at enrolment (T0), 4 weeks (T1), at the end of treatment (EOT) and after 12 weeks of follow up (F-UP), by means of MDRS, HAM-D, HAM-A, MRS, Y-BOCS and SF-36. Afterwards the sample was divided into two groups as a function of a positive psychiatric history (19) and compared with each other.ResultsTotal sample mean scores between W0 and F-UP were compared and an improving trend was observed in all administered scales. An SF-36 items analysis showed a statistically significant difference in emotional role functioning between W0 vs EOT and EOT vs F-UP, in change in overall health status between W0 vs EOT and W0 vs F-UP.A multivariate logistic regression analysis showed that a positive psychiatric history was not associated with an improvement in vitality of 4.3 (minimal clinically important difference). Comparing the two groups, no significant fluctuations in SF-36 scores were founded and major deviations score increases were recorded in patients with a psychiatric history in all scales.ConclusionsOur real world data shows that new regimens do not seem to be associated with psychiatric side effects and conversely a clinical improvement compared to baseline was found, suggesting an immediate gain in PROs over the treatment period, particularly the psychiatric subgroup.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Six-month and 12-month patient outcomes based on inflammatory subphenotypes in sepsis-associated ARDS: secondary analysis of SAILS-ALTOS trial

Thorax ◽  
2021 ◽  
pp. thoraxjnl-2020-216613
Author(s):  
Mohamed D Hashem ◽  
Ramona O Hopkins ◽  
Elizabeth Colantuoni ◽  
Victor D Dinglas ◽  
Pratik Sinha ◽  
...  
Keyword(s):  
Mental Health ◽  
Patient Reported Outcomes ◽  
Secondary Analysis ◽  
Cognitive Outcomes ◽  
Short Term ◽  
Sf 36 ◽  
Significant Difference ◽  
Patient Reported ◽  
Sepsis Trial

BackgroundPrior acute respiratory distress syndrome (ARDS) trials have identified hypoinflammatory and hyperinflammatory subphenotypes, with distinct differences in short-term outcomes. It is unknown if such differences extend beyond 90 days or are associated with physical, mental health or cognitive outcomes.Methods568 patients in the multicentre Statins for Acutely Injured Lungs from Sepsis trial of rosuvastatin versus placebo were included and assigned a subphenotype. Among 6-month and 12-month survivors (N=232 and 219, respectively, representing 243 unique survivors), subphenotype status was evaluated for association with a range of patient-reported outcomes (eg, mental health symptoms, quality of life). Patient subsets also were evaluated with performance-based tests of physical function (eg, 6 min walk test) and cognition.FindingsThe hyperinflammatory versus hypoinflammatory subphenotype had lower overall 12-month cumulative survival (58% vs 72%, p<0.01); however, there was no significant difference in survival beyond 90 days (86% vs 89%, p=0.70). Most survivors had impairment across the range of outcomes, with little difference between subphenotypes at 6-month and 12-month assessments. For instance, at 6 months, in comparing the hypoinflammatory versus hyperinflammatory subphenotypes, respectively, the median (IQR) patient-reported SF-36 mental health domain score was 47 (33–56) vs 44 (35–56) (p=0.99), and the per cent predicted 6 min walk distance was 66% (48%, 80%) vs 66% (49%, 79%) (p=0.76).InterpretationComparing the hyperinflammatory versus hypoinflammatory ARDS subphenotype, there was no significant difference in survival beyond 90 days and no consistent findings of important differences in 6-month or 12-month physical, cognitive and mental health outcomes. These findings, when considered with prior results, suggest that inflammatory subphenotypes largely reflect the acute phase of illness and its short-term impact.

Psychiatric side effects induced by supraphysiological doses of combinations of anabolic steroids correlate to the severity of abuse

2006 ◽  
Vol 21 (8) ◽  
pp. 551-562 ◽  
Author(s):  
Thomas A. Pagonis ◽  
Nikiforos V. Angelopoulos ◽  
George N. Koukoulis ◽  
Christos S. Hadjichristodoulou
Keyword(s):  
Side Effects ◽  
Anabolic Steroids ◽  
Linear Regression Analysis ◽  
Control Group ◽  
Time Interval ◽  
Psychological Consequences ◽  
Psychometric Instruments ◽  
Wide Range ◽  
Significant Difference ◽  
Psychiatric Side Effects

AbstractObjectiveThe objective of our study was to evaluate the psychological consequences of real-world AAS use in athletes abusing such agents, in comparison with a placebo and control group of comparable athletes, while correlating the severity of abuse with the side effects observed. The hypothesis tested by the study was that the use of AAS induces a wide range of psychological side effects whose impact and emergence is dependent upon the severity of the abuse.DesignThe study includes a substantial group of AAS abusing athletes and two more groups demographically similar to the first, one composed of athletes not using any substance and a placebo group. All athletes were stratified according to the severity of AAS abuse. Psychometric instruments were applied to all athletes in specific time intervals, dependent to the AAS abusers' regimens, providing us with a final psychological profile that was to be compared to the pre-study profile. All results were comparable (within and between groups) for statistically significant differences and correlated to the severity of the abuse. Homogeneity of all groups was safeguarded by random doping controls, monitoring of drug levels and analysis of all self obtained drugs by method of liquid chromatography/mass spectrometry. All athletes were provided with a common exercise and dietary regime, so common training and nutritional conditions were achieved.MethodsWe studied a cohort of 320 body-building, amateur and recreational athletes, of whom 160 were active users of AAS (group C), 80 users administering placebo drugs (group B) and 80 not abusing any substance (Group A). Group C athletes were stratified according to AAS abuse parameters, thus providing us with three subgroups of “light, medium and heavy abuse”. Athletes of groups A and B were included in a “no abuse” subgroup. The psychometric instruments used were the Symptoms Check List-90 (SCL-90) and the Hostility and Direction of Hostility Questionnaire (HDHQ). The psychometric evaluations took place within a time interval of 13 months. Statistical analysis was performed by using the Mann–Whitney/Wilcoxon two-sample non-parametric test (Kruskal–Wallis test for two groups) for data that were not normally distributed and Linear regression analysis was used to ascertain the correlation between severity of use and escalation of side effects.ResultsThe study showed a statistically significant increase in all psychometric subscales recorded in group C, and no statistically significant difference in group C and A. There was a significant increase in the scorings of group C for all subscales of SCL-90 and HDHQ. Correlation of abuse severity and side effects showed that there was a statistical significant increase in Δ values of all SCL-90 and HDHQ subscales that escalated from light abuse to medium and heavy abuse/consumption patterns.ConclusionsThe results of the study suggest that the wide range of psychiatric side effects induced by the use of AAS is correlated to the severity of abuse and the force of these side effects intensifies as the abuse escalates.

scholarly journals Perceived functioning, well-being and psychiatric symptoms in patients with stable schizophrenia treated with long-acting risperidone for 1 year

2005 ◽  
Vol 187 (2) ◽  
pp. 131-136 ◽  
Author(s):  
W. Wolfgang Fleischhacker ◽  
Jonathan Rabinowitz ◽  
Georg Kemmler ◽  
Mariëlle Eerdekens ◽  
Angelika Mehnert
Keyword(s):  
Mental Component Summary ◽  
Psychiatric Symptoms ◽  
Short Form ◽  
Mental Component Summary Score ◽  
Well Being ◽  
Psychotic Symptoms ◽  
Open Label ◽  
Sf 36 ◽  
Patient Reported ◽  
Long Acting

BackgroundThe extent to which antipsychotics improve patients' well-being is uncertain.AimsTo examine psychopathology and patient-rated functioning and well-being in patients treated with risperidone.MethodIn a 1-year, open-label, international multicentre trial of long-acting risperidone in 615 stable adult patients with schizophrenia, self-rated functioning and well-being were measured every 3 months using the Short Form 36-item questionnaire (SF–36). Psychopathology was quantified using the Positive and Negative Syndrome Scale (PANSS).ResultsSignificant improvements were found on the SF–36 mental component summary score and vitality and social functioning scales. PANSS and mental component summary scores were moderately correlated.ConclusionsPatient-reported functioning and well-being appear to differ from investigator-rated psychotic symptoms. Patient-rated well-being should be assessed with symptoms to help measure treatment outcomes.

scholarly journals Performance of the PROMIS in Patients After Anterior Cruciate Ligament Reconstruction

2018 ◽  
Vol 6 (5) ◽  
pp. 232596711877450 ◽  
Author(s):  
Elizabeth J. Scott ◽  
Robert Westermann ◽  
Nathalie A. Glass ◽  
Carolyn Hettrich ◽  
Brian R. Wolf ◽  
...  
Keyword(s):  
Anterior Cruciate Ligament ◽  
Physical Function ◽  
Acl Reconstruction ◽  
Cruciate Ligament ◽  
Sf 36 ◽  
Significant Difference ◽  
Patient Reported ◽  
Floor Effects ◽  
Anterior Cruciate ◽  
Pro Instruments

Background: The Patient-Reported Outcomes Measurement Information System (PROMIS) is designed to advance patient-reported outcome (PRO) instruments by utilizing question banks for major health domains. Purpose: To compare the responsiveness and construct validity of the PROMIS physical function computer adaptive test (PF CAT) with current PRO instruments for patients before and up to 2 years after anterior cruciate ligament (ACL) reconstruction. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: Initially, 157 patients completed the PROMIS PF CAT, Short Form–36 Health Survey (SF-36 physical function [PF] and general health [GH]), Marx Activity Rating Scale (MARS), Knee injury and Osteoarthritis Outcome Score (KOOS activities of daily living [ADL], sport, and quality of life [QOL]), and EuroQol–5 dimensions questionnaire (EQ-5D) at 6 weeks, 6 months, and 2 years after ACL reconstruction. Correlations between instruments, ceiling and floor effects, effect sizes (Cohen d), and standardized response means to describe responsiveness were evaluated. Subgroup analyses compared participants with and without additional arthroscopic procedures using linear mixed models. Results: At baseline, 6 weeks, and 6 months, the PROMIS PF CAT showed excellent or excellent-good correlations with the SF-36 PF ( r = 0.75-0.80, P < .01), KOOS-ADL ( r = 0.63-0.70, P < .01), and KOOS-sport ( r = 0.32-0.69, P < .01); excellent-good correlation with the EQ-5D ( r = 0.60-0.71, P < .01); and good correlation with the KOOS-QOL ( r = 0.52-0.58, P < .01). As expected, there were poor correlations with the MARS ( r = 0.00-0.24, P < .01) and SF-36 GH ( r = 0.16-0.34, P < .01 ). At 2 years, the PROMIS PF CAT showed good to excellent correlations with all PRO instruments ( r = 0.42-0.72, P < .01), including the MARS ( r = 0.42, P < .01), indicating frequent return to preinjury function. The PROMIS PF CAT had the fewest ceiling or floor effects of all instruments tested, and patients answered, on average, 4 questions. There was no significant difference in baseline physical function scores between subgroups; at follow-up, all groups showed improvements in scores that were not statistically different. Conclusion: The PROMIS PF CAT is a valid tool to assess outcomes after ACL reconstruction up to 2 years after surgery, demonstrating the highest responsiveness to change with the fewest ceiling and floor effects and a low time burden among all instruments tested. The PROMIS PF CAT is a beneficial alternative for assessing physical function in adults before and after ACL reconstruction.

Abstract 13633: Predictors of Mental and Physical Health Outcomes of Patients Undergoing an Appointment-based Cardiac Rehabilitation Program

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Catherine Xie ◽  
Sean Fournier ◽  
Susan Hiller ◽  
Joyce Oen Hsiao ◽  
Rachel P Dreyer
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Cardiac Rehabilitation ◽  
General Health ◽  
Health Related Quality ◽  
Sf 36 ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

Introduction: Cardiac rehabilitation (CR) is an evidence-based program to improve secondary prevention outcomes for patients with cardiovascular disease (CVD). Lower health-related quality of life is a known risk factor for worse CVD outcomes. We examined the effects of a patient-driven appointment-based CR program on health-related quality of life. Methods: We utilized data from the Yale New-Haven Health (YNHH) CR program over a 6-year period (2012-2017). Data was collected on patient demographics, clinical characteristics and socioeconomic status. The Medical Outcome Short-Form General Health Survey (SF-36) was used to measure general health status. We evaluated SF-36 score changes pre and post CR with paired T-tests and conducted logistic regression analysis to examine predictors of improvements in health-related quality of life. Results: Over the 6-year study period, a total of 2,135 patients (27.9% women, mean age 65±12 years) were enrolled in the CR program. Patients demonstrated significant improvements in both the SF-36 physical, mental and health transition components (P<0.001) (Table) . In particular, patients had significant improvement in the social functioning domain (measures limitations patients see in their ability to participate in social activities due to physical/emotional issues), with an increase of 23.3 points out of 100. Physician-reported patient stress and/or depression on intake medical exam were significant negative predictors for improvement in the total SF-36 score (OR 0.23, 95% CI 0.08-0.80, P=0.021), with the effect driven largely by its impact on the physical component of SF-36 (OR 0.27, 95% CI 0.09-0.83, P=0.022). Conclusion: We demonstrated that a novel appointment-based CR program produced improvements in patient-reported health-related quality of life. Appointment-based CR could be a viable alternative for patients who prefer more scheduling flexibility, to optimize health status improvement and CVD outcomes.

scholarly journals Lower quality of life in longstanding mild primary hyperparathyroidism

2013 ◽  
Vol 57 (2) ◽  
pp. 139-143 ◽  
Author(s):  
Andreia Veras ◽  
Juliana Maia ◽  
Patricia Mesquita ◽  
Catia Eufrazino ◽  
Francisco Bandeira
Keyword(s):  
Quality Of Life ◽  
Primary Hyperparathyroidism ◽  
Functional Capacity ◽  
General Health ◽  
Sf 36 ◽  
Significant Difference ◽  
Mild Primary Hyperparathyroidism ◽  
Recent Diagnosis ◽  
Time Since Diagnosis

OBJECTIVE: To describe the non-classical manifestations and quality of life in patients with primary hyperparathyroidism (PHPT). SUBJECTS AND METHODS: We evaluated non-classical manifestations and quality of life of 22 patients with PHPT using the SF-36 questionnaire according to the time since diagnosis. RESULTS: In the scores of quality of life, a significant difference was found comparing the groups with previous and recent diagnosis of PHPT in terms of functional capacity (39 + 22.83 vs. 76.25 + 22.37; p = 0.001), limitation of physical aspects (30 + 38.73 vs. 75 + 21.32; p = 0.006), general health (57.20 + 19.16 vs. 77.75 + 15.70; p = 0.012), and vitality (49.00 + 21.19 vs. 70.00 + 24.12; p = 0.044). CONCLUSION: We found a significant difference in quality of life in relation to the time of the diagnosis of PHPT.

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