Abstract Objectives The goal of this study was to measure the presence of pathogenic gut flora and intestinal permeability (IP) and their correlations with disease severity, venous blood congestion, ...and inflammation in patients with chronic heart failure (CHF). Background Evidence suggests that translocation of gut flora and/or their toxins from the intestine to the bloodstream is a possible trigger of systemic CHF inflammation. However, the relation between pathogenic gut flora and CHF severity, as well as IP, venous blood congestion as right atrial pressure (RAP), and/or systemic inflammation (C-reactive protein CRP), is still unknown. Methods This study analyzed 60 well-nourished patients in stable condition with mild CHF (New York Heart Association NYHA functional class I to II; n = 30) and moderate to severe CHF (NYHA functional class III to IV; n = 30) and matched healthy control subjects (n = 20). In all subjects, the presence and development in the feces of bacteria and fungi ( Candida species) were measured; IP according to cellobiose sugar test results was documented. The study data were then correlated with RAP (echocardiography) and systemic inflammation. Results Compared with normal control subjects, the entire CHF population had massive quantities of pathogenic bacteria and Candida such as Campylobacter (85.3 ± 3.7 CFU/ml vs. 1.0 ± 0.3 CFU/ml; p < 0.001), Shigella (38.9 ± 12.3 CFU/ml vs. 1.6 ± 0.2 CFU/ml; p < 0.001), Salmonella (31.3 ± 9.1 CFU/ml vs 0 CFU/ml; p < 0.001), Yersinia enterocolitica (22.9 ± 6.3 CFU/ml vs. 0 CFU/ml; p < 0.0001), and Candida species (21.3 ± 1.6 CFU/ml vs. 0.8 ± 0.4 CFU/ml; p < 0.001); altered IP (10.2 ± 1.2 mg vs. 1.5 ± 0.8 mg; p < 0.001); and increased RAP (12.6 ± 0.6 mm Hg) and inflammation (12.5 ± 0.6 mg/dl). These variables were more pronounced in patients with moderate to severe NYHA functional classes than in patients with the mild NYHA functional class. Notably, IP, RAP, and CRP were mutually interrelated (IP vs. RAP, r = 0.55, p < 0.0001; IP vs. CRP, r = 0.78, p < 0.0001; and RAP vs. CRP, r = 0.78, p < 0.0001). Conclusions This study showed that patients with CHF may have intestinal overgrowth of pathogenic bacteria and Candida species and increased IP associated with clinical disease severity, venous blood congestion, and inflammation.
Evaluation of the psychometric properties of a translated and culturally adapted questionnaire.
Translating, culturally adapting, and validating the Italian version of the Tampa Scale of ...Kinesiophobia (TSK-I) to allow its use for Italian-speaking patients with low back pain.
Increasing attention is being given to standardized outcome measures as a means of improving interventions for low back pain. A translated form of the TSK in patients with low back pain has never been validated in the Italian population.
The development of the TSK-I questionnaire involved its translation and back-translation, a final review by an expert committee, and testing of the prefinal version to establish its correspondence to the original English version. Psychometric testing included factor analysis, reliability by internal consistency (Cronbach's alpha) and test-retest repeatability (Intraclass Coefficient Correlation), discriminant validity (Pearson correlation) by comparing TSK-I to a visual analogue scale, the Roland Morris Disability Questionnaire, Beck's Depression Inventory and Anxiety Inventory.
It took the authors 5 months to achieve a shared version of the TSK-I, which proved to be satisfactorily acceptable when administered to 178 subjects. Factor analysis indicated a 2-factor 13-item solution (38% of explained variance). The questionnaire showed acceptable internal consistency (alpha = 0.772) and high test-retest reliability (ICC = 0.956). Discriminant validity showed moderate to low correlations with visual analogue scale (r = 0.345), the Roland Morris Disability (r = 0.337), and Beck's Depression Inventory and Anxiety Inventory (r = 0.258 and r = 283). The subscales were also psychometrically analyzed.
The TSK was successfully translated into Italian, showing a good factorial structure and psychometric properties, and replicating the results of existing English versions of the questionnaire. Its use is recommended for research purposes.
Objectives
To assess the effects of active music therapy (MT) and individualized listening to music (LtM) on behavioral and psychological symptoms of dementia (BPSDs) in persons with dementia (PWDs).
...Design
Randomized controlled trial.
Setting
Nine Italian institutions.
Participants
Persons with moderate to severe dementia and BPSDs (N = 120) were randomized to one of three treatments.
Interventions
All groups received standard care (SC), and two groups attended 20 individualized MT or LtM sessions, twice a week, in addition to SC.
Measurements
The Neuropsychiatric Inventory (NPI), Cornell Scale for Depression in Dementia (CSDD), and Cornell‐Brown Scale for Quality of Life in Dementia (CBS‐QoL) were administered before treatment, after treatment, and at follow‐up to evaluate behavioral and psychological outcomes. A specific coding scheme (Music Therapy Check List—Dementia) was used to evaluate the MT process.
Results
Behavioral assessment did not show significant differences between groups. All groups showed a reduction over time in NPI global score (P ≤ .001), CSDD (P = .001), and CBS‐QoL (P = .01). The NPI global score fell 28% in the MT group, 12% in the LtM group, and 21% in the SC group at the end of treatment. An exploratory post hoc analysis showed similar within‐group improvements for the NPI Delusion, Anxiety, and Disinhibition subscales. In the MT group, communication and relationships between the music therapists and PWDs showed a positive albeit nonsignificant trend during treatment.
Conclusion
The addition of MT or LtM to standard care did not have a significant effect on BPSDs in PWDs. Further studies on the effects of the integration of standard care with different types of music interventions on BPSD in PWD are warranted.
The heightened risk of dementia resulting from multiple comorbid conditions calls for innovative strategies. Engaging in physical and cognitive activities emerges as a protective measure against ...cognitive decline. This protocol aims to discuss a multidomain intervention targeting individuals with dementias secondary to cerebrovascular or other medical diseases, emphasizing an often underrepresented demographic. This study primary objectives are: a) to identify patients affected by Neurocognitive disorder due to vascular disease or multiple etiologies (screening and diagnostic phase) and b) to evaluate the effectiveness of distinct rehabilitation protocols (intervention phase): motor training alone, paper-based cognitive rehabilitation combined with motor training, digital-based cognitive rehabilitation coupled with motor training. Identifying cognitive impairment beyond rigid neurological contexts can facilitate timely and targeted interventions. This protocol strives to address the complex interplay of cognitive decline and comorbidities through a multidimensional approach, providing insights that can shape future interventions and enhancing overall well-being in this vulnerable population.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
We describe the distribution of cough peak flows (CPFs) in a random population of healthy children and adolescents.
Spirometric and peak expiratory flows including CPF data were collected on 649 (341 ...females, 308 males) healthy children ages 4-18 yrs, using a portable spirometer and a peak flow meter. CPFs were related to anthropometric characteristics, age, and gender by linear multiple regression analysis. Reference values for CPF were estimated through regression models and calculation of empirical percentiles of data distribution.
Other than peak expiratory flow rate, which was normally distributed, all other variables required logarithmic transformation to attain normal distribution. Significant relationships were found between CPF and gender, height, and body mass surface (P < 0.001) in both males and females. Age, even if correlated with CPF, does not add predictive value to the model. Fiftieth percentiles were from 147 to 488 liters/min and from 162 to 728 liters/min in females and males, respectively, through an age range of 4-18 yrs, with levels in males being generally higher than those in females at any particular age. CPF values also significantly correlated with other respiratory variables.
The availability of reference levels for CPF in the pediatric population, as provided by this study, could be useful for establishing the risk of acute respiratory complications for young patients with weak coughs, particularly those with neuromuscular disease and restrictive pulmonary syndromes.
In the European Union (EU) and United States (US), specific regulations have been released to provide incentives to develop and sell orphan medicinal products. We analysed the status of orphan drugs ...designated that not yet received a marketing authorisation or already marketed for patients affected by rare diseases in the EU and US up to December 2015. For each drug, the following data were extracted: designation date, active substance(s), orphan condition and indication, trade name, approved therapeutic indication, approved ages, genetic nature of disease and if affects children.
In the EU, 1264 Orphan Drug Designations have been granted and 133 medicinal products were approved covering a total of 179 indications and 122 rare conditions. Among these, 79 were approved under Regulation (EC)141/2000 (65 still listed in the Orphan Medicinal Products Register and 14 lost the orphan designation but still authorised) and 23 were approved centrally by the European Agency before the Orphan Regulation entered into force. On the other hand, in the US 3082 designations and 415 orphan products, covering a total of 521 indications and 300 rare conditions, were granted. As a result, the mean of designations per year is 79 in the EU and 93.4 in the US, while the mean of approved indications per year is 8.5 in the EU and 15.8 in the US. No orphan product is marketed in the EU for bone and connective tissue, ophthalmic, poisoning/overdose, renal, urinary and reproductive rare diseases. Among the marketed medicinal products, only 46.6% in the EU and 35.2% in the US are approved for children. If all the existing market approvals were merged, 362 additional therapeutic indications in the EU and 72 in the US would be covered.
Our data show that notwithstanding the incentives issued, the number of medicines for rare diseases is still limited, and this is more evident in certain therapeutic areas. However, by merging all the existing approvals, patients would benefit of substantial advantages in both geographic areas. Efforts and cooperation between EU and US seem the only way to speed up the development and marketing of drugs for rare diseases.
Purpose The aim of this study was to create an Italian version of the Pain Catastrophising Scale (PCS-I) and evaluate its psychometric properties in a sample with chronic low back pain. Methods The ...PCS was culturally adapted in accordance with international standards. The psychometric testing included factor analysis, reliability by internal consistency (Cronbach's alpha) and test—retest repeatability (intraclass coefficient correlations), and concurrent validity by comparing the PCS-I with a numerical rating scale (NRS), the Tampa Scale of Kinesiophobia (TSK), the Roland Morris Disability Questionnaire (RMDQ), the Hospital Anxiety and Depression Scale (HADS) and the Positive Affect and Negative Affect Scale (PANAS) (Pearson's correlation). Results It took 4 months to develop an agreed version of the PCS-I, which was satisfactorily administered to 180 subjects with chronic low back pain. Factor analysis revealed a three-factor 13-item solution (68% of explained variance). The questionnaire was internally consistent with one exception (α = 0.92 as a whole; 0.89 for Helplessness, 0.87 for Rumination and 0.56 for Magnification subscales) and showed a high degree of test—retest reliability (ICC = 0.842). Concurrent validity showed moderate correlations with the NRS (r = 0.44), TSK (r = 0.59), RMDQ (r = 0.45), HADS (Anxiety: r = 0.57; Depression r = 0.46) and PANAS (Negative Affect r = 0.54). The minimum detectable change was 10.45. The subscales were also psychometrically analysed. Conclusion The successfully translated Italian version of the PCS has good psychometric properties replicating those of other versions.
The COVID-19 pandemic has posed great challenges in inpatient rehabilitation services, not only to implement the preventative measures to avoid the spreading of the virus in a highly interactive, ...multidisciplinary setting but also to create a rehabilitation pathway for post-COVID-19 patients. The aim of this retrospective study was to describe the role of a digital and artificial intelligence platform (DAIP) in facilitating the implementation of changes in a rehabilitation service during the COVID-19 pandemic.
We gathered qualitative and quantitative descriptors of the DAIP, including measures to assess its efficiency in scheduling therapy sessions, and staff satisfaction using two simple numeric rating scales and the System Usability Scale. We describe how the volume of activity and the quality of care of our rehabilitation service have changed when the DAIP was implemented by comparing the pre-COVID-19 and the pandemic periods for patients' sex, age, co-morbidities, diagnosis, and Functional Independence Measure (FIM) gain and service's (bed occupancy, patients' length of stay, and staff capacity) characteristics.
Bed occupancy and the impact of rehabilitation on patients' outcome remained stable between the two periods. The DAIP provided a qualitative support for goal setting from remote; 95% of the planned sessions were delivered; the time for scheduling and registering sessions dropped by 50%. Staff satisfaction was about 70% for the easiness and 60% for the usefulness, and the mean "usability" score was close to the cut off for sufficient usability (mean score 65 where 68 is the cut off).
By applying the DAIP to rehabilitation treatment, it was shown that the management of rehabilitation can be efficiently performed even in the COVID-19 pandemic. Staff satisfaction reflected a good acceptance of the changes considering the turbulent changes and the stress burden occurring at the time of the pandemic.
Evaluation of the psychometric properties of a translated, culturally adapted questionnaire.
Translating, culturally adapting, and validating the Italian version of the Oswestry Disability Index ...(ODI-I), allowing its use in Italian-speaking patients with low back pain inside and outside Italy.
Growing attention is devoted to standardized outcome measures to improve interventions for low back pain. A translated form of the ODI in patients with low back pain has never been validated within the Italian population.
The ODI-I questionnaire was developed involving forward-backward translation, final review by an expert committee and test of the prefinal version to establish as better as possible proper correspondence with the original English latest version (2.1a). Psychometric testing included factor analysis, reliability by internal consistency (Cronbach alpha) and test-retest repeatability (Intraclass Coefficient Correlation), concurrent validity by comparing the ODI-I to Visual Analogue Scale, (Pearson correlation), and construct validity by comparing the ODI-I to Roland Morris Disability Questionnaire, RMDQ, and to Short Form Health Survey, Short Form Health Survey-36 (Pearson correlation).
The authors required a 3-month period before achieving a shared version of the ODI-I. The questionnaire was administered to 126 subjects, showing satisfying acceptability. Factor analysis demonstrated a 1-factor structure (45% of explained variance). The questionnaire showed high internal consistency (alpha = 0.855) and good test-retest reliability (ICC = 0.961). Concurrent validity was confirmed by a high correlation with Visual Analogue Scale (r = 0.73, P < 0.001), Construct validity revealed high correlations with RMDQ (r = 0.819, P < 0.001), and with Short Form Health Survey-36 domains, highly significant with the exception of Mental Health (r = -0.139, P = 0.126).
The ODI outcome measure was successfully translated into Italian, showing good factorial structure and psychometric properties, replicating the results of existing language versions of the questionnaire. Its use is recommended in research practice.
COVID-19 is strongly influenced by age and comorbidities. Acute kidney injury (AKI) is a frequent finding in COVID-19 patients and seems to be associated to mortality and severity. On the other hand, ...the role of kidney dysfunction in COVID-19 is still debated. We performed a retrospective study in a cohort of 174 hospitalized COVID-19 patients in Italy from March 3rd to May 21st 2020, to investigate the role of kidney dysfunction on COVID-19 severity and mortality. Moreover, we examined in depth the relationship between kidney function, age, and progression of COVID-19, also using different equations to estimate the glomerular filtration rate (GFR). We performed logistic regressions, while a predictive analysis was made through a machine learning approach. AKI and death occurred respectively in 10.2% and 19.5%, in our population. The major risk factors for mortality in our cohort were age adjusted HR, 6.2; 95% confidence interval (CI) 1.8-21.4 and AKI 3.36 (1.44-7.87), while, in these relationships, GFR at baseline mitigated the role of age. The occurrence of AKI was influenced by baseline kidney function, D-dimer, procalcitonin and hypertension. Our predictive analysis for AKI and mortality reached an accuracy of ≥ 94% and ≥ 91%, respectively. Our study scales down the role of kidney function impairment on hospital admission , especially in elderly patients. BIS-1 formula demonstrated a worse performance to predict the outcomes in COVID-19 patients when compared with MDRD and CKD-EPI.
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