Predictive factors for decompensating events in patients with cirrhosis with primary biliary cholangitis under different lines of therapy.

BACKGROUND AND AIMS: The landscape in primary biliary cholangitis (PBC) has changed with the advent of second-line treatments. However, the use of obeticholic acid (OCA) and fibrates in PBC-related cirrhosis is challenging. We assessed the impact of receiving a second-line therapy as a risk factor for decompensated cirrhosis in a real-world population with cirrhosis and PBC, and identify the predictive factors for decompensated cirrhosis in these patients. APPROACH AND RESULTS: Multicenter study enrolling 388 patients with PBC-cirrhosis from the Spanish ColHai registry. Biopsy (20%), ultrasound (59%), or transient elastography (21%) defined cirrhosis, and the presence of varices and splenomegaly defined clinically significant portal hypertension (CSPH). Paris-II and PBC OCA international study of efficacy criteria determined the response to ursodeoxycholic acid (UDCA), fibrates (n=93), and OCA (n=104). The incidence of decompensated cirrhosis decreased for UDCA versus OCA or fibrates in the real-world population, but they were similar considering the propensity score-matched cohort (UDCA 3.77 vs. second-line therapy 4.5 100 persons-year, respectively), as patients on second-line therapy exhibited advanced liver disease. Consequently, GGT, albumin, platelets, clinically significant portal hypertension, and UDCA response were associated with a decompensating event. OCA response (achieved in 52% of patients) was associated with bilirubin (OR 0.21 [95% CI: 0.06-0.73]) and AST (OR 0.97 [95% CI: 0.95-0.99]), while fibrate response (achieved in 55% of patients) with AST [OR 0.96 (95% CI: 0.95-0.98]). In patients treated with OCA, drug response (sHR 0.23 [95% CI: 0.08-0.64]), diabetes (sHR 5.62 [95% CI: 2.02-15.68]), albumin (sHR 0.34 [95% CI: 0.13-0.89]), and platelets (sHR 0.99 [95% CI: 0.98-1.00]) were related to decompensation. In patients treated with fibrate, drug response (sHR 0.36 (95% CI: 0.14-0.95]), albumin (sHR 0.36 (95% CI: 0.16-0.81]), and clinically significant portal hypertension (sHR 3.70 (95% CI: 1.17-11.70]) were associated with decompensated cirrhosis. CONCLUSIONS: Advanced PBC, rather than OCA and fibrates, was found to be associated with decompensating events. Therefore, biochemical and clinical variables should be considered when making decisions about the management of these drugs. Moreover, a positive response to OCA and fibrates reduced the risk of decompensation.

Effectiveness, safety and clinical outcomes of direct-acting antiviral therapy in HCV genotype 1 infection: Results from a Spanish real-world cohort.

BACKGROUND & AIMS: Clinical trials evaluating second-generation direct-acting antiviral agents (DAAs) have shown excellent rates of sustained virologic response (SVR) and good safety profiles in patients with chronic hepatitis C virus (HCV) genotype 1 infection. We aimed to investigate the effectiveness and safety of two oral DAA combination regimens, ombitasvir/paritaprevir/ritonavir plus dasabuvir (OMV/PTV/r+DSV) and ledipasvir/sofosbuvir (LDV/SOF), in a real-world clinical practice. METHODS: Data from HCV genotype 1 patients treated with either OMV/PTV/r+DSV±ribavirin (RBV) (n=1567) or LDV/SOF±RBV (n=1758) in 35 centers across Spain between April 1, 2015 and February 28, 2016 were recorded in a large national database. Demographic, clinical and virological data were analyzed. Details of serious adverse events (SAEs) were recorded. RESULTS: The two cohorts were not matched with respect to baseline characteristics and could not be compared directly. The SVR12 rate was 96.8% with OMV/PTVr/DSV±RBV and 95.8% with LDV/SOF±RBV. No significant differences were observed in SVR according to HCV subgenotype (p=0.321 [OMV/PTV/r+DSV±RBV] and p=0.174 [LDV/SOF]) or degree of fibrosis (c0.548 [OMV/PTV/r/DSV±RBV] and p=0.085 [LDV/SOF]). Only baseline albumin level was significantly associated with failure to achieve SVR (p<0.05) on multivariate analysis. Rates of SAEs and SAE-associated treatment discontinuation were 5.4% and 1.7%, in the OMV/PTV/r+DSV subcohort and 5.5% and 1.5% in the LDV/SOF subcohort, respectively. Hepatocellular carcinoma (HCC) recurred in 30% of patients with a complete response to therapy for previous HCC. Incident HCC was reported in 0.93%. CONCLUSIONS: In this large cohort of patients managed in the real-world setting in Spain, OMV/PTV/r+DSV and LDV/SOF achieved high rates of SVR12, comparable to those observed in randomized controlled trials, with similarly good safety profiles. LAY SUMMARY: In clinical trials, second-generation direct-acting antiviral agents (DAAs) have been shown to cure over 90% of patients chronically infected with the genotype 1 hepatitis C virus and have been better tolerated than previous treatment regimens. However, patients enrolled in clinical trials do not reflect the real patient population encountered in routine practice. The current study, which includes almost 4,000 patients, demonstrates comparable rates of cure with two increasingly used DAA combinations as those observed in the clinical trial environment, confirming that clinical trial findings with DAAs translate into the real-world setting, where patient populations are more diverse and complex.

Efficacy of Biofeedback Therapy in the Treatment of Dyssynergic Defecation in Community-Dwelling Elderly Women.

AIM OF THE STUDY: The aim of this study was to evaluate the efficacy of biofeedback therapy in the treatment of dyssynergic defecation in chronically constipated community-dwelling elderly women. MATERIALS AND METHODS: After an initial assessment phase carried out during 1 month, 20 chronically constipated women with dyssynergic defecation were randomly assigned to either electromyographic biofeedback (EMG-BF) group (n=10) or control group (n=10). Outcome measures used to evaluate the efficacy of treatment were weekly stool frequency, sensation of incomplete evacuation, difficulty evacuation level, mean EMG-activity (µV) of the external anal sphincter during straining to defecate and Anismus index. RESULTS: The results obtained in this randomized controlled trial showed significant differences between the groups in all the dependent variables after 1 month of treatment. Moreover, there was no difference between the groups neither in age nor in the duration of chronic constipation symptoms. At the follow-up, 3 months later, clinical gains were maintained. CONCLUSIONS: This study demonstrates that the EMG-BF is an effective behavioral therapy for the treatment of dyssynergic defecation in community-dwelling elderly women.

Relevance of the Clinical and Psychophysiological Variables in the Dyssynergic Defecation: A Comparative Study in Elderly Subjects.

The relevance of several clinical and psychophysiological variables in the dyssynergic defecation in elderly subjects was investigated in this study. To accomplish this, 30 elderly subjects (10 without anorectal disorders, 10 with chronic constipation and 10 with dyssynergic defecation) were repeatedly assessed once per week for 4 weeks, with the following measures being collected at each session: EMG-activity (µV) of the external anal sphincter (at rest, during squeezing, and during straining to defecate), stool frequency, difficulty defecation level, pain grade during defecation, and satisfaction level after evacuation. A 3 (group) × 4 (sessions) mixed-measures MANOVA revealed a significant main effect for group (Wilks's lambda = 0.006; F = 28.45; p < 0.01), but not for sessions (Wilks's lambda = 0.874; F = 0.94; p > 0.05) or for the group x sessions interaction (Wilks's lambda = 0.811; F = 1.45; p > 0.05). One-way ANOVA and Scheffé's posthoc tests were used to isolate the differences between the groups with respect to the seven different measures. These analysis showed significant differences between the groups on all four clinical variables but only for one psychophysiological variable, EMG-activity during straining to defecate. Significant differences were evidenced between all pairs examined for the difficulty defecation level and pain grade. The complete results of these analysis are presented and the conclusions drawn from them are discussed.

Different cryopreservation requirements in foetal versus adult skin cells from an endangered mammal, the Iberian lynx (Lynx pardinus).

Cryobanking somatic foetal cells acquire much relevance in endangered species for biodiversity conservation purposes. Such cells could be later used to reintroduce the lost genes into the breeding pool, by inducing pluripotency and/or nuclear transfer if necessary. Since requirements for preserving foetal cells are not always the same as for adult ones, we evaluated the cryosensitivity of foetal skin cells in comparison with adult ones from the critically endangered Iberian lynx. Responses to cryoinjury were analyzed in both thawed cell types by means of cell viability and functionality (by analyzing their membrane integrity, metabolic activity, glycosaminoglycan content and proliferative activity). Freezing media included the permeating cryoprotectant Me2SO, either alone or along with the non-permeating cryoprotectant sucrose at 0.1 or 0.2M. When Me2SO was the only cryoprotectant, survival rate fell in thawed foetal cells to 54±4% (against 89±6% for thawed adult ones) and both proliferative and metabolic activities remained significantly lower than values for thawed adult cells. However, the combination of sucrose (both 0.1 as 0.2) and Me2SO in foetal cells significantly increased their survival rates (to 71±4% and 73±5%, respectively), proliferative activities (partially at day 7 and completely at day 14 after thawing) and metabolic activities. Our findings clearly show a difference between foetal and adult cells concerning their cryopreservation sensitivity and requirements, as well as their recovery time after thawing. These results are of relevance for the cryopreservation of foetal and adult cells from the Iberian lynx and could be also useful for other mammals.

A randomized controlled pilot study of a cognitive-behavioral video game intervention for the promotion of active aging.

Background: Due to the accessibility barriers of in-person programs for active aging, the development of programs that use innovative technologies is needed. Video games can be an engaging tool for disseminating active aging interventions. Objective: The objective of this pilot study was to analyze the feasibility of a cognitive-behavioral intervention to promote active aging administered through a video game. Methods: Fifty-five participants (63.6% women, mean age = 53.0 years) were randomly assigned to a cognitive-behavioral intervention to promote active aging administered through an interactive multimedia online video game with a complementary app (CBI-V; n = 29) or to a control group that received nonspecific online information (CG; n = 26). Results: Only 3.6% of the participants dropped out of the study (6.9% in CBI-V and 0.0% in CG; without significant differences between groups). The mean number of modules completed was 7.6 (SD = 0.9) out of 8 in the CBI-V and 7.9 (SD = 0.5) in the control group (CG), without significant between-group differences. In the CBI-V, the mean total time dedicated to the game was 516.8 min (SD = 94.3), including 143.2 min (SD = 31.6) of cognitive training tasks, and the mean of completed tasks was 206.2 (SD = 33.7) out of 259. Participants were highly engaged (M = 39.9, SD = 8.6) and satisfied (M = 25.8, SD = 4.5) with the intervention. After the intervention, the CBI-V group significantly improved on SF-36 dimensions of General Health (p = .0386), Vitality (p = .0283), Social Functioning (p = .0130), and Physical Summary Index (p = .0370) compared to the CG, with medium effect sizes (d = 0.56-0.75). Conclusions: The results demonstrate the feasibility of the video game intervention to promote active aging and encourage conducting a large-scale randomized controlled trial.

Long-term surveillance of the feline leukemia virus in the endangered Iberian lynx (Lynx pardinus) in Andalusia, Spain (2008-2021).

Feline leukemia virus (FeLV) infection is considered one of the most serious disease threats for the endangered Iberian lynx (Lynx pardinus) Over 14 years (2008-2021), we investigated FeLV infection using point-of-care antigen test and quantitative real-time TaqMan qPCR for provirus detection in blood and tissues in lynxes from Andalusia (Southern Spain). A total of 776 samples from 586 individuals were included in this study. The overall prevalence for FeLV antigen in blood/serum samples was 1.4% (5/360) (95% CI: 0.2-2.6), FeLV proviral DNA prevalence in blood samples was 6.2% (31/503) (95% CI: 4.1-8.6), and FeLV proviral DNA in tissues samples was 10.2% (34/333) (95% CI: 7-13.5). From a subset of 129 longitudinally sampled individuals, 9.3% (12/129) PCR-converted during the study period. Our results suggest that FeLV infection in the Andalusian population is enzootic, with circulation of the virus at low levels in almost all the sampling years. Moreover, since only one viremic individual succumbed to the infection, this study suggests that lynxes may therefore control the infection decreasing the possibility of developing a more aggressive outcome. Although our results indicate that the FeLV infection in the Iberian lynx from Andalusia tends to stay within the regressive stage, continuous FeLV surveillance is paramount to predict potential outbreaks and ensure the survival of this population.

Cardiac function and aminoterminal pro-brain natriuretic peptide levels in liver-transplanted cirrhotic patients.

BACKGROUND: Cirrhosis is associated with structural and functional abnormalities of the heart. We examined the evolution of these abnormalities after liver transplantation (LT). METHODS: Sixty cirrhotic patients, without cardiovascular disease, were included. Clinical data, echocardiography, and aminoterminal pro-brain natriuretic peptide (NT-proBNP) levels were analyzed before and after transplantation. Healthy controls (n = 25) were included for reference. RESULTS: Before transplantation, cirrhotic patients had higher left atrium diameter, left ventricular (LV) mass index, and ejection fraction than controls. After transplantation, LV mass index increased (105 ± 31 vs. 119 ± 35 g/m(2) ; p < 0.05), diastolic cardiac function deteriorated, expressed as a reduction in E/A wave ratio (1.105 ± 0.295 vs. 0.798 ± 0.248; p < 0.001), and NT-proBNP levels decreased significantly in patients compared to pre-transplantation values (1759 ± 1154 vs. 1117 ± 600 pg/mL; p < 0.001), although they were still above levels found in controls (1117 ± 600 vs. 856 ± 123 pg/mL; p < 0.05). NT-proBNP levels above 2000 pg/mL before transplantation were significantly associated with risk for cardiovascular events after procedure (37% vs. 9%, p = 0.008). CONCLUSIONS: In cirrhotic patients, diastolic function and cardiac structure deteriorate after LT. Compared to controls, NT-proBNP levels tend to be higher before and after transplantation. The mechanisms and consequences of these results require further study.

Levels of Physical Activity and Their Relationship With Motivational Determinants, Self-Regulation, and Other Health-Related Parameters in University Students.

Motivational processes and emotional self-regulation are relevant factors for predicting the practice of physical exercise and for certain health-related parameters. The aim of the present work, developed along two different phases, was, on the one hand, to determine the prevalence of physical inactivity and, on the other hand, to carry out a comparative analysis between physically active and inactive university students in relation to their motivational determinants, emotional self-regulation, physical condition, health-related quality of life and other health parameters. The results obtained showed a prevalence of physical inactivity of 12.78%. Physically inactive participants showed significantly lower scores in intrinsic motivation, emotion regulation, and in some dimensions of health-related quality of life, as well as significantly high levels of body fat mass. Lastly, logistic regression analysis identified low scores in Emotional Clarity (p= .009) and Identified Regulation (p = .011), and high scores in Amotivation (p = .006) as reliable predictors of a physically inactive lifestyle. These results are useful for the design and implementation of programs aimed at promoting health and physical activity, with special attention on physically inactive youth populations.

Prevalence and Associated Factors with Poor Sleep Quality in Non-Professional Caregivers.

This study aimed to determine the prevalence and associated factors of poor sleep quality in non-professional caregivers. With this purpose, cross-sectional data were collected from 201 dependent people's family caregivers using the Pittsburgh Sleep Quality Index (PSQI), the Caregiver Burden Inventory (CBI), the General Health Questionnaire (GHQ-12), and an ad hoc questionnaire to obtain sociodemographic data. A total of 153 family caregivers were categorized as poor sleepers (PSQI > 5), resulting in a prevalence of poor sleep quality of 76.1% (95% CI = 70.5-82.5). Poor sleepers were more likely to care for persons with mental disorders (χ2 = 7.31; p < 0.01) and scored significantly higher on perceived burden (z = -4.44; p < 0.001), psychological distress (z = -6.24; p < 0.001), and in all the PSQI subscales (p < 0.001), compared with good sleepers (PSQI ≤ 5). By contrast, no differences were found between poor and good sleepers in age, gender, years providing care, and daily hours of care. Multiple linear regression analysis showed that the factors of caregiver burden (ß = 0.15; p < 0.05) and psychological distress (ß = 0.53; p < 0.001) were significantly associated with sleep quality in dependent people's family caregivers. Cognitive-behavioral strategies to improve sleep quality in the primary health care of family caregivers are suggested.

Factorial Structure and Psychometric Properties of the Spanish Version of the Pittsburgh Sleep Quality Index in Non-Professional Caregivers.

Although sleep issues are among the symptoms commonly experienced by the non-professional caregiver population, and the Pittsburgh Sleep Quality Index (PSQI) is the most widely used instrument for the assessment of sleep quality, this has not been validated specifically for this population. The objective of this study was to analyze the factorial structure and psychometric properties of the Spanish version of the PSQI in a sample of Spanish non-professional caregivers. Trained clinical psychologists assessed sleep quality using the PSQI, as well as caregiver burden and psychological distress in 201 non-professional caregivers (87.1% female, Mage = 56.2 years). The internal consistency of the PSQI was 0.75. The two-factor model (Sleep quality and Disturbances) had an acceptable fit to the data, was found to be superior to the one-factor model, and more parsimonious than the three-factor model. There was a significant correlation between the PSQI and caregiver burden, as well as between the PSQI and psychological distress (p < 0.001 in all cases). A total score ≥ 9 allowed the identification of caregivers with possible anxiety and depression disorders (sensitivity 70.5%, specificity 71.9%). The results show that the PSQI is a reliable and valid instrument for the assessment of sleep quality in caregivers.

Sleep Disturbance, Psychological Distress and Perceived Burden in Female Family Caregivers of Dependent Patients with Dementia: A Case-Control Study.

This case-control study analyzed the sleep disturbance, psychological distress and perceived burden in female family caregivers of dependent people with dementia (n = 74) compared with female family caregivers of dependent people without dementia (n = 74) and with age-matched non-caregiver control females (n = 74). Participants completed the Pittsburgh Sleep Quality Index (PSQI), the 12-item General Health Questionnaire (GHQ-12), the Caregiver Burden Inventory (CBI) and an ad hoc questionnaire to collect sociodemographic data. There were significant differences between the groups in PSQI total (F = 24.93; p < 0.001), psychological distress (F = 26.71; p < 0.001) and in all sleep domains assessed: subjective sleep quality (F = 16.19; p < 0.001), sleep latency (F = 9.5; p< 0.001), sleep duration (F = 18.57; p < 0.001), habitual sleep efficiency (F = 19.77; p < 0.001), sleep disturbances (F = 9.22; p < 0.001), use of sleep medications (F = 4.24; p< 0.01) and daytime dysfunction (F = 5.57; p < 0.01). In all measures, the female family caregivers of dependent people with dementia showed the significantly higher mean scores. Regarding the two groups of female caregivers, statistically significant differences were found in daily hours of care (t = −2.45; p < 0.05) and perceived burden (t = −3.65; p < 0.001), as well as in the following dimensions of caregiver burden: time-dependence burden (t = −5.09; p < 0.001), developmental burden (t = −2.42; p < 0.05) and physical burden (t = −2.89; p < 0.01). These findings suggest that female family caregivers of dependent patients with dementia should be subject to psychopathological screening and preventive cognitive-behavioral interventions in clinical practice in primary health care.

Celsior versus University of Wisconsin preserving solutions for liver transplantation: postreperfusion syndrome and outcome of a 5-year prospective randomized controlled study.

BACKGROUND: Celsior solution (CS) is a high-sodium, low-potassium, low-viscosity extracellular solution that has been used for liver graft preservation in recent years, although experience with it is still limited. We performed an open-label randomized active-controlled trial comparing CS with the University of Wisconsin solution (UW) for liver transplantation (LT), with a follow-up period of 5 years. METHODS: Adult transplant recipients (n=102) were prospectively randomized to receive either CS (n=51) or UW (n=51). The two groups were comparable with respect to donor and recipient characteristics. The primary outcome measure was the incidence of postreperfusion syndrome (PRS). Secondary outcome measures included primary nonfunction (PNF) or primary dysfunction (PDF), liver retransplantation, and graft and patient survival. Other secondary outcome measures were days in the intensive care unit (ICU) and the rates of acute rejection, chronic rejection, infectious complications, postoperative reoperations, and vascular and biliary complications. RESULTS: In all, 14 posttransplant variables revealed no significant differences between the groups. There were no cases of PNF or PDF. The incidence of PRS was 5.9% in the CS group and 21.6% in the UW group (P=0.041). After reperfusion, CS revealed greater control of serum potassium (P=0.015), magnesium levels (P=0.005), and plasma glucose (P=0.042) than UW. Respective patient survivals at 3, 12, and 60 months were 95.7, 87.2, and 82.0% for the CS group and 95.7, 83.3, and 66.6% for the UW group (P=0.123). CONCLUSIONS: While retaining the same degree of safety and effectiveness as UW for LT, CS may yield postliver graft reperfusion benefits, as shown in this study by a significant reduction in the incidence of PRS and greater metabolic control.

Cryobanking the genetic diversity in the critically endangered Iberian lynx (Lynx pardinus) from skin biopsies. Investigating the cryopreservation and culture ability of highly valuable explants and cells.

Cryobanking skin samples permit preserving a maximum of genetic representation from the population biodiversity. This is a relevant aspect for threatened species, potentially menaced by an epizooty and from which it is difficult to obtain gametes. As a first step for properly cryobanking skin samples of a given species, the optimal conditions of culture and freezing have to be studied by covering a broad range of possibilities. This paper presents, for the first time, a systematic study of such conditions for the Iberian lynx (Lynx pardinus). To that end, we have analyzed twenty different culture conditions and fifteen different freezing solutions for skin explants, as well as three freezing solutions for isolated cells derived from them. The culture conditions included both two different culture strategies and several combinations of nutritional supplements and mitotic agents. For the freezing solutions, we have considered different concentrations of the permeating cryoprotectant dimethyl sulfoxide (Me(2)SO) either alone (5%, 7.5%, 10%, 12.5% and 15% v/v for explants, 10% for isolated cells) or along with the non-permeating cryoprotectant sucrose (0.1 or 0.2M). Our results have been analyzed through several quantitative parameters and show that only thawed explants cryopreserved in Me(2)SO (10%) either alone or with sucrose (0.2M) presented similar properties to those in optimal fresh cultures. In addition, for these freezing conditions, isolated thawed cells also presented high survival rates (90%) and percentages of cellular functionality (85%). These results, focussed on the most endangered felid in the world, could be also useful for other threatened/endangered species.

[Depression, gender and systemic manifestations in chronic inflammatory bowel diseases]. / Depresión, género y manifestaciones sistémicas en las enfermedades inflamatorias crónicas del intestino.

The purpose of this study was to assess the relation between depression, gender and systemic manifestations in chronic inflammatory bowel diseases. With this aim, 106 patients (57 with Crohn disease and 49 with ulcerative colitis) were divided into 4 groups: men with extraintestinal manifestations (n= 10), men without extraintestinal manifestations (n= 36), women with extraintestinal manifestations (n= 15), and women without extraintestinal manifestations (n= 45). Depression was assessed with the Beck Depression Inventory. The results reveal significant effects both in the systemic manifestations factor (F= 28,33; p<0.01), and in the interaction between systemic manifestations and gender (F= 5,2; p<0.05); the gender factor, in contrast, was nonsignificant (F= 0,28; p>0.05). The finding of higher levels of depression in patients with systemic manifestations, particularly in men, underlines the need for psychological intervention aimed at detection and effective treatment.

Psychophysiological profile in dyssynergic defecation patients: an individual and situational response specificity analysis.

The aim of this study was to evaluate the temporal stability and the situational specificity of the intra-anal EMG-activity, as well as the individual specificity of this response in dyssynergic defecation patients. With this purpose, 26 individuals (13 with dyssynergic defecation and 13 without anorectal pathology) participated in two sessions of psychophysiological assessment, with an inter-session period of 1 week. At each session, the EMG-activity of external anal sphincter was recorded under four different conditions (baseline, voluntary contraction, reflex contraction and simulated defecation). The findings provide empirical evidence about temporal stability of the intra-anal EMG-activity, situational specificity of this response and the existence of a specific profile of intra-anal EMG-activity characteristic of patients with dyssynergic defecation.

Behavioural treatment of the dyssynergic defecation in chronically constipated elderly patients: a randomized controlled trial.

A randomized controlled trial was carried out with the purpose to determine the effectiveness of EMG-biofeedback in the treatment of chronically constipated elderly patients with dyssynergic defecation as compared to a control condition characterized by information about the bowel functioning and counseling focused on the behavioural mechanisms involved in the defecation. With this purpose, after an initial assessment period (4 weeks), 30 chronically constipated elderly patients with dyssynergic defecation (11 males, 19 females) were randomly assigned to either EMG-biofeedback group (n = 15) or control group (n = 15). The results shown significant improvements in psychophysiological measures (EMG-activity during straining to defecate and anismus index), as well as in clinical variables (frequency of defecations per week, sensation of incomplete evacuation, difficulty evacuation level and perianal pain at defecation) only in the EMG-biofeedback group. The clinical benefits of this behavioural treatment were maintained at the follow-up period 2 months later.

A Randomized Controlled Trial on the Effects of Electromyographic Biofeedback on Quality of Life and Bowel Symptoms in Elderly Women With Dyssynergic Defecation.

Dyssynergic defecation is a usual cause of chronic constipation in elderly women, with a negative impact on health-related quality of life. The present randomized controlled trial aims to evaluate the effects of behavioral treatment through electromyographic biofeedback (EMG-BF) on quality of life and bowel symptoms in elderly women with dyssynergic defecation. Twenty chronically constipated elderly women, due to dyssynergic defecation, were enrolled in the study. Outcome measures included weekly stool frequency, anismus index, severity of patient-reported chronic constipation symptoms (abdominal, rectal, and stool symptoms), and overall measure of quality of life. After 1 month of baseline, participants were randomly assigned to either EMG-BF group (n = 10) or control group (n = 10). Three months after treatment, female patients were once again assessed following the same procedure in baseline. One-way multivariate analysis of variance MANOVA revealed no significant differences between the groups before treatment in any of the measured dependent variables (Wilks's λ = 0.74; F6,13 = 0.77; p = 0.61). Likewise, univariate analysis showed no differences between the groups, either in terms of age (F1,18 = 0.96; p = 0.34) or mean disease duration (F1,18 = 2.99; p = 0.11). Three months after treatment, MANOVA revealed statistically significant differences between the groups (Wilks's λ = 0.29; F6,13 = 5.19; p < 0.01). These differences were significant in all outcome measures. EMG-BF produces significant improvements in bowel symptoms and health-related quality of life of elderly women with dyssynergic defecation.

Caregiver Burden and Sleep Quality in Dependent People's Family Caregivers.

This study examined the relationship between caregiver burden and sleep quality in dependent people's family caregivers. A cross-sectional study was carried out with 201 dependent people's family caregivers and 92 non-caregivers controls. Participants completed the Pittsburgh Sleep Quality Index (PSQI), the Caregiver Burden Inventory (CBI), and an ad-hoc questionnaire to collect sociodemographic data. Based on CBI scores, subjects were categorized into three groups: family caregivers with high levels of perceived burden, family caregivers with low and medium levels of perceived burden and non-caregiver controls. There were significant differences among the groups in the PSQI total (F = 40.39; p < 0.001), subjective sleep quality (F = 25.55; p < 0.001), sleep latency (F = 16.99; p < 0.001), sleep disturbances (F = 14.90; p < 0.001), use of sleep medications (F = 6.94; p < 0.01) and daytime dysfunction (F = 20.12; p < 0.001). These differences were found only between the caregivers with high levels of perceived burden and the other two groups (p < 0.05). There were also significant differences between the groups in sleep duration (F = 18.34; p < 0.001) and habitual sleep efficiency (F = 24.24; p < 0.001). In these dependent measures, the differences were found in all the pairs examined (p < 0.05). These results suggest that caregiver burden is related to sleep quality, so that caregivers with greater perceived burden have a worse sleep quality.

Psychometric Properties of the Spanish Version of the Caregiver Burden Inventory.

Although the Caregiver Burden Inventory (CBI) is the most widely used multidimensional burden instrument for assessing perceived burden of caregivers, there is no data on its psychometric properties in Spanish, nor on caregivers of dependent persons with various diseases. The objective of this study was to translate the CBI into Spanish and validate it in caregivers of dependent persons with various diseases. Trained evaluators administered the CBI and assessed emotional distress and probable mental disorder in 201 caregivers (87.1% women, mean age 56.2 years). The internal consistency of the CBI was 0.89 (0.74⁻0.83 among the subscales). There was a significant correlation of emotional distress with both the total burden and each subscale (p < 0.001 in all cases). A total score of 39 and scores of 16, 9, 8, 4, and 2 in burden per time dedicated to care, personal life burden, physical burden, social burden, and emotional burden were suitable cut-off points to discriminate caregivers with probable mental disorder (sensitivity = 63.0%⁻75.6%, specificity = 63.4%⁻74.4%). To achieve a greater goodness of fit, the model was re-specified, resulting in a shortened (15-item) instrument. The internal consistency reliability coefficients of the 15-item CBI were satisfactory (Cronbach α = 0.83; 0.77⁻0.86 among the subscales). Within the 15-item CBI, emotional distress was significantly correlated with the total burden, personal life burden, physical burden, social burden (p < 0.001 in all those cases), and emotional burden (p = 0.001). A total score of 25 and scores of 12, 5, 5, 3, and 1, respectively, in the subscales were identified as cut-off points to discriminate caregivers with probable mental disorder (sensitivity = 46.2%⁻70.6%, specificity = 43.9%⁻79.3%). Therefore, the 15-item CBI validly measured caregiver burden with better fit and more parsimoniously than the original CBI.