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Objectives Lipoatrophy is a long-term adverse effect of some antiretrovirals that affects quality of life, compromises adherence and may limit the clinical impact of HIV treatments. This paper explores the effect of tenofovir/emtricitabine ( TDF/ FTC) on the amount of limb fat in patients with virological suppression. Methods A randomized, prospective clinical trial was performed to compare continuation on a zidovudine/lamivudine ( ZDV/3TC)-based regimen with switching to a TDF/ FTC-based regimen in terms of the effect on limb fat mass as assessed by DEXA over a 72-week period. Results Eighty patients were included (39 in the TDF/ FTC arm and 41 in the ZDV/3 TC arm) and 73 completed the study (37 and 36, respectively). In the switch arm, limb fat increased by a median of 540 g from baseline ( P = 0.022), while in the ZDV/3TC arm it decreased by a median of 379 g ( P = 0.112; p between groups = 0.007). Subjects with baseline limb fat ≤ 7200 g, previous time on ZDV > 5 years or a body mass index > 25 kg/m2 experienced higher limb fat gains than other subjects, and these differences were statistically significant. Haemoglobin increased by a median of 1.0 g/d L in the TDF/ FTC arm ( P < 0.001) and remained unchanged in the ZDV/3TC arm (p between groups = 0.0002). There were no significant differences between groups in other secondary endpoints (body weight, total body and trunk fat content, total body bone mineral density, laboratory parameters, CD4 cell count and viral load). Conclusions Switching from a ZDV/3TC-based to a TDF/ FTC-based regimen led to a statistically significant improvement in limb fat, in contrast to the progressive loss of limb fat in subjects continuing ZDV/3TC. [ABSTRACT FROM AUTHOR]

Abstract: Objective: The aim of this paper is to explore the prevalence of psychiatric morbidity in different immigrant groups in Spain. In keeping with prior studies carried out in Europe, it is expected that the immigrant population will have elevated levels of psychopathology, with some variation across immigrant groups. Method: Design: Multicenter, observational, cross-sectional study. Setting: Primary care settings of two Spanish regions. Sample: N=1.503 immigrants paired with the same number of Spanish controls, adjusted by gender and age. Variables: Demographic variables, MINI International Neuropsychiatric Interview and Standardized Polyvalent Psychiatric Interview, somatic symptoms section. Student''s t tests, ORs and logistic regressions were used to analyze the data. Results: No differences in psychiatric morbidity were found (native born 30.9%, population vs. immigrants 29.6%, OR=.942, CI=.806–1.100) when comparing immigrants to native born Spaniards. Relative to Spaniards (30.9%), Latin American immigrants had significantly higher levels of psychopathology (36.8%), Sub-Saharan Africans (24.4%) and Asians (16%) had significantly lower levels, and Eastern Europeans (31.4%) and North Africans (26.8%) showed no significant difference. Conclusions: The hypotheses were only partially supported. Although overall immigrants did not differ from the native born population, when analyzed by geographic origin, only Latin Americans had higher levels of psychopathology. It is concluded that multiple factors need to be taken into consideration when studying the mental health of immigrants given that different immigrant groups have different levels of psychopathology. [Copyright &y& Elsevier]

Purpose: Increased awareness of the importance of dietary fibre has led to increased interest in 'functional' fibre components like digestion-resistant maltodextrin (RMD). This randomized, placebo-controlled, double-blind study assessed the effects of RMD in the colonic transit time (CTT) and defecation characteristics (frequency, stool volume and consistency). Methods: Sixty-six healthy adult volunteers (32 men) who did not have a daily defecation habit had a 7-day run-in period before the 21-day intervention period with RMD or placebo. CTT and segmental CTT (SCTT) were assessed by a single abdominal X-ray film taken at the end of both periods after radiopaque marker ingestion. Defecation characteristics and intestinal functions were also assessed, which were self-reported by patients. Intragroup comparisons were evaluated by Student's paired t test, Bonferroni test and Chi-square test, while time comparisons by analysis of variance (ANOVA) and time-by-treatment interaction by repeated-measures ANOVA. Results: Fifty-seven subjects were assessed for CTT (placebo, n = 28; RMD, n = 29). In the RMD group, the total CTT, left SCTT and rectosigmoidal SCTT decreased significantly compared to baseline ( p < 0.01 each; −13.3, −4.7, −8.7 h, respectively). Significant differences between groups were observed in total CTT and left SCTT. Significant time-by-treatment interaction was observed in the RMD group for stool volume ( p = 0.014), increasing 56 % compared to baseline ( p < 0.01), while remained unchanged in the placebo group. Stool consistency was improved only in the RMD group ( p < 0.01). No adverse effects related to study products were observed. Conclusions: The results show that RMD improved CTT, stool volume, stool consistency and some intestinal functions in a healthy population. [ABSTRACT FROM AUTHOR]

Objectives To compare the use of sonic powered or manual toothbrush in patients with intellectual disability ( ID) in terms of plaque (PlI) and gingival ( GI) indices and adverse effects. Material and Methods Subjects with ID were recruited for this cluster-randomized, single blinded (examiner), 6-month clinical trial, comparing powered versus manual toothbrushing. Outcome variables included PlI and GI, evaluated at baseline and 3 months after supervised toothbrushing and after 3 additional months of unsupervised used. Clinical outcome variables were analysed by repeated measures ANCOVA considering time and group as factors and respective baseline values as covariates (generalized linear model). Results Sixty-four patients (34 male, mean age 34.5) in six clusters were included in the study. No statistically significant effect of toothbrushing group was observed for PlI or GI. A significant effect of time was identified ( p < 0.001) with mean reductions ranging 0.44-0.45 for PlI and 0.30-0.36 for GI from baseline to 3-6 months. No relevant adverse effect or technical problems were observed. Conclusion The tested sonic powered toothbrush was as effective and safe as the manual toothbrush. The use of powered or manual toothbrushes, together with fluoride toothpaste, may improve plaque and gingivitis levels, in patients with mild to limit ID. [ABSTRACT FROM AUTHOR]

STUDY DESIGN: Secondary analysis of a randomized trial. BACKGROUND: A clinical prediction rule to identify patients with carpal tunnel syndrome (CTS) most likely to respond to manual physical therapy has been published but requires further testing to determine its validity. OBJECTIVE: To assess the validity of a clinical prediction rule proposed for the management of patients with CTS in a different group of patients with a variety of treating clinicians. METHODS: A preplanned secondary analysis of a randomized controlled trial investigating the efficacy of manual physical therapies, including desensitization maneuvers of the central nervous system, in 120 women suffering from CTS was performed. Patients were randomized to receive 3 sessions of manual physical therapy (n = 60) or surgical release/decompression of the carpal tunnel (n = 60). Self-perceived improvement with a global rating of change was recorded at 6- and 12-month follow-ups. Pain intensity (mean pain and worst pain on a 0-to-10 numeric pain-rating scale) and scores on the Boston Carpal Tunnel Questionnaire (functional status and symptom severity subscales) were assessed at baseline and at 1,3, 6, and 12 months. A baseline assessment of status on the clinical prediction rule was performed (positive status on the clinical prediction rule was defined as meeting at least 2 of the following criteria: pressure pain threshold of less than 137 kPa over the affected C5-6 joint; heat pain threshold of less than 39.6°C over the affected carpal tunnel; and general health score [Medical Outcomes Study 36-Item Short-Form Health Survey] of greater than 66 points). Linear mixed models with repeated measures were used to examine the validity of the rule. RESULTS: Participants with a positive status on the rule who received manual physical therapy did not experience greater improvements compared to those with a negative status on the rule for mean pain (P = .65), worst pain (P = .86), function (P = .99), or symptom severity (P = .85). Further, the clinical prediction rule performed no better than chance in identifying the individuals with CTS most likely to respond to manual physical therapy or surgery (mean pain, P = .87; worst pain, P = .91; function, P = .60; severity, P = .66). No differences in self-perceived improvement were observed at either 6 (P = .68) or 12 (P = .36) months, according to the rule. CONCLUSION: The results of this study did not support the validity of the previously developed clinical prediction rule for manual physical therapy in women with CTS. [ABSTRACT FROM AUTHOR]

Background: It is known that making people change their habits is challenging. It is crucial to identify the most effective approach that general practitioners (GPs) should use to help their patients change unhealthy habits. The objective this study was to assess the efficacy of a multifactorial intervention based on Motivational Interviewing performed by general practitioners to enhance lipid levels in patients with dyslipidemia, as compared to standard care. Methods: A multicenter, controlled, randomized, cluster, two-parallel arm trial with a 12-month follow-up conducted in 25 community health centers of the Spanish. 38 GPs and 227 primary care patients with uncontrolled dyslipidemia were included in the trial. GPs performed an intervention based either on Motivational Interviewing (MI) or standard practice. Lipid levels were measured, and the control degree was analyzed based on the criteria of clinical guidelines. Results: 107 were assigned to the Experimental Group (EG) and 120 to the Control Group (CG). An overall improvement was achieved in total cholesterol levels (Mean Difference -MD- = -19.60; 95 % CI:-15.33 at-23.87 mg/dl; p< 0.001), LDL-cholesterol levels (MD = -13.78; 95 % CI: -9.77 at -17.79 mg/dl; p < 0.001 ) and triglycerides (MD = -19.14; CI 95 %: -11.29 at -26.99 mg/dl; p < 0.001). No differences were found between the two groups. However, when we assessed the degree of lipid control by combining cholesterol <200 mg/dl and LDL-cholesterol < 130 mg/dl parameters, it was observed that a higher percentage of patients achieved target figures in the EG versus CG (13.1 % vs. 5.0 %; adjusted OR = 5.77, 95% CI: 1.67-19.91). Conclusion: A Motivational Interviewing-based approach conducted by Primary Care physicians aimed at patients with dyslipidemia, achieved a significant reduction in all lipid parameters, cardiovascular risk, weight reduction and the adherence to the Mediterranean diet, similar to that obtained with the usual intervention and superior in the proportion of patients achieving combined lipid control goals and the level of physical exercise. [ABSTRACT FROM AUTHOR]

Background Tobacco smoke pollution (TSP) has major negative effects on infant health. Our objectives were to determine the effectiveness of a brief primary care intervention directed at parents who smoke in reducing babies’ TSP exposure, and to establish variables related to greater exposure. Method A multicentre, open, cluster-randomised clinical trial in Catalonia. The 83 participating primary health paediatric teams of the Catalan Health Service recruited 1101 babies whose parents were smokers. The intervention group (IG) received a brief TSP intervention; the control group (CG) received the usual care. Outcomes were measured by parents’ reported strategies to avoid TSP exposure. Baseline clinical data and characteristics of each baby’s TSP exposure were collected, along with infant hair samples and parents’ tobacco use and related attitudes/behaviours. At 3-month and 6-month follow-up, behavioural changes to avoid TSP exposure were recorded; the association between reported parental behaviours and nicotine concentration in infant hair samples was tested in a random sample of 253 babies at baseline and 6 months. Results During follow-up, TSP-avoidance strategies improved more in the IG than in the CG: 35.4% and 26.9% ( p=0.006) at home, and 62.2% and 53.1% in cars (p=0.008). Logistic regression showed adjusted ORs for appropriate measures in the IG versus CG of 1.59 (95% CI 1.21 to 2.09) at home and 1.30 (95% CI 0.97 to 1.75) in cars. Hair samples showed that 78.7% of the babies tested were exposed. Reduced nicotine concentration was associated with improved implementation of effective strategies reported by parents at home (p=0.029) and in cars (p=0.014). Conclusions The intervention produced behavioural changes to avoid TSP exposure in babies. The proportion of babies with nicotine (>=1ng/mg) in hair samples at baseline is a concern. [ABSTRACT FROM AUTHOR]

Background. Educational initiatives for informal caregivers have proved efficient at reducing some of their symptoms, consequence of their involvement in care giving. However, more progress must be made in terms of the design of more successful interventions. Aims: Randomized clinical trial to test the efficiency of an Education Program for Primary Informal Caregivers of Hospitalized Dependent Patients in relation to their burden, mental and physical health, and care related knowledge. Methods. Design: Cluster Randomized Trial. Sample: 151 participants, primary caregivers of hospitalized, dependent patients, carried out from February 2009 to March 2010. They were assigned at random to two groups: one received an intensive educational program (n = 78), and the other just a generic speech (n = 73). The degree of burden of caregivers was recorded (Zarit Test), as well as their physical and mental health (SF12) and their knowledge of caregiving, before, immediately, after and one and a half months after the intervention. These analyses were carried out according to the Generalized Estimated Equations Method, in order to assess any possible improvements. Results. Participants´ burden did not improve, as measured by Zarit Test (p = 0,338), nor did their physical (p = 0,917) or mental health (p = 0,345). However there was an improvement in their hygiene caregiving (p = 0,001) and mobility care giving (p = 0,001). Conclusions. Caregivers found useful the education program, providing them with an informal support group. Interventions need to be longer and more customized as well as adapted to specific demands. There is a lack of validated questionnaires to assess improvements in care knowledge. There is a need to develop programs that contemplate continuity of care from primary to specialized caregiving. [ABSTRACT FROM AUTHOR]

Aims To compare the effectiveness of care delivered by nurses to the usual care delivered by general practitioners, in adult patients requesting same day appointments in primary care practices in Catalonia ( Spain). Background Same day appointments conducted by nurses are characterized by high patient satisfaction and a high resolution index. The profile of nursing and the organization of primary care services in our country differ from other countries. Design Multicentre, randomized, unblinded clinical trial with two parallel groups. Methods Patients were randomized to an intervention group (seen by nurses trained to respond to low complexity problems) or a control group (seen by the general practitioner) using an automatic probabilistic function. Setting: 38 primary care practices in Catalonia, 142 general practitioners and 155 nurses participated. Population study: ≥ 18-year-old patients who requested a same day consultation. Recruitment period: January- May, 2009. Of the 1,461 randomized patients, 92·5% completed the study. Main outcome measures: resolution of symptoms and patient satisfaction 2 weeks after the visit. Results Seven hundred and fifty-three patients were assigned to the intervention group and 708 to the control group. Nurses successfully solved 86·3% of the cases. We did not observe any differences in resolution of symptoms or patient satisfaction between the groups. Conclusions Nurses trained specifically to resolve acute health problems of low complexity give comparable quality of care to that provided by general practitioners in terms of resolution of the problem 15 days after the visit and in patient satisfaction with the visit. [ABSTRACT FROM AUTHOR]