Vagus Nerve Stimulation for the Treatment of Heart Failure: The INOVATE-HF Trial.

BACKGROUND: Heart failure (HF) is increasing in prevalence and is a major cause of morbidity and mortality despite advances in medical and device therapy. Autonomic imbalance, with excess sympathetic activation and decreased vagal tone, is an integral component of the pathophysiology of HF. OBJECTIVES: The INOVATE-HF (Increase of Vagal Tone in Heart Failure) trial assessed the safety and efficacy of vagal nerve stimulation (VNS) among patients with HF and a reduced ejection fraction. METHODS: INOVATE-HF was a multinational, randomized trial involving 85 centers including patients with chronic HF, New York Heart Association functional class III symptoms and ejection fraction ≤40%. Patients were assigned to device implantation to provide VNS (active) or continued medical therapy (control) in a 3:2 ratio. The primary efficacy endpoint was composite of death from any cause or first event for worsening HF. RESULTS: Patients (n = 707) were randomized and followed up for a mean of 16 months. The primary efficacy outcome occurred in 132 of 436 patients in the VNS group, compared to 70 of 271 in the control group (30.3% vs. 25.8%; hazard ratio: 1.14; 95% confidence interval: 0.86 to 1.53; p = 0.37). During the trial, the estimated annual mortality rates were 9.3% and 7.1%, respectively (p = 0.19). Quality of life, New York Heart Association functional class, and 6-min walking distance were favorably affected by VNS (p < 0.05), but left ventricular end-systolic volume index was not different (p = 0.49). CONCLUSIONS: VNS does not reduce the rate of death or HF events in chronic HF patients. (INcrease Of VAgal TonE in CHF [INOVATE-HF]; NCT01303718).

The Children's Dermatology Life Quality Index (CDLQI): linguistic and cultural validation in Serbian.

BACKGROUND: The Children's Dermatology Life Quality Index (CDLQI) evaluates the impact of skin diseases on the patient's quality of life. OBJECTIVE: The purpose of the study was to translate and to validate the CDLQI into Serbian. METHODS: The CDLQI was translated into Serbian following international recommendations for translation and cultural adaptation. The validation study was carried out on a large cohort of secondary schoolchildren who self-reported acne. RESULTS: Translating the CDLQI consisted of forward translation, reconciliation, back translation, back-translation review, and cognitive debriefing. The good internal consistency of the scale was demonstrated with a Cronbach alpha coefficient of 0.87. A Spearman correlation coefficient of 0.66 between the CDLQI and the Cardiff Acne Disability Index (CADI) was deemed satisfactory to demonstrate concurrent validity. CONCLUSION: The translation, cross-cultural adaptation, and psychometric qualities of the CDLQI were satisfactory, enabling its application in clinical practice and future studies.

The Cardiff Acne Disability Index (CADI): linguistic and cultural validation in Serbian.

PURPOSE: The aims of this study were to translate the Cardiff Acne Disability Index (CADI) into Serbian and to assess its validity and reliability in Serbian acne patients. METHODS: The CADI was translated and linguistically validated into Serbian according to published guidelines. This version of CADI, along with the Serbian version of Children's Dermatology Life Quality Index (CDLQI) and a short demographic questionnaire, was administrated to a cohort of secondary school pupils. The Global Acne Grading Score was used to measure the clinical severity of acne. The internal consistency reliability of the Serbian version of CADI was assessed by Cronbach's alpha coefficient while its concurrent validity was assessed by Spearman's correlation coefficient. Construct validity was examined by factor analysis. RESULTS: A total of 465 pupils completed questionnaires. Self-reported acne was present in 76% of pupils (353/465). The Serbian version of CADI showed high internal consistency reliability (Cronbach's alpha coefficient = 0.79). The mean item-total correlation coefficient was 0.74 with a range of 0.53-0.81. The concurrent validity of the scale was supported by a moderate but highly significant correlation with the CDLQI (Spearman's rho = 0.66; P < 0.001). Factor analysis revealed the presence of two dimensions underlying the factor structure of the scale. CONCLUSIONS: The Serbian version of the CADI is a reliable, valid, and valuable tool for assessing the impact of acne on the quality of life of Serbian-speaking patients.

Quality of life among schoolchildren with acne: results of a cross-sectional study.

BACKGROUND: Acne is a common problem in adolescent children and has a considerable impact on their quality of life. AIMS: The purpose of this study was to assess health-related quality of life (HRQoL) among Serbian adolescents with acne, using 2 questionnaires: The Children's Dermatology Life Quality Index (CDLQI) and the Cardiff Acne Disability Index (CADI) and to provide a cross validation of 2 scales. METHODS: This cross-sectional study was conducted among the pupils of the secondary railway-technical school in Belgrade, Serbia. 478 pupils (aged 15 - 18 years) completed 2 HRQoL questionnaires: CDLQI and CADI. We used t-test for differences between mean values of CDLQI and CADI and Spearman's rho coefficient for correlation between 2 questionnaires. RESULTS: Self-reported acne was present in 71.6% of pupils (64.3% boys and 35.7% girls). The overall mean CDLQI score (4.35 of max. 30) and the overall mean CADI score (3.57 of max. 15) were low, indicating a mild impairment of HRQoL among adolescants. There was good correlation between the 2 questionnaires (Spearman' rho = 0.66). CONCLUSION: The CADI and the CDLQI questionnaires represent simple and reliable instruments for the assesment of HRQoL among schoolchildren with acne. In this study, we identified 17% of boys and 18% of girls perceived their acne as a major problem. It is important to detect and treat such adolescents on time to reduce the psychosocial burden associated with acne.