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Reaching Statistical Significance (reaching + statistical_significance)
Selected AbstractsSmoking cessation in severe mental illness: what works?ADDICTION, Issue 7 2010Lindsay Banham ABSTRACT Aims The physical health of people with severe mental illness (SMI) is poor. Smoking-related illnesses are a major contributor to excess mortality and morbidity. An up-to-date review of the evidence for smoking cessation interventions in SMI is needed to inform clinical guidelines. Methods We searched bibliographic databases for relevant studies and independently extracted data. Included studies were randomized controlled trials (RCTs) of smoking cessation or reduction conducted in adult smokers with SMI. Interventions were compared to usual care or placebo. The primary outcome was smoking cessation and secondary outcomes were smoking reduction, change in weight, change in psychiatric symptoms and adverse events. Results We included eight RCTs of pharmacological and/or psychological interventions. Most cessation interventions showed moderate positive results, some reaching statistical significance. One study compared behavioural support and nicotine replacement therapy (NRT) to usual care and showed a risk ratio (RR) of 2.74 (95% CI 1.10,6.81) for short-term smoking cessation, which was not significant at longer follow-up. We pooled five trials that effectively compared bupropion to placebo giving an RR of 2.77 (95% CI 1.48,5.16), which was comparable to Hughes et al.'s 2009 figures for general population data; RR = 1.69 (95% CI 1.53,1.85). Smoking reduction data were too heterogeneous for meta-analysis, but results were generally positive. Trials suggest few adverse events. All trials recorded psychiatric symptoms and the most significant changes favoured the intervention groups over the control groups. Conclusions Treating tobacco dependence is effective in patients with SMI. Treatments that work in the general population work for those with severe mental illness and appear approximately equally effective. Treating tobacco dependence in patients with stable psychiatric conditions does not worsen mental state. [source] Genetic analysis of three important genes in pigmentation and melanoma susceptibility: CDKN2A, MC1R and HERC2/OCA2EXPERIMENTAL DERMATOLOGY, Issue 9 2010Maider Ibarrola-Villava Please cite this paper as: Genetic analysis of three important genes in pigmentation and melanoma susceptibility: CDKN2A, MC1R and HERC2/OCA2. Experimental Dermatology 2010; 19: 836,844. Abstract:, The CDKN2A gene is regarded as the major familial malignant melanoma (MM) susceptibility gene. Human pigmentation is one of the main modulators of individual risk of developing MM. Therefore, the genes involved in the determination of skin colour and tanning response are potentially implicated in MM predisposition and may be useful predictors of MM risk in the general population. The human melanocortin-1 receptor gene (MC1R) plays a crucial role in pigmentation and also appears to be important in MM. The OCA2 gene has emerged as a new and significant determinant of human iris colour variation. We present a case,control study in Spanish population including 390 consecutive patients with melanoma and 254 control subjects. Sequence analysis of the entire coding region and genotyping of 5 tag-SNPs in the genomic region of MC1R was performed. We identified 27 variants, two reaching statistical significance [R160W (OR: 4.18, 95% CI: 1.24,14.04, P = 0.02) and D294H (OR: 3.10, 95% CI: 1.37,7.01, P = 0.01)] and we detected two novel non-synonymous changes: V92L and T308M. Odds ratio for carrying two functional variants was 4.25 (95% CI: 2.30,7.84, P = 3.63 × 10,6). Haplotypes of the entire MC1R region have been established, and we observed an enrichment of a rare European haplotype similar to African values carrying variants V92M and I155T. In addition, three potentially functional SNPs were selected in p16/CDKN2A and in the promoter region of OCA2/HERC2. Our data for CDKN2A gene did not reach statistically significant results for any of the two studied alleles. We found that the variant allele A > G of OCA2/HERC2 (rs12913832) was associated with pigmentation features: eye, hair and skin colour; P -values = 1.8 × 10,29, 9.2 × 10,16, 1.1 × 10,3, respectively, validating previous results. [source] Sperm DNA integrity in cancer patients: the effect of disease and treatmentINTERNATIONAL JOURNAL OF ANDROLOGY, Issue 6 2009O. Ståhl Summary As oncological treatment might impair the patients' fertility, male cancer patients are offered to cryopreserve semen prior to treatment. Impaired sperm DNA quality is associated with reduced fertility, and in case of assisted reproduction, sperm DNA integrity may have an impact on choice of method. Therefore, we have assessed sperm DNA integrity in cancer patients, comparing pre- and post-treatment quality. Sperm DNA integrity was investigated in cryopreserved semen from 121 cancer patients, the predominating diagnoses were germ cell cancer (GCC) and Hodgkin's lymphoma (HL). Post-treatment samples, with a median follow-up of 3 years, were analysed for 58 of the men, allowing a pre- and post-treatment analysis on an individual basis. Sperm DNA integrity was assessed using the Sperm Chromatin Structure Assay and expressed here as the DNA Fragmentation Index (DFI%). One hundred and thirty-seven fertile men served as controls. Before treatment, GCC (n = 84) and HL (n = 18) patients had higher DFI% than controls (n = 143) with a mean difference of 7.7 (95% CI 3.2,8.8) and 7.0 (95% CI 2,12), respectively. The same trend was observed for other cancer diagnoses, but without reaching statistical significance (mean difference 3.6, 95% CI ,1.2 to 8.4). No increase was seen in DFI% comparing pre- and post-treatment semen, regardless of treatment modality. A moderate elevation of DFI% was observed in cryopreserved semen from cancer patients. Oncological treatment, generally, did not induce any increase in DFI. These findings should be considered when discussing the utilization of pre-treatment cryopreserved semen vs. post-treatment fresh sperm in cancer patients undergoing assisted reproduction. [source] Reduced Fluoroscopy During Atrial Fibrillation Ablation: Benefits of Robotic Guided NavigationJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 1 2010DANIEL STEVEN M.D. Reduced Fluoroscopy in PVI Using RN.,Background: Recently, a nonmagnetic robotic navigation system (RN, Hansen-SenseiÔ) has been introduced for remote catheter manipulation. Objective: To investigate the influence of RN combined with intuitive 3-dimensional mapping on the fluoroscopy exposure to operator and patient during pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) in a prospective randomized trial. Methods: Sixty patients were randomly assigned to undergo PVI either using a RN guided (group 1; n = 30, 20 male, 62 ± 7.7 years) or conventional ablation approach (group 2; n = 30, 14 male, 61 ± 7.6 years). A 3-dimensional mapping system (NavXÔ) was used in both groups. Results: Electrical disconnection of the ipsilateral pulmonary veins (PVs) was achieved in all patients. Use of RN significantly lowered the overall fluoroscopy time (9 ± 3.4 vs 22 ± 6.5 minutes; P < 0.001) and reduced the operator's fluoroscopy exposure (7 ± 2.1 vs 22 ± 6.5 minutes; P < 0.001). The difference in fluoroscopy duration between both groups was most pronounced during the ablation part of the procedure (3 ± 2.4 vs 17 ± 6.3 minutes; P < 0.001). The overall procedure duration tended to be prolonged using RN without reaching statistical significance (156 ± 44.4 vs 134 ± 12 minutes, P = 0.099). No difference regarding outcome was found during a midterm follow-up of 6 months (AF freedom group 1 = 73% vs 77% in group 2 [P = 0.345]). Conclusion: The use of RN for PVI seems to be effective and significantly reduces overall fluoroscopy time and operator's fluoroscopy exposure without affecting mid-term outcome after 6-month follow-up. (J Cardiovasc Electrophysiol, Vol. 21, pp. 6,12, January 2010) [source] Changes in Plasma Amino Acids During Extracorporeal Liver Support by Fractionated Plasma Separation and AdsorptionARTIFICIAL ORGANS, Issue 2 2010Kinan Rifai Abstract In patients with liver failure, amino acid dysbalance is common and associated with hepatic encephalopathy. Prometheus is a newly designed extracorporeal liver support system based upon fractionated plasma separation and adsorption (FPSA). We evaluated the influence of FPSA on plasma amino acid patterns in patients with liver failure and hepatic encephalopathy. We studied nine patients with acute-on-chronic liver failure, hepatic encephalopathy, and concomitant renal failure. A single session of FPSA therapy for 5 ± 1 h was performed in all patients. Twenty-six different plasma amino acids were measured by high-performance liquid chromatography before and after FPSA treatment. Total amino acids as well as Fischer index were calculated. Additionally, a variety of clinical and biochemical parameters were assessed. Before FPSA was started, plasma levels of most amino acids were elevated. Plasma ammonia levels correlated with glutamine levels (P < 0.04). During FPSA, plasma levels of nearly all amino acids significantly decreased except for branched-chain amino acids. The Fischer index improved without reaching statistical significance. FPSA therapy tends to normalize plasma amino acids in patients with combined liver and renal failure. This may contribute to positive pathophysiologic effects, especially on hepatic encephalopathy. However, the clinical significance of these findings needs to be further evaluated. [source] Tibolone and low-dose continuous combined hormone treatment: vaginal bleeding pattern, efficacy and tolerabilityBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 12 2007ML Hammar Objectives, The primary objective was to compare the vaginal bleeding pattern during administration of tibolone and low-dose continuous combined estradiol plus norethisterone acetate (E2/NETA). The secondary objectives were efficacy on vasomotor symptoms and vaginal atrophy. Design, A randomised, double-blind, double-dummy, group comparative intervention trial. Setting, Multicentre study executed in 32 centres in 7 European countries. Sample, Five hundred and seventy-two healthy symptomatic postmenopausal women, aged 45,65 years. Methods, Participants were randomised to receive 2.5 mg tibolone or 1 mg 17, estradiol plus 0.5 mg norethisterone acetate (E2/NETA) daily for 48 weeks. Main outcome measures, Prevalence of vaginal bleeding, hot flushes and adverse events. Results, The incidence of bleeding was significantly lower in the tibolone group during the first 3 months of treatment (18.3 versus 33.1%; P < 0.001) when compared with the E2/NETA group. This effect on the bleeding pattern was sustained throughout the study, although reaching statistical significance again only in 7,9 months of treatment (11 versus 19%; P < 0.05). In both treatment groups, vasomotor symptoms and vaginal atrophy were significantly reduced to a similar extent when compared with baseline. The prevalence of breast pain/tenderness was significantly lower with tibolone compared with E2/NETA (3.2 versus 9.8%; P < 0.001). Conclusion, Tibolone reduces menopausal symptoms to a similar extent as conventional low-dose continuous combined hormone therapy but causes significant less vaginal bleeding in the first 3 months of treatment. This constitutes an important argument for woman adherence to therapy. [source] Long-term outcome of transpupillary thermotherapy as primary treatment of selected choroidal melanomaACTA OPHTHALMOLOGICA, Issue 7 2009Raffaele Parrozzani Abstract. Purpose:, To evaluate prospectively, on a long-term range, the clinical outcomes of transpupillary thermotherapy (TTT) as primary treatment of selected choroidal melanoma. Methods:, Seventy-seven eyes of 77 patients affected by small posterior choroidal melanoma were treated with TTT as a sole treatment, using an infrared diode laser at 810 nm according to a standard procedure. Follow-up was longer than 36 months. Results:, Seventeen tumours (22%) were parapapillary (PP) and 60 tumours (78%) were non-parapapillary (NPP) in location. Mean follow-up was 55.2 ± 17.9 months in PP tumours and 44.3 ± 23.7 months in NPP tumours. Thirteen (76%) PP tumours and 55 (92%) NPP tumours regressed (P > 0.05). Nine tumours recurred: seven were retreated using Iodine-125 brachytherapy and two were enucleated (both parapapillary). Four patients (5%) developed liver metastasis and died during follow-up. Tumour thickness was found to be predictive of recurrence (odds ratio: 4.3). Complications were found in 20 eyes (26%): macular pucker in 11 (14%), macular oedema in three (4%), retinal vein occlusion in six (8%), vitreous and subretinal haemorrhage in two (3%) and neovascular glaucoma in three (4%). PP tumours had more local complications (but this was not statistically significant; P > 0.05). Complications appeared more frequently in tumours treated with more than one TTT session (P = 0.01), and time-risk to develop intraocular complications seems longer in the PP group, without reaching statistical significance (P = 0.07). Conclusion:, TTT may be a clinically effective method for conservative treatment of selected, non-parapapillary, small posterior choroidal melanoma. [source] | ||||||||||