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Secondary Outcome Variables (secondary + outcome_variable)
Selected AbstractsImplant-supported fixed cantilever prosthesis in partially edentulous jaws: a cohort prospective studyCLINICAL ORAL IMPLANTS RESEARCH, Issue 11 2009Eugenio Romeo Abstract: Background: Reconstructive procedures present a higher rate of biological costs due to the necessity of bone harvest and grafts, use of semipermeable barriers etc. On the hand, implant supported cantilever prostheses could allow a simpler rehabilitation procedure. Aims: The aim of the present study was to assess the clinical outcome of patients treated with implant-supported fixed partial dentures (FPD) with cantilever after a mean follow-up time of 8 years. Material and methods: The study included 45 consecutive partially edentulous patients treated between January 1994 and August 2006 with 59 partial cantilever fixed prostheses supported by 116 ITI® implants. The primary outcome variable considered was the presence of complications at the subject and bridge level; the secondary outcome variable was marginal bone loss (MBL). The frequency of complications was analyzed according to cantilever location and opposite dentition and tested by Fisher's exact test. A multilevel regression model was constructed to analyze the factors influencing MBL with three levels: subject as the highest, and then implant and site. During the follow-up period, 11 implants showed a bone loss exceeding the limit for success, out of which two implants showed an infection of the peri-implant tissue. Results: After an average observation of 8.2 years of cantilever prostheses loading, the implant success and survival rates were 90.5% and 100%, respectively. Besides, the prosthetic success and survival rate were 57.7% and 100%, respectively. Discussion: None of the predictors included in the multilevel model presented a significant impact on the bone loss between baseline and the follow-up examination. Conclusions: The authors concluded that the prognosis of implant-supported FPDs and marginal bone loss at implants were not influenced by the position or the length of the cantilever, the location of the bridge and type of opposite dentition. Implant-supported fixed cantilever prosthesis can be considered a suitable treatment choice. [source] Obese Patients with Abdominal Pain Presenting to the Emergency Department Do Not Require More Time or Resources for Evaluation Than Nonobese PatientsACADEMIC EMERGENCY MEDICINE, Issue 8 2005Timothy F. Platts-Mills MD Abstract Objectives: The authors describe the evaluation of obese and nonobese adult patients with abdominal pain presenting to an emergency department (ED). The hypothesis was that more ED and hospital resources are used to evaluate and treat obese patients. Methods: A prospective observational study of obese (n= 98; body mass index ,30 kg/m2) and nonobese (n= 176; body mass index < 30 kg/m2) adults presenting to the ED with abdominal pain was performed. ED length of stay (LOS) was the primary outcome. Secondary outcomes included use of laboratory tests, computed tomography, and ultrasonography, and rates of consultations, operations, and admissions. ED diagnoses were compared between the two groups. Results: Obese patients were older (41.9 vs. 38.3 years; p = 0.027) and more often female (69% vs. 51%; p = 0.003) than nonobese patients. There were no significant differences between obese and nonobese patients in either the primary or the secondary outcome measures. Obese patients were similar to nonobese patients in regard to LOS (457 vs. 486 minutes), laboratory studies (3.2 vs. 2.9 tests), abdominopelvic computed tomographic scans (30% vs. 31%), and abdominal ultrasounds (16% vs. 13%). Obese and nonobese patients were also similar in their rates of consultations (27% vs. 31%), operations (14% vs. 12%), and admissions (18% vs. 24%). No difference was found for LOS between obese and nonobese patients as evaluated by the Wilcoxon rank-sum test (p = 0.81). Logistic regression analysis controlling for baseline characteristics revealed no significant differences between obese and nonobese patients for secondary outcome variables. ED diagnoses for obese and nonobese patients were similar except that genitourinary diagnoses were less common in obese patients (8% vs. 21%; p = 0.01). Conclusions: In contradiction to the hypothesis, the results suggest that LOS and ED resource use in obese patients with abdominal pain are not increased when compared with nonobese patients. [source] Suboccipital Nerve Blocks for Suppression of Chronic Migraine: Safety, Efficacy, and Predictors of OutcomeHEADACHE, Issue 6 2010Silvia Weibelt RN (Headache 2010;50:1041-1044) Background., Approximately 1 in 50 Americans is afflicted by chronic migraine (CM). Many patients with CM describe cervicogenic headache. Options for treating CM effectively are at present quite limited. Objective., To determine the safety and efficacy of occipital nerve blocks (ONBs) used to treat cervicogenic chronic migraine (CCM) and to identify variables predictive of a positive treatment response. Methods., Using a uniform dose and injection paradigm, we performed ONBs consecutively on a series of patients presenting with CCM. Patients were stratified according to specific findings found to be present or absent on physical examination. A positive treatment outcome was defined as a 50% or greater reduction in headache days per month over the 30 days following treatment relative to the 30-day pre-treatment baseline. We used a 5-point Likert scale as one of the secondary outcome variables. Results., We treated 150 consecutive patients with unilateral (37) or bilateral (113) ONBs. At the 1-month follow-up visit 78 (52%) exhibited evidence of a positive treatment response according to the primary outcome variable, and 90 (60%) reported their headache disorder to be "better" (44; 29%) or "much better" (46; 30%). A total of 8 (5%) patients reported adverse events within the ensuing 72 hours, and 3 (2%) experienced adverse events that reversed spontaneously but required emergent evaluation and management. Conclusion., For suppression of CCM, ONBs may offer an attractive alternative to orally administered prophylactic therapy. [source] Trospium chloride once-daily extended release is effective and well tolerated for the treatment of overactive bladder syndrome: an integrated analysis of two randomised, phase III trialsINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 12 2009D. R. Staskin Summary Background:, Trospium chloride is an antimuscarinic agent with a hydrophilic polar quaternary amine structure that is minimally metabolised by hepatic cytochrome P450 and is actively excreted in the urine, each of which confers a potential benefit with regard to efficacy and tolerability. Purpose:, We analysed pooled data from two identically designed phase III trials of a once-daily, extended-release (XR) formulation of trospium chloride (trospium XR 60-mg capsules) in subjects with overactive bladder syndrome (OAB). Methods:, Adults with OAB of , 6 months' duration with urinary urgency, frequency and , 1 urge urinary incontinence (UUI) episode/day were enrolled in these multicentre, parallel-group, double-blind trials. Participants were randomised (1 : 1) to receive trospium XR 60 mg or placebo for 12 weeks. Primary efficacy variables were changes in urinary frequency and the number of UUI episodes/day. Adverse events (AEs) were recorded throughout. Results:, In total, 1165 subjects were randomised (trospium XR, 578; placebo, 587). At baseline, subjects averaged 12.8 toilet voids/day and 4.1 UUI episodes/day. Compared with placebo, subjects treated with trospium XR had significantly greater reductions from baseline in the mean number of toilet voids/day (,1.9 vs. ,2.7; p < 0.001) and UUI episodes/day (,1.8 vs. ,2.4; p < 0.001) at week 12. The most frequent AEs considered possibly related to study treatment were dry mouth (trospium XR, 10.7%; placebo, 3.7%) and constipation (trospium XR, 8.5%; placebo, 1.5%). Notably, rates of central nervous system (CNS) AEs were lower with trospium XR vs. placebo (dizziness: 0.2% vs. 1.0%; headache: 1.4% vs. 2.4%). Conclusions:, Treatment with trospium XR resulted in statistically significant improvements in both of the dual primary and all of the secondary outcome variables. Trospium XR demonstrated favourable rates of AEs, particularly CNS AEs (numerically lower than with placebo) and dry mouth (lower than previously reported with trospium immediate-release, although not compared in a head-to-head study). [source] Modafinil reduces patient-reported tiredness after sedation/analgesia but does not improve patient psychomotor skillsACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 2 2010E. GALVIN Background: Early recovery of patients following sedation/analgesia and anesthesia is important in ambulatory practice. The aim of this study was to assess whether modafinil, used for the treatment of narcolepsy, improves recovery following sedation/analgesia. Methods: Patients scheduled for extracorporeal shock wave lithotripsy were randomly assigned to one of four groups. Two groups received a combination of fentanyl/midazolam with either modafinil or placebo. The remaining groups received remifentanil/propofol with either modafinil or placebo. Modafinil 200 mg was administered to the treatment group patients 1 h before sedation/analgesia. Groups were compared using the digital symbol substitution test (DSST), trail making test (TMT), observer scale of sedation and analgesia (OAA/S) and Aldrete score. Verbal rating scale (VRS) scores for secondary outcome variables e.g. energy, tiredness and dizziness were also recorded before and after treatment. Results: Sixty-seven patients successfully completed the study. Groups received similar doses of sedation and analgesic drugs. No statistically significant difference was found for DSST between groups. No significant adverse effects occurred in relation to modafinil. No statistically significant difference between groups was identified for TMT, OAA/S and Aldrete scores. The mean VRS score for tiredness was lesser in the modafinil/fentanyl/midazolam group [1.3 (2.0)] compared with the placebo group [3.8 (2.5)], P=0.02. Such a difference was not found between the remifentanil/propofol groups [placebo 2.6 (2.2) vs. modafinil 3.1(2.7)], p>0.05. Dizziness was greater in the modafinil/remifentanil/propofol group 1.7 (2.0) vs. placebo 0.0 (0.5), p<0.05. Conclusion: Modafinil reduces patient-reported tiredness after sedation/analgesia but does not improve recovery in terms of objective measures of patient psychomotor skills. [source] Gender Differences in Alcohol Treatment: An Analysis of Outcome From the COMBINE StudyALCOHOLISM, Issue 10 2010Shelly F. Greenfield Background:, Relatively few studies have examined gender differences in the effectiveness of specific behavioral or pharmacologic treatment of alcohol dependence. The aim of this study is to assess whether there were gender differences in treatment outcomes for specific behavioral and medication treatments singly or in combination by conducting a secondary analysis of public access data from the national, multisite NIAAA-sponsored COMBINE study. Methods:, The COMBINE study investigated alcohol treatment among 8 groups of patients (378 women, 848 men) who received medical management (MM) with 16 weeks of placebo, naltrexone (100 mg/day), acamprosate (3 g/day), or their combination with or without a specialist-delivered combined behavioral intervention. We examined efficacy measures separately for men and women, followed by an overall analysis that included gender and its interaction with treatment condition in the analyses. These analyses were performed to confirm whether the findings reported in the parent trial were also relevant to women, and to more closely examine secondary outcome variables that were not analyzed previously for gender effects. Results:, Compared to men, women reported a later age of onset of alcohol dependence by approximately 3 years, were significantly less likely to have had previous alcohol treatment, and drank fewer drinks per drinking day. Otherwise, there were no baseline gender differences in drinking measures. Outcome analyses of 2 primary (percent days abstinent and time to first heavy drinking day) and 2 secondary (good clinical response and percent heavy drinking days) drinking measures yielded the same overall pattern in each gender as that observed in the parent COMBINE study report. That is, only the naltrexone by behavioral intervention interaction reached or approached significance in women as well as in men. There was a naltrexone main effect that was significant in both men and women in reduction in alcohol craving scores with naltrexone-treated subjects reporting lower craving than placebo-treated subjects. Conclusions:, This gender-focused analysis found that alcohol-dependent women responded to naltrexone with COMBINE's Medical Management, similar to the alcohol-dependent men, on a wide range of outcome measures. These results suggest that clinicians can feel comfortable prescribing naltrexone for alcohol dependence in both men and women. In this study, it is also notable that fewer women than men reported receiving any alcohol treatment prior to entry into the COMBINE study. Of note, women tend to go to primary health care more frequently than to specialty substance abuse programs for treatment, and so the benefit we confirm for women of the naltrexone and MM combination has practical implications for treating alcohol-dependent women. [source] Recommendations on Use of Biomarkers in Alcoholism Treatment TrialsALCOHOLISM, Issue 10 2003John P. Allen Background: Biochemical markers of heavy drinking are playing increasingly prominent roles in alcohol treatment efficacy studies, especially in those designed to evaluate medications. Among these roles are serving as inclusion or exclusion criteria for research participants, corroboration of self-report of drinking status, assessment of the safety of the agent being evaluated, and determination of treatment outcome. Methods: Recent alcohol medication development trials that included biomarker information were reviewed and critiqued from the perspectives of how biomarker measures were used and how findings on them were reported. Results: Although generally the application of biomarkers as inclusion criteria is not recommended, they may aid in exclusion of potential subjects (e.g., elevated liver function measures in trials of agents that could result in liver damage). Biomarkers are most commonly used as indicators of outcome, usually serving as secondary outcome variables. The relationship of outcome findings on biomarker and self-report measures is positive, but only moderate. As used to date, biomarkers of drinking tend to be less sensitive than well-standardized and properly administered self-report measures. Nevertheless, they do provide a useful, unique source of information on drinking status. Conclusions: The contribution of biomarkers to alcoholism clinical research would be enhanced if certain design strategies were incorporated into their application and if critical information were included in the research publication. This article offers a series of recommendations to improve on their use in a research context. [source] A comparison of volatile and non volatile agents for cardioprotection during on-pump coronary surgeryANAESTHESIA, Issue 9 2009S. De Hert Summary A randomised study of 414 patients undergoing coronary artery surgery with cardiopulmonary bypass was conducted to compare the effects of a volatile anaesthetic regimen with either deesflurane or sevoflurane, and a total intravenous anaesthesia (TIVA) regimen on postoperative troponin T release. The primary outcome variable was postoperative troponin T release, secondary outcome variables were hospital length of stay and 1-year mortality. Maximal postoperative troponin T values did not differ between groups (TIVA: 0.30 [0.00,4.79] ng.ml,1 (median [range]), sevoflurane: 0.33 [0.02,3.68] ng.ml,1, and desflurane: 0.39 [0.08,3.74] ng.ml,1). The independent predictors of hospital length of stay were the EuroSCORE (p < 0.001), female gender (p = 0.042) and the group assignment (p < 0.001). The one-year mortality was 12.3% in the TIVA group, 3.3% in the sevoflurane group, and 6.7% in the desflurane group. The EuroSCORE (p = 0.003) was the only significant independent predictor of 1-year mortality. [source] | ||||||||||