CONGENITAL ANOMALIES, Issue 2 2005
Bengt A.J. Källén
ABSTRACT The review presented here discusses and exemplifies problems in epidemiological studies of drug teratogenesis according to methodology: case,control studies, cohort studies, or total population studies. Sources of errors and the possibility of confounding are underlined. The review stresses the caution with which conclusions have to be drawn when exposure data are retrospective or other possible bias exists. It also stresses the problem with the multiple testing situation that is usually present in the studies. It is therefore difficult to draw any firm conclusion from single studies and still more difficult to draw conclusions on causality. As randomized studies are in most cases out of the question, one has to rely on the type of studies which can be made, but the interpretation of the results should be cautious. The ideal study, next to a randomized one, is a large prospective study with detailed exposure information and detailed and unbiased outcome data. Even so, such a study can mainly be used for identifying possible associations which have to be verified or rejected in new studies. Nearly every finding of a risk increase, if not extremely strong, should only be regarded as a tentative signal to be tested in independent studies. [source]

Chloroatranol, an extremely potent allergen hidden in perfumes: a dose-response elicitation study

CONTACT DERMATITIS, Issue 4 2003
Jeanne Duus Johansen
Oak moss absolute is a long-known, popular natural extract widely used in perfumes. It is reported as the cause of allergic reactions in a significant number of those with perfume allergy. Oak moss absolute has been the target of recent research to identify its allergenic components. Recently, chloroatranol, a hitherto unknown fragrance allergen, was identified in oak moss absolute. The objective was to assess the clinical importance of chloroatranol as a fragrance allergen by characterizing its elicitation profile. 13 patients previously showing a positive patch test to oak moss absolute and chloroatranol were included, together with a control group of 10 patients without sensitization to either of the 2 materials. A serial dilution patch test was performed on the upper back with concentrations ranging from 200 to 0.0063 p.p.m. of chloroatranol in ethanol. Simultaneously, the participant performed an open test simulating the use of perfumes on the volar aspect of the forearms in a randomized and double-blinded design. A solution with 5 p.p.m. chloroatranol was used for 14 days, and, in case of no reaction, the applications were continued for another 14 days with a solution containing 25 p.p.m. All test subjects (13/13) developed an allergic reaction at the site of application of the solution containing chloroatranol. Among them, 12/13 (92%) gave a positive reaction to the 5 p.p.m. solution and 1 to 25 p.p.m. None of the controls reacted (P < 0.001). The use test was terminated at median day 4. The dose eliciting a reaction in 50% of the test subjects at patch testing was 0.2 p.p.m. In conclusion, the hidden exposure to a potent allergen widely used in perfumes has caused a highly sensitized cohort of individuals. Judged from the elicitation profile, chloroatranol is the most potent allergen present in consumer products today. [source]

Randomized trial of botulinum toxin injections into the salivary glands to reduce drooling in children with neurological disorders

DEVELOPMENTAL MEDICINE & CHILD NEUROLOGY, Issue 2 2008
S M Reid MClinEpi BAppSc (physio)
The primary aim of this randomized, controlled trial was to assess the effectiveness of botulinum toxin A (BoNT-A) injections into the submandibular and parotid glands on drooling in children with cerebral palsy (CP) and other neurological disorders. Secondary aims were to ascertain the duration of any such effect and the timing of maximal response. Of the 48 participants (27 males, 21 females; mean age 11y 4mo [SD 3y 3mo], range 6-18y), 31 had a diagnosis of CP and 15 had a primary intellectual disability; 27 children were non-ambulant. Twenty-four children randomized to the treatment group received 25 units of BoNT-A into each parotid and submandibular gland. Those randomized to the control group received no treatment. The degree and impact of drooling was assessed by carers using the Drooling Impact Scale questionnaire at baseline and at monthly intervals up to 6 months postinjection/baseline, and again at 1 year. Maximal response was at 1 month at which time there was a highly significant difference in the mean scores between the groups. This difference remained statistically significant at 6 months. Four children failed to respond to the injections, four had mediocre results, and 16 had good results. While the use of BoNT-A can help to manage drooling in many children with neurological disorders, further research is needed to fully understand the range of responses. [source]

Twice daily biphasic insulin aspart improves postprandial glycaemic control more effectively than twice daily NPH insulin, with low risk of hypoglycaemia, in patients with type 2 diabetes

DIABETES OBESITY & METABOLISM, Issue 6 2003
J. S. Christiansen
Objective:, Biphasic insulin aspart 30 (BIAsp30) is a dual release formulation, containing 30% soluble and 70% protamine-crystallized insulin aspart. This study compared the glycaemic control and safety profiles achieved with either twice daily BIAsp30 or NPH insulin in patients with type 2 diabetes not optimally controlled by oral hypoglycaemic agents (OHAs), NPH insulin or a combination of both. Methods:, In this 16-week multinational, parallel-group, double-blind trial, 403 such patients were randomized to receive either BIAsp30 or NPH insulin immediately before breakfast and evening meals. OHAs were discontinued at randomization. Efficacy was assessed by glycosylated haemoglobin (HbA1c) and self-recorded daily 8-point blood glucose (BG) profiles. Hypoglycaemic and other adverse events were the chosen safety parameters. Results:, HbA1c concentration decreased by >0.6% (p < 0.0001 vs. baseline) in both groups, with metabolic control continuing to improve throughout the trial without reaching a stable level. Patients who switched from once or twice daily NPH monotherapy to twice daily BIAsp30 achieved a significantly greater reduction in HbA1c (0.78%) than those randomized to twice daily NPH insulin (0.58%; p = 0.03). BIAsp30 decreased mean daily postprandial glycaemic exposure to a greater extent than NPH insulin (mean difference = 0.69 mmol/l; p < 0.0001), reflecting greater decreases in the postbreakfast and postdinner increments (of 1.26 and 1.33 mmol/l, respectively), although postlunch increment was relatively increased (by 0.56 mmol/l). Despite the greater reduction in overall postprandial glycaemic exposure in the BIAsp30 group, the overall safety profile of BIAsp30 was equivalent to that of NPH insulin with <2% of patients experiencing major hypoglycaemia, and approximately 33% reporting minor hypoglycaemic episodes, in both groups. Conclusion:, Twice daily BIAsp30 reduced postprandial glucose exposure to a significantly greater extent than NPH insulin and was at least as effective at reducing HbA1c in patients with type 2 diabetes. Both insulins were well tolerated. In patients poorly controlled on OHAs or NPH alone, glycaemic control can be improved by switching to twice daily BIAsp30, without increasing hypoglycaemic risk. [source]

A brief alcohol intervention for hazardously drinking incarcerated women

ADDICTION, Issue 3 2010
Michael D. Stein
ABSTRACT Objective To test the hypothesis that among hazardously drinking incarcerated women who are returning to the community, a brief alcohol intervention will result in less alcohol use at follow-up relative to standard of care. Methods Eligible participants endorsed hazardous alcohol consumption,four or more drinks at a time on at least 3 separate days in the previous 3 months or a score of 8 or above on the Alcohol Use Disorders Identification Test. Participants were randomized to either an assessment-only condition or to two brief motivationally focused sessions, the first delivered during incarceration, the second 1 month later after community re-entry. Participants recalled drinking behaviors at 3 and 6 months after the baseline interview using a 90-day time-line follow-back method. Results The 245 female participants averaged 34 years of age, and were 71% Caucasian. The mean percentage of alcohol use days in the 3 months prior to incarceration was 51.7% and heavy alcohol use days was 43.9%. Intervention effects on abstinent days were statistically significant at 3 months (odds ratio = 1.96, 95% confidence interval 1.17, 3.30); the percentage of days abstinent was 68% for those randomized to intervention and 57% for controls. At 6 months the effect of the intervention was attenuated and no longer statistically significant. Conclusions Among incarcerated women who reported hazardous drinking, a two-session brief alcohol intervention increased abstinent days at 3 months, but this effect decayed by 6 months. Study participants continued to drink heavily after return to the community. More intensive intervention pre-release and after re-entry may benefit hazardously drinking incarcerated women. [source]

Linking opioid-dependent hospital patients to drug treatment: health care use and costs 6 months after randomization

ADDICTION, Issue 12 2006
Paul G. Barnett
ABSTRACT Aims To conduct an economic evaluation of the first 6 months' trial of treatment vouchers and case management for opioid-dependent hospital patients. Design Randomized clinical trial and evaluation of administrative data. Setting Emergency department, wound clinic, in-patient units and methadone clinic in a large urban public hospital. Participants The study randomized 126 opioid-dependent drug users seeking medical care. Interventions Participants were randomized among four groups. These received vouchers for 6 months of methadone treatment, 6 months of case management, both these interventions, or usual care. Findings During the first 6 months of this study, 90% of those randomized to vouchers alone enrolled in methadone maintenance, significantly more than the 44% enrollment in those randomized to case management without vouchers (P < 0.001). The direct costs of substance abuse treatment, including case management, was $4040 for those who received vouchers, $4177 for those assigned to case management and $5277 for those who received the combination of both interventions. After 3 months, the vouchers alone group used less heroin than the case management alone group. The difference was not significant at 6 months. There were no significant differences in other health care costs in the 6 months following randomization. Conclusion Vouchers were slightly more effective but no more costly than case management during the initial 6 months of the study. Vouchers were as effective and less costly than the combination of case management and vouchers. The finding that vouchers dominate is tempered by the possibility that case management may lower medical care costs. [source]

Carisbamate as adjunctive treatment of partial onset seizures in adults in two randomized, placebo-controlled trials

EPILEPSIA, Issue 3 2010
Michael R. Sperling
Summary Purpose:, To assess the efficacy, safety, and tolerability of the investigational drug carisbamate as adjunctive treatment for partial-onset seizures (POS). Methods:, Two identical, randomized, placebo-controlled, double-blind studies were conducted in adults with POS uncontrolled for ,1 year. Therapy-refractory epilepsy patients (,16 years) remained on stable doses of prescribed antiepileptic drugs (,2) for an 8-week prospective baseline phase and were then randomized (1:1:1) to carisbamate 200 mg/day, carisbamate 400 mg/day, or placebo, for a 12-week double-blind phase. Primary efficacy end points were percent reduction in seizure frequency and responder rate (patients with ,50% reduction in POS frequency) during the double-blind phase compared with the prospective baseline phase. Results:, Of the 565 patients randomized in study 1, 93% completed the study; of the 562 randomized in study 2, 94% completed the study. Patient characteristics were similar across both studies and treatment arms: mean age, 35 years (study 1, range 16,75 years) and 36 years (study 2, range 16,74 years); approximately 50% were men. Treatment with carisbamate 400 mg/day resulted in significant improvement (p < 0.01) in both efficacy measures compared with placebo in study 1 but not in study 2. Carisbamate 200 mg/day did not differ statistically from placebo in either study. Among the most common treatment-emergent adverse events (,5% in any group), those with an incidence exceeding placebo (,3%) were dizziness (400 mg/day group) and somnolence. Conclusions:, Carisbamate 400 mg/day was effective in patients with refractory partial-onset seizures in one of these global studies. More than 200 mg/day of carisbamate is required for efficacy. Carisbamate was well-tolerated in both studies. [source]

Effect of Evidence-Based Acute Pain Management Practices on Inpatient Costs

HEALTH SERVICES RESEARCH, Issue 1 2009
John M. Brooks
Objectives. To estimate hospital cost changes associated with a behavioral intervention designed to increase the use of evidence-based acute pain management practices in an inpatient setting and to estimate the direct effect that changes in evidence-based acute pain management practices have on inpatient cost. Data Sources/Study Setting. Data from a randomized "translating research into practice" (TRIP) behavioral intervention designed to increase the use of evidence-based acute pain management practices for patients hospitalized with hip fractures. Study Design. Experimental design and observational "as-treated" and instrumental variable (IV) methods. Data Collection/Extraction Methods. Abstraction from medical records and Uniform Billing 1992 (UB92) discharge abstracts. Principal Findings. The TRIP intervention cost on average $17,714 to implement within a hospital but led to cost savings per inpatient stay of more than $1,500. The intervention increased the cost of nursing services, special operating rooms, and therapy services per inpatient stay, but these costs were more than offset by cost reductions within other cost categories. "As-treated" estimates of the effect of changes in evidence-based acute pain management practices on inpatient cost appear significantly underestimated, whereas IV estimates are statistically significant and are distinct from, but consistent with, estimates associated with the intervention. Conclusions. A hospital treating more that 12 patients with acute hip fractures can expect to lower overall cost by implementing the TRIP intervention. We also demonstrated the advantages of using IV methods over "as-treated" methods to assess the direct effect of practice changes on cost. [source]

Failure of Helicobacter pylori Treatment After Regimes Containing Clarithromycin: New Practical Therapeutic Options

HELICOBACTER, Issue 6 2008
Bruno Sanches
Abstract Failure of Helicobacter pylori treatment is a growing problem in daily practice. Aim:, To evaluate the efficacy of two new regimes as second-line options in a randomized and prospective study. Methods:, Patients in whom a first eradication regime containing clarithromycin had failed were included. After performing gastroscopy and a 13C-urea breath test (UBT), the patients were randomized to receive a combination of 20 mg of rabeprazole, 500 mg of levofloxacin, and 200 mg (two tablets) of furazolidone administered once daily for 10 days (RLF) or the combination of 20 mg of rabeprazole, 120 mg (two tablets) of bismuth subcitrate, 100 mg of doxycycline, and 200 mg of furazolidone, administered twice daily for 10 days (RBDF). Clinical examinations and new UBT were performed 60 days after therapy. Results:, Sixty patients were included (mean age, 46 years, 57% females). Two patients were excluded: one because of adverse effects and another as a result of protocol violation. Compliance was similar in both groups (90% took all medications correctly). Side-effects (96% mild) were observed in 87% of the patients and were comparable between groups, except diarrhea, which was more frequent in group RLF (p= .025). Intention-to-treat cure rates were 77% (95% confidence interval (CI): 62,93%) in the RLF group and 83% (95% CI: 68,97%) in the RBDF group (p= .750). Per-protocol cure rates were 80% (95% CI: 65,95%) in the RLF group and 82% (95% CI: 67,96%) in the RBDF group (p= 1.0). Conclusions:, Both once-daily triple (rabeprazole, levofloxacin, and furazolidone) and twice-daily quadruple therapy (rabeprazole, bismuth subcitrate, doxycycline, and furazolidone) for 10 days achieved encouraging results. Subsequent studies should be performed to evaluate antibiotic resistance, doses, dosing intervals, duration of treatment, and safety of these two regimes. [source]

Nocturnal nutritional supplementation improves total body protein status of patients with liver cirrhosis: A randomized 12-month trial,

HEPATOLOGY, Issue 2 2008
Lindsay D. Plank
Patients with liver cirrhosis exhibit early onset of gluconeogenesis after short-term fasting. This accelerated metabolic reaction to starvation may underlie their increased protein requirements and muscle depletion. A randomized controlled trial was conducted to test the hypothesis that provision of a late-evening nutritional supplement over a 12-month period would improve body protein stores in patients with cirrhosis. A total of 103 patients (68 male, 35 female; median age 51, range 28,74; Child-Pugh grading: 52A, 31B, 20C) were randomized to receive either daytime (between 0900 and 1900 hours) or nighttime (between 2100 and 0700 hours) supplementary nutrition (710 kcal/day). Primary etiology of liver disease was chronic viral hepatitis (67), alcohol (15), cholestatic (6), and other (15). Total body protein (TBP) was measured by neutron activation analysis at baseline, 3, 6, and 12 months. Total daily energy and protein intakes were assessed at baseline and at 3 months by comprehensive dietary recall. As a percentage of values predicted when well, TBP at baseline was similar for the daytime (85 ± 2[standard error of the mean]%) and nighttime (84 ± 2%) groups. For the nighttime group, significant increases in TBP were measured at 3 (0.38 ± 0.10 kg, P = 0.0004), 6 (0.48 ± 0.13 kg, P = 0.0007), and 12 months (0.53 ± 0.17 kg, P = 0.003) compared to baseline. For the daytime group, no significant changes in TBP were seen. Daily energy and protein intakes at 3 months were higher than at baseline in both groups (P < 0.0001), and these changes did not differ between the groups. Conclusion: Provision of a nighttime feed to patients with cirrhosis results in body protein accretion equivalent to about 2 kg of lean tissue sustained over 12 months. This improved nutritional status may have important implications for the clinical course of these patients. (HEPATOLOGY 2008.) [source]

A placebo-controlled, double-blind trial of Ginkgo biloba for antidepressant-induced sexual dysfunction

HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 6 2002
Byung-Jo Kang
Abstract The aim of this study was to examine the effect of Ginkgo biloba on antidepressant-induced sexual dysfunction. The Ginkgo biloba (n=19) and the placebo groups (n=18) were divided; each to be administered with Ginkgo biloba and placebo respectively for 2 months by means of a randomized placebo-controlled, double-blind study. The results of this 2 month trial were: (1) there was no statistical significant difference from the placebo at weeks 2, 4 and 8 after medication; (2) in comparison with baseline, both the Ginkgo biloba group and the placebo group showed improvement in some part of the sexual function, which is suggestive of the importance of the placebo effect in assessing sexual function. This study did not replicate a prior positive finding supporting the use of Ginkgo biloba for antidepressant, especially SSRI, induced sexual dysfunction. Copyright © 2002 John Wiley & Sons, Ltd. [source]

Nutriose, a prebiotic low-digestible carbohydrate, stimulates gut mucosal immunity and prevents TNBS-induced colitis in piglets,

INFLAMMATORY BOWEL DISEASES, Issue 5 2010
Philippe R. Pouillart PhD
Abstract Background: We investigated a prebiotic low-digestible carbohydrate (LDC) as a possible food ingredient to stimulate bowel functions in the treatment of inflammatory bowel disease. The study aimed to assess a fermentable dextrin fiber (Nutriose) and its relationship to the immune management of the disease and the microbiota profile in colitis-bearing piglets. Methods: In a randomized placebo-controlled parallel blind preclinical study, 32 male piglets were fed LDC (4% Nutriose) or dextrose placebo for 44 days before being challenged with trinitrobenzene sulfonic acid (TNBS) to induce colitis. We followed the microbiota profile using real-time polymerase chain reaction (PCR) targeted to 9 bacterial genera. Secretory IgA was evaluated by enzyme-linked immunosorbent assay (ELISA). Inflammatory protein profiles were monitored in blood and colonic tissues. Both histological scoring of biopsy samples and live endoscopic scoring were used to measure colitis development. Results: Prior and continuing LDC supplementation alleviated the symptoms of colitis (body weight loss, bloody stools) induced by a TNBS challenge. This effect was associated with an improvement in endoscopic and histological scores. LDC was shown to selectively downregulate some of the proinflammatory factors and their concomitant pyretic events and to stimulate the Th2-related immune pathway (IL-10 and s-IgA). Conclusions: At the dose tested, LDC is a well-tolerated prebiotic agent able to not only stimulate butyrogenic bacteria strains and reduce intestinal transit disorders and energy intake, but also to prevent chronic inflammatory intestinal injuries. Inflamm Bowel Dis 2010 [source]

Randomized double-blind placebo-controlled donepezil augmentation in antidepressant-treated elderly patients with depression and cognitive impairment: a pilot study

INTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 7 2008
Gregory H. Pelton
Abstract Objective To assess combined antidepressant and cognitive enhancer treatment in elderly patients presenting with depression plus cognitive impairment. Methods Twenty-three elderly (>50 years old) depressed, cognitively impaired (DEP-CI) patients participated in a pilot study. We evaluated whether, after 8 weeks of open antidepressant treatment, donepezil HCl (Aricept) would afford added cognitive benefit compared to placebo in a randomized 12-week trial. A subsample continued in an 8-month extension phase of open treatment with donepezil. Neuropsychological testing (NPT) was performed and antidepressant response monitored at baseline and the 8, 20, and 52-week time points. Results At 8-weeks, the antidepressant response rate was 61% (14/23). Improvement in SRT immediate recall (SRT-IR; e.g. episodic verbal memory) was observed in responders compared to non-responders. During the 12-week, placebo-controlled, donepezil add-on trial, patients on donepezil showed further improvement in SRT-IR versus patients on placebo. In the open extension phase, patients who continued open donepezil treatment (n,=,6) maintained improvement in memory and tended to show an advantage over patients who never received donepezil and were evaluated at the 52-week time point (n,=,6). There were no observed significant donepezil effects on non-memory cognitive domains. Conclusion These preliminary findings suggest that addition of a cholinesterase inhibitor (AChEI) following antidepressant medication treatment in elderly Dep-CI patients may improve cognition, and support the need for a confirmatory, larger randomized placebo-controlled trial. Copyright © 2007 John Wiley & Sons, Ltd. [source]

Clinical randomized controlled trial of chemomechanical caries removal (CarisolvÔ)

INTERNATIONAL JOURNAL OF PAEDIATRIC DENTISTRY, Issue 3 2006
M. A. LOZANO-CHOURIO
Summary., Objectives., The purpose of this study was to compare the chemomechanical caries-removal system (CarisolvÔ) with high-speed excavation in cavitated occlusal caries of primary molars. Design and setting., The study was a randomized controlled, clinical trial in which the two techniques were compared in each subject. Participants were chosen from public schools, in Maracaibo County, Zulia State, Venezuela. Sample and methods. The sample consisted of 80 primary molars selected from 40 children (mean age 7·7 ± 0·7 years). Each patient had at least two contralateral primary molars with cavitated occlusal caries and approximately equal-size access to lesions. The outcome variables were: clinically complete caries removal, size of the opening of the cavity, volume of carious tissue removed, pain during caries removal, anaesthesia requested by the patient, caries-removal time, and behaviour and preference of patients. Results., All treated molars were clinically caries free whichever caries-removal procedure was used. When Carisolv, was used the final cavity entrance sizes were smaller (P < 0·001) and the estimated volume of tissue removed was less (P < 0·001). The time taken for caries removal was three times longer (7·51 ± 1·83 min, P < 0·001). Some pain was reported by seven (17·5%) participants when Carisolv was used, compared with 16 (40%) when high-speed excavation was used (P < 0·05). Using the Carisolv method there was a higher proportion of patients with positive behaviour (P < 0·01), and 71·0% (P < 0·05) preferred this treatment. Conclusion., Carisolv is an effective clinical alternative treatment for the removal of occlusal dentinal caries in cavitated primary molars; it is more conservative of dental tissue and appeared to be more comfortable for most patients, although the clinical time spent is longer than when using high-speed excavation. [source]

Is nerve stimulation needed during an ultrasound-guided lateral sagittal infraclavicular block?

ACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 4 2010
Y. GÜRKAN
Background: The objective of the study was to evaluate the influence of ultrasound (US) guidance alone vs. neurostimulation (NS) and US (NSUS) guidance techniques on block performance time and block success rate for the lateral sagittal infraclavicular block (LSIB). Methods: In a randomized and prospective manner, 110 adult patients scheduled for distal upper limb surgery were allocated to the US or the NSUS groups. In the US group, a local anesthetic (LA) was administered only with US guidance to produce a ,U'-shaped distribution around the axillary artery. In the NSUS group, LA was administered under US guidance only after electrolocation of one of the median, ulnar or radial nerve-type responses. A total of 30 ml of LA (10 ml of levobupivacaine 5 mg/ml and 20 ml of lidocaine 20 mg/ml) was administered in both groups. Sensory block was tested at 10 min intervals for 30 min. Successful block was defined as analgesia or anesthesia of all five nerves distal to the elbow. Results: Block success rate was 94.5% in both groups. Block performance time was significantly shorter in the US than the NSUS group (157 ± 50 vs. 230 ± 104 s) (P=0.000). Block onset time was similar in both groups (12.5 ± 4.8 in the US vs. 12.8 ± 5.4 min in the NSUS groups). There were two arterial punctures in the NSUS group. Conclusions: During LSIB performance US guidance alone produces block success rate identical to both US and NS guidance yet with a shorter block performance time. [source]

A Comparison of Computerized and Pencil-and-Paper Tasks in Assessing Cognitive Function in Community-Dwelling Older People in the Newcastle 85+ Pilot Study

JOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 10 2007
Joanna Collerton MRCP
OBJECTIVES: To compare the acceptability and feasibility of computerized and pencil-and-paper tests of cognitive function in 85-year-old people. DESIGN: Group comparison of participants randomly allocated to pencil-and-paper (Wechsler Adult Intelligence and Memory Scales) or computerized (Cognitive Drug Research) tests of verbal memory and attention. SETTING: The Newcastle 85+ Pilot Study was the precursor to the Newcastle 85+ Study a United Kingdom Medical Research Council/Biotechnology and Biological Sciences Research Council cohort study of health and aging in the oldest-old age group. PARTICIPANTS: Eighty-one community-dwelling individuals aged 85. MEASUREMENTS: Participant and researcher acceptability, completion rates, time taken, validity as cognitive measures, and psychometric utility. RESULTS: Participants randomized to computerized tests were less likely to rate the cognitive function tests as difficult (odds ratio (OR)=0.16, 95% confidence interval (CI)=0.07,0.39), stressful (OR=0.18, 95% CI=0.07,0.45), or unacceptable (OR=0.18, 95% CI=0.08,0.48) than those randomized to pencil-and-paper tests. Researchers were also less likely to rate participants as being distressed in the computer test group (OR=0.19, 95% CI=0.07,0.46). Pencil-and-paper tasks took participants less time to complete (mean±standard deviation 18±4 minutes vs 26±4 minutes) but had fewer participants who could complete all tasks (91% vs 100%). Both types of task were equally good measures of cognitive function. CONCLUSION: Computerized and pencil-and-paper tests are both feasible and useful means of assessing cognitive function in the oldest-old age group. Computerized tests are more acceptable to participants and administrators. [source]

The role of SeprafilmÔ bioresorbable membrane in the prevention and therapy of endometrial synechiae

JOURNAL OF BIOMEDICAL MATERIALS RESEARCH, Issue 1 2002
Vassilios S. Tsapanos
Abstract This randomized controlled blind prospective study is undertaken to evaluate the safety and efficacy of SeprafilmÔ,a novel bioresorbable membrane of chemically modified hyaluronic acid and carboxymethylcellulose,in prevention and reduction of postoperative endometrial and endocervical synechiae formation after general suction evacuation or curettage for incomplete, missed, and recurrent abortion. In total, 150 patients with incomplete or missed abortion participated in the clinical study. The study population was divided into two main groups. In the treatment (SeprafilmÔ) group (n=50), application of SeprafilmÔ membrane in the endometrial cavity and the cervical canal was used after the suction evacuation and/or the curettage. In the control group (n=100), nothing was inserted in the uterus. Both groups were divided into two subgroups: patients who had no previous suction or curettage, (with no previous D&C) (n=88), and patients who had at least one previous suction or curettage (with one or more previous D&C) (n=62). In the treatment (SeprafilmÔ) group, 32 patients had no previous D&C and 18 patients had one or more previous D&C. In the control group, 56 patients had no previous D&C and 44 patients had one or more previous D&C. Further fertility was estimated by pregnancy success in all groups. Endometrial synechiae formation was evaluated with the use of hysterosalpingography (HSG) in patients of all groups without pregnancy success 8 months after the intervention. Registering any adverse reaction and performing ultrasound controls assessed the safety of SeprafilmÔ use. From the subgroup with no previous D&C, all 32 patients (100%) who received SeprafilmÔ had a pregnancy in the following 8 months; in the controls, pregnancy occurred only in 54%. It was also demonstrated with hysterosalpingography (HSG) that patients with one or more previous interventions and no pregnancy 8 months later were adhesion free in 90% of the patients where SeprafilmÔ was used, and only 50% in the untreated group. The membrane was tested on the endometrial area of the uterus and did not produce any adverse reaction. Ultrasound controls did not show any abnormal echoes. Intrauterine insertion of SeprafilmÔ is safe, prevents the appearance of endocervical adhesions or endometrial synechiae after curettage, and reduces the area of the endometrial cavity occupied by them in a large percent of cases. It also seems that its use improves the possibility of a new pregnancy and fertility. © 2001 Wiley Periodicals, Inc. J Biomed Mater Res (Appl Biomater) 63: 10,14, 2002 [source]

Comparison of Cool Tip Versus 8-mm Tip Catheter in Achieving Electrical Isolation of Pulmonary Veins for Long-Term Control of Atrial Fibrillation: A Prospective Randomized Pilot Study

JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 10 2006
SANJAY DIXIT M.D.
Objective: To compare safety and efficacy of 8-mm versus cooled tip catheter in achieving electrical isolation (EI) of pulmonary veins (PV) for long-term control of atrial fibrillation (AF). Background: There is paucity of studies comparing safety/efficacy of 8-mm and cooled tip catheters in patients undergoing AF ablation. Methods and Results: This was a randomized and patient-blinded study. Subjects were followed by clinic visits (at 6 weeks and 6 months) and transtelephonic monitoring (3-week duration) done around each visit. Primary endpoints were: (1) long-term AF control (complete freedom and/or >90% reduction in AF burden on or off antiarrhythmic drugs at 6 months after a single ablation), and (2) occurrence of serious adverse events (cardiac tamponade, stroke, LA-esophageal fistula, and/or death). Eighty-two patients (age 56 ± 9 years, 60 males, paroxysmal AF = 59) were randomized (42 patients to 8-mm tip and 40 patients to cooled tip). EI of PVs was achieved in shorter time by the 8-mm tip as compared with cooled tip catheter (40 ± 23 minutes vs 50 ± 30 minutes; P < 0.05) but long-term AF control was not different between the two (32 patients [78%] vs 28 patients [70%], respectively; P = NS). One serious adverse event occurred in each group (LA-esophageal fistula and stroke, respectively) and no significant PV stenosis was observed in either. Conclusion: EI of PVs using either 8-mm or cooled tip catheter results in long-term AF control in the majority after a single ablation procedure, with comparable efficacy and safety. [source]

A chlorhexidine varnish implemented treatment strategy for chronic periodontitis

JOURNAL OF CLINICAL PERIODONTOLOGY, Issue 7 2005
Short-term clinical observations
Abstract Objectives: The aim of this study was to investigate the clinical outcome of a subgingivally applied chlorhexidine varnish when used as an adjunct to scaling and root planing (SRP) in the treatment of chronic periodontitis. Material and methods: A randomized controlled, single blind, parallel trial was conducted on the basis of 16 volunteers suffering from chronic periodontitis. The control group received oral hygiene instructions and was scaled and root planed in two sessions. The test group received the same instructions and treatment, however, all pockets were additionally disinfected using a chlorhexidine varnish. The gingival index, plaque index, bleeding on probing, probing pocket depth (PPD) and clinical attachment level (CAL) were recorded at baseline and subsequently after 1 and 3 months. Results: Both treatment strategies showed significant reductions in PPD and CAL at both follow-up visits by comparison with baseline levels (p<0.001). Yet, at study termination, combination therapy resulted in additional pocket reductions between 0.73 and 1.23 mm (p<0.02), and clinical attachment gains between 0.63 and 1.09 mm (p<0.02). Conclusions: These findings suggest that a varnish-implemented strategy may improve the clinical outcome for the treatment of chronic periodontitis in comparison with SRP alone. [source]

CLINICAL SCHOLARSHIP: Systematic Review of Educational Interventions for Improving Advance Directive Completion

JOURNAL OF NURSING SCHOLARSHIP, Issue 3 2010
Christine R. Durbin RN
Abstract Purpose: To systematically analyze evidence about the outcome and percent of newly completed ADs, focusing on the effectiveness of (a) types of educational interventions versus controls and (b) one educational intervention over another. Design: Systematic review of literature based on Cochrane review criteria. Methods: Twelve randomized and four nonrandomized studies were selected from the nursing, medical, and social work literature that met the following criteria: described educational interventions, provided information to calculate the percent of newly completed ADs as an outcome, and published between 1991 and 2009. The review focused primarily on randomized studies. Reviewers calculated the percent of newly completed ADs by determining the number of subjects per group without an AD at baseline and the percentage of those who then completed one by the end of the studies. Findings: Findings were inconsistent regarding all types of educational interventions studied versus controls. Sufficient evidence exists to conclude that combined written and verbal educational interventions were more effective than single written interventions in increasing the percent of newly completed ADs in adult clinic outpatients and hospitalized elderly. Conclusions: Calculating the percent of newly completed ADs was successful in allowing for study result comparisons. Overall, the evidence base regarding the effectiveness of single or combined educational interventions in increasing AD completion is weak. Randomized studies with diverse samples should be conducted against controls before more studies comparing interventions are undertaken. Clinical Relevance: This article provides nurses with a summary of research related to educational interventions and AD completion and identifies where future study is needed. [source]

Matrix-induced autologous chondrocyte implantation in sheep: objective assessments including confocal arthroscopy

JOURNAL OF ORTHOPAEDIC RESEARCH, Issue 3 2008
C. W. Jones
Abstract The assessment of cartilage repair has largely been limited to macroscopic observation, magnetic resonance imaging (MRI), or destructive biopsy. The aims of this study were to establish an ovine model of articular cartilage injury repair and to examine the efficacy of nondestructive techniques for assessing cartilage regeneration by matrix-induced autologous chondrocyte implantation (MACI). The development of nondestructive assessment techniques facilitates the monitoring of repair treatments in both experimental animal models and human clinical subjects. Defects (Ø 6 mm) were created on the trochlea and medial femoral condyle of 21 sheep randomized into untreated controls or one of two treatment arms: MACI or collagen-only membrane. Each group was divided into 8-, 10-, and 12-week time points. Repair outcomes were examined using laser scanning confocal arthroscopy (LSCA), MRI, histology, macroscopic ICRS grading, and biomechanical compression analysis. Interobserver analysis of the randomized blinded scoring of LSCA images validated our scoring protocol. Pearson correlation analysis demonstrated the correlation between LSCA, MRI, and ICRS grading. Testing of overall treatment effect independent of time point revealed significant differences between MACI and control groups for all sites and assessment modalities (Asym Sig,<,0.05), except condyle histology. Biomechanical analysis suggests that while MACI tissue may resemble native tissue histologically in the early stages of remodeling, the biomechanical properties remain inferior at least in the short term. This study demonstrates the potential of a multisite sheep model of articular cartilage defect repair and its assessment via nondestructive methods. © 2007 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 26:292,303, 2008 [source]

Scintigraphic study to investigate the effect of food on a HPMC modified release formulation of UK-294,315

JOURNAL OF PHARMACEUTICAL SCIENCES, Issue 4 2009
J. Davis
Abstract The objective of the study was to use the combined approach of gamma scintigraphy and pharmacokinetics, in order to understand the mechanisms explaining the pharmacokinetic differences observed for a modified release (MR) formulation, when administered either in the fed or fasted state. Ten healthy subjects were recruited into a randomized three period single dose study, each subject receiving UK-294,315 40 mg IR (fasted), 100 mg MR (fasted) or 100 mg MR (after a high fat meal). Cmax values were markedly higher for the MR tablet in the fed state versus fasted and mean residence time was about 3 h longer for fasted versus fed; there was little difference in apparent oral clearance. In the fasted state, average gastric emptying of the intact tablet occurred at 1.2 h postdose, with gastric emptying of intact tablet observed in all subjects. In the fed state, rapid disintegration of the MR tablet was observed by scintigraphy, with 7/9 subjects showing complete disintegration in the stomach. Complete disintegration occurred 10.1 h postdose in the fasted state versus 5.9 h after a high fat meal. The study showed that in the fed state, the MR tablet eroded more rapidly than in the fasted state, leading to an overall increase in the rate of absorption. © 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:1568,1576, 2009 [source]

Evidence-based review of hair removal using lasers and light sources

JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY, Issue 1 2006
M Haedersdal
Abstract Background, Unwanted hair growth remains a therapeutic challenge and there is a considerable need for an effective and safe treatment modality. Objective, From an evidence-based view to summarize efficacy and adverse effects from hair removal with ruby, alexandrite, diode, and Nd:YAG lasers and intense pulsed light (IPL). Methods, Original publications of controlled clinical trials were identified in Medline and the Cochrane Library. Results, A total of 9 randomized controlled (RCTs) and 21 controlled trials (CTs) were identified. The best available evidence was found for the alexandrite (three RCTs, eight CTs) and diode (three RCTs, four CTs) lasers, followed by the ruby (two RCTs, six CTs) and Nd:YAG (two RCTs, four CTs) lasers, whereas limited evidence was available for IPL sources (one RCT, one CT). Based on the present best available evidence we conclude that (i) epilation with lasers and light sources induces a partial short-term hair reduction up to 6 months postoperatively, (ii) efficacy is improved when repeated treatments are given, (iii) efficacy is superior to conventional treatments (shaving, wax epilation, electrolysis), (iv) evidence exists for a partial long-term hair removal efficacy beyond 6 months postoperatively after repetitive treatments with alexandrite and diode lasers and probably after treatment with ruby and Nd:YAG lasers, whereas evidence is lacking for long-term hair removal after IPL treatment, (v) today there is no evidence for a complete and persistent hair removal efficacy, (vi) the occurrence of postoperative side-effects is reported low for all the laser systems. Conclusion, The evidence from controlled clinical trials favours the use of lasers and light sources for removal of unwanted hair. We recommend that patients are pre-operatively informed of the expected treatment outcome. [source]

Clinical trial: the effects of adding ranitidine at night to twice daily omeprazole therapy on nocturnal acid breakthrough and acid reflux in patients with systemic sclerosis , a randomized controlled, cross-over trial

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 9 2007
P. JANIAK
Summary Background, Gastro-oesophageal reflux disease (GERD) is an important problem in systemic sclerosis due to impaired salivation and oesophageal function. Aim, To determine the efficacy of adding ranitidine at bedtime to control nocturnal acid breakthrough (NAB) and GERD in patients with systemic sclerosis already prescribed high-dose omeprazole. Methods, Patients with systemic sclerosis and GERD symptoms (n = 14) were treated with omeprazole 20 mg b.d. and either placebo or ranitidine 300 mg at bedtime for 6 weeks in a randomized, cross-over, placebo controlled study. At the end of each period a 24 h pH-study with intragastric and oesophageal pH measurement was performed. Results, Pathological acid reflux occurred in eight patients with omeprazole/placebo and in seven with omeprazole/ranitidine (P = ns) with technically adequate oesophageal pH-studies (n = 13). NAB was present in eight patients with omeprazole/placebo and six with omeprazole/ranitidine (P = ns) in whom technically adequate gastric pH-studies were obtained (n = 10). The addition of ranitidine had no consistent effect on patient symptoms or quality of life. Conclusion, Many patients with systemic sclerosis experienced NAB and pathological oesophageal acid exposure despite high-dose acid suppression with omeprazole b.d. Adding ranitidine at bedtime did not improve NAB, GERD or quality of life in this population. [source]

Non-ablative 1,550,nm fractional laser therapy versus triple topical therapy for the treatment of melasma: A randomized controlled split-face study,,

LASERS IN SURGERY AND MEDICINE, Issue 7 2010
Bas S. Wind MD
Abstract Background Melasma is a uichronic, often relapsing skin disorder, with poor long-term results from all current therapies. Objective To assess efficacy and safety of non-ablative 1,550,nm fractional laser therapy (FLT) as compared to the gold standard, triple topical therapy (TTT). Study design Twenty-nine patients with melasma were included in a randomized controlled observer-blinded study with split-face design. Each side of the face was randomly allocated to either 4,5 non-ablative FLT sessions (15,mJ/microbeam, 14,20% coverage) or TTT (hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% cream). TTT was applied once daily for 15 weeks until the last FLT session. After this last treatment, patients were asked to apply TTT twice weekly on both sides of the face during follow-up. Improvement of melasma was assessed by patient's global assessment (PGA), patient's satisfaction, physician's global assessment (PhGA), melanin index, and lightness (L -value) at 3 weeks, and at 3 and 6 months after the last treatment. Results Mean PGA and satisfaction were significantly lower at the FLT side (P<0.001). PhGA, melanin index, and L -value showed a significant worsening of hyperpigmentation at the FLT side. At the TTT side, no significant change was observed. At 6 months follow-up, most patients preferred TTT. Side effects of FLT were erythema, burning sensation, edema, and pain. Nine patients (31%) developed PIH after two or more laser sessions. Side effects of TTT were erythema, burning sensation, and scaling. Conclusions Given the high rate of postinflammatory hyperpigmentation, non-ablative 1,550,nm fractional laser at 15,mJ/microbeam is not recommendable in the treatment of melasma. TTT remains the gold standard treatment. Lasers Surg. Med. 42:607,612, 2010. © 2010 Wiley-Liss, Inc. [source]

Sacral nerve stimulation for fecal incontinence and constipation in adults: A short version cochrane review,,

NEUROUROLOGY AND URODYNAMICS, Issue 3 2008
G. Mowatt
Background Fecal incontinence and constipation are disabling conditions that reduce quality of life. If conservative treatment fails, one option is sacral nerve stimulation (SNS), a minimally invasive technique allowing modulation of the nerves and muscles of the pelvic floor and hindgut. Objectives To assess the effects of SNS for fecal incontinence and constipation in adults. Search strategy We searched the Cochrane Incontinence Group Specialized Trials Register (searched 24 April 2007) and the reference lists of relevant articles. Selection criteria All randomized or quasi-randomized trials assessing the effects of SNS for fecal incontinence or constipation in adults. Data collection and analysis Two review authors independently screened the search results, assessed the methodological quality of the included studies, and undertook data extraction. Main results Three crossover studies were included. Two, enrolling 34 (Leroi) and two participants (Vaizey), assessed the effects of SNS for fecal incontinence, and one (Kenefick), enrolling two participants, assessed SNS for constipation. In the study by Leroi, following the crossover period, participants, while still blinded, chose the period of stimulation they had preferred. Outcomes at different time points were reported separately for 19 participants who preferred the "on" and five who preferred the "off" period. For the group of 19, the median (range) episodes of fecal incontinence per week fell from 1.7 (0,9) during the "off" period to 0.7 (0,5) during the "on" period; for the group of five, however, the median (range) rose from 1.7 (0,11) during the "off" period compared with 3.7 (0,11) during the "on" period. Vaizey reported an average of six, and one, episodes of fecal incontinence per week during the "off" and "on" periods, respectively. Leroi reported that four of 27 participants experienced an adverse event resulting in removal of the stimulator; Vaizey did not report adverse events. For SNS for constipation, during the "off" crossover period the participants experienced an average of two bowel movements per week, compared with five during the "on" period. Abdominal pain and bloating occurred 79% of the time during the "off" period compared with 33% during the "on" period. No adverse events occurred. Authors' conclusions The very limited evidence from the included studies suggests that SNS can improve continence in selected people with fecal incontinence, and reduce symptoms in selected people with constipation. However, temporary, percutaneous stimulation for a 2,3-week period does not always successfully identify those for whom a permanent implant will be beneficial. Larger, good quality randomized crossover trials are needed to allow the effects of SNS for these conditions to be assessed with more certainty. Neurourol. Urodynam. 27:155,161, 2008. © 2008 Wiley-Liss, Inc. [source]

Estimating false discovery rates for peptide and protein identification using randomized databases

PROTEINS: STRUCTURE, FUNCTION AND BIOINFORMATICS, Issue 12 2010
Gregory Hather
Abstract MS-based proteomics characterizes protein contents of biological samples. The most common approach is to first match observed MS/MS peptide spectra against theoretical spectra from a protein sequence database and then to score these matches. The false discovery rate (FDR) can be estimated as a function of the score by searching together the protein sequence database and its randomized version and comparing the score distributions of the randomized versus nonrandomized matches. This work introduces a straightforward isotonic regression-based method to estimate the cumulative FDRs and local FDRs (LFDRs) of peptide identification. Our isotonic method not only performed as well as other methods used for comparison, but also has the advantages of being: (i) monotonic in the score, (ii) computationally simple, and (iii) not dependent on assumptions about score distributions. We demonstrate the flexibility of our approach by using it to estimate FDRs and LFDRs for protein identification using summaries of the peptide spectra scores. We reconfirmed that several of these methods were superior to a two-peptide rule. Finally, by estimating both the FDRs and LFDRs, we showed for both peptide and protein identification, moderate FDR values (5%) corresponded to large LFDR values (53 and 60%). [source]

Serum trace element levels in COPD patient: The relation between trace element supplementation and period of mechanical ventilation in a randomized controlled trial

RESPIROLOGY, Issue 8 2009
May EL-ATTAR
ABSTRACT Background and objective: Many trace elements play important roles in activating or inhibiting enzymatic reactions, by competing with other elements and metalloproteins for binding sites, by affecting the permeability of cell membranes and by other mechanisms. They play important roles in the oxidant/antioxidant balance. As such, trace elements are thought to be involved directly or indirectly in the pathogenesis of several diseases. The aim of the present study is to investigate the effect trace elements (Se, Mn and Zn) intravenously administered on the period the COPD patients spend on mechanical ventilation. Methods: In a randomized double-blinded controlled trial a set of 120 subjects (40 normal volunteers and 80 COPD) were recruited. Serum concentration levels of Se, Mn and Zn were determined for all enrolled subjects with Inductively Coupled Plasma spectroscopy. COPD patients received intravenous supplementation of the above trace elements and the period the patients spent on mechanical ventilation was determined. Results: There was a significant reduction (P = 0.013) in the period the patients with COPD spent on the mechanical ventilation when received intravenous supplementation (9.4 ± 7.3 days) compared with the COPD patients who received placebo (17.8 ± 7.6 days). Conclusions: Trace element (Se, Mn and Zn) status is altered in critically ill patients with COPD. The supplementation achieved a reduction in the period those patients spent on the mechanical ventilation. A larger multi-centre trial is required to confirm this preventive effect and to explore its applicability to other critical care conditions. [source]

Acute Otitis Externa: Efficacy and Tolerability of N-Chlorotaurine, a Novel Endogenous Antiseptic Agent,

THE LARYNGOSCOPE, Issue 5 2004
Andreas Neher MD
Abstract Objective: The study's objective was to test the tolerability and efficacy of the endogenous antiseptic N-chlorotaurine (NCT) in comparison with a standard clinical treatment according to a phase IIb clinical trial protocol. Study Design: The antimicrobial agent NCT was compared with the antibiotic component drops Otosporin (containing neomycin, polymyxin B, and hydrocortisone) for topical treatment of acute otitis externa in a randomized and rater-blinded clinical study. Methods: Fifty patients suffering from acute otitis externa were divided into two groups according to a randomized list. The test group was treated with 1 mL of 1% aqueous NCT solution, the reference group with 1 mL of Otosporin. The substances were applied to the external ear canal at one daily session until the signs of infection disappeared. Efficacy and tolerability were evaluated daily by visual analogue scale and a six-step infection score. In addition, smears were analyzed to identify the causative pathogens. Results: Both medications were equally well tolerated by the patients. The treatment was successful for all patients of the NCT group, whereas in one patient from the reference group, the infection did not disappear. The inflammation score improved more rapidly in the NCT group, which resulted in an earlier termination of the therapy. This difference became highly significant on days 4 to 7 (P < .01 each). Time needed for disappearance of inflammation (score 0) was 5.6 ± 1.6 (mean ± SD, range 3,9) days in the NCT group and 7.4 ± 1.6 (range 4,10) days in the Otosporin group (P < .001). As expected, micro-biologic cultures from ear swabs revealed Pseudomonas aeruginosa (58%) followed by Staphylococcus aureus (18%) as the main causative pathogens. Conclusions: NCT appears to be well tolerated and more effective than the therapy using antibiotic component drops. Because of its endogenous nature and its higher efficacy, NCT appears to be a good choice for topical treatment of acute otitis externa. [source]

Three-month Follow-up of Brief Computerized and Therapist Interventions for Alcohol and Violence Among Teens

ACADEMIC EMERGENCY MEDICINE, Issue 11 2009
Rebecca M. Cunningham MD
Abstract Objectives:, Alcohol use and violent behaviors are well documented among adolescents and have enormous effects on morbidity and mortality. The authors hypothesized that universal computer screening of teens in an inner-city emergency department (ED), followed by a brief intervention (BI), would be 1) feasible (as measured by participation and completion of BI during the ED visit) and well received by teens (as measured by posttest process measures of intervention acceptability) and 2) effective at changing known precursors to behavior change such as attitudes, self-efficacy, and readiness to change alcohol use and violence. Methods:, Adolescent patients (ages 14,18 years) at an urban ED were approached to complete a computerized survey. The survey was conducted daily from 12 noon to 11 pm from September 2006 through November 2008. Adolescents reporting both alcohol use and violence in the past year were randomized to a control group or a 35-minute BI delivered by a computer or therapist as part of the SafERteens study. Validated measures were administered, including demographics, alcohol use, attitudes toward alcohol and violence, self-efficacy for alcohol and violence, readiness to change alcohol and violence, and process questions, including likeability of intervention. Results:, A total of 2,423 adolescents were screened. Thirteen percent of those approached refused. The population was 45% male, 58% African American, and 6.2% Hispanic. Of those screened, 637 adolescents (26%) screened positive; 533 were randomized to participate, and 515 completed the BI prior to discharge. The BIs were well received by the adolescents overall; 97% of those randomized to a BI self-reported that they found one intervention section "very helpful." At posttest, significant reductions in positive attitudes for alcohol use and violence and significant increases in self-efficacy related to alcohol/violence were found for both therapist and computer interventions. At 3-month follow-up there was 81% retention, and generalized estimating equations (GEE) analysis showed that participants in both interventions had significant reductions in positive attitudes for alcohol use (therapist p = 0.002, computer p = 0.0001) and violence (therapist p = 0.012, computer p = 0.007) and significant increases in self-efficacy related to violence (therapist p = 0.0.04, computer p = 0.002); alcohol self-efficacy improved in the therapist BI condition only (therapist p = 0.050, computer p = 0.083). Readiness to change was not significantly improved. Conclusions:, This initial evaluation of the SafERteens study shows that universal computerized screening and BI for multiple risk behaviors among adolescents is feasible, well received, and effective at altering attitudes and self-efficacy. Future evaluations of the SafERteens study will evaluate the interventions' effects on behavioral change (alcohol use and violence) over the year following the ED visit. [source]