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Risk Ratio (risk + ratio)
Kinds of Risk Ratio Selected AbstractsAcupuncture for Alcohol Dependence: A Systematic ReviewALCOHOLISM, Issue 8 2009Seung-Hun Cho Background:, Acupuncture has been used in the treatment of substance-related disorders for the past 30 years. However, a systematic review to assess the effect of various types of acupuncture for alcohol dependence has not yet been performed. The present systematic review assessed the results of randomized controlled trials (RCTs). Methods:, Nineteen electronic databases, including English, Korean, Japanese, and Chinese databases, were systematically searched for RCTs of acupuncture for alcohol dependence up to June 2008 with no language restrictions. The methodological qualities of eligible studies were assessed using the criteria described in the Cochrane Handbook. Results:, Eleven studies, which comprised a total of 1,110 individual cases, were systematically reviewed. Only 2 of 11 trials reported satisfactorily all quality criteria. Four trials comparing acupuncture treatment and sham treatments reported data for alcohol craving. Three studies reported that there were no significant differences. Among 4 trials comparing acupuncture and no acupuncture with conventional therapies, 3 reported significant reductions. No differences between acupuncture and sham treatments were found for completion rates (Risk Ratio = 1.07, 95% confidence interval, CI = 0.91 to 1.25) or acupuncture and no acupuncture (Risk Ratio = 1.15, 95% CI = 0.79 to 1.67). Only 3 RCTs reported acupuncture-related adverse events, which were mostly minimal. Conclusions:, The results of the included studies were equivocal, and the poor methodological quality and the limited number of the trials do not allow any conclusion about the efficacy of acupuncture for treatment of alcohol dependence. More research and well-designed, rigorous, and large clinical trials are necessary to address these issues. [source] Gender differences in the association of overweight and asthma morbidity among urban adolescents with asthmaPEDIATRIC ALLERGY AND IMMUNOLOGY, Issue 4 2009C. L. M. Joseph Asthma and obesity disproportionately affect US African-American youth. Among youth with asthma, obesity has been associated with poor control. The impact of gender on this association is unclear. We examined these relationships in a sample of urban, African-American adolescents with asthma. Questionnaires were used to identify high school students with asthma, and to examine the association of body mass index (BMI) to asthma morbidity, by gender. Of 5967 students completing questionnaires, 599 (10%) met criteria for asthma and 507 had data sufficient for inclusion in further analyses (46% male, mean age = 15.1 yr). Univariately, BMI > 85th percentile was significantly related only to reported emergency department visits (ED) and school days missed for any reason, Odds Ratio (95%Confidence Interval) = 1.7(1.1,2.7), p = 0.01 and 1.8(1.1,3.0), p = 0.01, respectively. A significant gender-BMI interaction (p < 0.05) was observed in multivariate models for ED visits, hospitalizations and school days missed for asthma. In gender-specific models, adjusted Risk Ratios for BMI > 85th and ED visits, hospitalizations, and school days missed because of asthma were 1.7(0.9,3.2), 6.6(3.1,14.6) and 3.6(1.8,7.2) in males. These associations were not observed in females. Gender modifies the association between BMI and asthma-related morbidity among adolescents with asthma. Results have implications for clinical management as well as future research. [source] Risk Ratios and Odds Ratios for Common Events in Cross-sectional and Cohort StudiesACADEMIC EMERGENCY MEDICINE, Issue 6 2010Scott T. Wilber MD No abstract is available for this article. [source] Lower airway obstruction is associated with increased morbidity in children with sickle cell disease,PEDIATRIC PULMONOLOGY, Issue 3 2009Jessica H. Boyd MD Abstract Rationale The association between pulmonary function and morbidity in children with sickle cell disease (SCD) has not been previously evaluated. Our objective was to study the relationship between abnormalities in pulmonary function and morbidity as represented by the rate of hospitalizations for pain or acute chest syndrome (ACS) in children with SCD. Methods Results of pulmonary function tests obtained for clinical indications in children ages 6,18 years were classified as lower airway obstruction (forced expiratory volume in 1 sec/forced volume capacity <95% confidence interval adjusted for age, gender, race, and height), restriction (total lung capacity <80% predicted adjusted for gender, age, race, and height), and normal lung function. Incidence rates of pain or ACS were compared between children with lower airway obstruction or restriction and children with normal lung function. Results A total of 102 children, mean age at evaluation 12.0 years with follow-up of 3.8 years, were included. Children with lower airway obstruction had twice the rate of morbidity compared to children with normal lung function (2.5 vs. 1.2 hospitalizations for pain or ACS per patient-year, P,=,0.003) (Risk ratio: 2.0; 95% CI: 1.3,3.3). Children with restriction did not have different rates of future morbidity compared to children with normal lung function (1.4 vs. 1.2 hospitalizations for pain or ACS per patient-year, P,=,0.68) (Rate ratio: 1.1; 95% CI: 0.6,2.1). Conclusions We conclude that children with SCD who have lower airway obstruction should have increased surveillance for future morbidity. Pediatr Pulmonol. 2009; 44:290,296. © 2009 Wiley-Liss, Inc. [source] Intravenous magnesium sulfate in acute severe asthmaRESPIROLOGY, Issue 3 2000Chaichan Boonyavorakul Objective: Intravenous magnesium sulfate (MgSO4), as an adjunctive medication to the standard treatment of acute asthma, improves admission rate or severity score in acute severe asthma patients. Methodology: We conducted a randomized double-blind placebo controlled trial with subjects from the emergency room, Ramathibodi Hospital, Bangkok, Thailand. Patients, aged 15,65 years with acute severe asthma attack, whose severity scores were greater than 4 and who were willing to be enrolled in a study during March to November 1997 participated in the study. Randomly allocated patients received either 2 g intravenous MgSO4 or placebo, sterile water, as an adjunctive medication to standard therapy for acute asthma. The medication was diluted in 50 mL of 0.9% normal saline. Measurement: Severity scores were measured by two investigators using Fischl's indices. The times interval of measurements were at the initial (0), 60, 120, 180, and 240 min from receipt of treatment. Patients were hospitalized if the severity scores at 240 min exceeded 1. Risk ratio (RR) and 95% confidence interval (CI) of RR were applied to estimate the risk of admission. Analysis of variance with repeated measurement on time was used to determine the severity score between two groups. Results: Thirty-four patients with acute severe asthma were enrolled in the present study. One patient from the placebo group was excluded because he did not consent to undergoing peak expiratory flow rate. Seventeen patients received MgSO4 and 16 patients received placebo. The general characteristics between the two groups were not significantly different, which reflected the quality of randomization. The admission rates of the placebo and MgSO4 group were 25.00% and 17.65%, respectively. Patients who received MgSO4 had preventive risk to be hospitalized 0.71 times relative to patients who received placebo. However, this preventive risk did not reach statistical significance (95% CI of RR = 0.19,2.67). The severity score at any time between the two groups was also not statistically significantly different (P = 0.366). Conclusion: With the present evidence, the hypothesis was not confirmed. Magnesium sulphate as an adjunct to standard therapy did not improve either admission rate or severity score in patients with acute severe asthma. [source] Does opioid substitution treatment in prisons reduce injecting-related HIV risk behaviours?ADDICTION, Issue 2 2010A systematic review ABSTRACT Objectives To review systematically the evidence on opioid substitution treatment (OST) in prisons in reducing injecting-related human immunodeficiency virus (HIV) risk behaviours. Methods Systematic review in accordance with guidelines of the Cochrane Collaboration. Electronic databases were searched to identify studies of prison-based opioid substitution treatment programmes that included assessment of effects of prison OST on injecting drug use, sharing of needles and syringes and HIV incidence. Published data were used to calculate risk ratios for outcomes of interest. Risk ratios were not pooled due to the low number of studies and differences in study designs. Results Five studies were included in the review. Poor follow-up rates were reported in two studies, and representativeness of the sample was uncertain in the remaining three studies. Compared to inmates in control conditions, for treated inmates the risk of injecting drug use was reduced by 55,75% and risk of needle and syringe sharing was reduced by 47,73%. No study reported a direct effect of prison OST on HIV incidence. Conclusions There may be a role for OST in preventing HIV transmission in prisons, but methodologically rigorous research addressing this question specifically is required. OST should be implemented in prisons as part of comprehensive HIV prevention programmes that also provide condoms and sterile injecting and tattooing equipment. [source] Mortality after care among young adult foster children in SwedenINTERNATIONAL JOURNAL OF SOCIAL WELFARE, Issue 3 2001Bo Vinnerljung This exploratory study looks at mortality after care among 13,100 former Swedish foster children, placed before their teens. Sources used are two national databases, on child welfare interventions and causes of death. Risk ratios of death for foster children are compared with those of their peers in the general population and with a comparison group, consisting of 10,668 young adults from adverse home backgrounds, who never entered foster family care before their teens. Both ex-foster children and the comparison group were young adults (19,26 years old) at time of follow-up. Results show a moderately elevated risk ratio for both groups compared with peers in the general population, mainly due to more frequent unnatural deaths, especially suicides. Time at first placement was not related to mortality among men, but there was a weak tendency of a higher risk ratio for girls placed at age 7,12. Information on time spent in care is used with caution, due to possible problems with reliability. Almost all comparisons between the foster care and the comparison group fell short of statistical significance. For foster children who had spent more than five years in care, the risk ratio tended to be higher than for foster children with shorter care experience, and similar to that of the comparison group. Foster children who had been in care for less then six years thus tended to have a lower risk ratio than the comparison group. [source] ESTIMATING EFFECTS OF SYSTEMATIC TREATMENT ON RENAL FAILURE AND DEATH WITHOUT A PARALLEL PLACEBO CONTROL GROUPNEPHROLOGY, Issue 3 2000Hoy We Background: Chronic disease programs are poorly developed in most Aboriginal communities. Much disease is unrecognised or inadequately treated, although appropriate interventions profoundly reduce morbidity and mortality in nonAboriginal populations. Programs of improved management must aspire to best practice for all, so that maintaining parallel untreated control groups is unethical. This poses challenges for evaluating effect. Methods: We identified a large burden of chronic disease in a 1990-1995 screening program in one community, and started a renal & cardiovascular-protection program in Nov 1995. This centred around use of ACE inhibitors, rigorous BP control, better control of glycemia and lipids, & health education. By late 1999 about 275 people, or 30% of all adults had enrolled. The courses of BP, albuminuria and GFR was compared with those in the pre-program era (ANZSN, 1999). Treatment effects on renal failure & natural death were estimated in 3 ways. 1) Comparison of these endpoints in the "intention to treat" group with those in persons potentially eligible for treatment on their 1990-1995 screening results, ,controls'. There was 50% overlap between the groups, & controls were younger and had less severe disease than the treatment group. 2.Community-based trends in endpoints. 3. Comparison of these trends with those in other NT Top End communities. Results: 1. Risk ratios of rates, Kaplan Meier survivals, and Cox hazard ratios all showed better survival of the treated group over controls, with estimates of 41%-64% reductions in endpoints, after accounting for disease severity. 2. Dialysis starts in the entire community have fallen by at least 38% and natural deaths by 32%. 3. In contrast dialysis continue to increase at 11% per yr in other communities and deaths have not fallen. These results all suggest a marked benefit from the treatment program. Similar methods might be used where truly controlled observations are not feasible. [source] ESTIMATING EFFECTS OF SYSTEMATIC TREATMENT ON RENAL FAILURE AND DEATH WITHOUT A PARALLEL PLACEBO CONTROL GROUPNEPHROLOGY, Issue 3 2000Hoy We Background: Chronic disease programs are poorly developed in most Aboriginal communities. Much disease is unrecognised or inadequately treated, although appropriate interventions profoundly reduce morbidity and mortality in nonAboriginal populations. Programs of improved management must aspire to best practice for all, so that maintaining parallel untreated control groups is unethical. This poses challenges for evaluating effect. Methods: We identified a large burden of chronic disease in a 1990-1995 screening program in one community, and started a renal & cardiovascular-protection program in Nov 1995. This centred around use of ACE inhibitors, rigorous BP control, better control of glycemia and lipids, & health education. By late 1999 about 275 people, or 30% of all adults had enrolled. The courses of BP, albuminuria and GFR was compared with those in the pre-program era (ANZSN, 1999). Treatment effects on renal failure & natural death were estimated in 3 ways. 1) Comparison of these endpoints in the "intention to treat" group with those in persons potentially eligible for treatment on their 1990-1995 screening results, ,controls'. There was 50% overlap between the groups, & controls were younger and had less severe disease than the treatment group. 2.Community-based trends in endpoints. 3. Comparison of these trends with those in other NT Top End communities. Results: 1. Risk ratios of rates, Kaplan Meier survivals, and Cox hazard ratios all showed better survival of the treated group over controls, with estimates of 41%-64% reductions in endpoints, after accounting for disease severity. 2. Dialysis starts in the entire community have fallen by at least 38% and natural deaths by 32%. 3. In contrast dialysis continue to increase at 11% per yr in other communities and deaths have not fallen. These results all suggest a marked benefit from the treatment program. Similar methods might be used where truly controlled observations are not feasible. [source] Management practices and risk of occupational blood exposure in U.S. paramedics: NeedlesticksAMERICAN JOURNAL OF INDUSTRIAL MEDICINE, Issue 9 2010Jack K. Leiss PhD Abstract Background The purpose of this study was to present risk estimates for needlestick in U.S. paramedics and estimated risk ratios for selected management practices. Methods A mail survey was conducted among a national sample of U.S. paramedics in 2002,2003. Results The adjusted response rate was 55% (n,=,2,664). The overall 12-month risk of needlestick was 6.7% (95% confidence interval, 5.4,7.9). Risk ratios for provision of safety-engineered medical devices and two supervisory behaviors that emphasized safe work practices ranged from 2.5 to 3.2. The protective effect of working in an environment that included both of the supervisory behaviors was greater than the protective effect of always being provided with safety devices. A sensitivity analysis indicated that the risk ratio estimates were unlikely to be inflated by nonresponse bias. Conclusions These results suggest that greater provision of safety devices and interventions aimed at management practices that promote worker safety could substantially reduce the risk of needlestick among U.S. paramedics. Am. J. Ind. Med. 53:866,874, 2010. © 2010 Wiley-Liss, Inc. [source] Caries risk factors in the permanent dentition of Tanzanian children: a cohort study (1997,2003)COMMUNITY DENTISTRY AND ORAL EPIDEMIOLOGY, Issue 6 2007Flemming Scheutz Abstract Objective:, The aims of the cohort study were to study the association between permanent dentition caries and malnutrition and other risk factors or indicators in a group of children with little or no access to restorative and preventive dental care. Methods:, The study was conducted at two primary schools in Dar es Salaam, Tanzania in the period 1997,2003. One school recruits its children from affluent families and the other school is attended by the children of poor families. The children attended grade 1 at the first examination and had a mean age of 7.6 years (SD = 0.4); when the study was completed, the mean age was 13.3 years. Two-hundred and eighteen children examined in 1997 were re-examined in 1999; 147 of the children were examined in 1997 as well as in 2003, and 122 children were examined in all three years. An age- and sex-based body mass index (BMI) was computed to determine the nutritional status of each child. Each year, the same standard methods were used to determine the count of lactobacilli and mutans streptococci, stimulated flow rate and buffering capacity of saliva, and caries. Risk ratios were computed with generalized linear models using the tooth as the unit of analysis. Results:, Mean annual caries increment was 0.27 in the period 1997,1999 and 0.80 in the period 1999,2003 with most children developing no caries at all. Malnutrition at baseline in 1997 was insignificantly predictive for the development of caries, whereas a low stimulated flow rate of saliva (,0.7 ml/min) and a high count of lactobacilli (,100 000/ml) at baseline in 1997 were significantly associated. However, the generalized linear models for the two time periods 1997,1999 and 1999,2003 presented a confusing picture with different risk ratios and without consistency of the associations between the exposure variables and the development of caries. In accordance with this finding, the consistency of the exposure variables over time for the individuals was very low. Conclusions:, The results were inconclusive and left us with more questions than answers. The findings do, however, support the view that our methods for predicting caries are inappropriate or nonexistent. [source] Early intervention in patients at ultra high risk of psychosis: benefits and risksACTA PSYCHIATRICA SCANDINAVICA, Issue 6 2009M. B. De Koning Objective:, Prediction of transition to psychosis in the prodromal phase of schizophrenia has raised interest in intervention prior to the onset of frank psychosis. The aim of this review was to examine whether interventions in the prodromal phase have a favourable benefit/risk ratio. Method:, A literature search in PubMed, EMBASE and PsycINFO was performed. Results:, Three randomized clinical trials with antipsychotic medication and/or cognitive behavioural therapy as clinical intervention suggested a positive effect at the end of treatment, but no significant differences were found at the end of follow-up periods from 1 to 4 years. Naturalistic studies present a hypothesis about a possible preventive effect of antidepressive medication. The results of eight other studies are more difficult to interpret. Side-effects of antipsychotic medication and non-adherence with medication are essential problems. Conclusion:, At the present time, the data concerning the benefits and risks do not justify prodromal intervention as standard clinical practice. [source] To Replace or Not to Replace: A Systematic Approach to Respond to Device AdvisoriesJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 2 2009Ph.D., SILVIA G. PRIORI M.D. Aim: The decision of whether and when to replace a device in response to an "advisory" letter requires careful consideration, because device replacement carries related risks and is influenced by the clinical characteristics of the patient. Methods and Results: The risk/benefit of device replacement depends on four parameters: expected annual sudden cardiac death rate; residual device life; difference in failure rate between the device listed on the advisory letter and the replacement device; and the replacement procedure mortality risk. Using these four factors, we have developed an equation that provides the "number needed to replace" (NNR) to save one life. Per our model, patients implanted with a device with a failure rate approaching 1% and a probability of requiring device intervention ,25% per year,in particular, pacemaker-dependent patients,have an NNR <250. Pacemaker-dependent patients, with devices having three or more years longevity, but with device failure rates ,0.5%, have an NNR <100. Patients with arrhythmic risk ,2.5% per year and those with devices having failure rates <0.1% have a high NNR and stand more risk to be harmed than benefited from device replacement. Conclusions: Pacemaker-dependent patients and those with high arrhythmic risk (,25% annually) when having "advisory" devices with high failure rate (,1%) have an NNR <250 and, hence, could be considered for device replacement. Conversely, patients with arrhythmic risk ,2.5% per year and those with devices having failure rates ,0.1% have a high NNR or even risk of "harm" from device replacement. In all the intermediate cases, the NNR will quantify the benefit/risk ratio of replacement, thus helping physicians and patients decide on the preferred approach. The NNR methodology proposed here is also applicable to advisory notices issued to leads, but the high morbidity associated with lead replacement will generally rule out interventions to replace leads. [source] Signaling, delivery and age as emerging issues in the benefit/risk ratio outcome of tPA For treatment of CNS ischemic disordersJOURNAL OF NEUROCHEMISTRY, Issue 2 2010William M. Armstead J. Neurochem. (2010) 113, 303,312. Abstract Stroke is a leading cause of morbidity and mortality. While tissue-type plasminogen activator (tPA) remains the only FDA-approved treatment for ischemic stroke, clinical use of tPA has been constrained to roughly 3% of eligible patients because of the danger of intracranial hemorrhage and a narrow 3 h time window for safe administration. Basic science studies indicate that tPA enhances excitotoxic neuronal cell death. In this review, the beneficial and deleterious effects of tPA in ischemic brain are discussed along with emphasis on development of new approaches toward treatment of patients with acute ischemic stroke. In particular, roles of tPA-induced signaling and a novel delivery system for tPA administration based on tPA coupling to carrier red blood cells will be considered as therapeutic modalities for increasing tPA benefit/risk ratio. The concept of the neurovascular unit will be discussed in the context of dynamic relationships between tPA-induced changes in cerebral hemodynamics and histopathologic outcome of CNS ischemia. Additionally, the role of age will be considered since thrombolytic therapy is being increasingly used in the pediatric population, but there are few basic science studies of CNS injury in pediatric animals. [source] Clinical trial: renzapride treatment of women with irritable bowel syndrome and constipation , a double-blind, randomized, placebo-controlled, studyALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 9 2010A. J. LEMBO Aliment Pharmacol Ther,31, 979,990 Summary Background, Renzapride, a 5-hydroxytryptamine type-4 (5-HT4) receptor agonist and 5-HT3 receptor antagonist, has been proposed as a new treatment of irritable bowel syndrome with constipation (IBS-C). Aim, To assess the efficacy and safety of renzapride in women with IBS-C. Methods, Women with IBS-C were randomized to renzapride 4 mg daily, 2 mg b.d. or placebo for 12 weeks. The primary outcome measure was global relief of IBS symptoms. A subset of patients were enrolled in a 12-month, open-label study of renzapride 4 mg daily. Results, A total of 1798 patients were included in the efficacy analysis and 971 patients entered the long-term study. The mean (S.E.M.) number of months with relief of overall IBS symptoms was 0.55 (0.04), 0.60 (0.04) and 0.44 (0.04) in the renzapride 4 mg daily, 2 mg b.d. and placebo groups (P = 0.027 and P = 0.004 respectively). Small yet statistically significant differences in favour of renzapride were observed on stool consistency and frequency, and bloating/abdominal distension scores. Renzapride was generally well tolerated; however, three episodes of ischaemic colitis were reported in the long-term study. Conclusion, Given the limited increase in efficacy over placebo and the incidence of ischaemic colitis observed, our data suggest that the benefit/risk ratio of renzapride is not sufficient to warrant further study in IBS-C. [source] Systematic review: adverse event reports for oral sodium phosphate and polyethylene glycolALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 1 2009J. BELSEY Summary Background, Screening colonoscopy exposes healthy patients to the risk of serious adverse events associated with bowel preparation. Randomized controlled trials are not an effective method for evaluating this risk. Aim, To search published literature in order to characterize the risk of adverse events associated with oral polyethylene glycol (PEG) or sodium phosphate (NaP). Methods, A systematic review identified case reports of any serious events associated with PEG or NaP. Reports to the Food and Drug Administration (FDA) were also examined. Results, Fifty-eight publications of significant events in 109 patients using NaP and 22 patients using PEG were identified. As the total number of prescriptions issued is unknown, rates for the two agents cannot be directly compared. Most commonly reported were electrolyte disturbances, renal failure and colonic ulceration for NaP and Mallory,Weiss tear, electrolyte disturbances and allergic reactions for PEG between January 2006 and December 2007; there were 171 cases of renal failure reported to the FDA following use of NaP and 10 following PEG. Conclusions, Adverse events following bowel preparation are uncommon, but potentially serious. Given that many of these patients are healthy individuals undergoing screening, the benefit/risk ratio must be carefully considered when deciding which preparation to prescribe in individual patients. [source] Efficacy and tolerability of EPs 7630 in patients (aged 6,18 years old) with acute bronchitisACTA PAEDIATRICA, Issue 4 2010A randomized, double-blind, placebo-controlled clinical dose-finding study Abstract Aim:, For EPs-7630, a herbal drug preparation from Pelargonium sidoides roots, therapeutic effects in respiratory tract infections outside the strict indication for antibiotics have already been demonstrated in adults. Now, a dose-finding study for EPs-7630 was performed in children and adolescents. Methods:, A total of 400 patients (aged 6,18 years) were randomized to receive either 30 mg, 60 mg or 90 mg EPs-7630 or placebo daily. Primary outcome criterion was the change in the Bronchitis Severity Score (BSS) from day 0 to day 7. Results:, After 7 days of treatment, the change in the BSS total score was significantly better in the 60 mg and 90 mg groups compared with placebo that of the without relevant differences between these two dosages. Especially ,coughing', ,sputum' and ,rales at auscultation' improved under EPs-7630. Onset of effect was faster, time of bed rest shorter and treatment outcome and satisfaction with treatment were rated better. Tolerability was comparable with placebo in all treatment groups. Conclusion:, EPs-7630 is effective in acute bronchitis outside the strict indication for antibiotics in 6,18 years old patients, with a dose of 60 mg or 90 mg daily offering the best benefit/risk ratio. EPs-7630 significantly reduces the severity of symptoms, leads to a more favourable course of the disease and a faster recovery from acute bronchitis compared with the placebo, and is well tolerated. [source] Haematopoietic stem cell transplantation in the treatment of severe autoimmune disease: results from phase I/II studies, prospective randomized trials and future directionsCLINICAL & EXPERIMENTAL IMMUNOLOGY, Issue 1 2005A. Tyndall Summary Around 700 patients have received an autologous haematopoietic stem cell transplant (HSCT) as treatment for a severe autoimmune disease (AD). The majority of these have been within the context of phase I/II clinical trials and following international guidelines proposed 7 years ago. In general, a positive benefit/risk ratio has led to phase III prospective randomized controlled trials in multiple sclerosis (MS), systemic sclerosis (SSc) and rheumatoid arthritis (RA) in Europe. In the US, similar trials are being planned for SSc, MS and systemic lupus erythematosus (SLE). Transplant related mortality (TRM) has fallen in all disease subgroups since the inception due to more appropriate patient selection, and so far a clear advantage of the more intense myeloablative regimens in terms of remission induction and relapse rate has not emerged. Although each AD has a different profile, over a third of patients have sustained a durable remission, often with no further need for immunosuppressive drugs. In those who relapsed, many responded to agents which pre transplant had been ineffective. The study of immune reconstitution and gene expression pre and post HSCT is being undertaken to further understand the mechanism of autoimmunity. [source] Modelling risk and uncertainty with the analytic hierarchy processJOURNAL OF MULTI CRITERIA DECISION ANALYSIS, Issue 2 2002Ido Millet Abstract This paper proposes methods for modelling risk and uncertainty with the analytic hierarchy process (AHP). We start by showing why benefit/risk ratios, as described in previous literature, might be an improper modelling approach. We then introduce prototypical case studies where risk plays a role in multicriteria decision making. These cases demonstrate how the AHP can be used to derive relative probabilities, multiple criteria outcome measures, risk criteria, and risk adjustment factors. Copyright © 2003 John Wiley & Sons, Ltd. [source] Augmentation of clozapine with a second antipsychotic , a meta-analysis of randomized, placebo-controlled studiesACTA PSYCHIATRICA SCANDINAVICA, Issue 6 2009D. M. Taylor Objective:, Inadequate response to clozapine treatment is frequently encountered in practice and augmentation strategies have been developed in an attempt to improve response. Aims of the study were to evaluate the therapeutic effect of adding an antipsychotic drug to clozapine treatment. Method:, Meta-analysis of randomized, placebo-controlled studies of antipsychotic augmentation of clozapine treatment. Results:, Ten studies (including 522 subjects) met inclusion criteria. Antipsychotic augmentation showed significant benefit over the addition of placebo on only one outcome measure examined [mean effect size for rating scale score (BPRS/PANSS) ,0.180, 95% CI ,0.356 to ,0.004]. Antipsychotic augmentation showed no advantage on withdrawals from trials (risk ratio 1.261, 95% CI 0.679,2.345) or on CGI scores (effect size ,0.661, 95% CI ,1.475 to 0.151). Duration of study was not associated with outcome (P = 0.95). There was no evidence of publication bias. Conclusion:, In studies lasting up to 16 weeks, the addition of an antipsychotic to clozapine treatment has marginal therapeutic benefit. Longer and larger trials are necessary to demonstrate the precise therapeutic utility of antipsychotic co-therapy with clozapine. [source] Clinical Assessment and Rest and Stress Echocardiography for Prediction of Long-Term Prognosis in African Americans with Known or Suspected Coronary Artery DiseaseECHOCARDIOGRAPHY, Issue 5 2009Stephen G. Sawada M.D. Background: There is limited information on noninvasive risk stratification of African Americans, a high-risk group for cardiovascular events. We investigated the value of clinical assessment and echocardiography for the prediction of a long-term prognosis in African Americans. Methods: Dobutamine echocardiography was performed in 324 African Americans. Two-dimensional measurements were performed at rest, and rest and stress wall motion was assessed. A retrospective follow-up was conducted for cardiac events: myocardial infarction (MI) or cardiac death (CD). Results: The mean age was 59 ± 12 years, and 83% of patients had hypertension. The follow-up was obtained in 318 (98%) patients for a mean of 5.3 years. The events occurred in 107 (33%) subjects. The independent predictors of events were history of MI (P = 0.001, risk ratio [RR] 2.04), ischemia (P = 0.007, RR 1.97), fractional shortening (P = 0.033, RR 0.08), and left atrial (LA) dimension (P = 0.034, RR 1.39). An LA size of 3.6 cm and a fractional shortening of 0.30 were the best cutoff values for the prediction of events. Prior MI, ischemia, LA size >3.6 cm, and fractional shortening <0.30 were each considered independent risk predictors for events. The event rates were 13%, 21%, 38%, 59%, and 57% in patients with 0, 1, 2, 3, and 4 risk predictors, respectively. Event-free survival progressively worsened with an increasing number of predictors: 0 or 1 versus 2 predictors, P < 0.001; 2 versus 3 or 4 predictors, P = 0.003. Conclusion: The long-term prognosis of African Americans can be accurately predicted by clinical assessment combined with rest and stress echocardiography. [source] Smoking 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] Pesticide residues in the aquatic environment of banana plantation areas in the North Atlantic Zone of Costa RicaENVIRONMENTAL TOXICOLOGY & CHEMISTRY, Issue 8 2000Luisa E. Castillo Abstract A study of pesticide residues in surface waters and sediments was undertaken in the Suerte River Basin, Costa Rica, that drains into the Tortuguero conservation area. Samples were collected in streams, packing plants, and the Suerte River. The most frequently measured compounds in surface water samples were the fungicides thiabendazole, propiconazole, and imazalil; the nematicides terbufos and cadusafos; and the insecticide chlorpyrifos. At the conservation area, propiconazole was detected in 43% of the samples at concentrations ranging from 0.05 to 1.0 ,g/L. In 25% of the samples collected at this site, a nematicide (cadusafos, carbofuran, or ethoprophos) was detected (0.06,6.2 ,g/L). According to this study, most of the insecticide-nematicides analyzed pose a risk for acute or chronic toxicity to aquatic organisms based on the exposure levels and toxicity values from the literature. Ametryn, imazalil, and thiabendazole also exceeded the calculated chronic risk ratio. The most frequently detected compounds in sediments were thiabendazole, chlorpyrifos, imazalil, and propiconazole. The occurrence was higher in the packing plants and streams. Pesticides in waters and sediments of Tortuguero conservation area could pose a threat to this wetland and an additional stress to the endangered species that inhabit this area. More information is needed regarding the distribution and stability of pesticides in the lagoon system as well as of the effects of mixtures of low levels of pesticides and their degradation products on representative species of the Tortuguero ecosystem. Meanwhile, all measures to reduce the emissions of pesticides from the banana plantations and the packing plants should be taken. [source] A randomized controlled trial of transcatheter arterial chemoembolization with lipiodol, doxorubicin and cisplatin versus intravenous doxorubicin for patients with unresectable hepatocellular carcinomaEUROPEAN JOURNAL OF CANCER CARE, Issue 5 2009M. MABED md, professor Hepatocellular carcinoma (HCC) is a major and often therapeutically frustrating oncological problem. A total of 100 patients with unresectable HCC were recruited and randomized to be treated with either transcatheter arterial chemoembolization (TACE) or systemic chemotherapy. Fifty patients were treated with TACE using lipiodol, doxorubicin and cisplatin, while 50 patients were treated with systemic doxorubicin alone. Patients treated with TACE achieved a significantly higher response rate, with partial response achieved in 16 patients (32%) versus five patients (10%) in the chemotherapy arm (P = 0.007). A significantly more favourable tumour response to chemoembolization was found in patients with single lesions (P = 0.02), Child class A (P = 0.007), Okuda stage 1 (P = 0.005) and ,-feto protein less than 400 ng/mL (P < 0.001). The probability of tumour progression was significantly lower in cases treated with TACE where the median progression free survival was 32 weeks (range, 16,70 weeks) versus 26 weeks (range, 14,54 weeks) for patients treated with systemic chemotherapy (P = 0.03). However, the median overall survival did not differ significantly in cases treated with TACE (38 weeks) compared with those treated with chemotherapy (32 weeks) (P = 0.08), except for patients with serum albumin >3.3 g/dL (60 vs. 36 weeks; P = 0.003). Multivariate Cox regression analysis showed that a rise of serum albumin by 1 g/dL is associated with a decrease in the risk of death by 33% (95% confidence interval: 0.12,0.94, P = 0.038). Mortality in the chemoembolization arm was due to tumour progression in 18 patients (53%), liver failure in 11 patients (32%) and gastro intestinal tract (GIT) bleeding in 5 patients (15%). Mortality in the chemotherapy arm was due to tumour progression in 23 patients (64%), liver failure in 9 patients (25%) and GIT bleeding in 4 patients (11%). Treatment-related mortality was 4% in the TACE arm versus 0% in the chemotherapy arm. In conclusion, the overall survival benefits of TACE and systemic doxorubicin are similar for patients with unresectable HCC amenable to either treatment. It is crucial to optimize the benefit,risk ratio of TACE. In this setting, serum albumin level is a candidate marker for selection of cases who may benefit from this procedure. [source] Case-only genome-wide interaction study of disease risk, prognosis and treatmentGENETIC EPIDEMIOLOGY, Issue 1 2010Brandon L. Pierce Abstract Case-control genome-wide association (GWA) studies have facilitated the identification of susceptibility loci for many complex diseases; however, these studies are often not adequately powered to detect gene-environment (G×E) and gene-gene (G×G) interactions. Case-only studies are more efficient than case-control studies for detecting interactions and require no data on control subjects. In this article, we discuss the concept and utility of the case-only genome-wide interaction (COGWI) study, in which common genetic variants, measured genome-wide, are screened for association with environmental exposures or genetic variants of interest. An observed G-E (or G-G) association, as measured by the case-only odds ratio (OR), suggests interaction, but only if the interacting factors are unassociated in the population from which the cases were drawn. The case-only OR is equivalent to the interaction risk ratio. In addition to risk-related interactions, we discuss how the COGWI design can be used to efficiently detect G×G, G×E and pharmacogenetic interactions related to disease outcomes in the context of observational clinical studies or randomized clinical trials. Such studies can be conducted using only data on individuals experiencing an outcome of interest or individuals not experiencing the outcome of interest. Sharing data among GWA and COGWI studies of disease risk and outcome can further enhance efficiency. Sample size requirements for COGWI studies, as compared to case-control GWA studies, are provided. In the current era of genome-wide analyses, the COGWI design is an efficient and straightforward method for detecting G×G, G×E and pharmacogenetic interactions related to disease risk, prognosis and treatment response. Genet. Epidemiol. 34:7,15, 2010. © 2009 Wiley-Liss, Inc. [source] Stratified case sampling and the use of family controlsGENETIC EPIDEMIOLOGY, Issue 3 2001Kimberly D. Siegmund Abstract We compare the asymptotic relative efficiency (ARE) of different study designs for estimating gene and gene-environment interaction effects using matched case-control data. In the sampling schemes considered, cases are selected differentially based on their family history of disease. Controls are selected either from unrelated subjects or from among the case's unaffected siblings and cousins. Parameters are estimated using weighted conditional logistic regression, where the likelihood contributions for each subject are weighted by the fraction of cases sampled sharing the same family history. Results showed that compared to random sampling, over-sampling cases with a positive family history increased the efficiency for estimating the main effect of a gene for sib-control designs (103,254% ARE) and decreased efficiency for cousin-control and population-control designs (68,94% ARE and 67,84% ARE, respectively). Population controls and random sampling of cases were most efficient for a recessive gene or a dominant gene with an relative risk less than 9. For estimating gene-environment interactions, over-sampling positive-family-history cases again led to increased efficiency using sib controls (111,180% ARE) and decreased efficiency using population controls (68,87% ARE). Using case-cousin pairs, the results differed based on the genetic model and the size of the interaction effect; biased sampling was only slightly more efficient than random sampling for large interaction effects under a dominant gene model (relative risk ratio = 8, 106% ARE). Overall, the most efficient study design for studying gene-environment interaction was the case-sib-control design with over-sampling of positive-family-history-cases. Genet. Epidemiol. 20:316,327, 2001. © 2001 Wiley-Liss, Inc. [source] Postoperative adjuvant transarterial chemoembolization for participants with hepatocellular carcinoma: A meta-analysisHEPATOLOGY RESEARCH, Issue 10 2010Jian-Hong Zhong Aim:, The efficacy of transarterial chemoembolization (TACE) for inoperable hepatocellular carcinoma (HCC) is positive, but for postoperative HCC, many studies have reported controversial results. The present study aimed to evaluate the efficacy of postoperative adjuvant TACE for participants with HCC. Methods:, Electronic and manual searches were conducted to identify randomized controlled trials (RCT) evaluating postoperative adjuvant TACE for participants with HCC. Results:, Six RCT totaling 659 participants, of whom almost all were of stage IIIA HCC, were included. For the 1-year tumor recurrence rate, hepatectomy plus TACE showed statistically significant less incidence of recurrence, with a pooled risk ratio (RR) of 0.68 (95% confidence interval [CI] = 0.55,0.84, P = 0.0003). For 1-year mortality, the trials were favorable for TACE with a pooled risk ratio of 0.48 (95% CI = 0.35,0.65, P < 0.00001). For 3-year mortality, the trials also revealed statistically significant less incidence, with a pooled risk ratio of 0.76 (95% CI = 0.64,0.90, P = 0.002). However, for 5-year mortality, TACE did not demonstrate statistically significant less incidence (RR = 0.94, 95% CI = 0.81,1.08, P = 0.36). Transient fever and nausea/vomiting were reported as side-effects of TACE but were well tolerated by most participants. Conclusion:, Postoperative adjuvant TACE seems promising for participants with HCC with risk factors (multiple nodules of >5 cm or vascular invasion) but requires further trial. [source] Hazardous drinking is associated with an elevated aspartate aminotransferase to platelet ratio index in an urban HIV-infected clinical cohortHIV MEDICINE, Issue 3 2009AA Chaudhry Objectives The aim of the study was to determine the relationship between alcohol consumption and liver fibrosis as assessed by aspartate aminotransferase to platelet ratio index (APRI) in HIV-infected adults and to explore the relative contributions of alcohol and hepatitis C virus (HCV) to APRI among HIV/HCV-coinfected adults. Methods We performed a cross-sectional analysis of data from an observational clinical cohort. Alcohol consumption was categorized according to National Institute on Alcohol Abuse and Alcoholism guidelines. We defined significant liver disease as APRI>1.5, and used multinomial logistic regression to identify correlates of increased APRI. Results Among 1358 participants, 10.4% reported hazardous drinking. It was found that 11.6% had APRI>1.5, indicating liver fibrosis. Hazardous drinking was associated with increased APRI [adjusted relative risk ratio (RRR) 2.30; 95% confidence interval (CI) 1.26,4.17]. Other factors associated with increased APRI were male gender, viral hepatitis, and HIV transmission category of injecting drug use. Among coinfected individuals, 18.3% had APRI>1.5, and hazardous drinking was not associated with APRI. Among non-HCV-infected individuals, 5.3% had APRI>1.5 and hazardous drinking was associated with increased APRI (adjusted RRR 3.72; 95% CI 1.40,9.87). Conclusions Hazardous drinking is an important modifiable risk factor for liver fibrosis, particularly among non-HCV-infected patients. Clinicians and researchers must address alcohol use as the burden of liver disease increases among HIV-positive individuals. [source] Incidence of anaemia among HIV-infected patients treated with highly active antiretroviral therapy,HIV MEDICINE, Issue 8 2007SM Curkendall Objective The aim of the study was to compare the incidence of anaemia in patients treated with zidovudine (ZDV) with that in patients treated with highly active antiretroviral therapy (HAART) not including ZDV. Methods Using HIV Insight, a database of abstracted US HIV care centre medical charts, ZDV-naïve patients starting ZDV-containing HAART were compared with those starting non-ZDV, nucleoside reverse transcriptase inhibitor-containing HAART. Cohorts were divided as follows: group 1: without baseline anaemia [haemoglobin (Hb) ,11 g/dL]; group 2: with baseline anaemia (Hb <11 g/dL). The incidence of anaemia (anaemia diagnosis, Hb <11 g/dL, erythropoietic therapy or blood transfusion) was computed for group 1. The anaemia hazard ratio (HR) was adjusted using Cox regression. The rate of worsening anaemia (Hb decrease ,1.0 g/dL) was computed for group 2. Results In group 1, the incidence of anaemia was 24.3 and 8.1 per 100 person-years in the ZDV and non-ZDV cohorts, respectively, after 6 months of follow-up, and 12.5 and 5.3 per 100 person-years after 24 months. Significant predictors of anaemia were ZDV, low initial Hb, injecting drug use, CD4 count <200 cells/,L and AIDS. The adjusted HR for ZDV was 1.6 (P=0.005). In group 2, the ZDV/non-ZDV risk ratio for worsening anaemia was 2.2 (95% confidence interval 1.1,4.3). Conclusions Patients initiating ZDV-containing HAART are at greater risk of developing new anaemia or worsening anaemia than patients initiating non-ZDV-containing HAART. [source] The therapeutic promise of single enantiomers: introductionHUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue S2 2001Irving W. Wainer Abstract This review uses several examples drawn from the literature to show how using active enantiomers as therapeutic agents may yield several benefits, including more predictable pharmacokinetics, more accurate drug monitoring and enhanced tolerability. As a result of these benefits, the therapeutic use of single enantiomers will become increasingly important not only in psychopharmacology, but in medicine generally. Indeed, over the early years of the new millennium, the therapeutic use of single active enantiomers is set to redefine the benefit,risk ratio in the management of many common conditions. Copyright © 2001 John Wiley & Sons, Ltd. [source] | ||||||||||||||||||||||||||||||||||||||||