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Trial Evidence (trial + evidence)
Kinds of Trial Evidence Selected AbstractsModification of cardiovascular risk in hemodialysis patients: An evidence-based reviewHEMODIALYSIS INTERNATIONAL, Issue 1 2007David W. JOHNSON Abstract Cardiovascular disease accounts for 40% to 50% of deaths in dialysis populations. Overall, the risk of cardiac mortality is 10-fold to 20-fold greater in dialysis patients than in age and sex-matched controls without chronic kidney disease. The aim of this paper is to review critically the evidence that cardiac outcomes in dialysis patients are modified by cardiovascular risk factor interventions. There is limited, but as yet inconclusive controlled trial evidence that cardiovascular outcomes in dialysis populations may be improved by antioxidants (vitamin E or acetylcysteine), ensuring that hemoglobin levels do not exceed 120 g/L (especially in the setting of known cardiovascular disease), prescribing carvedilol in the setting of dilated cardiomyopathy, and by using cinacalcet in uncontrolled secondary hyperparathyroidism. Similarly, there are a number of negative controlled trials, which have demonstrated that statins, high-dose folic acid, angiotensin-converting enzyme inhibitors, multiple risk factor intervention via multidisciplinary clinics, and high-dose or high-flux dialysis are ineffective in preventing cardiovascular disease. Although none of these studies could be considered conclusive, the negative trials to date should raise significant concerns about the heavy reliance of current clinical practice guidelines on extrapolation of findings from cardiovascular intervention trials in the general population. It may be that cardiovascular disease in dialysis populations is less amenable to intervention, either because of the advanced stage of chronic kidney disease or because the pathogenesis of cardiovascular disease in dialysis patients is different from that in the general population. Large, well-conducted, multicenter randomized-controlled trials in this area are urgently required. [source] Barriers to Optimal Hypertension ControlJOURNAL OF CLINICAL HYPERTENSION, Issue 8 2008Gbenga Ogedegbe MD There is an obvious gap in the translation of clinical trial evidence into practice with regards to optimal hypertension control. The three major categories of barriers to BP control are patient-related, physician-related, and medical environment/health care system factors. Patient-related barriers include poor medication adherence, beliefs about hypertension and its treatment, depression, health literacy, comorbidity, and patient motivation. The most pertinent is medication adherence, given its centrality to the other factors. The most salient physician-related barrier is clinical inertia,defined, as the failure of health care providers to initiate or intensify drug therapy in a patient with uncontrolled BP. The major reasons for clinical inertia are: 1) overestimation of the amount of care that physicians provide; 2) lack of training on how to attain target BP levels; and 3) clinicians' use of soft reasons to avoid treatment intensification by adopting a "wait until next visit" approach in response to patients' excuses. [source] A systematic review of wound cleansing for pressure ulcersJOURNAL OF CLINICAL NURSING, Issue 15 2008FFNMRCSI, Zena Moore MSc Aim., The aim of this study was to use a Cochrane systematic review process to explore the effect of wound cleansing solutions and techniques on pressure ulcer healing. Background., Pressure ulcers impose a significant financial burden on health care systems and negatively affect the quality of life. Wound cleansing is an important component of pressure ulcer care; however, there is uncertainty regarding best practice. Design., Systematic review. Methods., The Specialised Trials Register of the Cochrane Wounds Group, the Cochrane Central Register of Controlled Trials and bibliographies of relevant publications were searched. Drug companies and experts in the field were also contacted. Randomized controlled trials (RCTs) comparing wound cleansing with no wound cleansing, or different wound cleansing solutions, or different cleansing techniques, were eligible for inclusion. For dichotomous outcomes, relative risk (RR) plus 95% confidence intervals (CI) were calculated; for continuous outcomes, weighted mean difference plus 95% CI were calculated. Meta analysis was not conducted because of the small number of diverse RCTs identified. Results., No studies compared cleansing with no cleansing. A statistically significant improvement in healing occurred for wounds cleansed with saline spray containing Aloe vera, silver chloride and decyl glucoside (Vulnopur) compared with isotonic saline (p = 0·025). No statistically significant change in healing was seen when water was compared with saline (RR 3·00, 95% CI 0·21, 41·89). No statistically significant change in healing was seen for ulcers cleansed with, or without, a whirlpool (RR 2·10, 95% CI 0·93,4·76). Conclusion., There is little trial evidence to support the use of any particular wound cleansing solution or technique for pressure ulcers. Relevance to clinical practice., No firm recommendations for ways of cleansing pressure ulcers in clinical practice can be made, the lack of RCT evidence should be a concern for health care providers. [source] Guidelines to Practice Gap in the Use of Glycoprotein IIb/IIIa Inhibitors: From ISAR-REACT to Overreact?JOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 2 2009G. VISWANATHAN M.R.C.P. Adjunctive use of glycoprotein IIb/IIIa inhibitors (GPI) is associated with favorable outcomes following percutaneous coronary intervention (PCI). Guidelines for use of GPI have been published by various national societies including National Institute of Clinical Excellence (NICE), United Kingdom. The latter has not been updated since publication. The impact of contemporary trials such as ISAR-REACT (which showed no benefit of abciximab and 600 mg of clopidogrel compared with 600 mg of clopidogrel alone, in elective patients) on adherence to NICE guidelines is unknown. Methods: We audited use of GPI against NICE guidelines following publication in May 2002. Data were collected from 1,685 patients between September and November in years 2002, 2003, 2004, and 2007. Results: In 2002 and 2003, only 10.2% and 11.8%, respectively, of patients were noncompliant to NICE guidelines. Over time, there was an increase in patients not given GPI despite meeting NICE criteria. After publication of ISAR-REACT, the comparative figures for noncompliance in 2004 and 2007 were 40.0% and 44.5%. A similar pattern was seen in patients with diabetes; in 2002 and 2003 noncompliance was 16.7% and 11.1%, respectively, and in 2004 and 2007 noncompliance was 38.0% and 44.7%, respectively. Qualitatively, similar findings were recorded in patients with NSTE-ACS. The overall noncompliance to NICE guidelines increased from 11.0% to 42.1% (P < 0.0001) after the ISAR-REACT study. Conclusions: We found a decline in compliance to NICE guidelines on GPI usage during PCI. This was likely influenced by contemporary trials demonstrating little or no benefit of GPI in patients undergoing elective PCI who are adequately pretreated with clopidogrel. Our findings suggest the need for a mechanism whereby regular updates to guidelines can be disseminated following new trial evidence. [source] Systematic review: standard- and double-dose proton pump inhibitors for the healing of severe erosive oesophagitis , a mixed treatment comparison of randomized controlled trialsALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 6 2009S. J. EDWARDS Summary Background, No randomized controlled trial (RCT) has compared all European-licensed standard- and double-dose PPIs for the healing of severe erosive oesophagitis. Aim, To compare the effectiveness of licensed doses of PPIs for healing severe erosive oesophagitis (i.e. esomeprazole 40 mg, lansoprazole 30 mg, omeprazole 20 mg and 40 mg, pantoprazole 40 mg and rabeprazole 20 mg). Methods, Systematic review of CENTRAL, EMBASE and MEDLINE for RCTs in patients with erosive oesophagitis (completed October 2008). Endoscopically verified healing rates at 4 and 8 weeks were extracted and re-calculated if not analysed by intention-to-treat. A mixed treatment comparison was used to combine direct treatment comparisons with indirect trial evidence while maintaining randomization. Odds ratios (OR) are reported compared to omeprazole 20 mg. Results, A total of 3021 papers were identified in the literature search; 12 were of sufficient quality to be included in the analysis. Insufficient data were available to included rabeprazole. Esomeprazole 40 mg was found to provide significantly higher healing rates at 4 weeks [OR 1.84, 95% Credible Interval (95% CrI): 1.50 to 2.22] and 8 weeks (OR 1.91, 95% CrI: 1.13 to 2.88). No other PPI investigated had significantly higher healing rates than omeprazole 20 mg. Conclusion, Esomeprazole 40 mg consistently demonstrates higher healing rates compared with licensed standard- and double-dose PPIs. [source] Bisphosphonates and oral surgeryORAL SURGERY, Issue 2 2009R. Oliver Abstract Osteonecrosis of the jaws, or the threat of it, because of the use of bisphosphonates, is an increasing problem facing all dentists and oral surgeons. The link is somewhat circumstantial but compelling and there are emerging risk factors that increase a patient's susceptibility to developing osteonecrosis including the use of intravenous bisphosphonates, length of time taking the drug, smoking and possibly a genetic predisposition. There is a lack of randomised trial evidence regarding the best strategies for prevention and treatment of the condition. This article discusses current evidence, largely from observational studies on the development, prevention and management of bisphosphonate-related osteonecrosis. [source] Melatonin (Circadin): a novel hypnotic for use in older patientsPRESCRIBER, Issue 20 2008MRPharmS, Steve Chaplin MSc Melatonin is a new hypnotic with a novel mode of action for the short-term treatment of insomnia in older patients. In this New products review, Steve Chaplin discusses the clinical trial evidence for its efficacy, and Professor David Nutt describes its place in treatment. Copyright © 2008 Wiley Interface Ltd [source] Clinical practice guidelines for the management of acute limb compartment syndrome following traumaANZ JOURNAL OF SURGERY, Issue 3 2010Christopher J. Wall Abstract Background:, Acute compartment syndrome is a serious and not uncommon complication of limb trauma. The condition is a surgical emergency, and is associated with significant morbidity if not managed appropriately. There is variation in management of acute limb compartment syndrome in Australia. Methods:, Clinical practice guidelines for the management of acute limb compartment syndrome following trauma were developed in accordance with Australian National Health and Medical Research Council recommendations. The guidelines were based on critically appraised literature evidence and the consensus opinion of a multidisciplinary team involved in trauma management who met in a nominal panel process. Results:, Recommendations were developed for key decision nodes in the patient care pathway, including methods of diagnosis in alert and unconscious patients, appropriate assessment of compartment pressure, timing and technique of fasciotomy, fasciotomy wound management, and prevention of compartment syndrome in patients with limb injuries. The recommendations were largely consensus based in the absence of well-designed clinical trial evidence. Conclusions:, Clinical practice guidelines for the management of acute limb compartment syndrome following trauma have been developed that will support consistency in management and optimize patient health outcomes. [source] Effects of pre-trial publicity and jury deliberation on juror bias and source memory errorsAPPLIED COGNITIVE PSYCHOLOGY, Issue 1 2007Christine Ruva We examined the effects of exposure to pre-trial publicity (PTP) and jury deliberation on juror memory and decision making. Mock jurors either read news articles containing negative PTP or articles unrelated to the trial. They later viewed a videotaped murder trial, after which they either made collaborative group decisions about guilt or individual decisions. Finally, all participants independently attributed specific information as having been presented during the trial or in the news articles. Exposure to PTP significantly affected guilty verdicts, sentence length, perceptions of defendant credibility, and misattributions of PTP as having been presented as trial evidence. Jury deliberation had significant effects on jury verdicts, perceptions of defendant credibility, source memory for trial items, and confidence in source memory judgements, but did not affect sentences or critical source memory errors. Copyright © 2006 John Wiley & Sons, Ltd. [source] What's new in atopic eczema?CLINICAL & EXPERIMENTAL DERMATOLOGY, Issue 3 20102008., An analysis of systematic reviews published in 200 Summary This review summarizes clinically important findings from systematic reviews indexed in bibliographical databases between August 2007 and August 2008 that dealt with disease prevention (six reviews) and treatment of atopic eczema (seven reviews). Regarding disease prevention, two independent systematic reviews found some clinical trial evidence that ingestion of probiotics by mothers during pregnancy might reduce the incidence of subsequent eczema. Another review failed to find any clear benefit of prebiotics in eczema prevention. Although furry pets are often cited as causing allergic disease, a systematic review of observational studies found no evidence that exposure to cats or dogs at birth increases eczema risk. One very large review of studies of breastfeeding found some evidence of a protective effect on eczema risk, although all the studies were limited by their observational nature. A German group has attempted an overview of eczema prevention studies with a view to informing national guidelines. In terms of eczema treatment, two systematic reviews have confirmed the efficacy of topical tacrolimus ointment. Another review of 31 trials confirms the efficacy of topical pimecrolimus, although many of those trials were vehicle controlled, which limits their clinical utility. A review of 23 studies of desensitization therapy for allergic diseases found some evidence of benefit for eczema, which needs to be explored further. Despite the popularity of antistaphylococcal therapies for eczema, a Cochrane Review of 21 trials failed to show any clear benefit for any of the therapies for infected or clinically noninfected eczema. Another Cochrane Review dealt with dietary exclusions for people with eczema and found little evidence to support any dietary exclusion, apart from avoidance of eggs in infants with suspected egg allergy supported by evidence of sensitization. A review of 13 studies of probiotics for treating established eczema did not show convincing evidence of a clinically worthwhile benefit, an observation that has been substantiated in a subsequent Cochrane Review. [source] Carvedilol in the failing heartCLINICAL CARDIOLOGY, Issue 12 2001William L. Lombardi M.D. Abstract Patients with chronic heart failure due to left ventricular systolic dysfunction of ischemic or nonischemic etiology have shown improvement in morbidity and mortality with carvedilol therapy. In patients with symptomatic (New York Heart Association class II,IV) heart failure, carvedilol improves left ventricular ejection fraction and clinical status, and slows disease progression, reducing the combined risk of mortality and hospitalization. Despite the overwhelming evidence for their benefit, there continues to be a large treatment gap between those who would derive benefit and those who actually receive the drug. In this article, the pharmacology, clinical trial evidence, and the potential differences between carvedilol and other beta blockers are discussed. Carvedilol provides powerful therapy in the treatment of chronic heart failure caused by a variety of etiologies and in a wide array of clinical settings. [source] | ||||||||||