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Control Trials (control + trials)
Kinds of Control Trials Terms modified by Control Trials Selected Abstracts"Congratulations, You Have Been Randomized Into the Control Group!(?)": Issues to Consider When Recruiting Schools for Matched-Pair Randomized Control Trials of Prevention ProgramsJOURNAL OF SCHOOL HEALTH, Issue 3 2008Peter Ji PhD ABSTRACT Background:, Recruiting schools into a matched-pair randomized control trial (MP-RCT) to evaluate the efficacy of a school-level prevention program presents challenges for researchers. We considered which of 2 procedures would be most effective for recruiting schools into the study and assigning them to conditions. In 1 procedure (recruit and match/randomize), we would recruit schools and match them prior to randomization, and in the other (match/randomize and recruitment), we would match schools and randomize them prior to recruitment. Method:, We considered how each procedure impacted the randomization process and our ability to recruit schools into the study. After implementing the selected procedure, the equivalence of both treatment and control group schools and the participating and nonparticipating schools on school demographic variables was evaluated. Results:, We decided on the recruit and match/randomize procedure because we thought it would provide the opportunity to build rapport with the schools and prepare them for the randomization process, thereby increasing the likelihood that they would accept their randomly assigned conditions. Neither the treatment and control group schools nor the participating and nonparticipating schools exhibited statistically significant differences from each other on any of the school demographic variables. Conclusions:, Recruitment of schools prior to matching and randomization in an MP-RCT may facilitate the recruitment of schools and thus enhance both the statistical power and the representativeness of study findings. Future research would benefit from the consideration of a broader range of variables (eg, readiness to implement a comprehensive prevention program) both in matching schools and in evaluating their representativeness to nonparticipating schools. [source] The REFLECT Statement: Methods and Processes of Creating Reporting Guidelines for Randomized Controlled Trials for Livestock and Food SafetyJOURNAL OF VETERINARY INTERNAL MEDICINE, Issue 1 2010A.M. O'Connor The conduct of randomized controlled trials in livestock with production, health, and food-safety outcomes presents unique challenges that might not be adequately reported in trial reports. The objective of this project was to modify the CONSORT (Consolidated Standards of Reporting Trials) statement to reflect the unique aspects of reporting these livestock trials. A 2-day consensus meeting was held on November 18,19, 2008 in Chicago, IL, to achieve the objective. Before the meeting, a Web-based survey was conducted to identify issues for discussion. The 24 attendees were biostatisticians, epidemiologists, food-safety researchers, livestock production specialists, journal editors, assistant editors, and associate editors. Before the meeting, the attendees completed a Web-based survey indicating which CONSORT statement items would need to be modified to address unique issues for livestock trials. The consensus meeting resulted in the production of the REFLECT (Reporting Guidelines for Randomized Control Trials) statement for livestock and food safety and 22-item checklist. Fourteen items were modified from the CONSORT checklist, and an additional subitem was proposed to address challenge trials. The REFLECT statement proposes new terminology, more consistent with common usage in livestock production, to describe study subjects. Evidence was not always available to support modification to or inclusion of an item. The use of the REFLECT statement, which addresses issues unique to livestock trials, should improve the quality of reporting and design for trials reporting production, health, and food-safety outcomes. [source] Adjunctive Low Molecular Weight Heparin During Fibrinolytic Therapy in Acute ST-Segment Elevation Myocardial Infarction: A Meta-Analysis Of Randomized Control TrialsCLINICAL CARDIOLOGY, Issue 7 2009Sarabjeet Singh MD Background Recent data suggests that low molecular weight heparins (LMWHs) may be superior to unfractionated heparin (UFH) as an adjunct to fibrinolytic therapy in patients with acute ST-segment elevation myocardial infarction (STEMI). Hypothesis We evaluated cardiac outcomes and the risk of major bleeding with LMWHs vs UFH in the management of STEMI. Methods Seven randomized trials of patients with acute STEMI treated with fibrinolytic therapy and adjunctive LMWHs through the index hospitalization or weight-based UFH for at least 48 hours were identified. We analyzed both primary endpoints (death and nonfatal recurrent myocardial infarction through 30 days), and secondary endpoints (death, recurrent myocardial infarction, and major bleeding during index hospitalization at 7 days). Outcomes were computed using the Mantel-Haenszel fixed-effect model. A 2-sided alpha error of < 0.05 was considered significant. Results Compared to UFH, LMWH significantly reduced reinfarction (p < 0.001) during hospitalization at 7 days and the effect remained consistent at 30 d (p < 0.001). When analyzed for mortality at 7 days and 30 days follow-up, there were no statistically significant differences observed between the 2 groups. Additionally the LMWH group had higher risk of major bleeding (p < 0.001). Conclusions The present meta-analysis suggests in patients receiving fibrinolytic therapy for STEMI, LMWHs as an adjunctive therapy is superior to UFH in reducing reinfarction during hospitalization at 7 days and at 30 days. The mortality was not significant between the 2 groups during hospitalization at 7 days and at 30 days. However, UFH is superior to LMWHs in the reduction of major bleeding at 7 days index hospitalization. Copyright © 2009 Wiley Periodicals, Inc. [source] Meta-analysis: the effects of proton pump inhibitors on cardiovascular events and mortality in patients receiving clopidogrelALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 8 2010C. S. KWOK Summary Background, Recent studies have suggested an adverse interaction between proton pump inhibitors (PPI) and clopidogrel. Aim, To perform a meta-analysis of cardiovascular outcomes and mortality in patients taking clopidogrel, with and without concomitant PPI. Methods, We searched MEDLINE, EMBASE, Cochrane Controlled Trials Register in October 2009, and checked conference abstracts for randomized and nonrandomized studies that reported the risk of cardiovascular events and mortality with PPI exposure in patients taking clopidogrel. We performed random effects meta-analysis, stratified by study design and assessed heterogeneity using the I2 statistic. Results, Our review included 23 studies covering 93 278 patients. There was substantial heterogeneity in the meta-analyses of major cardiovascular events (19 studies, I2 = 79%) or myocardial infarction (12 studies, I2 = 77%). Analysis of propensity-matched or randomized trial participants showed no associated cardiovascular risk with PPIs, whereas other observational studies generally showed a significant association. Meta-analysis of 13 studies showed no significant association between PPI use and overall mortality (RR 1.09, 95% CI: 0.94,1.26, P = 0.23, I2 = 60%). Conclusion, As there are conflicting and inconsistent data regarding the adverse clopidogrel,PPI interaction, clinicians should focus on potential harm from ulcers/haemorrhage before deciding to omit PPIs in patients taking clopidogrel. [source] Meta-analysis: octreotide prevents post-ERCP pancreatitis, but only at sufficient dosesALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 11 2009Y. ZHANG Summary Background, Effects of octreotide on post-endoscopic retrograde cholangiopancreatography pancreatitis have been studied in many clinical trials. These trials have yielded inconclusive results. Results of more recent studies using larger doses, however, seem to be more optimistic. Aim, To examine effects of octreotide at different doses on PEP. Methods, A comprehensive search of relevant databases, including Medline, Embase, the Cochrane Controlled Trials Register, the Cochrane Library and Science Citation Index yielded 18 randomized controlled trials (RCTs). Trials were divided into two groups according to the total dosage of octreotide: <0.5 mg (OCT1), ,0.5 mg (OCT2). The rate of PEP was analysed using a fixed effect model. Results, At doses of ,0.5 mg, octreotide reduced the rate of PEP. In the OCT2 group, analysis revealed a statistically significant difference on PEP between the octreotide group and the controls (3.4% vs. 7.5%, pooled OR = 0.45; 95% CI: 0.28,0.73; P = 0.001, NNT = 25). In the OCT1 group, the rate of PEP was similar between patients receiving octreotide and the controls (7.2% vs. 6.0%, pooled OR = 1.23; 95% CI: 0.80,1.91; P = 0.35). Conclusion, Octreotide is effective in preventing PEP, but only at sufficient doses (,0.5 mg). [source] Helicobacter pylori eradication therapy vs. antisecretory non-eradication therapy for the prevention of recurrent bleeding from peptic ulcerALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 6 2004J. P. Gisbert Summary Aim :,To perform a meta-analysis comparing the efficacy of Helicobacter pylori eradication therapy vs. antisecretory non-eradication therapy for the prevention of recurrent bleeding from peptic ulcer. Methods :,A search was made of the Cochrane Controlled Trials Register, MEDLINE, EMBASE, CINAHL and several congresses for controlled clinical trials comparing the efficacy of H. pylori eradication therapy vs. antisecretory non-eradication therapy for the prevention of peptic ulcer re-bleeding. Studies with all patients taking non-steroidal anti-inflammatory drugs were excluded. Extraction and quality assessment of the studies were performed by two reviewers. Results :,In the first meta-analysis, the mean percentage of re-bleeding in the H. pylori eradication therapy group was 4.5%, compared with 23.7% in the non-eradication therapy group without long-term antisecretory therapy [odds ratio, 0.18; 95% confidence interval (CI), 0.09,0.37; ,number needed to treat' (NNT), 5; 95% CI, 4,8]. In the second meta-analysis, the re-bleeding rate in the H. pylori eradication therapy group was 1.6%, compared with 5.6% in the non-eradication therapy group with maintenance antisecretory therapy (odds ratio, 0.25; 95% CI, 0.08,0.76; NNT, 20; 95% CI, 12,100). When only patients with successful H. pylori eradication were included, the re-bleeding rate was 1%. Conclusions :,The treatment of H. pylori infection is more effective than antisecretory non-eradication therapy (with or without long-term maintenance antisecretory treatment) in the prevention of recurrent bleeding from peptic ulcer. Consequently, all patients with peptic ulcer bleeding should be tested for H. pylori, and eradication therapy should be prescribed to infected patients. [source] An integrative review of Canadian childhood obesity prevention programmesOBESITY REVIEWS, Issue 1 2007S. Conroy Summary To examine successful Canadian nursing and health promotion intervention programmes for childhood obesity prevention during gestation and infancy, an integrative review was performed of the literature from 1980 to September 2005. The following databases were used: PubMed; Cochrane Database of Systematic Reviews; Cochrane Controlled Trials Register; Database of Abstracts of Reviews of Effects; ACP Journal Club; MEDLINE; EMBASE; CINAHL; Web of Science; Scopus; Sociological Abstracts; Sport Discus; PsycInfo; ERIC and HealthStar. MeSH headings included: infancy (0,24 months), gestation, gestational diabetes, nutrition, prenatal care, pregnancy, health education, pregnancy outcome, dietary services with limits of Canadian, term birth. Of 2028 articles found, six Canadian childhood obesity prevention programmes implemented during gestation and/or infancy were found; three addressed gestational diabetes with five targeting low-income Canadian urban and/or Aboriginal populations. No intervention programmes specifically aimed to prevent childhood obesity during gestation or infancy. This paucity suggests that such a programme would be innovative and much needed in an effort to stem the alarming increase in obesity in children and adults. Any attempts either to develop new approaches or to replicate interventions used with obese adults or even older children need careful evaluation and pilot testing prior to sustained use within the perinatal period. [source] The Physician/Investigator's Obligation to Patients Participating in Research: The Case of Placebo Controlled TrialsTHE JOURNAL OF LAW, MEDICINE & ETHICS, Issue 3 2005Kathleen Cranley Glass First page of article [source] OPTICAL/DIGITAL CHROMOENDOSCOPY DURING COLONOSCOPY USING NARROW-BAND IMAGING SYSTEMDIGESTIVE ENDOSCOPY, Issue 2005Yasushi Sano This review is regarding the narrow-band imaging (NBI) system which has been developed at National Cancer Center Hospital East, Japan. The technology of the NBI system is based on modifying the spectral features by narrowing the bandwidth of spectral transmittance using various optical filters. The NBI system consists of three filters, 415,30 nm, 445,30 nm, and 500,30 nm, which are used as observing the fine capillaries in the superficial mucosa is essential to identify gastrointestinal neoplasms. The NBI system has been in development since 1999 and the first report of it's efficacy for gastrointestinal tract use was reported in 2001. In our pilot study, the NBI system may be sufficient to differentiate hyperplastic polyp from adenomatous polyp, and to visualize neoplasia with image processing in real-time during colonoscopy without the need for dye spraying. Herein, we propose the term ,optical/digital chromoendoscopy' using the NBI system and hope that this instrument will become standard endoscopy for in the 21st century. To estimate the feasibility and efficacy of using the NBI system for surveillance or screening examination, randomized control trials should be conducted in the future. [source] REVIEW: Aortic Atheromas: Current Concepts and Controversies,A Review of the LiteratureECHOCARDIOGRAPHY, Issue 2 2008Thenappan Thenappan M.D. The frequent use of transesophageal echocardiogram (TEE) has led to the increased recognition of aortic atheromas. Retrospective and prospective follow-up studies have reported an association between aortic atheromas and stroke in the high-risk patient population, with complex plaques being more likely to embolize than simple plaques. However, TEE-based studies in the low-risk cohorts have failed to show a similar association. There is growing body of evidence suggesting that aortic atheroma is a marker of generalized atherosclerosis. Although magnetic resonance (MR) imaging and computed tomography (CT) scan are emerging as a powerful noninvasive tool for characterization of aortic atheromas, TEE is the imaging modality of choice. Currently, treatment of aortic atheromas is not well defined, and mixed outcomes have been reported for anticoagulation therapy with warfarin. Statins appear promising based on their plaque stabilization properties. However, there are no randomized control trials to establish the role of both anticoagulation and statins in patients with aortic atheromas, and are warranted in the future. [source] Industry sponsorship and selection of comparators in randomized clinical trialsEUROPEAN JOURNAL OF CLINICAL INVESTIGATION, Issue 2 2010D. N. Lathyris Eur J Clin Invest 2010; 40 (2): 172,182 Abstract Background, Most clinical trials on medical interventions are sponsored by the industry. The choice of comparators shapes the accumulated evidence. We aimed to assess how often major companies sponsor trials that involve only their own products. Methods, Studies were identified by searching ClinicalTrials.gov for trials registered in 2006. We focused on randomized trials involving the 15 companies that had sponsored the largest number of registered trials in ClinicalTrials.gov in that period. Results, Overall, 577 randomized trials were eligible for analysis and 82% had a single industry sponsor [89% (166/187) of the placebo-control trials, 87% (91/105) of trials comparing different doses or ways of administration of the same intervention, and 78% (221/285) of other active control trials]. The compared intervention(s) belonged to a single company in 67% of the trials (89%, 81% and 47% in the three categories respectively). All 15 companies strongly preferred to run trials where they were the only industry sponsor or even the only owner of the assessed interventions. Co-sponsorship typically reflected co-ownership of the same intervention by both companies. Head-to-head comparison of different active interventions developed by different companies occurred in only 18 trials with two or more industry sponsors. Conclusions, Each company generates a clinical research agenda that is strongly focused on its own products, while comparisons involving different interventions from different companies are uncommon. This diminishes the ability to understand the relative merits of different interventions for the same condition. [source] Effectiveness of interventions that assist caregivers to support people with dementia living in the community: a systematic reviewINTERNATIONAL JOURNAL OF EVIDENCE BASED HEALTHCARE, Issue 2 2008Deborah Parker BA, MSocSci Executive summary Objectives, The objective of this review was to assess the effectiveness of interventions that assist caregivers to provide support for people living with dementia in the community. Inclusion criteria, Types of participants, Adult caregivers who provide support for people with dementia living in the community (non-institutional care). Types of interventions, Interventions designed to support caregivers in their role such as skills training, education to assist in caring for a person living with dementia and support groups/programs. Interventions of formal approaches to care designed to support caregivers in their role, care planning, case management and specially designated members of the healthcare team , for example dementia nurse specialist or volunteers trained in caring for someone with dementia. Types of studies, This review considered any meta-analyses, systematic reviews, randomised control trials, quasi-experimental studies, cohort studies, case control studies and observational studies without control groups that addressed the effectiveness of interventions that assist caregivers to provide support for people living with dementia in the community. Search strategy, The search sought to identify published studies from 2000 to 2005 through the use of electronic databases. Only studies in English were considered for inclusion. The initial search was conducted of the databases, CINAHL, MEDLINE and PsychINFO using search strategies adapted from the Cochrane Dementia and Cognitive Improvement Group. A second more extensive search was then conducted using the appropriate Medical Subject Headings (MeSH) and keywords for other available databases. Finally, hand searching of reference lists of articles retrieved and of core dementia, geriatric and psycho geriatric journals was undertaken. Assessment of quality, Methodological quality of each of the articles was assessed by two independent reviewers using appraisal checklist developed by the Joanna Briggs Institute and based on the work of the Cochrane Collaboration and Centre for Reviews and Dissemination. Data collection and analysis, Standardised mean differences or weighted mean differences and their 95% confidence intervals were calculated for each included study reported in the meta-analysis. Results from comparable groups of studies were pooled in statistical meta-analysis using Review Manager Software from the Cochrane Collaboration. Heterogeneity between combined studies was tested using standard chi-square test. Where statistical pooling was not appropriate or possible, the findings are summarised in narrative form. Results, A comprehensive search of relevant databases, hand searching and cross referencing found 685 articles that were assessed for relevance to the review. Eighty-five papers appeared to meet the inclusion criteria based on title and abstract, and the full paper was retrieved. Of the 85 full papers reviewed, 40 were accepted for inclusion, three were systematic reviews, three were meta-analysis, and the remaining 34 were randomised controlled trials. For the randomised controlled trials that were able to be included in a meta-analysis, standardised mean differences or weighted mean differences and their 95% confidence intervals were calculated for each. Results from comparable groups of studies were pooled in statistical meta-analysis using Review Manager Software and heterogeneity between combined studies was assessed by using the chi-square test. Where statistical pooling was not appropriate or possible, the findings are summarised in narrative form. The results are discussed in two main sections. Firstly it was possible to assess the effectiveness of different types of caregiver interventions on the outcome categories of depression, health, subjective well-being, self-efficacy and burden. Secondly, results are reported by main outcome category. For each of these sections, meta-analysis was conducted where it was possible; otherwise, a narrative summary describes the findings. Effectiveness of intervention type, Four categories of intervention were included in the review , psycho-educational, support, multi-component and other. Psycho-educational Thirteen studies used psycho-educational interventions, and all but one showed positive results across a range of outcomes. Eight studies were entered in a meta-analysis. No significant impact of psycho-educational interventions was found for the outcome categories of subjective well-being, self-efficacy or health. However, small but significant results were found for the categories of depression and burden. Support Seven studies discussed support only interventions and two of these showed significant results. These two studies were suitable for meta-analysis and demonstrated a small but significant improvement on caregiver burden. Multi-component Twelve of the studies report multi-component interventions and 10 of these report significant outcomes across a broad range of outcome measures including self-efficacy, depression, subjective well-being and burden. Unfortunately because of the heterogeneity of study designs and outcome measures, no meta-analysis was possible. Other interventions Other interventions included the use of exercise or nutrition which resulted in improvements in psychological distress and health benefits. Case management and a computer aided support intervention provided mixed results. One cognitive behavioural therapy study reported a reduction in anxiety and positive impacts on patient behaviour. Effectiveness of interventions using specific outcome categories, In addition to analysis by type of intervention it was possible to analyse results based on some outcome categories that were used across the studies. In particular the impact of interventions on caregiver depression was available for meta-analysis from eight studies. This indicated that multi-component and psycho-educational interventions showed a small but significant positive effect on caregiver depression. Five studies using the outcome category of caregiver burden were entered into a meta-analysis and findings indicated that there were no significant effects of any of interventions. No meta-analysis was possible for the outcome categories of health, self-efficacy or subjective well-being. Implications for practice, From this review there is evidence to support the use of well-designed psycho-educational or multi-component interventions for caregivers of people with dementia who live in the community. Factors that appear to positively contribute to effective interventions are those which: ,,Provide opportunities within the intervention for the person with dementia as well as the caregiver to be involved ,,Encourage active participation in educational interventions for caregivers ,,Offer individualised programs rather than group sessions ,,Provide information on an ongoing basis, with specific information about services and coaching regarding their new role ,,Target the care recipient particularly by reduction in behaviours Factors which do not appear to have benefit in interventions are those which: ,,Simply refer caregivers to support groups ,,Only provide self help materials ,,Only offer peer support [source] What is the evidence for the use of probiotics in the treatment of inflammatory bowel disease?JOURNAL OF CLINICAL NURSING, Issue 7-8 2010Virginia A Cary Aims and objectives., The purpose of this article is to investigate the use of probiotics in the treatment of inflammatory bowel disease. Background., Probiotics have been successfully used to treat various acute illnesses such as Clostridium difficile infection, rotovirus diarrhoea and traveller's diarrhoea. Recently, some studies have reported success with probiotics in the treatment of chronic intestinal diseases such as inflammatory bowel disease. Design., Literature review. Methods., A literature search was performed to include studies on Bifidobacteria -fermented milk, Escherichia coli, Lactobacillus, Saccharomyces boulardii, VSL #3 and probiotic use. Results of the literature are analysed, and a discussion is made regarding evaluation of the literature and implications for care. Results., The majority of probiotics studied have proven to have beneficial effects in the treatment of inflammatory bowel disease, especially when taken as a dietary adjunctive to standard treatment. All probiotics studied, with the exception of Lactobacillus GG and LA1, demonstrated positive results. Conclusions., The increasing use of probiotics combined with the insufficient knowledge regarding the use of probiotics in treating inflammatory bowel disease requires that future multilevel, multicentre large randomised control trials be conducted to understand better the specific measures and effectiveness of such treatment. Relevance to clinical practice., Given that few clinical trials exist to study the potential role of probiotics in the treatment of inflammatory bowel disease, it is imperative that healthcare providers become knowledgeable about the use of probiotics and their effects on inflammatory bowel disease. [source] A systematic review of the effectiveness of cutaneous warming systems to prevent hypothermiaJOURNAL OF CLINICAL NURSING, Issue 5 2009Cristina M Galvão Aims., To retrieve and critique recent randomised trials of cutaneous warming systems used to prevent hypothermia in surgical patients during the intraoperative period and to identify gaps in current evidence and make recommendations for future trials. Background., Hypothermia affects up to 70% of anaesthetised surgical patients and is associated with several significant negative health outcomes. Design., Systematic review using integrative methods. Methods., We searched CINAHL, EMBASE, Cochrane Register of Controlled Trials and Medline databases (January 2000,April 2007) for recent reports on randomised controlled trials of cutaneous warming systems used with elective patients during the intraoperative period. Inclusion criteria., We included randomised control trials examining the effects of cutaneous warming systems used intraoperatively on patients aged 18 years or older undergoing non-emergency surgery. Studies published in English, Spanish or Portuguese with a comparison group that consisted of either usual care or active cutaneous warming systems without prewarming were reviewed. Results., Of 193 papers initially identified, 14 studies met the inclusion criteria. There was moderate evidence to indicate that carbon-fibre blankets and forced-air warming systems are equally effective and that circulating-water garments are most effective for maintaining normothermia during the intraoperative period. Few trials reported costs. Conclusions., Carbon-fibre blankets and forced-air warming systems are effective and circulating-water garments may be preferable. Future research should measure the direct and indirect costs associated with competing systems. Relevance to clinical practice., Nurses can use this review to inform their selection of warming interventions in perioperative nursing practice. They can also assess other factors such as nursing workload, staff training and equipment maintenance, which should be incorporated into future research. [source] The effectiveness of silver-releasing dressings in the management of non-healing chronic wounds: a meta-analysisJOURNAL OF CLINICAL NURSING, Issue 5 2009Shu-Fen Lo Aim., The purpose of this study was to examine the efficacy of silver-releasing dressings in the management of non-healing chronic wounds. Background., Non-healing chronic wounds often have a negative physical impact on patients and place a financial burden on healthcare systems. Silver dressings are wound products designed to control infection and provide a wound environment conducive to healing. However, validation of the clinical efficacy of these dressings is lacking. Design., Systematic review and meta-analysis. Methods., A systematic search of the major electronic databases PubMed, CINAHL, Cochrane, MEDLINE, British Nursing Index, EBSCO, OCLC and Proquest between 1950,June 2007 was conducted. Hand searches of selected periodicals, textbooks and checking reference lists and contacting experts was also performed. Results., Eight studies were selected from a potentially relevant 1957 references screened. Analysis incorporated data from 1399 participants in the eight randomised control trials. We found that silver dressings significantly improved wound healing (CI95: 0·16,0·39, p < 0·001), reduced odour (CI95: 0·24,0·52, p < 0·001) and pain-related symptoms (CI95: 0·18,0·47, p < 0·001), decreased wound exudates (CI95: 0·17,0·44, p < 0·001) and had a prolonged dressing wear time (CI95: 0·19,0·48, p = 0·028) when compared with alternative wound management approaches. An analysis of sensitivity in these studies by subgroup analysis generally supported these associations. Furthermore, studies indicated an improvement in quality of life (CI95: 0·04,0·33, p = 0·013) using silver dressings in wound management with no associated severe adverse events. Conclusion., This meta-analysis confirms the effectiveness of silver dressings in wound healing and improving patients' quality of life. However, it also highlights the need for additional well-designed randomised controlled trials to evaluate the effectiveness of silver-related dressings further. Relevance to clinical practice., The results of this study provide objective data on the effectiveness of silver-related dressing when applied to non-healing chronic wounds. [source] Systematic review on the effectiveness of caffeine abstinence on the quality of sleepJOURNAL OF CLINICAL NURSING, Issue 1 2009Celia WM Sin Aim., The aim of the present study is to review the effects of caffeine abstinence on the quality of sleep. Background., Insomnia is a common problem and abstinence from caffeine is the most popular component in sleep hygiene advice. However, there have been inconsistent results relating to the effectiveness of caffeine abstinence in improving sleep. Design., Systematic review. Methods., We browsed several electronic databases and reference lists of articles about the correlation of caffeine consumption and sleep deprivation. We selected the articles according to predefined inclusion and exclusion criteria. Two reviewers assessed the quality of trials, which were selected according to the Jadad quality assessment scale. We included the trials scoring three or above in the systematic review and extracted their data. We assessed the heterogeneity of the studies before we considered whether or not to combine the studies' results. Results., Three randomised control trials fulfilled the selection criteria among which two trials scored ,3 on the Jadad scale. We included these two trials in our systematic review. The designs and outcome measurements of these two trials were not homogeneous, therefore, we did not combine their results. Instead, we conducted a critical appraisal. In one trial, caffeine abstinence was associated with significant lengthening of sleep duration (p < 0·01) and better sleep quality (p < 0·05). In another trial, subjects had less difficulty falling asleep on days when they drank decaffeinated coffee (p < 0·05). Conclusions., The results showed that caffeine abstinence for a whole day could improve sleep quality. Thus, health practitioners were recommended to include caffeine abstinence in the instructions for sleep hygiene. Relevance to clinical practice., This study demonstrates the effectiveness of caffeine abstinence in improving sleep quality. It provides evidence for the practice of including caffeine abstinence in sleep hygiene advice. [source] Atrial fibrillation: insights from clinical trials and novel treatment optionsJOURNAL OF INTERNAL MEDICINE, Issue 6 2007Y. Blaauw Abstract., Blaauw Y, Crijns HJGM (University Hospital Maastricht, Maastricht, The Netherlands). Atrial fibrillation: insights from clinical trials and novel treatment options (Review). J Intern Med 2007; 262: 593,614. Atrial fibrillation (AF) is the most common encountered sustained arrhythmia in clinical practice. The last decade the result of large ,rate' versus ,rhythm' control trials have been published that have changed the current day practise of AF treatment. It has become clear that rate control is at least equally effective as a rhythm control strategy in ameliorating morbidity as well as mortality. Moreover, in each individual patient the risk of thromboembolic events should be assessed and antithrombotic treatment be initiated. There have also been great advances in understanding the mechanisms of AF. Experimental studies showed that as a result of electrical and structural remodelling of the atria, ,AF begets AF'. Pharmacological prevention of atrial electrical remodelling has been troublesome, but it seems that blockers of the renin angiotensin system, and perhaps statins, may reduce atrial structural remodelling by preventing atrial fibrosis. Clinical studies demonstrated that the pulmonary veins exhibit foci that can act as initiator and perpetuator of the arrhythmia. Isolation of the pulmonary veins using radiofrequency catheter ablation usually abolishes AF. The most promising advances in the pharmacological treatment of AF include atrial specific antiarrhythmic drugs and direct thrombin inhibitors. In the present review we will describe the results of recent experimental studies, discuss the latest clinical trials, and we will focus on novel treatment modalities. [source] On the evolution of statistical methods as applied to clinical trialsJOURNAL OF INTERNAL MEDICINE, Issue 5 2004D. Machin Abstract. This paper describes how statistical methods have evolved in parallel with activities associated with randomized control trials. In particular we emphasize the pivotal role of two papers published in British Journal of Cancer, and the paper describing the Cox proportional hazards model. In addition, the importance of early papers on estimating the sample size required for trials is highlighted. Later developments including the increasing roles for competing risks, multilevel modelling and Bayesian methodologies are described. The interplay between computer software and statistical methodological developments is stressed. Finally some future directions are indicated. [source] Use of activated protein c in liver transplantation patients with septic shock,LIVER TRANSPLANTATION, Issue 11 2008Laura Rinaldi Recombinant human activated protein C (rhAPC) has been approved for use in patients with severe sepsis at high risk of death. Because of the high risk of bleeding, liver transplantation (LT) patients have been excluded from the randomized control trials that evaluated efficacy and safety of rhAPC and, thus, few data are available on the use of this drug in LT patients with severe sepsis. We describe our experience with 5 LT recipients treated for septic shock with the best conventional therapy and rhAPC. Before rhAPC therapy, all the patients showed septic shock, with ,3 organ dysfunctions and thrombocytopenia with impairment of coagulation. rhAPC therapy started within 30 hours after septic shock onset in all the patients who recovered from sepsis-induced circulatory failure, improved organ dysfunction, and completed the 96 hours of rhAPC therapy. During rhAPC infusion, 4 patients received fresh frozen plasma and/or platelet concentrates because of thrombocytopenia and severe hemostasis dysfunction. No major bleeding occurred and only 1 patient presented with minor bleeding events. Liver Transpl 14:1598,1602, 2008. © 2008 AASLD. [source] Transcranial magnetic stimulation for the deficit syndrome of schizophrenia: A pilot investigationPSYCHIATRY AND CLINICAL NEUROSCIENCES, Issue 3 2005PERMINDER SACHDEV md, franzcp Abstract, In an open study, four subjects with a stable deficit syndrome of schizophrenia received high frequency repetitive transcranial magnetic stimulation (15 Hz at 90% of motor threshold, 1800 pulses each session, daily for 20 sessions over 4 weeks) over the left dorsolateral prefrontal cortex. Subjects showed a significant reduction in negative symptoms and improvement in function, with no change in positive symptoms. This improvement was maintained at the 1 month follow up. Repetitive transcranial magnetic stimulation as a treatment of the deficit syndrome of schizophrenia is feasible, safe and may be beneficial. A systematic study in randomized control trials would be appropriate. [source] The effect of ranitidine versus proton pump inhibitors on gastric secretions: a meta-analysis of randomised control trialsANAESTHESIA, Issue 6 2009K. Clark Summary Aspiration of acid into the lungs is an infrequent but potentially devastating complication of general anaesthesia. Routine practice often includes use of pharmacological agents to reduce gastric volume and increase gastric pH. The aim of this study was to compare the net benefit of proton pump inhibitors with histamine 2 blockers in a meta-analysis. Electronic databases were searched for trials that compared ranitidine vs proton pump inhibitors in their effect on volume and pH of gastric fluid aspirates. We identified nine trials of which seven were suitable for meta-analysis. Pooled outcomes suggest that premedication with ranitidine is more effective than proton pump inhibitors in reducing the volume of gastric secretions (by an average of 0.22 ml.kg,1; 95% confidence interval 0.04,0.41) and increasing gastric pH (by an average of 0.85 pH units; 95% confidence interval ,1.14 to ,0.28). [source] Vernal keratoconjunctivitis: a major reviewACTA OPHTHALMOLOGICA, Issue 2 2009Sunil Kumar Abstract. Vernal keratoconjunctivitis (VKC) is a chronic, bilateral, at times asymmetrical, seasonally exacerbated, allergic inflammation of the ocular surface, involving tarsal and/or bulbar conjunctiva. Though the allergic nature of this entity has been accepted for a long time, the accumulation of a large amount of immunological data has proved that the pathogenesis of VKC is much more complex than a mere type 1 hypersensitivity reaction. In the past several years, many clinical and experimental studies about the cells and mediators involved in initiating and perpetuating the ocular allergic inflammation have shown that T helper type 2 cells and their cytokines, corneal fibroblasts and epithelium along with various growth factors play an important role in the pathogenesis of VKC. Based on this information about the pathogenesis of VKC newer, more selective drugs like anti-chemokine receptor antibodies and leukotriene receptor antagonists are under evaluation. Cyclosporine has been shown to be effective in the treatment of VKC but further randomized control trials are required to establish the minimum effective concentration. [source] Australian Cancer Network Clinical Practice Guidelines for the Management of ocular and periocular Melanoma: an evidence-based literature analysisCLINICAL & EXPERIMENTAL OPHTHALMOLOGY, Issue 7 2008Simon E Skalicky MBBS Abstract Background:, With recent advances in the diagnosis and management of ocular and periocular melanoma, many of which are based on results from randomized control trials, there is an increasing need for an evidence-based review of the literature for the Australasian population. The Australian Cancer Network has recently redeveloped the evidence-based Clinical Practice Guidelines for the Management of Melanoma, including a chapter on ocular melanoma. These are the first evidence-based guidelines on ocular melanoma to be created by the Australian Cancer Network. Methods:, The primary research questions were formed and a detailed literature search was undertaken. Each relevant article was assessed and graded I,IV according to the level of evidence. Articles were grouped into bodies of evidence which were then assessed. Results:, A total of 107 relevant articles were identified and grouped into 12 bodies of evidence. Guidelines based on this analysis were formulated and graded. These are presented below. Conclusions:, The management of ocular melanoma has benefited from recent advances in imaging, molecular biology and cytogenetics, and tumours today are detected earlier and with greater accuracy than 25 years ago. With improved treatment ocular and periocular melanomas can be controlled locally, with good preservation of vision in many patients. However, there remains no cure for metastatic disease. [source] Trends in neonatology and pediatrics publications over the past 12 yearsACTA PAEDIATRICA, Issue 7 2007Amir Ben Tov Abstract Objective: To test the hypothesis that the number of publications in Neonatology and Pediatrics increases over time, and to verify whether the categories of publications all follow the same pattern over time. Design and setting: We evaluated all Medline articles during 1994,2005. Search was limited to humans, English and to ,newborn' or ,all-child'. We used regression analysis to determine the effect of year-of-publication upon the number-of-publications of each type. Results: Medline reported 36,141 publications in Neonatology and 169,823 in Pediatrics during the evaluation period. There was a significant linear increase in the number of publications in Neonatology and Pediatrics. There was a steady increase over time in Neonatology and in Pediatrics in meta-analyses, reviews and editorials. There was a steady decrease over time in letters in Neonatology, but no significant change in letters in Pediatrics. While there was no significant change in clinical trials (CTs), randomized control trials (RCTs) in Neonatology, there was a significant increase in CTs and RCTs in Pediatrics. Conclusions: The field of neonatology has not had a significant yearly increase of original studies, but has seen an increase of reviews, meta-analyses and editorials. This contrasts with Pediatrics, which shows a similar increase in reviews, meta-analyses and editorials, but also an increase in the number of CTs and RCTs and guidelines. [source] | ||||||||||||||||||||||