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Controlled Trials (controlled + trials)
Kinds of Controlled Trials Terms modified by Controlled Trials Selected AbstractsNo evidence for switching the antidepressant: systematic review and meta-analysis of RCTs of a common therapeutic strategyACTA PSYCHIATRICA SCANDINAVICA, Issue 3 2010T. Bschor Bschor T, Baethge C. No evidence for switching the antidepressant: systematic review and meta-analysis of RCTs of a common therapeutic strategy. Objective:, Switching antidepressants is a common strategy for managing treatment-resistant depressed patients. However, no systematic reviews have been conducted to date. Method:, We systematically searched MEDLINE/EMBASE/Cochrane Central Register of Controlled Trials and additional sources. We included double-blind studies of patients with depressive symptomatology who were not responding to initial antidepressant monotherapy and were subsequently randomized to another antidepressant or to continue the same antidepressant. Results were pooled for meta-analysis of response + remission rates using a fixed-effects model. Results:, A total of three studies were included. Switching to another antidepressant was not superior to continuing the initial antidepressant in any of these studies. Our meta-analysis showed no significant advantages to either strategy and no significant heterogeneity of results [OR for response rates: 0.85 (95% CI: 0.55,1.30) favoring continuing]. Conclusion:, There is a discrepancy between the published evidence and the frequent decision to switch antidepressants, indicating an urgent need for more controlled studies. Pending such studies we recommend that physicians rely on more thoroughly evaluated strategies. [source] Behavioral intervention to promote smoking cessation and prevent weight gain: a systematic review and meta-analysisADDICTION, Issue 9 2009Bonnie Spring ABSTRACT Aims The prospect of weight gain discourages many cigarette smokers from quitting. Practice guidelines offer varied advice about managing weight gain after quitting smoking, but no systematic review and meta-analysis have been available. We reviewed evidence to determine whether behavioral weight control intervention compromises smoking cessation attempts, and if it offers an effective way to reduce post-cessation weight gain. Methods We identified randomized controlled trials (RCTs) that compared combined smoking treatment and behavioral weight control to smoking treatment alone for adult smokers. English-language studies were identified through searches of PubMed, Ovid MEDLINE, CINAHL, EMBASE, PsycINFO and Cochrane Central Register of Controlled Trials. Of 779 articles identified and 35 potentially relevant RCTs screened, 10 met the criteria and were included in the meta-analysis. Results Patients who received both smoking treatment and weight treatment showed increased abstinence [odds ratio (OR) = 1.29, 95% confidence interval (CI) = 1.01, 1.64] and reduced weight gain (g = ,0.30, 95% CI = ,0.57, ,0.02) in the short term (<3 months) compared with patients who received smoking treatment alone. Differences in abstinence (OR = 1.23, 95% CI = 0.85, 1.79) and weight control (g = ,0.17, 95% CI = ,0.42, 0.07) were no longer significant in the long term (>6 months). Conclusions Findings provide no evidence that combining smoking treatment and behavioral weight control produces any harm and significant evidence of short-term benefit for both abstinence and weight control. However, the absence of long-term enhancement of either smoking cessation or weight control by the time-limited interventions studied to date provides insufficient basis to recommend societal expenditures on weight gain prevention treatment for patients who are quitting smoking. [source] Antiepileptogenesis and Seizure Prevention Trials with Antiepileptic Drugs: Meta-Analysis of Controlled TrialsEPILEPSIA, Issue 4 2001Nancy R. Temkin Summary: ,Purpose: To synthesize evidence concerning the effect of antiepileptic drugs (AEDs) for seizure prevention and to contrast their effectiveness for provoked versus unprovoked seizures. Methods: Medline, Embase, and The Cochrane Clinical Trials Register were the primary sources of trials, but all trials found were included. Minimal requirements: seizure-prevention outcome given as fraction of cases; AED or control assigned by random or quasi-random mechanism. Single abstracter. Aggregate relative risk and heterogeneity evaluated using Mantel,Haenszel analyses; random effects model used if heterogeneity was significant. Results: Forty-seven trials evaluated seven drugs or combinations for preventing seizures associated with fever, alcohol, malaria, perinatal asphyxia, contrast media, tumors, craniotomy, and traumatic brain injury. Effective: Phenobarbital for recurrence of febrile seizures [relative risk (RR), 0.51; 95% confidence interval (CI), 0.32,0.82) and cerebral malaria (RR, 0.36; CI, 0.23,0.56). Diazepam for contrast media,associated seizures (RR, 0.10; CI, 0.01,0.79). Phenytoin for provoked seizures after craniotomy or traumatic brain injury (craniotomy: RR, 0.42; CI, 0.25,0.71; TBI: RR, 0.33; CI, 0.19,0.59). Carbamazepine for provoked seizures after traumatic brain injury (RR, 0.39; CI, 0.17,0.92). Lorazepam for alcohol-related seizures (RR, 0.12; CI, 0.04,0.40). More than 25% reduction ruled out valproate for unprovoked seizures after traumatic brain injury (RR, 1.28; CI, 0.76,2.16), and carbamazepine for unprovoked seizures after craniotomy (RR, 1.30; CI, 0.75,2.25). Conclusions: Effective or promising results predominate for provoked (acute, symptomatic) seizures. For unprovoked (epileptic) seizures, no drug has been shown to be effective, and some have had a clinically important effect ruled out. [source] Quality-of-Life and Behavioral Outcome Measures in Randomized Controlled Trials of Antiepileptic Drugs: A Systematic Review of Methodology and Reporting StandardsEPILEPSIA, Issue 11 2000Gus A. Baker Summary: Purpose: To review the methodology and use of quality-of-life and behavioral measures used in randomized controlled trials (RCTs) of antiepileptic drugs in patients with epilepsy. Methods: Trial reports were found by searching a previously developed comprehensive database of epilepsy RCTs and searching through journals by hand. Inclusion and exclusion criteria were applied, and methodological and quality-of-life and behavioral measure data were extracted. Results: There were 52 different measures used in 46 trials, with the Profile of Mood States, the Minnesota Multiphasic Personality Inventory, and the Washington Psychosocial Seizure Inventory being applied the most frequently. Overall, evidence of the reliability, validity, and sensitivity of measures used in populations of people with epilepsy was sparse. There was also little information on the clinical interpretation of the results. Conclusion: Our results highlight a consistent failure to apply quality-of-life and behavioral measures in RCTs in a systematic way. We found repeated evidence of researchers' failure to review the use of previous measures and selection of measures without evidence of their appropriateness for use in a population with epilepsy. We recommend the use of quality-of-life and behavioral measures in RCTs with proven psychometric properties in a population with epilepsy. [source] EFNS guideline on the treatment of cerebral venous and sinus thrombosisEUROPEAN JOURNAL OF NEUROLOGY, Issue 6 2006K. Einhäupl Cerebral venous and sinus thrombosis (CVST) is a rather rare disease which accounts for <1% of all strokes. Diagnosis is still frequently overlooked or delayed due to the wide spectrum of clinical symptoms and the often subacute or lingering onset. Current therapeutic measures which are used in clinical practice include the use of anticoagulants such as dose-adjusted intravenous heparin or body weight-adjusted subcutaneous low-molecular-weight heparin (LMWH), the use of thrombolysis, and symptomatic therapy including control of seizures and elevated intracranial pressure. We searched MEDLINE (National Library of Medicine), the Cochrane Central Register of Controlled Trials (CENTRAL) and the Cochrane Library to review the strength of evidence to support these interventions and the preparation of recommendations on the therapy of CVST based on the best available evidence. Review articles and book chapters were also included. Recommendations were reached by consensus. Where there was a lack of evidence, but consensus was clear we stated our opinion as good practice points. Patients with CVST without contraindications for anticoagulation should be treated either with body weight-adjusted subcutaneous LMWH or dose-adjusted intravenous heparin (good practice point). Concomitant intracranial haemorrhage related to CVST is not a contraindication for heparin therapy. The optimal duration of oral anticoagulation after the acute phase is unclear. Oral anticoagulation may be given for 3 months if CVST was secondary to a transient risk factor, for 6,12 months in patients with idiopathic CVST and in those with ,mild' hereditary thrombophilia. Indefinite anticoagulation (AC) should be considered in patients with two or more episodes of CVST and in those with one episode of CVST and ,severe' hereditary thrombophilia (good practice point). There is insufficient evidence to support the use of either systemic or local thrombolysis in patients with CVST. If patients deteriorate despite adequate anticoagulation and other causes of deterioration have been ruled out, thrombolysis may be a therapeutic option in selected cases, possibly in those without intracranial haemorrhage (good practice point). There are no controlled data about the risks and benefits of certain therapeutic measures to reduce an elevated intracranial pressure (with brain displacement) in patients with severe CVST. Antioedema treatment (including hyperventilation, osmotic diuretics and craniectomy) should be used as life saving interventions (good practice point). [source] The management of dyslipidaemias in antiretroviral-treated HIV infection: a systematic reviewHIV MEDICINE, Issue 6 2007C McGoldrick Objectives The aim of the study was to assess the currently available evidence concerning the management of dyslipidaemias in HIV-infected individuals treated with antiretroviral therapy. Methods Randomized trials, published within the 5 years preceding 5 October 2005, were identified in PubMed Medline, Embase, and The Cochrane Central Register of Controlled Trials. Studies were then included or excluded, dependent on their meeting inclusion/exclusion criteria. The evidence obtained in the studies that were included was assessed using methods employed by the Scottish Intercollegiate Guidelines Network (SIGN). Results Thirteen relevant trials were identified, concerning the use of statins, fibrates, antiretroviral drug switches and insulin-sensitizing drugs. Most contained small numbers of trial participants. Conclusions Most studies suggested beneficial effects and satisfactory safety profiles for the interventions studied. However, the insulin-sensitizing drug rosiglitazone appeared to have some detrimental effects on lipid profiles. With the small numbers of participants in the majority of studies, these studies were likely to have been inadequately powered to assess the effects of the interventions examined. Larger trials are therefore necessary. [source] Preoperative chemoradiation versus radiation alone for stage II and III resectable rectal cancer: A systematic review and meta-analysisINTERNATIONAL JOURNAL OF CANCER, Issue 12 2009Wim Ceelen Abstract Combining chemotherapy with preoperative radiotherapy (RT) has a sound radiobiological rationale. We performed a systematic review and meta-analysis of trials comparing preoperative RT with preoperative chemoradiation (CRT) in rectal cancer patients. The Cochrane Central Register of Controlled Trials, Web of Science, Embase and Medline (Pubmed) were searched from 1975 until June 2007. Dichotomous parameters were summarized using the odds ratio while time to event data were analyzed using the pooled hazard ratio for death. From the primary search result of 324 trials, 4 relevant randomized trials were identified. The addition of chemotherapy significantly increased grade III and IV acute toxicity (p = 0.002) while no differences were observed in postoperative morbidity or mortality. Preoperative CRT significantly increased the rate of pathological complete response (p < 0.001) although this did not translate into a higher sphincter preservation rate (p = 0.29). The local recurrence rate was significantly lower in the CRT group (p < 0.001). No statistically significant differences were observed in disease free survival (p = 0.89) or overall survival (p = 0.79). Compared to preoperative RT alone, preoperative CRT improves local control in rectal cancer but is associated with a more pronounced treatment related toxicity. The addition of chemotherapy does not benefit sphincter preservation rate or long-term survival. Future trials should address improvements in the rate of distant metastasis and overall survival by incorporating more active chemotherapy. © 2008 UICC [source] Are obsessive-compulsive personality traits associated with a poor outcome in anorexia nervosa?INTERNATIONAL JOURNAL OF EATING DISORDERS, Issue 7 2007A systematic review of randomized controlled trials, naturalistic outcome studies Abstract Objective: Obsessive-compulsive personality disorder (OCPD) traits are commonly associated with anorexia nervosa (AN). The aim of this review was to systematically search the literature to examine whether OCPD traits have an impact on the outcome of AN. Method: A systematic electronic search of the literature (using Medline, PsycINFO, and the Cochrane Central Register of Controlled Trials) was undertaken to identify relevant publications (randomized controlled trials (RCT's) and naturalistic studies), until February 2006. Results: Eleven prospective longitudinal studies and 12 RCT's met criteria for inclusion. A meta-analysis was not feasible as the studies were too heterogeneous. Just over half of published longitudinal studies found that OCPD traits were associated with a negative outcome in AN. Additionally, results from three RCTs suggested that these traits may moderate outcome. OCPD traits were reduced after treatment in five RCTs. Conclusion: There is tentative support to suggest that individuals with AN and concomitant OCPD traits have a poorer prognosis, and that these traits moderate outcome. A reduction in these traits may mediate this change. An individualized case formulation with treatment tailored to OCPD traits may improve the outcome of AN. © 2007 by Wiley Periodicals, Inc. [source] Heart failure self-management education: a systematic review of the evidenceINTERNATIONAL JOURNAL OF EVIDENCE BASED HEALTHCARE, Issue 3 2009Suzanne Austin Boren PhD MHA Abstract Objective, The objective of this systematic review is to identify educational content and techniques that lead to successful patient self-management and improved outcomes in congestive heart failure education programs. Methods, MEDLINE, CINAHL and the Cochrane Central Register of Controlled Trials, as well as reference lists of included studies and relevant reviews, were searched. Eligible studies were randomised controlled trials evaluating congestive heart failure self-management education programs with outcome measures. Two of the investigators independently abstracted descriptive information, education content topics and outcomes data. Results, A total of 7413 patients participated in the 35 eligible congestive heart failure self-management education studies. The congestive heart failure self-management programs incorporated 20 education topics in four categories: (i) knowledge and self-management (diagnosis and prognosis, pathophysiology of how congestive heart failure affects the body, aims of treatment, management and symptoms, medication review and discussion of side-effects, knowing when to access/call the general practitioner, communication with the physician, follow up for assessment or reinforcement); (ii) social interaction and support (social interaction and support, stress, depression); (iii) fluids management (sodium restriction, fluid balance, daily measurement of weight, ankle circumference, self-monitoring and compliance relative to fluids); and (iv) diet and activity (dietary assessment and instructions, physical activity and exercise, alcohol intake, smoking cessation). A total of 113 unique outcomes in nine categories (satisfaction, learning, behaviour, medications, clinical status, social functioning, mortality, medical resource utilisation and cost) were measured in the studies. Sixty (53%) of the outcomes showed significant improvement in at least one study. Conclusion, Educational interventions should be based on scientifically sound research evidence. The education topic list developed in this review can be used by patients and clinicians to prioritise and personalise education. [source] Prophylactic steroids for paediatric open-heart surgery: a systematic reviewINTERNATIONAL JOURNAL OF EVIDENCE BASED HEALTHCARE, Issue 4 2008Suzi Robertson-Malt BHSc PhD Background, The immune response to cardiopulmonary bypass in infants and children can lead to a series of post-operative morbidities and mortality, that is, hemodynamic instability, increased infection and tachyarrhythmias. Administration of prophylactic doses of corticosteroids is sometimes used to try and ameliorate this pro-inflammatory response. However, the clinical benefits and harms of this type of intervention in the paediatric patient remain unclear. Objectives, To systematically review the beneficial and harmful effects of the prophylactic administration of corticosteroids, compared with placebo, in paediatric open-heart surgery. Search strategy, The trials registry of the Cochrane Heart Group, the Cochrane Central Register of Controlled Trials in The Cochrane Library (Issue 4, 2006), MEDLINE (1966 to January 2007), EMBASE (1980 to January 2007) were searched. An additional hand-search of the EMRO database for Arabic literature was performed. Grey literature was searched, and experts in the field were contacted for any unpublished material. No language restrictions were applied. Selection criteria, All randomised and quasi-randomised controlled trials of open-heart surgery in the paediatric population that received corticosteroids pre-, peri- or post-operatively, with reported clinical outcomes in terms of morbidity and mortality. Data collection and analysis, Eligible studies were abstracted and evaluated by two independent reviewers. All meta-analyses were completed using RevMan4.2.8. Weighted mean difference (WMD) was the primary summary statistic with data pooled using a random-effects model. Main results, All cause mortality could not be assessed as the data reports were incomplete. There was weak evidence in favour of prophylactic corticosteroid administration for reducing intensive care unit stay, peak core temperature and duration of ventilation (WMD (95% confidence intervals) ,0.50 h (,1.41 to 0.41); ,0.20°C (,1.16 to 0.77) and ,0.63 h (,4.02 to 2.75) respectively). [source] Effectiveness of cutaneous warming systems on temperature control: meta-analysisJOURNAL OF ADVANCED NURSING, Issue 6 2010Cristina Maria Galvão galvão c.m., liang y. & clark a.m. (2010) Effectiveness of cutaneous warming systems on temperature control: meta-analysis. Journal of Advanced Nursing,66(6), 1196,1206. Abstract Title.,Effectiveness of cutaneous warming systems on temperature control: meta-analysis. Aim., This paper is a report of a meta-analysis to identify the effectiveness of different types of cutaneous warming systems in temperature control for patients undergoing elective surgery. Background., Hypothermia is a common and serious complication of surgery. Different cutaneous warming systems are used to prevent hypothermia during surgery but there have been no previous meta-analyses of the effectiveness of different warming systems in controlling temperature. Data sources., We conducted a search of the CINAHL (2000 to April 2009), Medline (2000 to April 2009), Embase (2000 to April 2009) and the Cochrane Register of Controlled Trials (2000 to April 2009) databases for randomized controlled trials published in English, Spanish and Portuguese. The primary outcome measure of interest was core body temperature. Methods., A systematic review incorporating meta-analysis was carried out. Results., From 329 papers, 23 trials compared warming systems. Forced-air warming systems had a strong tendency towards superior temperature control over passive insulation via cotton blankets (mean difference: 0·29°C; 95% confidence interval: ,0·02 to 0·59, three trials 292 patients) and radiant warming systems (mean difference: 0·16°C; 95% confidence interval: ,0·01 to 0·33, three trials, 161 patients). However, circulating water garments tended to be more effective than forced-air warming systems (mean difference: ,0·73°C; 95% confidence interval: ,1·51 to 0·05, I2 = 97%; four trials, 198 patients). Pooled results approached statistical significance and indicated clinically meaningful differences in temperature control. Conclusion., Current evidence suggests that circulating water garments offer better temperature control than forced-air warming systems, and both are more effective than passive warming devices. [source] Preoperative Intra-Aortic Balloon Pump in Patients Undergoing Coronary Bypass Surgery: A Systematic Review and Meta-AnalysisJOURNAL OF CARDIAC SURGERY, Issue 1 2008Adel M. Dyub M.D., M.Sc. The primary outcome was hospital mortality and secondary outcomes were IABP-related complications (bleeding, leg ischemia, aortic dissection). Methods: MEDLINE, EMBASE, Cochrane registry of Controlled Trials, and reference lists of relevant articles were searched. We included randomized controlled trials (RCTs), and cohort studies that fulfilled our a priori inclusion criteria. Eligibility decisions, relevance, study validity, and data extraction were performed in duplicate using pre-specified criteria. Meta-analysis was conducted using a random effects model. Results: Ten publications fulfilled our eligibility criteria, of which four were RCTs and six were cohort studies with controls. There were statistical as well as clinical heterogeneity among included studies. A total of 1034 patients received preoperative IABP and 1329 did not receive preoperative IABP. The pooled odds ratio (OR) for hospital mortality in patients treated with preoperative IABP was 0.41 (95% CI, 0.21,0.82, p = 0.01). The number needed to treat was 17. The pooled OR for hospital mortality from randomized trials was 0.18 (95% CI, 0.06,0.57, p = 0.003) and from cohort studies was 0.54 (95% CI, 0.24,1.2, p = 0.13). Overall, 3.7% (13 of 349) of patients who received preoperative IABP developed either limb ischemia or haematoma at the IABP insertion site, and most of these complications improved after discontinuation of IABP. Conclusion: Evidence from this meta-analysis support the use of preoperative IABP in high-risk patients to reduce hospital mortality. [source] A systematic review of prophylactic antimicrobials in PEG placementJOURNAL OF CLINICAL NURSING, Issue 7 2009Allyson Lipp Aim., To establish whether prophylactic systemic antimicrobials reduce the risk of peristomal infection in placement of percutaneous endoscopic gastrostomies. Background., Percutaneous endoscopic gastrostomies, placed surgically through the anterior abdominal wall, maintain nutrition in the short or long term. Those undergoing percutaneous endoscopic gastrostomy placement are often vulnerable to infection. The increasing incidence of methicillin-resistant Staphylococcus aureus contributes an additional risk to the debate surrounding antibiotic prophylaxis. The aim of antimicrobial prophylaxis is to establish a bactericidal concentration of an antimicrobial drug in the patient, during placement. Design., Systematic review. Methods., We searched the Cochrane Wounds Group Specialised Register (July 2006); The Cochrane Central Register of Controlled Trials (The Cochrane Library 2006, Issue 2); handsearched wound care journals, relevant conference proceedings and bibliographies of publications identified, and contacted manufacturers and distributors of percutaneous endoscopic gastrostomy products. Randomised controlled trials were selected evaluating the use of prophylactic antimicrobials for percutaneous endoscopic gastrostomy placement, with no restrictions for language, date or publication status. Both authors performed data extraction and assessment of study quality. Meta-analysis was performed where appropriate. Results., Ten eligible randomised controlled trials were identified evaluating prophylactic antimicrobials in 1100 patients. All trials reported peristomal infection as an outcome and a pooled analysis resulted in a statistically significant reduction in the incidence of peristomal infection with prophylactic antibiotics (pooled OR 0·31, 95% CI 0·22,0·44). The relative reduction in risk of infection for those given antibiotics was 19% with the need to treat 5·8 patients to prevent one infection , NNT. Conclusions., Administration of systemic prophylactic antibiotics for percutaneous endoscopic gastrostomy placement reduces peristomal infection. Relevance to clinical practice., The nurse's role in endoscopy is expanding rapidly and demands that practice is based on the best available evidence. This systematic review seeks to make a contribution to best practice in percutaneous endoscopic gastrostomy placement. [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] 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] Improving the quality of reporting acupuncture interventions: describing the collaboration between STRICTA, CONSORT and the Chinese Cochrane CentreJOURNAL OF EVIDENCE BASED MEDICINE, Issue 1 2009Hugh MacPherson Background First published in 2001, STRICTA (STandards for Reporting Interventions in Controlled Trials of Acupuncture) was designed to expand on the reporting of one item within the CONSORT (Consolidated Standards of Reporting Trials) Statement checklist, the item relating to the intervention. Two recent reviews had found that STRICTA was highly regarded in the field and that there was a need for minor revisions. Objective To revise STRICTA within the CONSORT family of reporting guidelines. Design A collaborative effort involving the STRICTA Group, the CONSORT Group and the Chinese Cochrane Centre was agreed. A consultation process with 47 international experts provided detailed feedback on an initial draft of a revised checklist. These data, along with the two review studies, comprised the documentation for a consensus meeting in Freiburg, Germany in October 2008. A total of 21 participants attended the meeting, bringing their expertise as research methodologists, reporting guideline developers, acupuncturists, physicians and journal editors. Results At the workshop, a revised draft checklist was agreed. There was general consensus that STRICTA should continue to function as a stand-alone guideline as well as an extension to CONSORT. It was agreed that STRICTA should be sufficiently broad to cover all type of clinical studies, from case reports through uncontrolled studies to randomised controlled trials. It was also decided that explanations and examples, as with other CONSORT reporting guidelines, would provide a useful way of supporting the uptake to the new recommendations when published. Discussion The checklist will be subjected to further revision processes in order to further its impact and support wider dissemination. Journals that regularly publish acupuncture trials will be encouraged to adopt the revised STRICTA, include it in their guidelines for authors, and promote the adoption of its recommendations for clinical studies of acupuncture. [source] A review of low and reduced carbohydrate diets and weight loss in type 2 diabetesJOURNAL OF HUMAN NUTRITION & DIETETICS, Issue 6 2008P. A. Dyson Abstract Background, Recent evidence from randomized controlled trials of hypocaloric low carbohydrate diets in people without diabetes has shown that they promote significant weight loss over the short term. There is very little evidence for any effects of reduced carbohydrate intakes on body weight, glycaemia and cardiovascular risk in people with type 2 diabetes. Methods, An electronic search was performed using MEDLINE (1966 to March 2007), EMBASE (1988 to March 2007) and Cochrane Central Register of Controlled Trials (1991 to March 2007) using the keywords low carbohydrate, type 2 diabetes and weight loss. Studies including subjects with type 2 diabetes who adopted a reduced carbohydrate weight loss diet were identified. Data were extracted on study design, weight loss, effects on glycaemia and cardiovascular risk and potential adverse effects. Results, Six studies investigating the effects of hypocaloric reduced carbohydrate diets in people with type 2 diabetes were identified. The studies were heterogenous and most included small numbers, were short-term and provided varying amounts of carbohydrate. No studies were identified that were both low carbohydrate (<50 g day,1) and also designed as randomized controlled trials. All studies reported reductions in both body weight and glycated haemoglobin, with no deleterious effects on cardiovascular risk, renal function or nutritional intake. Conclusions, Conclusions are limited by study design and small numbers, but it appears that reduced carbohydrate diets are safe and effective over the short term for people with type 2 diabetes. [source] Scandinavian Clinical practice guidelines for therapeutic hypothermia and post-resuscitation care after cardiac arrestACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 3 2009M. CASTRÉN Background and aim: Sudden cardiac arrest survivors suffer from ischaemic brain injury that may lead to poor neurological outcome and death. The reperfusion injury that occurs is associated with damaging biochemical reactions, which are suppressed by mild therapeutic hypothermia (MTH). In several studies MTH has been proven to be safe, with few complications and improved survival, and is recommended by the International Liaison of Committee on Resuscitation. The aim of this paper is to recommend clinical practice guidelines for MTH treatment after cardiac arrest from the Scandinavian Society of Anaesthesiology and Intensive Care Medicine (SSAI). Methods: Relevant studies were identified after two consensus meetings of the SSAI Task Force on Therapeutic Hypothermia (SSAITFTH) and via literature search of the Cochrane Central Register of Controlled Trials and Medline. Evidence was assessed and consensus opinion was used when high-grade evidence (Grade of Recommendation, GOR) was unavailable. A management strategy was developed as a consensus from the evidence and the protocols in the participating countries. Results and conclusion: Although proven beneficial only for patients with initial ventricular fibrillation (GOR A), the SSAITFTH also recommend MTH after restored spontaneous circulation, if active treatment is chosen, in patients with initial pulseless electrical activity and asystole (GOR D). Normal ethical considerations, premorbid status, total anoxia time and general condition should decide whether active treatment is required or not. MTH should be part of a standardized treatment protocol, and initiated as early as possible after indication and treatment have been decided (GOR E). There is insufficient evidence to make definitive recommendations among techniques to induce MTH, and we do not know the optimal target temperature, duration of cooling and rewarming time. New studies are needed to address the question as to how MTH affects, for example, prognostic factors. [source] Improving Participant Comprehension in the Informed Consent ProcessJOURNAL OF NURSING SCHOLARSHIP, Issue 3 2007Elizabeth Cohn Purpose: To critically analyze studies published within the past decade about participants' comprehension of informed consent in clinical research and to identify promising intervention strategies. Design:Integrative review of literature. Methods: The Cumulative Index of Nursing and Allied Health Literature (CINAHL), PubMed, and the Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials were searched. Inclusion criteria included studies (a) published between January 1, 1996 and January 1, 2007, (b) designed as descriptive or interventional studies of comprehension of informed consent for clinical research, (c) conducted in nonpsychiatric adult populations who were either patients or volunteer participants, (d) written in English, and (e) published in peer-reviewed journals. Findings: Of the 980 studies identified, 319 abstracts were screened, 154 studies were reviewed, and 23 met the inclusion criteria. Thirteen studies (57%) were descriptive, and 10 (43%) were interventional. Interventions tested included simplified written consent documents, multimedia approaches, and the use of a trained professional (consent educator) to assist in the consent process. Collectively, no single intervention strategy was consistently associated with improved comprehension. Studies also varied in regard to the definition of comprehension and the tools used to measure it. Conclusions: Despite increasing regulatory scrutiny, deficiencies still exist in participant comprehension of the research in which they participate, as well as differences in how comprehension is measured and assessed. No single intervention was identified as consistently successful for improving participant comprehension, and results indicated that any successful consent process should at a minimum include various communication modes and is likely to require one-to-one interaction with someone knowledgeable about the study. [source] Acupuncture in xerostomia , a systematic reviewJOURNAL OF ORAL REHABILITATION, Issue 6 2005E. JEDEL summary, The aim of this systematic review was to assess the efficacy of acupuncture in the management of xerostomia. Assessing quality of studies aim to efficiently integrate valid information and provide a basis for sound decision making based on the best available evidence. Articles of controlled clinical trials evaluating the efficacy of acupuncture in the management of xerostomia were obtained by searching through the databases MEDLINE and Cochrane Central Register of Controlled Trials to September 2003. Three articles met the criteria for inclusion and a criteria list was used to assess the quality of these studies. The studies were considered to be of high quality or low quality in accordance with the criteria list utilized. The results of the trials were considered positive, negative or indifferent based on statistically significant between group differences. The criteria list utilized indicate that one of the three studies was of high quality and it presents indifferent results. One of the two studies of low quality presents positive results and one presents indifferent results. An analysis of the results degree of evidence resulted in no evidence for the efficacy of acupuncture in the management of xerostomia. This systematic review shows that there is no evidence for the efficacy of acupuncture in the management of xerostomia. There is a need for future high quality randomized controlled trials. [source] ORIGINAL ARTICLE: Subsegmental pulmonary embolism diagnosed by computed tomography: incidence and clinical implications.JOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 8 2010A systematic review, meta-analysis of the management outcome studies Summary.,Background:,Multiple-detectors computed tomographic pulmonary angiography (CTPA) has a higher sensitivity for pulmonary embolism (PE) within the subsegmental pulmonary arteries as compared with single-detector CTPA. Multiple-detectors CTPA might increase the rate of subsegmental PE diagnosis. The clinical significance of subsegmental PE is unknown. We sought to summarize the proportion of subsegmental PE diagnosed with single- and multiple-detectors CTPA and assess the safety of diagnostic strategies based on single- or multiple-detectors CTPA to exclude PE. Patients and methods:,A systematic literature search strategy was conducted using MEDLINE, EMBASE and the Cochrane Register of Controlled Trials. We selected 22 articles (20 prospective cohort studies and two randomized controlled trials) that included patients with suspected PE who underwent a CTPA and reported the rate of subsegmental PE. Two reviewers independently extracted data onto standardized forms. Results:,The rate of subsegmental PE diagnosis was 4.7% [95% confidence interval (CI): 2.5,7.6] and 9.4 (95% CI: 5.5,14.2) in patients that underwent a single- and multiple-detectors CTPA, respectively. The 3-month thromboembolic risks in patients with suspected PE and who were left untreated based on a diagnostic algorithm including a negative CTPA was 0.9% (95% CI: 0.4,1.4) and 1.1% (95% CI: 0.7,1.4) for single- and multiple-detectors CTPA, respectively. Conclusion:,Multiple-detectors CTPA seems to increase the proportion of patients diagnosed with subsegmental PE without lowering the 3-month risk of thromboembolism suggesting that subsegmental PE may not be clinically relevant. [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] Lamivudine prevents reactivation of hepatitis B and reduces mortality in immunosuppressed patients: systematic review and meta-analysisJOURNAL OF VIRAL HEPATITIS, Issue 2 2008L. H. Katz Summary., To assess the effects of prophylactic lamivudine on reactivation and mortality following immunosuppressive therapy in hepatitis B surface antigen (HBsAg)-positive patients, we performed a meta-analysis. Systematic review and meta-analysis of randomized and nonrandomized prospective controlled trials and retrospective comparative case series were identified through The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and LILACS. The primary outcomes were virological reactivation, clinical reactivation and mortality. Secondary outcomes included hepatitis B virus (HBV)-related mortality, liver histology, discontinuation or disruption of immunosuppressive therapy, lamivudine-resistant HBV strains and adverse events. A total of 21 studies were included, two of which were randomized controlled trials. Clinical and virological reactivation were significantly reduced in the lamivudine group [odds ratio (OR) 0.09; 95% confidence interval (CI) 0.05,0.15 and OR 0.04; 95% CI 0.01,0.14 respectively]. All-cause mortality was significantly reduced in the lamivudine group (OR 0.36; 95% CI 0.23,0.56) which translates to only 11 patients who need to be treated to prevent one death. Lamivudine significantly reduced HBV-related mortality, and discontinuations or disruptions of the immunosuppressive treatment. No adverse effects of lamivudine were recorded, and resistance to lamivudine occurred in low rates. We demonstrated a clear benefit of lamivudine in terms of clinical and virological HBV reactivation, overall mortality, HBV-related mortality and interruptions or discontinuations in the immunosuppressive treatment. Lamivudine should be administered prophylactically to HBsAg-positive patients who are about to receive immunosuppressive therapy. [source] Effectiveness of Monetary Incentives in Modifying Dietary Behavior: A Review of Randomized, Controlled TrialsNUTRITION REVIEWS, Issue 12 2006FAFPHM, Joanne Wall MBChB To review research evidence on the effectiveness of monetary incentives in modifying dietary behavior, we conducted a systematic review of randomized, controlled trials (RCTs) identified from electronic bibliographic databases and reference lists of retrieved relevant articles. Studies eligible for inclusion met the following criteria: RCT comparing a form of monetary incentive with a comparative intervention or control; incentives were a central component of the study intervention and their effect was able to be disaggregated from other intervention components; study participants were community-based; and outcome variables included anthropometric or dietary assessment measures. Data were extracted on study populations, setting, interventions, outcome variables, trial duration, and follow-up. Appraisal of trial methodological quality was undertaken based on comparability of baseline characteristics, randomization method, allocation concealment, blinding, follow-up, and use of intention-to-treat analysis. Four RCTs were identified as meeting the inclusion criteria. All four trials demonstrated a positive effect of monetary incentives on food purchases, food consumption, or weight loss. However, the trials had some methodological limitations including small sample sizes and short durations. In addition, no studies to date have assessed effects according to socioeconomic or ethnic group or measured the cost-effectiveness of such schemes. Monetary incentives are a promising strategy to modify dietary behavior, but more research is needed to address the gaps in evidence. In particular, larger, long-term RCTs are needed with population groups at high risk of nutrition-related diseases [source] A systematic review of psychological interventions for children with asthmaPEDIATRIC PULMONOLOGY, Issue 2 2007Grad., Janelle Yorke MSc Abstract Aim: Psychological factors may influence the symptoms and management of asthma in children in many ways. It is, therefore, suggested that psychological interventions may be appropriate for this population. This paper reports a systematic review assessing the efficacy of psychological interventions in improving health outcomes for children with asthma. Methodology: A review of Randomized Controlled Trials (RCT) was designed. RCTs assessing the effects of a psychological intervention in child participants were included in the review. Outcome measures included healthcare utilization, lung function, asthma symptoms, and psychological health status. The search was conducted until April 2005. Results: Twelve studies, involving 588 children, were included in the review; however, study quality was poor and sample sizes were frequently small. A meta-analysis was performed on two studies, examining the effects of relaxation therapy on PEFR which favored the treatment group (SD 0.82, CI 0.41,1.24). No other meta-analysis could be performed due to the diversity of interventions and the outcomes assessed. In addition, many studies reported insufficient data. Conclusions: This review was unable to draw firm conclusions for the role of psychological interventions for children with asthma. We recommend that valid outcome measures for evaluating the effectiveness of psychological interventions for children with asthma need to address adjustment to and coping with asthma, as well as other psychological indicators. The absence of an adequate evidence base is demonstrated, highlighting the need for well-conducted RCTs in this area. Pediatr Pulmonol. 2007; 42:114,124. © 2006 Wiley-Liss, Inc. [source] Phototherapy in the management of atopic dermatitis: a systematic reviewPHOTODERMATOLOGY, PHOTOIMMUNOLOGY & PHOTOMEDICINE, Issue 4 2007N. Bhavani Meduri Background/purpose: Atopic dermatitis (AD) is a common and extremely burdensome skin disorder with limited therapeutic options. Ultraviolet (UV) phototherapy is a well tolerated, efficacious treatment for AD, but its use is limited by a lack of guidelines in the optimal choice of modality and dosing. Given this deficit, we aim to develop suggestions for the treatment of AD with phototherapy by systematically reviewing the current medical literature. Methods: Data sources: All data sources were identified through searches of MEDLINE via the Ovid interface, the Cochrane Central Register of Controlled Trials, and a complementary manual literature search. Study selection: Studies selected for review met these inclusion criteria, as applied by multiple reviewers: controlled clinical trials of UV phototherapy in the management of AD in human subjects as reported in the English-language literature. Studies limited to hand dermatitis and studies in which subjects were allowed unmonitored use of topical corticosteroids or immunomodulators were excluded. Data extraction: Included studies were assessed by multiple independent observers who extracted and compiled the following data: number of patients, duration of treatment, cumulative doses of UV radiation, adverse effects, and study results. Data quality was assessed by comparing data sets and rechecking source materials if a discrepancy occurred. Results: Nine trials that met the inclusion criteria were identified. Three studies demonstrated that UVA1 is both faster and more efficacious than combined UVAB for treating acute AD. Two trials disclosed the advantages of medium dose (50 J/cm2) UVA1 for treating acute AD. Two trials revealed the superiority of combined UVAB in the management of chronic AD. Two additional studies demonstrated that narrow-band UVB is more effective than either broad-band UVA or UVA1 for managing chronic AD. Conclusion: On the basis of available evidence, the following suggestions can be made: phototherapy with medium-dose (50 J/cm2) UVA1, if available, should be used to control acute flares of AD while UVB modalities, specifically narrow-band UVB, should be used for the management of chronic AD. [source] Sustaining hope when communicating with terminally ill patients and their families: a systematic reviewPSYCHO-ONCOLOGY, Issue 7 2008Josephine M. Clayton Abstract The aim of this systematic review was to examine studies that have investigated sustaining hope during prognostic and end-of-life issues discussions with terminally ill patients and their families. A comprehensive search of databases (MEDLINE, EMBASE, CINAHL, PsychINFO, Cochrane Central Register of Controlled Trials) and handsearching, from 1985 to June 2006, identified 27 studies. This review suggests that the issues surrounding hope in this context are complex. Despite the lack of unanimity among researchers regarding the definition of hope, findings suggest that balancing hope with honesty is an important skill for health professionals (HPs). Many patients seem to be able to maintain a sense of hope despite acknowledging the terminal nature of their illness. Patients and caregivers mostly preferred honest and accurate information, provided with empathy and understanding. Many different sources of hope were identified in this context in broad aspects of life, not just the medical situation. HPs need to recognize this spectrum of hope and appreciate that patients may simultaneously hope for ,cure' while acknowledging the terminal nature of their illness. HPs may help patients to cope with their terminal prognosis by exploring and fostering realistic forms of hope that are meaningful for the particular patient and their family. Copyright © 2007 John Wiley & Sons, Ltd. [source] Subgroup Analyses in Randomized Controlled Trials: The Need for Risk Stratification in Kidney TransplantationAMERICAN JOURNAL OF TRANSPLANTATION, Issue 10 2009M. Wagner Although randomized controlled trials (RCT) are the gold standard for establishing causation in clinical research, their aggregated results can be misleading when applied to individual patients. A treatment may be beneficial in some patients, but its harms may outweigh benefits in others. While conventional one-variable-at-a-time subgroup analyses have well-known limitations, multivariable risk-based analyses can help uncover clinically significant heterogeneity in treatment effects that may be otherwise obscured. Trials in kidney transplantation have yielded the finding that a reduction in acute rejection does not translate into a similar benefit in prolonging graft survival and improving graft function. This paradox might be explained by the variation in risk for acute rejection among included kidney transplant recipients varying the likelihood of benefit or harm from intense immunosuppressive regimens. Analyses that stratify patients by their immunological risk may resolve these otherwise puzzling results. Reliable risk models should be developed to investigate benefits and harms in rationally designed risk-based subgroups of patients in existing RCT data sets. These risk strata would need to be validated in future prospective clinical trials examining long-term effects on patient and graft survival. This approach may allow better individualized treatment choices for kidney transplant recipients. [source] Meta-analysis on the effect of dopexamine on in-hospital mortalityANAESTHESIA, Issue 6 2009S. Gopal Summary The objective of the study was to determine whether dopexamine alters in-hospital mortality. The following databases were searched, Embase (1974,July 2007), Medline (1950,July 2007), CINAHL, PubMed and Cochrane Clinical Register of Controlled Trials (CENTRAL). Two reviewers independently checked the quality of the studies and extracted data. Six randomised controlled trials totalling 935 patients were included. Mortality was not significantly different with dopexamine treatment (relative risk 0.75, 95% confidence interval 0.48,1.18, p = 0.22). In conclusion, dopexamine does not improve in-hospital mortality in patients undergoing major abdominal surgery and in the critically ill. [source] Linezolid versus vancomycin for MRSA skin and soft tissue infections (systematic review and meta-analysis)ANZ JOURNAL OF SURGERY, Issue 9 2009Tristan John Dodds Abstract Background:, This review aims to compare the effectiveness of linezolid to vancomycin for the treatment of Methicillin Resistant Staphylococcus Aureus (MRSA) skin and soft tissue infections (SSTIs) in inpatients. Methods:, MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and reference lists were searched in March 2007. We included randomized controlled trials that looked at inpatients treated with linezolid versus vancomycin for the treatment of hospital-acquired MRSA SSTIs. Outcome measures were clinical cure (resolution of symptoms and signs) and microbiological cure (eradication of MRSA on wound culture). The validity of the included trials was assessed. The results were combined in meta-analyses, the robustness of which was tested in sensitivity analyses. Results:, Four trials were included in this review: three for clinical outcomes (174 participants) and three for microbiological outcomes (439 participants). For clinical outcomes there were non-significant trends in favour of linezolid (RR 0.34; 95% CI 0.04, 2.89; P = 0.32). For microbiological outcomes there was weak evidence of linezolid outperforming vancomycin (RR 0.55; 95% CI 0.30, 1.01; P = 0.05). Sensitivity analyses did not change the conclusions taken from the main analysis. Conclusion:, With the current available data no difference could be detected between the two treatments, but a trend towards higher effectiveness of linezolid was observed. More data will be required to determine if linezolid is superior to vancomycin for the treatment of MRSA SSTIs. Further systematic reviews are needed to look at other outcomes (length of hospital stay, safety and tolerability, cost-effectiveness) and at MRSA infections at other sites. [source] | ||||||||||||||||||||||||||||||||||||||||