WorldWideScience

Sample records for controlled trials meta-analyses

  1. 78 FR 63479 - Meta-Analyses of Randomized Controlled Clinical Trials (RCTs) for the Evaluation of Risk To...

    Science.gov (United States)

    2013-10-24

    ... pharmaceutical industry and health care organizations, and others from the general public, about the use of meta-analyses of randomized trials as a tool for safety assessment in the regulation of pharmaceutical products... PDUFA Goals Letter, titled ``Enhancing Regulatory Science and Expediting Drug Development,'' includes an...

  2. Hypnotics and driving safety: meta-analyses of randomized controlled trials applying the on-the-road driving test.

    Science.gov (United States)

    Verster, Joris C; Veldhuijzen, Dieuwke S; Patat, Alain; Olivier, Berend; Volkerts, Edmund R

    2006-01-01

    Many people who use hypnotics are outpatients and are likely to drive a car the day after drug intake. The purpose of these meta-analyses was to determine whether or not this is safe. Placebo-controlled, randomized, double-blind trials were selected if using the on-the-road driving test to determine driving ability the day following one or two nights of treatment administration. Primary outcome measure of the driving test was the Standard Deviation of Lateral Position (SDLP); i.e., the weaving of the car. Fixed effects model meta-analyses were performed. Effect size (ES) was computed using mean standardized (weighted) difference scores between treatment and corresponding placebo SDLP values. Ten studies, published from 1984 to 2002 (207 subjects), were included in the meta-analyses. The morning following bedtime administration, i.e. 10-11 hours after dosing, significant driving impairment was found for the recommended dose of various benzodiazepine hypnotics (ES=0.42; 95% Confidence Interval (CI)=0.14 to 0.71). Twice the recommended dose impaired driving both in the morning (ES=0.68; CI=0.39 to 0.97) and afternoon, i.e. 16-17 hours after dosing (ES=0.57; CI=0.26 to 0.88). Zopiclone 7.5 mg also impaired driving in the morning (ES=0.89; CI=0.54 to 1.23). Zaleplon (10 and 20 mg) and zolpidem (10 mg) did not affect driving performance the morning after dosing. Following middle-of-the-night administration, significantly impaired driving performance was found for zopiclone 7.5 mg (ES=1.51, CI=0.85 to 2.17), zolpidem 10 mg (ES=0.66, CI=0.13 to 1.19) and zolpidem 20 mg (ES=1.16, CI=0.60 to 1.72). Zaleplon (10 and 20 mg) did not affect driving performance. The analyses show that driving a car the morning following nocturnal treatment with benzodiazepines and zopiclone is unsafe, whereas the recommended dose of zolpidem (10 mg) and zaleplon (10 mg) do not affect driving ability.

  3. Effectiveness of acupuncture for cancer pain: protocol for an umbrella review and meta-analyses of controlled trials

    Science.gov (United States)

    He, Yihan; Liu, Yihong; May, Brian H; Zhang, Anthony Lin; Zhang, Haibo; Lu, ChuanJian; Yang, Lihong; Guo, Xinfeng; Xue, Charlie Changli

    2017-01-01

    Introduction The National Comprehensive Cancer Network guidelines for adult cancer pain indicate that acupuncture and related therapies may be valuable additions to pharmacological interventions for pain management. Of the systematic reviews related to this topic, some concluded that acupuncture was promising for alleviating cancer pain, while others argued that the evidence was insufficient to support its effectiveness. Methods and analysis This review will consist of three components: (1) synthesis of findings from existing systematic reviews; (2) updated meta-analyses of randomised clinical trials and (3) analyses of results of other types of clinical studies. We will search six English and four Chinese biomedical databases, dissertations and grey literature to identify systematic reviews and primary clinical studies. Two reviewers will screen results of the literature searches independently to identify included reviews and studies. Data from included articles will be abstracted for assessment, analysis and summary. Two assessors will appraise the quality of systematic reviews using Assessment of Multiple Systematic Reviews; assess the randomised controlled trials using the Cochrane Collaboration’s risk of bias tool and other types of studies according to the Newcastle-Ottawa Scale. We will use ‘summary of evidence’ tables to present evidence from existing systematic reviews and meta-analyses. Using the primary clinical studies, we will conduct meta-analysis for each outcome, by grouping studies based on the type of acupuncture, the comparator and the specific type of pain. Sensitivity analyses are planned according to clinical factors, acupuncture method, methodological characteristics and presence of statistical heterogeneity as applicable. For the non-randomised studies, we will tabulate the characteristics, outcome measures and the reported results of each study. Consistencies and inconsistencies in evidence will be investigated and discussed. Finally

  4. Endoscopic hemostasis for peptic ulcer bleeding: systematic review and meta-analyses of randomized controlled trials.

    Science.gov (United States)

    Baracat, Felipe; Moura, Eduardo; Bernardo, Wanderley; Pu, Leonardo Zorron; Mendonça, Ernesto; Moura, Diogo; Baracat, Renato; Ide, Edson

    2016-06-01

    Peptic ulcer represents the most common cause of upper gastrointestinal bleeding. Endoscopic therapy can reduce the risks of rebleeding, continued bleeding, need for surgery, and mortality. The objective of this review is to compare the different modalities of endoscopic therapy. Studies were identified by searching electronic databases MEDLINE, Embase, Cochrane, LILACS, DARE, and CINAHL. We selected randomized clinical trials that assessed contemporary endoscopic hemostatic techniques. The outcomes evaluated were: initial hemostasis, rebleeding rate, need for surgery, and mortality. The possibility of publication bias was evaluated by funnel plots. An additional analysis was made, including only the higher-quality trials. Twenty-eight trials involving 2988 patients were evaluated. Injection therapy alone was inferior to injection therapy with hemoclip and with thermal coagulation when evaluating rebleeding and the need for emergency surgery. Hemoclip was superior to injection therapy in terms of rebleeding; there were no statistically significant differences between hemoclip alone and hemoclip with injection therapy. There was considerable heterogeneity in the comparisons between hemoclip and thermal coagulation. There were no statistically significant differences between thermal coagulation and injection therapy, though their combination was superior, in terms of rebleeding, to thermal coagulation alone. Injection therapy should not be used alone. Hemoclip is superior to injection therapy, and combining hemoclip with an injectate does not improve hemostatic efficacy above hemoclip alone. Thermal coagulation has similar efficacy as injection therapy; combining these appears to be superior to thermal coagulation alone. Therefore, we recommend the application of hemoclips or the combined use of injection therapy with thermal coagulation for the treatment of peptic ulcer bleeding.

  5. Acupuncture-Related Techniques for Psoriasis: A Systematic Review with Pairwise and Network Meta-Analyses of Randomized Controlled Trials.

    Science.gov (United States)

    Yeh, Mei-Ling; Ko, Shu-Hua; Wang, Mei-Hua; Chi, Ching-Chi; Chung, Yu-Chu

    2017-12-01

    There has be a large body of evidence on the pharmacological treatments for psoriasis, but whether nonpharmacological interventions are effective in managing psoriasis remains largely unclear. This systematic review conducted pairwise and network meta-analyses to determine the effects of acupuncture-related techniques on acupoint stimulation for the treatment of psoriasis and to determine the order of effectiveness of these remedies. This study searched the following databases from inception to March 15, 2016: Medline, PubMed, Cochrane Central Register of Controlled Trials, EBSCO (including Academic Search Premier, American Doctoral Dissertations, and CINAHL), Airiti Library, and China National Knowledge Infrastructure. Randomized controlled trials (RCTs) on the effects of acupuncture-related techniques on acupoint stimulation as intervention for psoriasis were independently reviewed by two researchers. A total of 13 RCTs with 1,060 participants were included. The methodological quality of included studies was not rigorous. Acupoint stimulation, compared with nonacupoint stimulation, had a significant treatment for psoriasis. However, the most common adverse events were thirst and dry mouth. Subgroup analysis was further done to confirm that the short-term treatment effect was superior to that of the long-term effect in treating psoriasis. Network meta-analysis identified acupressure or acupoint catgut embedding, compared with medication, and had a significant effect for improving psoriasis. It was noted that acupressure was the most effective treatment. Acupuncture-related techniques could be considered as an alternative or adjuvant therapy for psoriasis in short term, especially of acupressure and acupoint catgut embedding. This study recommends further well-designed, methodologically rigorous, and more head-to-head randomized trials to explore the effects of acupuncture-related techniques for treating psoriasis.

  6. Reporting of conflicts of interests in meta-analyses of trials of pharmacological treatments

    NARCIS (Netherlands)

    Roseman, M.; Milette, K.; Bero, A.B.; Coyne, J.C.; Lexchin, J.; Turner, E.H.; Thombs, B.D.

    2011-01-01

    Abstract CONTEXT: Disclosure of conflicts of interest (COIs) from pharmaceutical industry study funding and author-industry financial relationships is sometimes recommended for randomized controlled trials (RCTs) published in biomedical journals. Authors of meta-analyses, however, are not required

  7. Treatments for acute bipolar depression: meta-analyses of placebo-controlled, monotherapy trials of anticonvulsants, lithium and antipsychotics

    NARCIS (Netherlands)

    Selle, V.; Schalkwijk, S.J.; Vazquez, G.H.; Baldessarini, R.J.

    2014-01-01

    BACKGROUND: Optimal treatments for bipolar depression, and the relative value of specific drugs for that purpose, remain uncertain, including agents other than antidepressants. METHODS: We searched for reports of placebo-controlled, monotherapy trials of mood-stabilizing anticonvulsants,

  8. Treatments for acute bipolar depression: meta-analyses of placebo-controlled, monotherapy trials of anticonvulsants, lithium and antipsychotics.

    Science.gov (United States)

    Selle, V; Schalkwijk, S; Vázquez, G H; Baldessarini, R J

    2014-03-01

    Optimal treatments for bipolar depression, and the relative value of specific drugs for that purpose, remain uncertain, including agents other than antidepressants. We searched for reports of placebo-controlled, monotherapy trials of mood-stabilizing anticonvulsants, second-generation antipsychotics, or lithium for acute major depressive episodes in patients diagnosed with type I or II bipolar disorder and applied random-effects meta-analysis to evaluate their efficacy, comparing outcomes based on standardized mean drug-placebo differences (SMD) in improvement, relative response rates (RR), and number-needed-to-treat (NNT). We identified 24 trials of 10 treatments (lasting 7.5 weeks, with ≥ 50 collaborating sites/trial) that met eligibility criteria: lamotrigine (5 trials), quetiapine (5), valproate (4), 2 each for aripiprazole, olanzapine, ziprasidone, and 1 each for carbamazepine, lithium, lurasidone, and olanzapine-fluoxetine. Overall, pooled drug-over-placebo responder-rate superiority (RR) was moderate (29% [CI: 19-40%]), and NNT was 8.2 (CI: 6.4-11). By SMD, apparent efficacy ranked: olanzapine + fluoxetine ≥ valproate > quetiapine > lurasidone > olanzapine, aripiprazole, and carbamazepine; ziprasidone was ineffective, and lithium remains inadequately studied. Notably, drugs were superior to placebo in only 11/24 trials (5/5 with quetiapine, 2/4 with valproate), and only lamotrigine, quetiapine and valproate had > 2 trials. Treatment-associated mania-like reactions were uncommon (drugs: 3.7%; placebo: 4.7%). Controlled trials of non-antidepressant treatments for bipolar depression remain scarce, but findings with olanzapine-fluoxetine, lurasidone, quetiapine, and perhaps carbamazepine and valproate were encouraging; lithium requires adequate testing. © Georg Thieme Verlag KG Stuttgart · New York.

  9. Acceptance and commitment therapy - Do we know enough? Cumulative and sequential meta-analyses of randomized controlled trials.

    Science.gov (United States)

    Hacker, Thomas; Stone, Paul; MacBeth, Angus

    2016-01-15

    Acceptance and Commitment Therapy (ACT) has accrued a substantial evidence base. Recent systematic and meta-analytic reviews suggest that ACT is effective compared to control conditions. However, these reviews appraise the efficacy of ACT across a broad range of presenting problems, rather than addressing specific common mental health difficulties. Focussing on depression and anxiety we performed a meta-analysis of trials of ACT. We incorporated sequential meta-analysis (SMA) techniques to critically appraise the sufficiency of the existing evidence base. Findings suggest that ACT demonstrates at least moderate group and pre-post effects for symptom reductions for both anxiety and depression. However using SMA findings are more qualified. There is currently insufficient evidence to confidently conclude that ACT for anxiety is efficacious when compared to active control conditions or as primary treatment for anxiety. Similarly, using SMA, there is currently insufficient evidence to suggest a moderate efficacy of ACT for depression compared to active control conditions. To stimulate further research we offer specific estimates of additional numbers of participants required to reach sufficiency to help inform future studies. We also discuss the appropriate strategies for future research into ACT for anxiety given the current evidence suggests no differential efficacy of ACT in the treatment of anxiety compared to active control conditions. Copyright © 2015 Elsevier B.V. All rights reserved.

  10. Reporting of Conflicts of Interest in Meta-analyses of Trials of Pharmacological Treatments

    NARCIS (Netherlands)

    Roseman, Michelle; Milette, Katherine; Bero, Lisa A.; Coyne, James C.; Lexchin, Joel; Turner, Erick H.; Thombs, Brett D.

    2011-01-01

    Context Disclosure of conflicts of interest (COIs) from pharmaceutical industry study funding and author-industry financial relationships is sometimes recommended for randomized controlled trials (RCTs) published in biomedical journals. Authors of meta-analyses, however, are not required to report

  11. Authorship characteristics of orthodontic randomized controlled trials, systematic reviews, and meta-analyses in non-orthodontic journals with impact factor.

    Science.gov (United States)

    Alqaydi, Ahlam R; Kanavakis, Georgios; Naser-Ud-Din, Shazia; Athanasiou, Athanasios E

    2017-12-08

    This study was conducted to explore authorship characteristics and publication trends of all orthodontic randomized controlled trials (RCTs), systematic reviews (SRs), and meta-analyses (MAs) published in non-orthodontic journals with impact factor (IF). Appropriate research strategies were developed to search for all articles published until December 2015, without restrictions regarding language or publication status. The initial search generated 4524 results, but after application of the inclusion criteria, the final number of articles was reduced to 274 (SRs: 152; MAs: 36; and RCTs: 86). Various authorship characteristics were recorded for each article. Frequency distributions for all parameters were explored with Pearson chi-square for independence at the 0.05 level of significance. More than half of the included publications were SRs (55.5 per cent), followed by RCTs (31.4 per cent) and MAs (13.1 per cent); one hundred seventy-eight (65 per cent) appeared in dental journals and 96 (35 per cent) were published in non-dental journals. The last decade was significantly more productive than the period before 2006, with 236 (86.1 per cent) articles published between 2006 and 2015. European countries produced 51.5 per cent of the total number of publications, followed by Asia (18.6 per cent) and North America (USA and Canada; 16.8 per cent). Studies published in journals without IF were not included. Level-1 evidence orthodontic literature published in non-orthodontic journals has significantly increased during 2006-15. This indicates a larger interest of other specialty journals in orthodontic related studies and a trend for orthodontic authors to publish their work in journals with impact in broader fields of dentistry and medicine. © The Author(s) 2017. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com

  12. Effect of reporting bias on meta-analyses of drug trials

    DEFF Research Database (Denmark)

    Hart, Beth; Lundh, Andreas; Bero, Lisa

    2012-01-01

    To investigate the effect of including unpublished trial outcome data obtained from the Food and Drug Administration (FDA) on the results of meta-analyses of drug trials.......To investigate the effect of including unpublished trial outcome data obtained from the Food and Drug Administration (FDA) on the results of meta-analyses of drug trials....

  13. False-positive findings in Cochrane meta-analyses with and without application of trial sequential analysis

    DEFF Research Database (Denmark)

    Imberger, Georgina; Thorlund, Kristian; Gluud, Christian

    2016-01-01

    outcome, a negative result and sufficient power. We defined a negative result as one where the 95% CI for the effect included 1.00, a positive result as one where the 95% CI did not include 1.00, and sufficient power as the required information size for 80% power, 5% type 1 error, relative risk reduction...... of 10% or number needed to treat of 100, and control event proportion and heterogeneity taken from the included studies. We re-conducted the meta-analyses, using conventional cumulative techniques, to measure how many false positives would have occurred if these meta-analyses had been updated after each...... new trial. For each false positive, we performed TSA, using three different approaches. RESULTS: We screened 4736 systematic reviews to find 100 meta-analyses that fulfilled our inclusion criteria. Using conventional cumulative meta-analysis, false positives were present in seven of the meta...

  14. Diet and ADHD, Reviewing the Evidence: A Systematic Review of Meta-Analyses of Double-Blind Placebo-Controlled Trials Evaluating the Efficacy of Diet Interventions on the Behavior of Children with ADHD.

    Directory of Open Access Journals (Sweden)

    Lidy M Pelsser

    Full Text Available Attention-deficit/hyperactivity disorder (ADHD is a debilitating mental health problem hampering the child's development. The underlying causes include both genetic and environmental factors and may differ between individuals. The efficacy of diet treatments in ADHD was recently evaluated in three reviews, reporting divergent and confusing conclusions based on heterogeneous studies and subjects. To address this inconsistency we conducted a systematic review of meta-analyses of double-blind placebo-controlled trials evaluating the effect of diet interventions (elimination and supplementation on ADHD.Our literature search resulted in 14 meta-analyses, six of which confined to double-blind placebo-controlled trials applying homogeneous diet interventions, i.e. artificial food color (AFC elimination, a few-foods diet (FFD and poly-unsaturated fatty acid (PUFA supplementation. Effect sizes (ES and Confidence intervals (CI of study outcomes were depicted in a forest plot. I2 was calculated to assess heterogeneity if necessary and additional random effects subgroup meta-regression was conducted if substantial heterogeneity was present.The AFC ESs were 0.44 (95% CI: 0.16-0.72, I2 = 11% and 0.21 (95% CI: -0.02-0.43, I2 = 68% [parent ratings], 0.08 (95% CI: -0.07-0.24, I2 = 0% [teacher ratings] and 0.11 (95% CI: -0.13-0.34, I2 = 12% [observer ratings]. The FFD ESs were 0.80 (95% CI: 0.41-1.19, I2 = 61% [parent ratings] and 0.51 (95% CI: -0.02-1.04, I2 = 72% [other ratings], while the PUFA ESs were 0.17 (95% CI: -0.03-0.38, I2 = 38% [parent ratings], -0.05 (95% CI: -0.27-0.18, I2 = 0% [teacher ratings] and 0.16 (95% CI: 0.01-0.31, I2 = 0% [parent and teacher ratings]. Three meta-analyses (two FFD and one AFC resulted in high I2 without presenting subgroup results. The FFD meta-analyses provided sufficient data to perform subgroup analyses on intervention type, resulting in a decrease of heterogeneity to 0% (diet design and 37.8% (challenge design

  15. Can trial sequential monitoring boundaries reduce spurious inferences from meta-analyses?

    DEFF Research Database (Denmark)

    Thorlund, Kristian; Devereaux, P J; Wetterslev, Jørn

    2008-01-01

    BACKGROUND: Results from apparently conclusive meta-analyses may be false. A limited number of events from a few small trials and the associated random error may be under-recognized sources of spurious findings. The information size (IS, i.e. number of participants) required for a reliable......-analyses after each included trial and evaluated their results using a conventional statistical criterion (alpha = 0.05) and two-sided Lan-DeMets monitoring boundaries. We examined the proportion of false positive results and important inaccuracies in estimates of treatment effects that resulted from the two...... approaches. RESULTS: Using the random-effects model and final data, 12 of the meta-analyses yielded P > alpha = 0.05, and 21 yielded P alpha = 0.05. The monitoring boundaries eliminated all false positives. Important inaccuracies in estimates were observed in 6 out of 21 meta-analyses using the conventional...

  16. Incorporating alternative design clinical trials in network meta-analyses

    Directory of Open Access Journals (Sweden)

    Thorlund K

    2014-12-01

    Full Text Available Kristian Thorlund,1–3 Eric Druyts,1,4 Kabirraaj Toor,1,5 Jeroen P Jansen,1,6 Edward J Mills1,3 1Redwood Outcomes, Vancouver, BC, 2Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada; 3Stanford Prevention Research Center, Stanford University, Stanford, CA, USA; 4Department of Medicine, Faculty of Medicine, 5School of Population and Public Health, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada; 6Department of Public Health and Community Medicine, Tufts University, Boston, MA, USA Introduction: Network meta-analysis (NMA is an extension of conventional pairwise meta-analysis that allows for simultaneous comparison of multiple interventions. Well-established drug class efficacies have become commonplace in many disease areas. Thus, for reasons of ethics and equipoise, it is not practical to randomize patients to placebo or older drug classes. Unique randomized clinical trial designs are an attempt to navigate these obstacles. These alternative designs, however, pose challenges when attempting to incorporate data into NMAs. Using ulcerative colitis as an example, we illustrate an example of a method where data provided by these trials are used to populate treatment networks. Methods: We present the methods used to convert data from the PURSUIT trial into a typical parallel design for inclusion in our NMA. Data were required for three arms: golimumab 100 mg; golimumab 50 mg; and placebo. Golimumab 100 mg induction data were available; however, data regarding those individuals who were nonresponders at induction and those who were responders at maintenance were not reported, and as such, had to be imputed using data from the rerandomization phase. Golimumab 50 mg data regarding responses at week 6 were not available. Existing relationships between the available components were used to impute the expected proportions in this missing subpopulation. Data for placebo maintenance

  17. Grey literature in meta-analyses of randomized trials of health care interventions.

    Science.gov (United States)

    Hopewell, S; McDonald, S; Clarke, M; Egger, M

    2007-04-18

    The inclusion of grey literature (i.e. literature that has not been formally published) in systematic reviews may help to overcome some of the problems of publication bias, which can arise due to the selective availability of data. To review systematically research studies, which have investigated the impact of grey literature in meta-analyses of randomized trials of health care interventions. We searched the Cochrane Methodology Register (The Cochrane Library Issue 3, 2005), MEDLINE (1966 to 20 May 2005), the Science Citation Index (June 2005) and contacted researchers who may have carried out relevant studies. A study was considered eligible for this review if it compared the effect of the inclusion and exclusion of grey literature on the results of a cohort of meta-analyses of randomized trials. Data were extracted from each report independently by two reviewers. The main outcome measure was an estimate of the impact of trials from the grey literature on the pooled effect estimates of the meta-analyses. Information was also collected on the area of health care, the number of meta-analyses, the number of trials, the number of trial participants, the year of publication of the trials, the language and country of publication of the trials, the number and type of grey and published literature, and methodological quality. Five studies met the inclusion criteria. All five studies showed that published trials showed an overall greater treatment effect than grey trials. This difference was statistically significant in one of the five studies. Data could be combined for three of the five studies. This showed that, on average, published trials showed a 9% greater treatment effect than grey trials (ratio of odds ratios for grey versus published trials 1.09; 95% CI 1.03-1.16). Overall there were more published trials included in the meta-analyses than grey trials (median 224 (IQR 108-365) versus 45(IQR 40-102)). Published trials had more participants on average. The most

  18. Benefit and harm of adding ketamine to an opioid in a patient-controlled analgesia device for the control of postoperative pain: systematic review and meta-analyses of randomized controlled trials with trial sequential analyses.

    Science.gov (United States)

    Assouline, Benjamin; Tramèr, Martin R; Kreienbühl, Lukas; Elia, Nadia

    2016-12-01

    Ketamine is often added to opioids in patient-controlled analgesia devices. We tested whether in surgical patients, ketamine added to an opioid patient-controlled analgesia decreased pain intensity by ≥25%, cumulative opioid consumption by ≥30%, the risk of postoperative nausea and vomiting by ≥30%, the risk of respiratory adverse effects by ≥50%, and increased the risk of hallucination not more than 2-fold. In addition, we searched for evidence of dose-responsiveness. Nineteen randomized trials (1349 adults, 104 children) testing different ketamine regimens added to various opioids were identified through searches in databases and bibliographies (to 04.2016). In 9 trials (595 patients), pain intensity at rest at 24 hours was decreased by 32% with ketamine (weighted mean difference -1.1 cm on the 0-10 cm visual analog scale [98% CI, -1.8 to -0.39], P ketamine (weighted mean difference -12.9 mg [-22.4 to -3.35], P = 0.002). In 7 trials (435 patients), the incidence of postoperative nausea and vomiting was decreased by 44% with ketamine (risk ratio 0.56 [0.40 to 0.78], P ketamine on pain intensity, cumulative morphine consumption, and postoperative nausea and vomiting and its inability to double the risk of hallucination. The available data did not allow us to make a conclusion on respiratory adverse events or to establish dose-responsiveness.

  19. Trial sequential analysis reveals insufficient information size and potentially false positive results in many meta-analyses

    DEFF Research Database (Denmark)

    Brok, J.; Thorlund, K.; Gluud, C.

    2008-01-01

    in 80% (insufficient information size). TSA(15%) and TSA(LBHIS) found that 95% and 91% had absence of evidence. The remaining nonsignificant meta-analyses had evidence of lack of effect. CONCLUSION: TSA reveals insufficient information size and potentially false positive results in many meta......OBJECTIVES: To evaluate meta-analyses with trial sequential analysis (TSA). TSA adjusts for random error risk and provides the required number of participants (information size) in a meta-analysis. Meta-analyses not reaching information size are analyzed with trial sequential monitoring boundaries...... analogous to interim monitoring boundaries in a single trial. STUDY DESIGN AND SETTING: We applied TSA on meta-analyses performed in Cochrane Neonatal reviews. We calculated information sizes and monitoring boundaries with three different anticipated intervention effects of 30% relative risk reduction (TSA...

  20. [Inguinal hernia repair: results of randomized clinical trials and meta-analyses].

    Science.gov (United States)

    Slim, K; Vons, C

    2008-01-01

    This evidence-based review of the literature aims to answer two questions regarding inguinal hernia repair: 1. should a prosthetic patch be used routinely? 2. Which approach is better - laparoscopic or open surgery? After a comprehensive search of electronic databases we retained only meta-analyses (n=14) and/or randomised clinical trials (n=4). Review of this literature suggests with a good level of evidence that prosthetic hernia repair is the gold standard; the laparoscopic approach has very few proven benefits and may involve more serious complications when performed outside expert centers. The role of laparoscopy for the repair of bilateral or recurrent hernias needs better evaluation.

  1. Quality control and conduct of genome-wide association meta-analyses

    DEFF Research Database (Denmark)

    Winkler, Thomas W; Day, Felix R; Croteau-Chonka, Damien C

    2014-01-01

    Rigorous organization and quality control (QC) are necessary to facilitate successful genome-wide association meta-analyses (GWAMAs) of statistics aggregated across multiple genome-wide association studies. This protocol provides guidelines for (i) organizational aspects of GWAMAs, and for (ii) QC...

  2. Trial sequential analyses of meta-analyses of complications in laparoscopic vs. small-incision cholecystectomy: more randomized patients are needed

    DEFF Research Database (Denmark)

    Keus, Frederik; Wetterslev, Jørn; Gluud, Christian

    2010-01-01

    Conclusions based on meta-analyses of randomized trials carry a status of "truth." Methodological components may identify trials with systematic errors ("bias"). Trial sequential analysis (TSA) evaluates random errors in meta-analysis. We analyzed meta-analyses on laparoscopic vs. small-incision ......Conclusions based on meta-analyses of randomized trials carry a status of "truth." Methodological components may identify trials with systematic errors ("bias"). Trial sequential analysis (TSA) evaluates random errors in meta-analysis. We analyzed meta-analyses on laparoscopic vs. small...

  3. Robustness assessments are needed to reduce bias in meta-analyses that include zero-event randomized trials

    DEFF Research Database (Denmark)

    Keus, F; Wetterslev, J; Gluud, C

    2009-01-01

    of statistical method on inference. RESULTS: In seven meta-analyses of seven outcomes from 15 trials, there were zero-event trials in 0 to 71.4% of the trials. We found inconsistency in significance in one of seven outcomes (14%; 95% confidence limit 0.4%-57.9%). There was also considerable variability......OBJECTIVES: Meta-analysis of randomized trials with binary data can use a variety of statistical methods. Zero-event trials may create analytic problems. We explored how different methods may impact inferences from meta-analyses containing zero-event trials. METHODS: Five levels of statistical...... methods are identified for meta-analysis with zero-event trials, leading to numerous data analyses. We used the binary outcomes from our Cochrane review of randomized trials of laparoscopic vs. small-incision cholecystectomy for patients with symptomatic cholecystolithiasis to illustrate the influence...

  4. Apparently conclusive meta-analyses may be inconclusive--Trial sequential analysis adjustment of random error risk due to repetitive testing of accumulating data in apparently conclusive neonatal meta-analyses

    DEFF Research Database (Denmark)

    Brok, Jesper; Thorlund, Kristian; Wetterslev, Jørn

    2008-01-01

    BACKGROUND: Random error may cause misleading evidence in meta-analyses. The required number of participants in a meta-analysis (i.e. information size) should be at least as large as an adequately powered single trial. Trial sequential analysis (TSA) may reduce risk of random errors due to repeti......BACKGROUND: Random error may cause misleading evidence in meta-analyses. The required number of participants in a meta-analysis (i.e. information size) should be at least as large as an adequately powered single trial. Trial sequential analysis (TSA) may reduce risk of random errors due...

  5. Meta-analyses on viral hepatitis

    DEFF Research Database (Denmark)

    Gluud, Lise L; Gluud, Christian

    2009-01-01

    This article summarizes the meta-analyses of interventions for viral hepatitis A, B, and C. Some of the interventions assessed are described in small trials with unclear bias control. Other interventions are supported by large, high-quality trials. Although attempts have been made to adjust...

  6. Can simply answering research questions change behaviour? Systematic review and meta analyses of brief alcohol intervention trials.

    Directory of Open Access Journals (Sweden)

    Jim McCambridge

    Full Text Available Participant reports of their own behaviour are critical for the provision and evaluation of behavioural interventions. Recent developments in brief alcohol intervention trials provide an opportunity to evaluate longstanding concerns that answering questions on behaviour as part of research assessments may inadvertently influence it and produce bias. The study objective was to evaluate the size and nature of effects observed in randomized manipulations of the effects of answering questions on drinking behaviour in brief intervention trials.Multiple methods were used to identify primary studies. Between-group differences in total weekly alcohol consumption, quantity per drinking day and AUDIT scores were evaluated in random effects meta-analyses. Ten trials were included in this review, of which two did not provide findings for quantitative study, in which three outcomes were evaluated. Between-group differences were of the magnitude of 13.7 (-0.17 to 27.6 grams of alcohol per week (approximately 1.5 U.K. units or 1 standard U.S. drink and 1 point (0.1 to 1.9 in AUDIT score. There was no difference in quantity per drinking day.Answering questions on drinking in brief intervention trials appears to alter subsequent self-reported behaviour. This potentially generates bias by exposing non-intervention control groups to an integral component of the intervention. The effects of brief alcohol interventions may thus have been consistently under-estimated. These findings are relevant to evaluations of any interventions to alter behaviours which involve participant self-report.

  7. Insomnia From Drug Treatments: Evidence From Meta-analyses of Randomized Trials and Concordance With Prescribing Information.

    Science.gov (United States)

    Doufas, Anthony G; Panagiotou, Orestis A; Panousis, Periklis; Wong, Shane Shucheng; Ioannidis, John P A

    2017-01-01

    To determine whether drugs used to treat diverse conditions cause insomnia symptoms and whether their prescription information is concordant with this evidence. We conducted a survey of meta-analyses (Cochrane Database of Systematic Reviews) and comparisons with package inserts compiled in the Physicians' Desk Reference (PDR). We identified randomized controlled trials (RCTs) in which any drug had been evaluated vs placebo and sleep had been assessed. We collectively referred to insomnia-related outcomes as sleep disturbance. We also searched the PDR to identify any insomnia symptoms listed for drugs with RCT evidence available. Seventy-four Cochrane systematic reviews corresponding to 274 RCTs assessed 88 drugs in 27 different conditions, providing evidence on 109 drug-condition pairs. Of these 88 drugs, 5 decreased sleep problems and 19 increased sleep problems; 64 drugs had no nominally statistically significant effect on sleep. Acetylcholinesterase inhibitors, dopamine agonists, and selective serotonin reuptake inhibitors were the drug classes most importantly associated with sleep disturbance. Of 35 drugs that included disturbed sleep as an adverse effect in the PDR, only 14 had RCT evidence supporting such effect, and 2 had evidence of increasing and decreasing sleep problems in RCTs, although this was not shown in the PDR. We identified weak concordance between the PDR and RCTs (weighted κ=0.31; P<.001). The RCTs offer substantial evidence about the common effects of drugs on the risk of sleep disturbance; currently, prescription information only partially agrees with the available randomized evidence. Copyright © 2016 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

  8. Chemotherapy in advanced ovarian cancer: four systematic meta-analyses of individual patient data from 37 randomized trials. Advanced Ovarian Cancer Trialists' Group.

    Science.gov (United States)

    Aabo, K.; Adams, M.; Adnitt, P.; Alberts, D. S.; Athanazziou, A.; Barley, V.; Bell, D. R.; Bianchi, U.; Bolis, G.; Brady, M. F.; Brodovsky, H. S.; Bruckner, H.; Buyse, M.; Canetta, R.; Chylak, V.; Cohen, C. J.; Colombo, N.; Conte, P. F.; Crowther, D.; Edmonson, J. H.; Gennatas, C.; Gilbey, E.; Gore, M.; Guthrie, D.; Yeap, B. Y.

    1998-01-01

    The purpose of this systematic study was to provide an up to date and reliable quantitative summary of the relative benefits of various types of chemotherapy (non-platinum vs platinum, single-agent vs combination and carboplatin vs cisplatin) in the treatment of advanced ovarian cancer. Also, to investigate whether well-defined patient subgroups benefit more or less from cisplatin- or carboplatin-based therapy. Meta-analyses were based on updated individual patient data from all available randomized controlled trials (published and unpublished), including 37 trials, 5667 patients and 4664 deaths. The results suggest that platinum-based chemotherapy is better than non-platinum therapy, show a trend in favour of platinum combinations over single-agent platinum, and suggest that cisplatin and carboplatin are equally effective. There is no good evidence that cisplatin is more or less effective than carboplatin in any particular subgroup of patients. Images Figure 1 Figure 2 Figure 3 PMID:9836481

  9. Rhythm vs. rate control of atrial fibrillation meta-analysed by number needed to treat

    OpenAIRE

    Kumana, Cyrus R; Cheung, Bernard M Y; Cheung, Giselle T Y; Ovedal, Tori; Pederson, Bjorn; Lauder, Ian J

    2005-01-01

    Background: Whenever feasible, rhythm control of atrial fibrillation (AF) was generally preferred over rate control, in the belief that it offered better symptomatic relief and quality of life, and eliminated the need for anticoagulation. However, recent trials appear to challenge these assumptions. Aims: To explore the desirability of rhythm vs. rate control of AF by systematic review of pertinent, published, randomized controlled trials (RCTs) and a meta-analysis by number needed to treat (...

  10. Comparison of metformin and insulin versus insulin alone for type 2 diabetes: systematic review of randomised clinical trials with meta-analyses and trial sequential analyses.

    Science.gov (United States)

    Hemmingsen, Bianca; Christensen, Louise Lundby; Wetterslev, Jørn; Vaag, Allan; Gluud, Christian; Lund, Søren S; Almdal, Thomas

    2012-04-19

    To compare the benefits and harms of metformin and insulin versus insulin alone as reported in randomised clinical trials of patients with type 2 diabetes. Systematic review of randomised clinical trials with meta-analyses and trial sequential analyses. The Cochrane Library, Medline, Embase, Science Citation Index Expanded, Latin American Caribbean Health Sciences Literature, and Cumulative Index to Nursing and Allied Health Literature until March 2011. We also searched abstracts presented at the American Diabetes Association and European Association for the Study of Diabetes Congresses, contacted relevant trial authors and pharmaceutical companies, hand searched reference lists of included trials, and searched the US Food and Drug Administration website. Two authors independently screened titles and abstracts for randomised clinical trials comparing metformin and insulin versus insulin alone (with or without placebo) in patients with type 2 diabetes, older than 18 years, and with an intervention period of at least 12 weeks. We included trials irrespective of language, publication status, predefined outcomes, antidiabetic interventions used before randomisation, and reported outcomes. We included 26 randomised trials with 2286 participants, of which 23 trials with 2117 participants could provide data. All trials had high risk of bias. Data were sparse for outcomes relevant to patients. Metformin and insulin versus insulin alone did not significantly affect all cause mortality (relative risk 1.30, 95% confidence interval 0.57 to 2.99) or cardiovascular mortality (1.70, 0.35 to 8.30). Trial sequential analyses showed that more trials were needed before reliable conclusions could be drawn regarding these outcomes. In a fixed effect model, but not in a random effects model, severe hypoglycaemia was significantly more frequent with metformin and insulin than with insulin alone (2.83, 1.17 to 6.86). In a random effects model, metformin and insulin resulted in reduced Hb

  11. Efficacy of cryotherapy for the treatment of cutaneous leishmaniasis: meta-analyses of clinical trials.

    Science.gov (United States)

    López-Carvajal, Liliana; Cardona-Arias, Jaiberth Antonio; Zapata-Cardona, María Isabel; Sánchez-Giraldo, Vanesa; Vélez, Iván Darío

    2016-07-26

    Cryotherapy is a local treatment for cutaneous leishmaniasis with variable efficacy and greater safety than conventional treatment. The objective of this study is to evaluate the efficacy and safety of cryotherapy for the treatment of cutaneous leishmaniasis and to compare it with pentavalent antimonials. A meta-analysis based on a search of nine databases with eight strategies was conducted. Inclusion and exclusion criteria were applied, the methodological quality of each article was evaluated, and the reproducibility of the study selection and information extraction from each clinical trial was assured. The per lesion and per patient efficacy was calculated, and a meta-analysis of relative risks with the random effects model and the Dersimonian and Laird's, Begg, and Egger tests, along with a sensitivity analysis, were performed. A meta-regression based on the methodological quality of the trials included was also performed. Eight studies were included in which respective per lesion efficacies of 67.3 % and 67.7 % were reported for cryotherapy and pentavalent antimonials. In 271 patients treated with cryotherapy and in 199 with pentavalent antimonials, respective per protocol and intent to treat efficacies of 63.6 % and 54.2 % were found in the first group, and per protocol and intent to treat efficacies of 74.7 % and 68.3 % were found in the second group. The relative risk for the comparison of efficacy in the two groups was 0.73 (0.42-1.29). The results of the sensitivity analysis and the meta-regression analysis of relative risks were statistically equal to the overall results. This investigation provides evidence in favor of the use of cryotherapy given that its efficacy is similar to that of pentavalent antimonials.

  12. The role of pragmatism in explaining heterogeneity in meta-analyses of randomised trials: a protocol for a cross-sectional methodological review

    Science.gov (United States)

    Aves, Theresa; Lawson, Daeria; Nieuwlaat, Robby; Beyene, Joseph; Mbuagbaw, Lawrence

    2017-01-01

    Introduction There has been increasing interest in pragmatic trials methodology. As a result, tools such as the Pragmatic-Explanatory Continuum Indicator Summary-2 (PRECIS-2) are being used prospectively to help researchers design randomised controlled trials (RCTs) within the pragmatic-explanatory continuum. There may be value in applying the PRECIS-2 tool retrospectively in a systematic review setting as it could provide important information about how to pool data based on the degree of pragmatism. Objectives To investigate the role of pragmatism as a source of heterogeneity in systematic reviews by (1) identifying systematic reviews with meta-analyses of RCTs that have moderate to high heterogeneity, (2) applying PRECIS-2 to RCTs of systematic reviews, (3) evaluating the inter-rater reliability of PRECIS-2, (4) determining how much of this heterogeneity may be explained by pragmatism. Methods A cross-sectional methodological review will be conducted on systematic reviews of RCTs published in the Cochrane Library from 1 January 2014 to 1 January 2017. Included systematic reviews will have a minimum of 10 RCTs in the meta-analysis of the primary outcome and moderate to substantial heterogeneity (I2≥50%). Of the eligible systematic reviews, a random selection of 10 will be included for quantitative evaluation. In each systematic review, RCTs will be scored using the PRECIS-2 tool, in duplicate. Agreement between raters will be measured using the intraclass correlation coefficient. Subgroup analyses and meta-regression will be used to evaluate how much variability in the primary outcome may be due to pragmatism. Dissemination This review will be among the first to evaluate the PRECIS-2 tool in a systematic review setting. Results from this research will provide inter-rater reliability information about PRECIS-2 and may be used to provide methodological guidance when dealing with pragmatism in systematic reviews and subgroup considerations. On completion, this

  13. The pharmacological and non-pharmacological treatment of attention deficit hyperactivity disorder in children and adolescents: A systematic review with network meta-analyses of randomised trials.

    Directory of Open Access Journals (Sweden)

    Ferrán Catalá-López

    Full Text Available Attention deficit hyperactivity disorder (ADHD is one of the most commonly diagnosed psychiatric disorders in childhood. A wide variety of treatments have been used for the management of ADHD. We aimed to compare the efficacy and safety of pharmacological, psychological and complementary and alternative medicine interventions for the treatment of ADHD in children and adolescents.We performed a systematic review with network meta-analyses. Randomised controlled trials (≥ 3 weeks follow-up were identified from published and unpublished sources through searches in PubMed and the Cochrane Library (up to April 7, 2016. Interventions of interest were pharmacological (stimulants, non-stimulants, antidepressants, antipsychotics, and other unlicensed drugs, psychological (behavioural, cognitive training and neurofeedback and complementary and alternative medicine (dietary therapy, fatty acids, amino acids, minerals, herbal therapy, homeopathy, and physical activity. The primary outcomes were efficacy (treatment response and acceptability (all-cause discontinuation. Secondary outcomes included discontinuation due to adverse events (tolerability, as well as serious adverse events and specific adverse events. Random-effects Bayesian network meta-analyses were conducted to obtain estimates as odds ratios (ORs with 95% credibility intervals. We analysed interventions by class and individually. 190 randomised trials (52 different interventions grouped in 32 therapeutic classes that enrolled 26114 participants with ADHD were included in complex networks. At the class level, behavioural therapy (alone or in combination with stimulants, stimulants, and non-stimulant seemed significantly more efficacious than placebo. Behavioural therapy in combination with stimulants seemed superior to stimulants or non-stimulants. Stimulants seemed superior to behavioural therapy, cognitive training and non-stimulants. Behavioural therapy, stimulants and their combination

  14. Nutraceuticals with a clinically detectable blood pressure-lowering effect: a review of available randomized clinical trials and their meta-analyses.

    Science.gov (United States)

    Borghi, Claudio; Cicero, Arrigo F G

    2017-01-01

    The aim of the present study was to review and comment on the available evidence on nutraceuticals with a clinically demonstrable blood pressure (BP)-lowering effect. We reviewed studies published in the English language from 1990 to 2015 on dietary supplements or nutraceuticals claiming to show an effect on human BP. An initial list of possibly effective agents and studies was obtained from the online reference, the Natural Medicine Comprehensive Database. Using PubMed, we searched agents identified from this list using the MeSH terms 'hypertension', 'blood pressure', 'dietary supplement' and 'nutraceuticals', alone and in combination. We then focused our attention on meta-analyses and randomized clinical trials. Beyond the well-known effects on BP of the Dietary Approaches to Stop Hypertension (DASH) and the Mediterranean diet, a large number of studies have investigated the possible BP-lowering effect of different dietary supplements and nutraceuticals, most of which are antioxidant agents with a high tolerability and safety profile. In particular, a relatively large body of evidence supports the use of potassium, magnesium, L-arginine, vitamin C, cocoa flavonoids, beetroot juice, coenzyme Q10, controlled-release melatonin and aged garlic extract. The antihypertensive effect of all these nutraceuticals seems to be dose related and the overall tolerability is good. Some nutraceuticals might have a positive impact on BP in humans. Further clinical research is needed, to identify from the available active nutraceuticals those with the best cost-effectiveness and risk-benefit ratio for widespread and long-term use in the general population with a low-added cardiovascular risk related to uncomplicated hypertension. © 2016 The British Pharmacological Society.

  15. A systematic review of the quality and impact of anxiety disorder meta-analyses.

    Science.gov (United States)

    Ipser, Jonathan C; Stein, Dan J

    2009-08-01

    Meta-analyses are seen as representing the pinnacle of a hierarchy of evidence used to inform clinical practice. Therefore, the potential importance of differences in the rigor with which they are conducted and reported warrants consideration. In this review, we use standardized instruments to describe the scientific and reporting quality of meta-analyses of randomized controlled trials of the treatment of anxiety disorders. We also use traditional and novel metrics of article impact to assess the influence of meta-analyses across a range of research fields in the anxiety disorders. Overall, although the meta-analyses that we examined had some flaws, their quality of reporting was generally acceptable. Neither the scientific nor reporting quality of the meta-analyses was predicted by any of the impact metrics. The finding that treatment meta-analyses were cited less frequently than quantitative reviews of studies in current "hot spots" of research (ie, genetics, imaging) points to the multifactorial nature of citation patterns. A list of the meta-analyses included in this review is available on an evidence-based website of anxiety and trauma-related disorders.

  16. Gabapentin for post-operative pain management - a systematic review with meta-analyses and trial sequential analyses

    DEFF Research Database (Denmark)

    Fabritius, M L; Geisler, A; Petersen, P L

    2016-01-01

    ). The primary outcomes were 24-h opioid consumption and incidence of serious adverse events (SAE). RESULTS: One hundred and thirty-two trials with 9498 patients were included. Thirteen trials with low risk of bias reported a reduction in 24-h opioid consumption of 3.1 mg [0.5, 5.6; TSA-adjusted CI: -0.2, 6...

  17. Lack of consensus on the role of endoscopic retrograde cholangiography in acute biliary pancreatitis in published meta-analyses and guidelines: a systematic review

    NARCIS (Netherlands)

    Geenen, E.J.M. van; Santvoort, H.C. van; Besselink, M.G.; Peet, D.L. van der; Erpecum, K.J. van; Fockens, P.; Mulder, C.J.; Bruno, M.J.

    2013-01-01

    OBJECTIVES: Several randomized controlled trials studied the role of endoscopic retrograde cholangiopancreaticography (ERCP) and endoscopic sphincterotomy (ES) in acute biliary pancreatitis (ABP). No study assessed whether these trials resulted in international consensus in published meta-analyses

  18. Lack of Consensus on the Role of Endoscopic Retrograde Cholangiography in Acute Biliary Pancreatitis in Published Meta-Analyses and Guidelines A Systematic Review

    NARCIS (Netherlands)

    van Geenen, Erwin-Jan M.; van Santvoort, Hjalmar C.; Besselink, Marc G. H.; van der Peet, Donald L.; van Erpecum, Karel J.; Fockens, Paul; Mulder, Chris J. J.; Bruno, Marco J.

    2013-01-01

    Objectives: Several randomized controlled trials studied the role of endoscopic retrograde cholangiopancreaticography (ERCP) and endoscopic sphincterotomy (ES) in acute biliary pancreatitis (ABP). No study assessed whether these trials resulted in international consensus in published meta-analyses

  19. Local anaesthetic infiltration for peri-operative pain control in total hip and knee replacement: systematic review and meta-analyses of short- and long-term effectiveness.

    Science.gov (United States)

    Marques, Elsa M R; Jones, Hayley E; Elvers, Karen T; Pyke, Mark; Blom, Ashley W; Beswick, Andrew D

    2014-07-05

    Surgical pain is managed with multi-modal anaesthesia in total hip replacement (THR) and total knee replacement (TKR). It is unclear whether including local anaesthetic infiltration before wound closure provides additional pain control. We performed a systematic review of randomised controlled trials of local anaesthetic infiltration in patients receiving THR or TKR. We searched MEDLINE, Embase and Cochrane CENTRAL to December 2012. Two reviewers screened abstracts, extracted data, and contacted authors for unpublished outcomes and data. Outcomes collected were post-operative pain at rest and during activity after 24 and 48 hours, opioid requirement, mobilisation, hospital stay and complications. When feasible, we estimated pooled treatment effects using random effects meta-analyses. In 13 studies including 909 patients undergoing THR, patients receiving local anaesthetic infiltration experienced a greater reduction in pain at 24 hours at rest by standardised mean difference (SMD) -0.61 (95% CI -1.05, -0.16; p = 0.008) and by SMD -0.43 (95% CI -0.78 -0.09; p = 0.014) at 48 hours during activity.In TKR, diverse multi-modal regimens were reported. In 23 studies including 1439 patients undergoing TKR, local anaesthetic infiltration reduced pain on average by SMD -0.40 (95% CI -0.58, -0.22; p SMD -0.27 (95% CI -0.50, -0.05; p = 0.018) at 48 hours during activity, compared with patients receiving no infiltration or placebo. There was evidence of a larger reduction in studies delivering additional local anaesthetic after wound closure. There was no evidence of pain control additional to that provided by femoral nerve block.Patients receiving local anaesthetic infiltration spent on average an estimated 0.83 (95% CI 1.54, 0.12; p = 0.022) and 0.87 (95% CI 1.62, 0.11; p = 0.025) fewer days in hospital after THR and TKR respectively, had reduced opioid consumption, earlier mobilisation, and lower incidence of vomiting.Few studies reported long-term outcomes. Local

  20. STRUCTURE OF RUSSIAN PUBLICATIONS IN CLINICAL IMMUNOLOGY AND ALLERGOLOGY (JOURNAL ARTICLES, CLINICAL TRIALS, META-ANALYSES AND PRACTICE GUIDELINES) IN COMPARISON WITH OTHER BRICS COUNTRIES IN 2008-2015

    OpenAIRE

    L. I. Lugacheva; M. I. Musatov

    2018-01-01

    It is obvious that any evolving scientific medical field is a dynamic system that cannot stay at the stage of accumulation of primary information, and inevitably goes to the stages of clinical trials, generalization of information in meta-analyses and completes the study by creation of practical guidelines. The purpose of this study was a quantitative analysis of publicly available data in the field of clinical immunology in Russia during 2008-2015, identifying the ratios of clinical trials, ...

  1. Effects of cognitive therapy versus interpersonal psychotherapy in patients with major depressive disorder: a systematic review of randomized clinical trials with meta-analyses and trial sequential analyses.

    Science.gov (United States)

    Jakobsen, J C; Hansen, J L; Simonsen, S; Simonsen, E; Gluud, C

    2012-07-01

    Major depressive disorder afflicts an estimated 17% of individuals during their lifetime at tremendous suffering and cost. Cognitive therapy and interpersonal psychotherapy are treatment options, but their effects have only been limitedly compared in systematic reviews. Using Cochrane systematic review methodology we compared the benefits and harm of cognitive therapy versus interpersonal psychotherapy for major depressive disorder. Trials were identified by searching the Cochrane Library's CENTRAL, Medline via PubMed, EMBASE, Psychlit, PsycInfo, and Science Citation Index Expanded until February 2010. Continuous outcome measures were assessed by mean difference and dichotomous outcomes by odds ratio. We conducted trial sequential analysis to control for random errors. We included seven trials randomizing 741 participants. All trials had high risk of bias. Meta-analysis of the four trials reporting data at cessation of treatment on the Hamilton Rating Scale for Depression showed no significant difference between the two interventions [mean difference -1.02, 95% confidence interval (CI) -2.35 to 0.32]. Meta-analysis of the five trials reporting data at cessation of treatment on the Beck Depression Inventory showed comparable results (mean difference -1.29, 95% CI -2.73 to 0.14). Trial sequential analysis indicated that more data are needed to definitively settle the question of a differential effect. None of the included trial reported on adverse events. Randomized trials with low risk of bias and low risk of random errors are needed, although the effects of cognitive therapy and interpersonal psychotherapy do not seem to differ significantly regarding depressive symptoms. Future trials should report on adverse events.

  2. Homeopathy: meta-analyses of pooled clinical data.

    Science.gov (United States)

    Hahn, Robert G

    2013-01-01

    In the first decade of the evidence-based era, which began in the mid-1990s, meta-analyses were used to scrutinize homeopathy for evidence of beneficial effects in medical conditions. In this review, meta-analyses including pooled data from placebo-controlled clinical trials of homeopathy and the aftermath in the form of debate articles were analyzed. In 1997 Klaus Linde and co-workers identified 89 clinical trials that showed an overall odds ratio of 2.45 in favor of homeopathy over placebo. There was a trend toward smaller benefit from studies of the highest quality, but the 10 trials with the highest Jadad score still showed homeopathy had a statistically significant effect. These results challenged academics to perform alternative analyses that, to demonstrate the lack of effect, relied on extensive exclusion of studies, often to the degree that conclusions were based on only 5-10% of the material, or on virtual data. The ultimate argument against homeopathy is the 'funnel plot' published by Aijing Shang's research group in 2005. However, the funnel plot is flawed when applied to a mixture of diseases, because studies with expected strong treatments effects are, for ethical reasons, powered lower than studies with expected weak or unclear treatment effects. To conclude that homeopathy lacks clinical effect, more than 90% of the available clinical trials had to be disregarded. Alternatively, flawed statistical methods had to be applied. Future meta-analyses should focus on the use of homeopathy in specific diseases or groups of diseases instead of pooling data from all clinical trials. © 2013 S. Karger GmbH, Freiburg.

  3. STRUCTURE OF RUSSIAN PUBLICATIONS IN CLINICAL IMMUNOLOGY AND ALLERGOLOGY (JOURNAL ARTICLES, CLINICAL TRIALS, META-ANALYSES AND PRACTICE GUIDELINES IN COMPARISON WITH OTHER BRICS COUNTRIES IN 2008-2015

    Directory of Open Access Journals (Sweden)

    L. I. Lugacheva

    2018-01-01

    Full Text Available It is obvious that any evolving scientific medical field is a dynamic system that cannot stay at the stage of accumulation of primary information, and inevitably goes to the stages of clinical trials, generalization of information in meta-analyses and completes the study by creation of practical guidelines. The purpose of this study was a quantitative analysis of publicly available data in the field of clinical immunology in Russia during 2008-2015, identifying the ratios of clinical trials, meta-analyses, and practical guidelines, as well as evaluating the results by comparison with other BRICS countries. Study design was performed by retrospective bibliometric methods. It is revealed, that, in Russia, 16 clinical trials, 3 meta-analyses and 1 practice guideline were issued per 1000 original journal articles. Accordingly in the People’s Republic of China this ratios have made 34/25/4; in Federal Republic of Brazil, 42/87/7; in Republic of India, 76/58/34, and in Republic of Southern Africa, 134/43/36. Moreover, we have obtained evidence which suggests optimistic prospectives for scientific clinical immunology in Russia. 

  4. Exercise improves depressive symptoms in older adults: An umbrella review of systematic reviews and meta-analyses.

    Science.gov (United States)

    Catalan-Matamoros, Daniel; Gomez-Conesa, Antonia; Stubbs, Brendon; Vancampfort, Davy

    2016-10-30

    Late-life depression is a growing public health concern. Exercise may be of added value but the literature remains equivocal. We conducted a systematic overview of meta-analyses and an exploratory pooled analysis of previous meta-analyses to determine the effect of exercise on depression in older adults. Two independent researchers searched Pubmed, CINAHL, Cochrane Plus, PsycArticles, and PsycInfo for meta-analyses on exercise in late-life depression. Methodological quality was assessed using the Assessment of Multiple Systematic Reviews (AMSTAR) Instrument. We pooled effect sizes from previous meta-analyses of randomized controlled trials to determine the effect of exercise on depression in older adults. The systematic review yielded 3 meta-analyses. In total, 16 unique cohorts of 1487 participants were included. The quality of the three included meta-analyses was considered as "moderate" according to AMSTAR scores. No serious adverse events were reported. Compared to controls (n=583), those exercising (n=541) significantly reduced depressive symptoms. Our umbrella review indicates that exercise is safe and efficacious in reducing depressive symptoms in older people. Since exercise has many other known health benefits, it should be considered as a core intervention in the multidisciplinary treatment of older adults experiencing depression. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  5. Impact of exercise on articular cartilage: Systematic reviews and meta-analyses of randomised controlled trials

    DEFF Research Database (Denmark)

    Bricca, Alessio

    2018-01-01

    This thesis summarizes the evidence on the impact of exercise on articular cartilage. No evidence was found to support beneficial effects of exercise on articular cartilage, although in people at risk of, or with, knee osteoarthritis, exercise is not harmful for articular cartilage structure and ...

  6. Effect of periodontal treatment on preterm birth rate: a systematic review of meta-analyses.

    Science.gov (United States)

    López, Néstor J; Uribe, Sergio; Martinez, Benjamín

    2015-02-01

    Preterm birth is a major cause of neonatal morbidity and mortality in both developed and developing countries. Preterm birth is a highly complex syndrome that includes distinct clinical subtypes in which many different causes may be involved. The results of epidemiological, molecular, microbiological and animal-model studies support a positive association between maternal periodontal disease and preterm birth. However, the results of intervention studies carried out to determine the effect of periodontal treatment on reducing the risk of preterm birth are controversial. This systematic review critically analyzes the methodological issues of meta-analyses of the studies to determine the effect of periodontal treatment to reduce preterm birth. The quality of the individual randomized clinical trials selected is of highest relevance for a systematic review. This article describes the methodological features that should be identified a priori and assessed individually to determine the quality of a randomized controlled trial performed to evaluate the effect of periodontal treatment on pregnancy outcomes. The AMSTAR and the PRISMA checklist tools were used to assess the quality of the six meta-analyses selected, and the bias domain of the Cochrane Collaboration's Tool was applied to evaluate each of the trials included in the meta-analyses. In addition, the methodological characteristics of each clinical trial were assessed. The majority of the trials included in the meta-analyses have significant methodological flaws that threaten their internal validity. The lack of effect of periodontal treatment on preterm birth rate concluded by four meta-analyses, and the positive effect of treatment for reducing preterm birth risk concluded by the remaining two meta-analyses are not based on consistent scientific evidence. Well-conducted randomized controlled trials using rigorous methodology, including appropriate definition of the exposure, adequate control of confounders for

  7. Efficacy of pharmacotherapy and psychotherapy for adult psychiatric disorders: a systematic overview of meta-analyses.

    Science.gov (United States)

    Huhn, Maximilian; Tardy, Magdolna; Spineli, Loukia Maria; Kissling, Werner; Förstl, Hans; Pitschel-Walz, Gabriele; Leucht, Claudia; Samara, Myrto; Dold, Markus; Davis, John M; Leucht, Stefan

    2014-06-01

    There is debate about the effectiveness of psychiatric treatments and whether pharmacotherapy or psychotherapy should be primarily used. To perform a systematic overview on the efficacy of pharmacotherapies and psychotherapies for major psychiatric disorders and to compare the quality of pharmacotherapy and psychotherapy trials. We searched MEDLINE, EMBASE, PsycINFO, and the Cochrane Library (April 2012, with no time or language limit) for systematic reviews on pharmacotherapy or psychotherapy vs placebo, pharmacotherapy vs psychotherapy, and their combination vs either modality alone. Two reviewers independently selected the meta-analyses and extracted efficacy effect sizes. We assessed the quality of the individual trials included in the pharmacotherapy and psychotherapy meta-analyses with the Cochrane risk of bias tool. The search yielded 45,233 results. We included 61 meta-analyses on 21 psychiatric disorders, which contained 852 individual trials and 137,126 participants. The mean effect size of the meta-analyses was medium (mean, 0.50; 95% CI, 0.41-0.59). Effect sizes of psychotherapies vs placebo tended to be higher than those of medication, but direct comparisons, albeit usually based on few trials, did not reveal consistent differences. Individual pharmacotherapy trials were more likely to have large sample sizes, blinding, control groups, and intention-to-treat analyses. In contrast, psychotherapy trials had lower dropout rates and provided follow-up data. In psychotherapy studies, wait-list designs showed larger effects than did comparisons with placebo. Many pharmacotherapies and psychotherapies are effective, but there is a lot of room for improvement. Because of the multiple differences in the methods used in pharmacotherapy and psychotherapy trials, indirect comparisons of their effect sizes compared with placebo or no treatment are problematic. Well-designed direct comparisons, which are scarce, need public funding. Because patients often benefit

  8. Random error in cardiovascular meta-analyses

    DEFF Research Database (Denmark)

    Albalawi, Zaina; McAlister, Finlay A; Thorlund, Kristian

    2013-01-01

    BACKGROUND: Cochrane reviews are viewed as the gold standard in meta-analyses given their efforts to identify and limit systematic error which could cause spurious conclusions. The potential for random error to cause spurious conclusions in meta-analyses is less well appreciated. METHODS: We exam...

  9. Patent foramen ovale closure vs medical therapy for stroke prevention: meta-analysis of randomized trials and review of heterogeneity in meta-analyses.

    Science.gov (United States)

    Udell, Jacob A; Opotowsky, Alexander R; Khairy, Paul; Silversides, Candice K; Gladstone, David J; O'Gara, Patrick T; Landzberg, Michael J

    2014-10-01

    Patent foramen ovale (PFO) might be a risk factor for unexplained ("cryptogenic") stroke or transient ischemic attack (TIA). We sought to determine the efficacy and safety of transcatheter PFO closure compared with antithrombotic therapy for secondary prevention of cerebrovascular events among patients with cryptogenic stroke. We performed a systematic review and meta-analysis of MedLine and Embase (from inception to March 2013) for randomized controlled trials (RCTs) that compared transcatheter PFO closure with medical therapy in subjects with cryptogenic stroke. Data were independently extracted on trial conduct quality, baseline characteristics, efficacy, and safety events from published articles and appendices. Risk ratios (RRs) and 95% confidence intervals (CIs) for the composite of stroke or TIA, and adverse cardiovascular events including atrial fibrillation/flutter were constructed. Three RCTs of 2303 subjects with previous stroke, TIA, or systemic arterial embolism (mean age, 45.7 years; 47.3% women; mean follow-up, 2.6 years) were included. PFO closure did not significantly reduce the risk of recurrent stroke/TIA (3.7% vs 5.2%; RR, 0.73; 95% CI, 0.50-1.07; P = 0.10); however, an increased risk of incident atrial fibrillation/flutter was detected (3.8% vs 1.0%; RR, 3.67; 95% CI, 1.95-6.89; P < 0.0001). No significant heterogeneity was detected for any end point among subgroups of patients stratified according to age, sex, index cardiovascular event, device type, interatrial shunt size, and presence of an atrial septal aneurysm (all P interactions ≥ 0.09). Meta-analysis of RCTs that assessed transcatheter PFO closure for secondary prevention of cerebrovascular events in subjects with cryptogenic stroke does not demonstrate benefit compared with antithrombotic therapy, and suggests potential risks. Copyright © 2014 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  10. Efficacy of adjuvant chemotherapy after surgery when considered over all cancer types: a synthesis of meta-analyses.

    Science.gov (United States)

    Bowater, Russell J; Abdelmalik, Sally M E; Lilford, Richard J

    2012-10-01

    Despite a large number of clinical trials having been conducted to assess the efficacy of adjuvant chemotherapy after surgery for various cancers, whether it is best to use this treatment remains a generally contentious issue for many common cancers. The purpose of this study was to ascertain whether any general conclusions can be drawn about the efficacy or inefficacy of this treatment within different cancer classifications. Meta-analyses of randomized, controlled trials (RCTs) of adjuvant chemotherapy after surgery were synthesized over as many types of cancer as possible. Data sources were Medline, Embase, and the Cochrane library. Eligible meta-analyses were meta-analyses of RCTs for any type of cancer that compared surgery followed by adjuvant chemotherapy with surgery followed by no adjuvant chemotherapy. The literature search found 25 meta-analyses for 15 cancer types that satisfied the criteria necessary for detailed analysis within this study. The estimates of relative risk for all cause mortality were reported as being less than one (indicating adjuvant chemotherapy is beneficial) by all meta-analyses apart from a meta-analysis for colorectal cancer metastasized to the liver. Moreover, 15 of these meta-analyses also reported that the 95% confidence interval for this relative risk is less than one (indicating statistical significance at the 5% level). The results for all cancer types included in this study except for cancer metastasized to the liver can be thought of as supporting each other through the idea of there being a common treatment effect or at least a common range of effect across all (or most) of these cancer types. For example, with regard to cancer types where the evidence in favor of adjuvant chemotherapy after surgery is only moderately strong, the results of this study may encourage more clinicians to regard the use of this treatment as standard practice.

  11. A case study of discordant overlapping meta-analyses: vitamin d supplements and fracture.

    Directory of Open Access Journals (Sweden)

    Mark J Bolland

    Full Text Available BACKGROUND: Overlapping meta-analyses on the same topic are now very common, and discordant results often occur. To explore why discordant results arise, we examined a common topic for overlapping meta-analyses- vitamin D supplements and fracture. METHODS AND FINDINGS: We identified 24 meta-analyses of vitamin D (with or without calcium and fracture in a PubMed search in October 2013, and analysed a sample of 7 meta-analyses in the highest ranking general medicine journals. We used the AMSTAR tool to assess the quality of the meta-analyses, and compared their methodologies, analytic techniques and results. Applying the AMSTAR tool suggested the meta-analyses were generally of high quality. Despite this, there were important differences in trial selection, data extraction, and analytical methods that were only apparent after detailed assessment. 25 trials were included in at least one meta-analysis. Four meta-analyses included all eligible trials according to the stated inclusion and exclusion criteria, but the other 3 meta-analyses "missed" between 3 and 8 trials, and 2 meta-analyses included apparently ineligible trials. The relative risks used for individual trials differed between meta-analyses for total fracture in 10 of 15 trials, and for hip fracture in 6 of 12 trials, because of different outcome definitions and analytic approaches. The majority of differences (11/16 led to more favourable estimates of vitamin D efficacy compared to estimates derived from unadjusted intention-to-treat analyses using all randomised participants. The conclusions of the meta-analyses were discordant, ranging from strong statements that vitamin D prevents fractures to equally strong statements that vitamin D without calcium does not prevent fractures. CONCLUSIONS: Substantial differences in trial selection, outcome definition and analytic methods between overlapping meta-analyses led to discordant estimates of the efficacy of vitamin D for fracture prevention

  12. Gr/gr deletions on Y-chromosome correlate with male infertility: an original study, meta-analyses, and trial sequential analyses

    Science.gov (United States)

    Bansal, Sandeep Kumar; Jaiswal, Deepika; Gupta, Nishi; Singh, Kiran; Dada, Rima; Sankhwar, Satya Narayan; Gupta, Gopal; Rajender, Singh

    2016-02-01

    We analyzed the AZFc region of the Y-chromosome for complete (b2/b4) and distinct partial deletions (gr/gr, b1/b3, b2/b3) in 822 infertile and 225 proven fertile men. We observed complete AZFc deletions in 0.97% and partial deletions in 6.20% of the cases. Among partial deletions, the frequency of gr/gr deletions was the highest (5.84%). The comparison of partial deletion data between cases and controls suggested a significant association of the gr/gr deletions with infertility (P = 0.0004); however, the other partial deletions did not correlate with infertility. In cohort analysis, men with gr/gr deletions had a relatively poor sperm count (54.20 ± 57.45 million/ml) in comparison to those without deletions (72.49 ± 60.06), though the difference was not statistically significant (p = 0.071). Meta-analysis also suggested that gr/gr deletions are significantly associated with male infertility risk (OR = 1.821, 95% CI = 1.39-2.37, p = 0.000). We also performed trial sequential analyses that strengthened the evidence for an overall significant association of gr/gr deletions with the risk of male infertility. Another meta-analysis suggested a significant association of the gr/gr deletions with low sperm count. In conclusion, the gr/gr deletions show a strong correlation with male infertility risk and low sperm count, particularly in the Caucasian populations.

  13. A journey into a Mediterranean diet and type 2 diabetes: a systematic review with meta-analyses.

    Science.gov (United States)

    Esposito, Katherine; Maiorino, Maria Ida; Bellastella, Giuseppe; Chiodini, Paolo; Panagiotakos, Demosthenes; Giugliano, Dario

    2015-08-10

    To summarise the evidence about the efficacy of a Mediterranean diet on the management of type 2 diabetes and prediabetic states. A systematic review of all meta-analyses and randomised controlled trials (RCTs) that compared the Mediterranean diet with a control diet on the treatment of type 2 diabetes and prediabetic states was conducted. Electronic searches were carried out up to January 2015. Trials were included for meta-analyses if they had a control group treated with another diet, if they were of sufficient duration (at least 6 months), and if they had at least 30 participants in each arm. A random-effect model was used to pool data. Adults with or at risk for type 2 diabetes. Dietary patterns that described themselves as using a 'Mediterranean' dietary pattern. The outcomes were glycaemic control, cardiovascular risk factors and remission from the metabolic syndrome. From 2824 studies, 8 meta-analyses and 5 RCTs were eligible. A 'de novo' meta-analysis of 3 long-term (>6 months) RCTs of the Mediterranean diet and glycaemic control of diabetes favoured the Mediterranean diet as compared with lower fat diets. Another 'de novo' meta-analysis of two long-term RCTs showed a 49% increased probability of remission from the metabolic syndrome. 5 meta-analyses showed a favourable effect of the Mediterranean diet, as compared with other diets, on body weight, total cholesterol and high-density lipoprotein cholesterol. 2 meta-analyses demonstrated that higher adherence to the Mediterranean diet reduced the risk of future diabetes by 19-23%. The Mediterranean diet was associated with better glycaemic control and cardiovascular risk factors than control diets, including a lower fat diet, suggesting that it is suitable for the overall management of type 2 diabetes. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  14. A journey into a Mediterranean diet and type 2 diabetes: a systematic review with meta-analyses

    Science.gov (United States)

    Esposito, Katherine; Maiorino, Maria Ida; Bellastella, Giuseppe; Chiodini, Paolo; Panagiotakos, Demosthenes; Giugliano, Dario

    2015-01-01

    Objectives To summarise the evidence about the efficacy of a Mediterranean diet on the management of type 2 diabetes and prediabetic states. Design A systematic review of all meta-analyses and randomised controlled trials (RCTs) that compared the Mediterranean diet with a control diet on the treatment of type 2 diabetes and prediabetic states was conducted. Electronic searches were carried out up to January 2015. Trials were included for meta-analyses if they had a control group treated with another diet, if they were of sufficient duration (at least 6 months), and if they had at least 30 participants in each arm. A random-effect model was used to pool data. Participants Adults with or at risk for type 2 diabetes. Interventions Dietary patterns that described themselves as using a ‘Mediterranean’ dietary pattern. Outcome measures The outcomes were glycaemic control, cardiovascular risk factors and remission from the metabolic syndrome. Results From 2824 studies, 8 meta-analyses and 5 RCTs were eligible. A ‘de novo’ meta-analysis of 3 long-term (>6 months) RCTs of the Mediterranean diet and glycaemic control of diabetes favoured the Mediterranean diet as compared with lower fat diets. Another ‘de novo’ meta-analysis of two long-term RCTs showed a 49% increased probability of remission from the metabolic syndrome. 5 meta-analyses showed a favourable effect of the Mediterranean diet, as compared with other diets, on body weight, total cholesterol and high-density lipoprotein cholesterol. 2 meta-analyses demonstrated that higher adherence to the Mediterranean diet reduced the risk of future diabetes by 19–23%. Conclusions The Mediterranean diet was associated with better glycaemic control and cardiovascular risk factors than control diets, including a lower fat diet, suggesting that it is suitable for the overall management of type 2 diabetes. PMID:26260349

  15. Dose-related beneficial and harmful effects of gabapentin in postoperative pain management - post hoc analyses from a systematic review with meta-analyses and trial sequential analyses

    DEFF Research Database (Denmark)

    Fabritius, Maria Louise; Wetterslev, Jørn; Mathiesen, Ole

    2017-01-01

    versus placebo were included. Four different dose intervals were investigated: 0-350, 351-700, 701-1050, and >1050 mg. Primary co-outcomes were 24-hour morphine consumption and serious adverse events (SAEs), with emphasis put on trials with low risk of bias. Results: One hundred and twenty-two randomized...

  16. Dose-related beneficial and harmful effects of gabapentin in postoperative pain management – post hoc analyses from a systematic review with meta-analyses and trial sequential analyses

    Directory of Open Access Journals (Sweden)

    Fabritius ML

    2017-11-01

    Full Text Available Maria Louise Fabritius,1 Jørn Wetterslev,2 Ole Mathiesen,3 Jørgen B Dahl1 1Department of Anaesthesiology and Intensive Care, Bispebjerg and Frederiksberg Hospitals, Copenhagen, Denmark; 2Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Copenhagen, Denmark; 3Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark Background: During the last 15 years, gabapentin has become an established component of postoperative pain treatment. Gabapentin has been employed in a wide range of doses, but little is known about the optimal dose, providing the best balance between benefit and harm. This systematic review with meta-analyses aimed to explore the beneficial and harmful effects of various doses of gabapentin administered to surgical patients.Materials and methods: Data in this paper were derived from an original review, and the subgroup analyses were predefined in an International Prospective Register of Systematic Reviews published protocol: PROSPERO (ID: CRD42013006538. The methods followed Cochrane guidelines. The Cochrane Library’s CENTRAL, PubMed, EMBASE, Science Citation Index Expanded, Google Scholar, and FDA database were searched for relevant trials. Randomized clinical trials comparing gabapentin versus placebo were included. Four different dose intervals were investigated: 0–350, 351–700, 701–1050, and >1050 mg. Primary co-outcomes were 24-hour morphine consumption and serious adverse events (SAEs, with emphasis put on trials with low risk of bias. Results: One hundred and twenty-two randomized clinical trials, with 8466 patients, were included. Sixteen were overall low risk of bias. No consistent increase in morphine-sparing effect was observed with increasing doses of gabapentin from the trials with low risk of bias. Analyzing all trials, the smallest and the highest dose subgroups demonstrated numerically the most prominent reduction in morphine consumption

  17. Effects of blood-pressure-lowering treatment on outcome incidence in hypertension: 10 - Should blood pressure management differ in hypertensive patients with and without diabetes mellitus? Overview and meta-analyses of randomized trials.

    Science.gov (United States)

    Thomopoulos, Costas; Parati, Gianfranco; Zanchetti, Alberto

    2017-05-01

    Type 2 diabetes mellitus is associated with an increased risk of hypertension, and cardiovascular and renal disease, and it has been recommended that management of hypertension should be more aggressive in presence than in absence of diabetes mellitus, but the matter is controversial at present. Meta-analysing all available randomized controlled trials (RCTs) to compare the effects on cardiovascular and renal outcomes of blood pressure BP lowering to different systolic BP (SBP) and diastolic BP (DBP) levels or by different drug classes in patients with and without diabetes mellitus. The database consisted of 72 BP-lowering RCTs (260 210 patients) and 50 head-to-head drug comparison RCTs (247 006). Among these two sets, RCTs or RCT subgroups separately reporting data from patients with and without diabetes mellitus were identified, and stratified by in-treatment achieved SBP and DBP, by drug class compared with placebo, and drug class compared with all other classes. Risk ratios and 95% confidence intervals, and absolute risk reductions of six fatal and non-fatal cardiovascular outcomes, all-cause death, and end-stage renal disease (ESRD) were calculated (random-effects model) separately for diabetes mellitus and no diabetes mellitus, and compared by interaction analysis. We identified 41 RCTs providing data on 61 772 patients with diabetes mellitus and 40 RCTs providing data on 191 353 patients without diabetes mellitus. For achieved SBP at least 140 mmHg, relative and absolute reductions of most cardiovascular outcomes were significantly greater in diabetes mellitus than no diabetes mellitus, whereas for achieved SBP below 130 mmHg, the difference disappeared or reversed (greater outcome reduction in no diabetes mellitus). Significant ESRD reduction was found only in diabetes mellitus, but it was greatest when achieved SBP was at least 140 mmHg, and no further effect was found at SBP below 140 mmHg. All antihypertensive drug classes reduced

  18. The Yusuf-Peto method was not a robust method for meta-analyses of rare events data from antidepressant trials

    DEFF Research Database (Denmark)

    Sharma, Tarang; Gøtzsche, Peter C.; Kuss, Oliver

    2017-01-01

    Objectives The aim of the study was to identify the validity of effect estimates for serious rare adverse events in clinical study reports of antidepressants trials, across different meta-analysis methods. Study Design and Setting Four serious rare adverse events (all-cause mortality, suicidality......, aggressive behavior, and akathisia) were meta-analyzed using different methods. The Yusuf-Peto odds ratio ignores studies with no events and was compared with the alternative approaches of generalized linear mixed models (GLMMs), conditional logistic regression, a Bayesian approach using Markov Chain Monte...... from 1. For example, the odds ratio for suicidality for children and adolescents was 2.39 (95% confidence interval = 1.32–4.33), using the Yusuf-Peto method but increased to 2.64 (1.33–5.26) using conditional logistic regression, to 2.69 (1.19–6.09) using beta-binomial, to 2.73 (1.37–5.42) using...

  19. Systematic review and meta-analyses

    DEFF Research Database (Denmark)

    Dreier, Julie Werenberg; Andersen, Anne-Marie Nybo; Berg-Beckhoff, Gabriele

    2014-01-01

    1990 were excluded. RESULTS: The available literature supported an increased risk of adverse offspring health in association with fever during pregnancy. The strongest evidence was available for neural tube defects, congenital heart defects, and oral clefts, in which meta-analyses suggested between a 1...

  20. Grey literature in meta-analyses.

    Science.gov (United States)

    Conn, Vicki S; Valentine, Jeffrey C; Cooper, Harris M; Rantz, Marilyn J

    2003-01-01

    In meta-analysis, researchers combine the results of individual studies to arrive at cumulative conclusions. Meta-analysts sometimes include "grey literature" in their evidential base, which includes unpublished studies and studies published outside widely available journals. Because grey literature is a source of data that might not employ peer review, critics have questioned the validity of its data and the results of meta-analyses that include it. To examine evidence regarding whether grey literature should be included in meta-analyses and strategies to manage grey literature in quantitative synthesis. This article reviews evidence on whether the results of studies published in peer-reviewed journals are representative of results from broader samplings of research on a topic as a rationale for inclusion of grey literature. Strategies to enhance access to grey literature are addressed. The most consistent and robust difference between published and grey literature is that published research is more likely to contain results that are statistically significant. Effect size estimates of published research are about one-third larger than those of unpublished studies. Unfunded and small sample studies are less likely to be published. Yet, importantly, methodological rigor does not differ between published and grey literature. Meta-analyses that exclude grey literature likely (a) over-represent studies with statistically significant findings, (b) inflate effect size estimates, and (c) provide less precise effect size estimates than meta-analyses including grey literature. Meta-analyses should include grey literature to fully reflect the existing evidential base and should assess the impact of methodological variations through moderator analysis.

  1. The effect of adding psychodynamic therapy to antidepressants in patients with major depressive disorder. A systematic review of randomized clinical trials with meta-analyses and trial sequential analyses.

    Science.gov (United States)

    Jakobsen, Janus Christian; Hansen, Jane Lindschou; Simonsen, Erik; Gluud, Christian

    2012-03-01

    Major depressive disorder afflicts an estimated 17% of individuals during their lifetimes at tremendous suffering and costs. Psychodynamic therapy may be a treatment option for depression, but the effects have only been limitedly assessed in systematic reviews. Using Cochrane systematic review methodology, we compared the benefits and harms of psychodynamic therapy versus 'no intervention' or sham for major depressive disorder. We accepted any co-intervention, including antidepressants, as long as it was delivered similarly in both intervention groups. Trials were identified by searching the Cochrane Library's CENTRAL, MEDLINE via PubMed, EMBASE, Psychlit, Psyc Info, and Science Citation Index Expanded until February 2010. Two authors independently extracted data. We evaluated risk of bias to control for systematic errors. We conducted trial sequential analysis to control for random errors. We included five trials randomizing a total of 365 participants who all received antidepressants as co-intervention. All trials had high risk of bias. Four trials assessed 'interpersonal psychotherapy' and one trial 'short psychodynamic supportive psychotherapy'. Meta-analysis showed that psychodynamic therapy significantly reduced depressive symptoms on the 17-item Hamilton Rating Scale for Depression (mean difference -3.01 (95% confidence interval -3.98 to -2.03; Ptherapy to antidepressants might benefit depressed patients, but the possible treatment effect measured on the Hamilton Rating Scale for Depression is small. Copyright © 2011 Elsevier B.V. All rights reserved.

  2. The effect of English-language restriction on systematic review-based meta-analyses: a systematic review of empirical studies.

    Science.gov (United States)

    Morrison, Andra; Polisena, Julie; Husereau, Don; Moulton, Kristen; Clark, Michelle; Fiander, Michelle; Mierzwinski-Urban, Monika; Clifford, Tammy; Hutton, Brian; Rabb, Danielle

    2012-04-01

    The English language is generally perceived to be the universal language of science. However, the exclusive reliance on English-language studies may not represent all of the evidence. Excluding languages other than English (LOE) may introduce a language bias and lead to erroneous conclusions. We conducted a comprehensive literature search using bibliographic databases and grey literature sources. Studies were eligible for inclusion if they measured the effect of excluding randomized controlled trials (RCTs) reported in LOE from systematic review-based meta-analyses (SR/MA) for one or more outcomes. None of the included studies found major differences between summary treatment effects in English-language restricted meta-analyses and LOE-inclusive meta-analyses. Findings differed about the methodological and reporting quality of trials reported in LOE. The precision of pooled estimates improved with the inclusion of LOE trials. Overall, we found no evidence of a systematic bias from the use of language restrictions in systematic review-based meta-analyses in conventional medicine. Further research is needed to determine the impact of language restriction on systematic reviews in particular fields of medicine.

  3. Meta-analyses of HFE variants in coronary heart disease.

    Science.gov (United States)

    Lian, Jiangfang; Xu, Limin; Huang, Yi; Le, Yanping; Jiang, Danjie; Yang, Xi; Xu, Weifeng; Huang, Xiaoyan; Dong, Changzheng; Ye, Meng; Zhou, Jianqing; Duan, Shiwei

    2013-09-15

    HFE gene variants can cause hereditary hemochromatosis (HH) that often comes along with an increased risk of coronary heart disease (CHD). The goal of our study is to assess the contribution of four HFE gene variants to the risk of CHD. We conducted four meta-analyses of the studies examining the association between four HFE gene variants and the risk of CHD. A systematic search was conducted using MEDLINE, EMBASE, Web of Science and China National Knowledge Infrastructure (CNKI), Wanfang Chinese Periodical. Meta-analyses showed that HFE rs1799945-G allele was associated with a 6% increased risk of CHD (P=0.02, odds ratio (OR)=1.06, 95% confidence interval (CI)=1.01-1.11). However, no association between the other three HFE gene variants (rs1800562, rs1800730, and rs9366637) and CHD risk was observed by the meta-analyses (all P values>0.05). In addition, the results of our case-control study indicated that rs1800562 and rs1800730 were monomorphic, and that rs1799945 and rs9366637 were not associated with CHD in Han Chinese. Our meta-analysis suggested that a significant association existed between rs1799945 mutation and CHD, although this mutation was rare in Han Chinese. Copyright © 2013 Elsevier B.V. All rights reserved.

  4. Does Male Circumcision Protect against Sexually Transmitted Infections? Arguments and Meta-Analyses to the Contrary Fail to Withstand Scrutiny.

    Science.gov (United States)

    Morris, Brian J; Hankins, Catherine A; Tobian, Aaron A R; Krieger, John N; Klausner, Jeffrey D

    2014-01-01

    We critically evaluate a recent article by Van Howe involving 12 meta-analyses that concludes, contrary to current evidence, that male circumcision increases the risk of various common sexually transmitted infections (STIs). Our detailed scrutiny reveals that these meta-analyses (1) failed to include results of all relevant studies, especially data from randomized controlled trials, (2) introduced bias through use of inappropriate control groups, (3) altered original data, in the case of human papillomavirus (HPV), by questionable adjustments for "sampling bias," (4) failed to control for confounders through use of crude odds ratios, and (5) used unnecessarily complicated methods without adequate explanation, so impeding replication by others. Interventions that can reduce the prevalence of STIs are important to international health. Of major concern is the global epidemic of oncogenic types of HPV that contribute to the burden of genital cancers. Meta-analyses, when well conducted, can better inform public health policy and medical practice, but when seriously flawed can have detrimental consequences. Our critical evaluation leads us to reject the findings and conclusions of Van Howe on multiple grounds. Our timely analysis thus reaffirms the medical evidence supporting male circumcision as a desirable intervention for STI prevention.

  5. Is grey literature essential for a better control of publication bias in psychiatry? An example from three meta-analyses of schizophrenia.

    Science.gov (United States)

    Martin, José Luis R; Pérez, Víctor; Sacristán, Montse; Alvarez, Enric

    2005-12-01

    Systematic reviews in mental health have become useful tools for health professionals in view of the massive amount and heterogeneous nature of biomedical information available today. In order to determine the risk of bias in the studies evaluated and to avoid bias in generalizing conclusions from the reviews it is therefore important to use a very strict methodology in systematic reviews. One bias which may affect the generalization of results is publication bias, which is determined by the nature and direction of the study results. To control or minimize this type of bias, the authors of systematic reviews undertake comprehensive searches of medical databases and expand on the findings, often undertaking searches of grey literature (material which is not formally published). This paper attempts to show the consequences (and risk) of generalizing the implications of grey literature in the control of publication bias, as was proposed in a recent systematic work. By repeating the analyses for the same outcome from three different systematic reviews that included both published and grey literature our results showed that confusion between grey literature and publication bias may affect the results of a concrete meta-analysis.

  6. Hyperhomocysteinemia, methylenetetrahydrofolate reductase c.677C>T polymorphism and risk of cancer: cross-sectional and prospective studies and meta-analyses of 75,000 cases and 93,000 controls

    DEFF Research Database (Denmark)

    Zacho, Jeppe; Yazdanyar, Shiva; Bojesen, Stig E

    2011-01-01

    including 74,671 cases and 93,344 controls. Cross-sectionally, plasma homocysteine levels were 12.9 and 11.6 µmol/L in those with and without cancer (p homocysteine levels increased with age and age-adjusted odds ratio for any cancer in those with homocysteine levels >12.4 versus ....4 µmol/L did not differ from 1.0. In cancer-free participants, plasma homocysteine levels were 14.7 and 11.7 µmol/L in MTHFR c.677C>T homozygtes and noncarriers (p T homozygotes versus noncarriers did not differ...... from 1.0. However, in meta-analyses odds ratio for MTHFR c.677C>T homozygotes versus noncarriers were 1.07 (95% CI: 1.01-1.12) for any cancer, 1.77 (1.17-2.68) for esophagus cancer, 1.40 (1.19-1.66) for gastric cancer and 0.85 (0.77-0.94) for colorectal cancer. Increased plasma homocysteine levels...

  7. Effects of Exercise in the Treatment of Overweight and Obese Children and Adolescents: A Systematic Review of Meta-Analyses

    Directory of Open Access Journals (Sweden)

    George A. Kelley

    2013-01-01

    Full Text Available Purpose. Conduct a systematic review of previous meta-analyses addressing the effects of exercise in the treatment of overweight and obese children and adolescents. Methods. Previous meta-analyses of randomized controlled exercise trials that assessed adiposity in overweight and obese children and adolescents were included by searching nine electronic databases and cross-referencing from retrieved studies. Methodological quality was assessed using the Assessment of Multiple Systematic Reviews (AMSTAR Instrument. The alpha level for statistical significance was set at P≤0.05. Results. Of the 308 studies reviewed, two aggregate data meta-analyses representing 14 and 17 studies and 481 and 701 boys and girls met all eligibility criteria. Methodological quality was 64% and 73%. For both studies, statistically significant reductions in percent body fat were observed (P=0.006 and P<0.00001. The number-needed-to treat (NNT was 4 and 3 with an estimated 24.5 and 31.5 million overweight and obese children in the world potentially benefitting, 2.8 and 3.6 million in the US. No other measures of adiposity (BMI-related measures, body weight, and central obesity were statistically significant. Conclusions. Exercise is efficacious for reducing percent body fat in overweight and obese children and adolescents. Insufficient evidence exists to suggest that exercise reduces other measures of adiposity.

  8. Preventive intervention possibilities in radiotherapy- and chemotherapy-induced oral mucositis : Results of meta-analyses

    NARCIS (Netherlands)

    Stokman, M A; Spijkervet, F K L; Boezen, H M; Schouten, J.P.; Roodenburg, J L N; de Vries, E. G. E.

    The aim of these meta-analyses was to evaluate the effectiveness of interventions for the prevention of oral mucositis in cancer patients treated with head and neck radiotherapy and/or chemotherapy, with a focus on randomized clinical trials. A literature search was performed for reports of

  9. Systematic review and meta-analyses of tranexamic acid use for bleeding reduction in prostate surgery.

    Science.gov (United States)

    Longo, Marcelo A; Cavalheiro, Bárbara T; de Oliveira Filho, Getúlio R

    2018-05-01

    Prostate cancer and benign prostatic hyperplasia have an increased incidence with aging. The most effective treatments are radical prostatectomy and transurethral resection of the prostate. To reduce perioperative bleeding in these surgeries, an approach is the use of tranexamic acid (TXA). Studies show that TXA is effective in reducing the blood loss and the need for transfusion in cardiac, orthopedic, and gynecological surgeries. In prostate surgeries, its efficacy and safety have not been established yet. To determine whether there are differences between TXA versus placebo in terms of intraoperative blood loss, transfusion requirements, hemoglobin levels and the incidence of thromboembolic events. Systematic review with meta-analyses. Anesthesia for prostate surgery. We searched the Medline, Cochrane, EBSCO, and Web of Science databases up to 2017 for randomized controlled trials that compared TXA administration with a control group in patients who submitted to prostate surgery. The primary outcomes were the intraoperative blood loss and transfusion rate. Data on hemoglobin levels and the incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) were also collected. Nine comparative studies were included in the meta-analyses. The estimated blood loss and transfusion rate were lower in patients receiving TXA, with a standardized mean difference of -1.93 (95% CI = -2.81 to -1.05, I 2  = 96%), and a risk ratio of 0.61 (95% CI = 0.47 to 0.80, I 2  = 0%), respectively. The hemoglobin levels and the incidence of DVT and PE did not differ between the groups. TXA reduced intraoperative blood loss and the need for transfusion, without increasing the risk of DVT and PE in prostate surgeries. Due to the limited number of studies and the high heterogeneity of the results, more clinical trials with a large number of patients are necessary to confirm these findings. Copyright © 2018 Elsevier Inc. All rights reserved.

  10. Night shift work and breast cancer risk: what do the meta-analyses tell us?

    Science.gov (United States)

    Pahwa, Manisha; Labrèche, France; Demers, Paul A

    2018-05-22

    Objectives This paper aims to compare results, assess the quality, and discuss the implications of recently published meta-analyses of night shift work and breast cancer risk. Methods A comprehensive search was conducted for meta-analyses published from 2007-2017 that included at least one pooled effect size (ES) for breast cancer associated with any night shift work exposure metric and were accompanied by a systematic literature review. Pooled ES from each meta-analysis were ascertained with a focus on ever/never exposure associations. Assessments of heterogeneity and publication bias were also extracted. The AMSTAR 2 checklist was used to evaluate quality. Results Seven meta-analyses, published from 2013-2016, collectively included 30 cohort and case-control studies spanning 1996-2016. Five meta-analyses reported pooled ES for ever/never night shift work exposure; these ranged from 0.99 [95% confidence interval (CI) 0.95-1.03, N=10 cohort studies) to 1.40 (95% CI 1.13-1.73, N=9 high quality studies). Estimates for duration, frequency, and cumulative night shift work exposure were scant and mostly not statistically significant. Meta-analyses of cohort, Asian, and more fully-adjusted studies generally resulted in lower pooled ES than case-control, European, American, or minimally-adjusted studies. Most reported statistically significant between-study heterogeneity. Publication bias was not evident in any of the meta-analyses. Only one meta-analysis was strong in critical quality domains. Conclusions Fairly consistent elevated pooled ES were found for ever/never night shift work and breast cancer risk, but results for other shift work exposure metrics were inconclusive. Future evaluations of shift work should incorporate high quality meta-analyses that better appraise individual study quality.

  11. Conclusive meta-analyses on antenatal magnesium may be inconclusive! Are we underestimating the risk of random error?

    DEFF Research Database (Denmark)

    Brok, Jesper; Huusom, Lene D; Thorlund, Kristian

    2012-01-01

    Results from meta-analyses significantly influence clinical practice. Both simulation and empirical studies have demonstrated that the risk of random error (i.e. spurious chance findings) in meta-analyses is much higher than previously anticipated. Hence, authors and users of systematic reviews a...... about the investigated intervention effect(s). We outline the rationale for conducting trial sequential analysis including some examples of the meta-analysis on antenatal magnesium for women at risk of preterm birth....

  12. Network meta-analyses could be improved by searching more sources and by involving a librarian.

    Science.gov (United States)

    Li, Lun; Tian, Jinhui; Tian, Hongliang; Moher, David; Liang, Fuxiang; Jiang, Tongxiao; Yao, Liang; Yang, Kehu

    2014-09-01

    Network meta-analyses (NMAs) aim to rank the benefits (or harms) of interventions, based on all available randomized controlled trials. Thus, the identification of relevant data is critical. We assessed the conduct of the literature searches in NMAs. Published NMAs were retrieved by searching electronic bibliographic databases and other sources. Two independent reviewers selected studies and five trained reviewers abstracted data regarding literature searches, in duplicate. Search method details were examined using descriptive statistics. Two hundred forty-nine NMAs were included. Eight used previous systematic reviews to identify primary studies without further searching, and five did not report any literature searches. In the 236 studies that used electronic databases to identify primary studies, the median number of databases was 3 (interquartile range: 3-5). MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials were the most commonly used databases. The most common supplemental search methods included reference lists of included studies (48%), reference lists of previous systematic reviews (40%), and clinical trial registries (32%). None of these supplemental methods was conducted in more than 50% of the NMAs. Literature searches in NMAs could be improved by searching more sources, and by involving a librarian or information specialist. Copyright © 2014 Elsevier Inc. All rights reserved.

  13. Does the inclusion of grey literature influence estimates of intervention effectiveness reported in meta-analyses?

    Science.gov (United States)

    McAuley, L; Pham, B; Tugwell, P; Moher, D

    2000-10-07

    The inclusion of only a subset of all available evidence in a meta-analysis may introduce biases and threaten its validity; this is particularly likely if the subset of included studies differ from those not included, which may be the case for published and grey literature (unpublished studies, with limited distribution). We set out to examine whether exclusion of grey literature, compared with its inclusion in meta-analysis, provides different estimates of the effectiveness of interventions assessed in randomised trials. From a random sample of 135 meta-analyses, we identified and retrieved 33 publications that included both grey and published primary studies. The 33 publications contributed 41 separate meta-analyses from several disease areas. General characteristics of the meta-analyses and associated studies and outcome data at the trial level were collected. We explored the effects of the inclusion of grey literature on the quantitative results using logistic-regression analyses. 33% of the meta-analyses were found to include some form of grey literature. The grey literature, when included, accounts for between 4.5% and 75% of the studies in a meta-analysis. On average, published work, compared with grey literature, yielded significantly larger estimates of the intervention effect by 15% (ratio of odds ratios=1.15 [95% CI 1.04-1.28]). Excluding abstracts from the analysis further compounded the exaggeration (1.33 [1.10-1.60]). The exclusion of grey literature from meta-analyses can lead to exaggerated estimates of intervention effectiveness. In general, meta-analysts should attempt to identify, retrieve, and include all reports, grey and published, that meet predefined inclusion criteria.

  14. A simple technique investigating baseline heterogeneity helped to eliminate potential bias in meta-analyses.

    Science.gov (United States)

    Hicks, Amy; Fairhurst, Caroline; Torgerson, David J

    2018-03-01

    To perform a worked example of an approach that can be used to identify and remove potentially biased trials from meta-analyses via the analysis of baseline variables. True randomisation produces treatment groups that differ only by chance; therefore, a meta-analysis of a baseline measurement should produce no overall difference and zero heterogeneity. A meta-analysis from the British Medical Journal, known to contain significant heterogeneity and imbalance in baseline age, was chosen. Meta-analyses of baseline variables were performed and trials systematically removed, starting with those with the largest t-statistic, until the I 2 measure of heterogeneity became 0%, then the outcome meta-analysis repeated with only the remaining trials as a sensitivity check. We argue that heterogeneity in a meta-analysis of baseline variables should not exist, and therefore removing trials which contribute to heterogeneity from a meta-analysis will produce a more valid result. In our example none of the overall outcomes changed when studies contributing to heterogeneity were removed. We recommend routine use of this technique, using age and a second baseline variable predictive of outcome for the particular study chosen, to help eliminate potential bias in meta-analyses. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. Coffee consumption and health: umbrella review of meta-analyses of multiple health outcomes.

    Science.gov (United States)

    Poole, Robin; Kennedy, Oliver J; Roderick, Paul; Fallowfield, Jonathan A; Hayes, Peter C; Parkes, Julie

    2017-11-22

    Objectives  To evaluate the existing evidence for associations between coffee consumption and multiple health outcomes. Design  Umbrella review of the evidence across meta-analyses of observational and interventional studies of coffee consumption and any health outcome. Data sources  PubMed, Embase, CINAHL, Cochrane Database of Systematic Reviews, and screening of references. Eligibility criteria for selecting studies  Meta-analyses of both observational and interventional studies that examined the associations between coffee consumption and any health outcome in any adult population in all countries and all settings. Studies of genetic polymorphisms for coffee metabolism were excluded. Results  The umbrella review identified 201 meta-analyses of observational research with 67 unique health outcomes and 17 meta-analyses of interventional research with nine unique outcomes. Coffee consumption was more often associated with benefit than harm for a range of health outcomes across exposures including high versus low, any versus none, and one extra cup a day. There was evidence of a non-linear association between consumption and some outcomes, with summary estimates indicating largest relative risk reduction at intakes of three to four cups a day versus none, including all cause mortality (relative risk 0.83 (95% confidence interval 0.79 to 0.88), cardiovascular mortality (0.81, 0.72 to 0.90), and cardiovascular disease (0.85, 0.80 to 0.90). High versus low consumption was associated with an 18% lower risk of incident cancer (0.82, 0.74 to 0.89). Consumption was also associated with a lower risk of several specific cancers and neurological, metabolic, and liver conditions. Harmful associations were largely nullified by adequate adjustment for smoking, except in pregnancy, where high versus low/no consumption was associated with low birth weight (odds ratio 1.31, 95% confidence interval 1.03 to 1.67), preterm birth in the first (1.22, 1.00 to 1.49) and second (1

  16. Cognitive Training for Attention-Deficit/Hyperactivity Disorder: Meta-Analysis of Clinical and Neuropsychological Outcomes From Randomized Controlled Trials

    NARCIS (Netherlands)

    Cortese, S.; Ferrin, M.; Brandeis, D.; Buitelaar, J.K.; Daley, D.; Dittmann, R.W.; Holtmann, M.; Santosh, P.; Stevenson, J.; Stringaris, A.; Zuddas, A.; Sonuga-Barke, E.J.

    2015-01-01

    OBJECTIVE: The authors performed meta-analyses of randomized controlled trials to examine the effects of cognitive training on attention-deficit/hyperactivity disorder (ADHD) symptoms, neuropsychological deficits, and academic skills in children/adolescents with ADHD. METHOD: The authors searched

  17. Stuttering, induced fluency, and natural fluency: a hierarchical series of activation likelihood estimation meta-analyses.

    Science.gov (United States)

    Budde, Kristin S; Barron, Daniel S; Fox, Peter T

    2014-12-01

    Developmental stuttering is a speech disorder most likely due to a heritable form of developmental dysmyelination impairing the function of the speech-motor system. Speech-induced brain-activation patterns in persons who stutter (PWS) are anomalous in various ways; the consistency of these aberrant patterns is a matter of ongoing debate. Here, we present a hierarchical series of coordinate-based meta-analyses addressing this issue. Two tiers of meta-analyses were performed on a 17-paper dataset (202 PWS; 167 fluent controls). Four large-scale (top-tier) meta-analyses were performed, two for each subject group (PWS and controls). These analyses robustly confirmed the regional effects previously postulated as "neural signatures of stuttering" (Brown, Ingham, Ingham, Laird, & Fox, 2005) and extended this designation to additional regions. Two smaller-scale (lower-tier) meta-analyses refined the interpretation of the large-scale analyses: (1) a between-group contrast targeting differences between PWS and controls (stuttering trait); and (2) a within-group contrast (PWS only) of stuttering with induced fluency (stuttering state). Copyright © 2014 Elsevier Inc. All rights reserved.

  18. The effects of exercise on the quality of life of patients with breast cancer (the UMBRELLA Fit study) : study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    Gal, Roxanne; Monninkhof, Evelyn M; Groenwold, Rolf H H; van Gils, Carla H; van den Bongard, Desiree H J G; Peeters, Petra H M; Verkooijen, Helena M; May, Anne M

    2017-01-01

    BACKGROUND: Meta-analyses of randomized controlled trials (RCTs) have shown that exercise has beneficial effects on quality of life (QoL) in patients with breast cancer. However, these effects were often small. Blinding in an exercise trial is not possible, which has the possible disadvantage of

  19. Parent-based adolescent sexual health interventions and effect on communication outcomes: a systematic review and meta-analyses.

    Science.gov (United States)

    Santa Maria, Diane; Markham, Christine; Bluethmann, Shirley; Mullen, Patricia Dolan

    2015-03-01

    Parent-based adolescent sexual health interventions aim to reduce sexual risk behaviors by bolstering parental protective behaviors. Few studies of theory use, methods, applications, delivery and outcomes of parent-based interventions have been conducted. A systematic search of databases for the period 1998-2013 identified 28 published trials of U.S. parent-based interventions to examine theory use, setting, reach, delivery mode, dose and effects on parent-child communication. Established coding schemes were used to assess use of theory and describe methods employed to achieve behavioral change; intervention effects were explored in meta-analyses. Most interventions were conducted with minority parents in group sessions or via self-paced activities; interventions averaged seven hours, and most used theory extensively. Meta-analyses found improvements in sexual health communication: Analysis of 11 controlled trials indicated a medium effect on increasing communication (Cohen's d, 0.5), and analysis of nine trials found a large effect on increasing parental comfort with communication (0.7); effects were positive regardless of delivery mode or intervention dose. Intervention participants were 68% more likely than controls to report increased communication and 75% more likely to report increased comfort. These findings point to gaps in the range of programs examined in published trials-for example, interventions for parents of sexual minority youth, programs for custodial grandparents and faith-based services. Yet they provide support for the effectiveness of parent-based interventions in improving communication. Innovative delivery approaches could extend programs' reach, and further research on sexual health outcomes would facilitate the meta-analysis of intervention effectiveness in improving adolescent sexual health behaviors. Copyright © 2015 by the Guttmacher Institute.

  20. Individual patient data meta-analyses in head and neck carcinoma: what have we learnt?

    International Nuclear Information System (INIS)

    Pignon, J.P.; Baujat, B.; Bourhis, J.

    2005-01-01

    Carcinoma of the upper aero-digestive tract (oral cavity, oropharynx, hypopharynx, nasopharynx, larynx) are frequent tumors for which surgery and/or radiotherapy are the main therapeutic agents. The main results of meta-analyses based on the collection of individual patients data are reported: 1) The meta-analysis on chemotherapy, regrouping data of nearly 11,000 patients issued from 63 randomized trials showed an absolute benefit of 4% at five years in overall survival, in favor of chemotherapy (P < 0.0001). Most of the benefit was seen with concomitant radio-chemotherapy, however with a relatively large heterogeneity in this subgroup of trials. An update of this meta-analysis was performed including 24 additional trials, which confirmed the magnitude of the benefit due to concomitant chemotherapy (8% at 5 years). 2) The meta-analysis on larynx preservation, using induction chemotherapy in larynx and hypopharynx carcinomas. No significant difference was seen between the control arm with total laryngectomy and the larynx preservation approach. 3) The meta-analysis on chemotherapy in nasopharynx carcinomas, from the data of 11 randomized trials including 2722 patients, and comparing the radiotherapy to radio-chemotherapy (1979-2001). The results showed an absolute benefit of 6% at five years in overall survival, in favor of chemotherapy (P < 0.0001). Most of the benefit was seen with concomitant radio-chemotherapy. 4) Finally, a meta-analysis on altered fractionated RT, compared to conventional RT in 15 randomized trials regrouping 6515 patients. The results showed a small but significant improvement in favor of altered fractionated RT for overall survival and local control with an absolute benefit at five years of 3 and 6%, respectively. (author)

  1. Hyperhomocysteinemia, methylenetetrahydrofolate reductase c.677C>T polymorphism and risk of cancer: cross-sectional and prospective studies and meta-analyses of 75,000 cases and 93,000 controls

    DEFF Research Database (Denmark)

    Zacho, Jeppe; Yazdanyar, Shiva; Bojesen, Stig E

    2011-01-01

    from 1.0. However, in meta-analyses odds ratio for MTHFR c.677C>T homozygotes versus noncarriers were 1.07 (95% CI: 1.01-1.12) for any cancer, 1.77 (1.17-2.68) for esophagus cancer, 1.40 (1.19-1.66) for gastric cancer and 0.85 (0.77-0.94) for colorectal cancer. Increased plasma homocysteine levels...... are not associated with an increased age-adjusted risk of any cancer. However, MTHFR c.677C>T homozygosity with lifelong hyperhomocysteinemia and hence hypomethylation associate with increased risk of esophagus and gastric cancer, and with decreased risk of colorectal cancer.......Global DNA hypomethylation associates with development of cancer. DNA hypomethylation also associates with hyperhomocysteinemia and MTHFR c.677C>T homozygosity, both of which may associate with increased risk of cancer. We tested the putative association of hyperhomocysteinemia with cancer...

  2. Electroconvulsive therapy in the continuation and maintenance treatment of depression: Systematic review and meta-analyses.

    Science.gov (United States)

    Elias, Alby; Phutane, Vivek H; Clarke, Sandy; Prudic, Joan

    2018-05-01

    Acute course of electroconvulsive therapy is effective in inducing remission from depression, but recurrence rate is unacceptably high following termination of electroconvulsive therapy despite continued pharmacotherapy. Continuation electroconvulsive therapy and maintenance electroconvulsive therapy have been studied for their efficacy in preventing relapse and recurrence of depression. The purpose of this meta-analysis was to examine the efficacy of continuation electroconvulsive therapy and maintenance electroconvulsive therapy in preventing relapse and recurrence of depression in comparison to antidepressant pharmacotherapy alone. We searched MEDLINE, Embase, PsycINFO, clinicaltrials.gov and Cochrane register of controlled trials from the database inception to December 2016 without restriction on language or publication status for randomized trials of continuation electroconvulsive therapy and maintenance electroconvulsive therapy. Two independent Cochrane reviewers extracted the data in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for systematic reviews and meta-analyses. The risk of bias was assessed using four domains of the Cochrane Collaboration Risk of Bias Tool. Outcomes were pooled using random effect model. The primary outcome was relapse or recurrence of depression. Five studies involving 436 patients were included in the meta-analysis. Analysis of the pooled data showed that continuation electroconvulsive therapy and maintenance electroconvulsive therapy, both with pharmacotherapy, were associated with significantly fewer relapses and recurrences than pharmacotherapy alone at 6 months and 1 year after a successful acute course of electroconvulsive therapy (risk ratio = 0.64, 95% confidence interval = [0.41, 0.98], p = 0.04, risk ratio = 0.46, 95% confidence interval = [0.21, 0.98], p = 0.05, respectively). There was insufficient data to perform a meta-analysis of stand

  3. Estimating required information size by quantifying diversity in random-effects model meta-analyses

    DEFF Research Database (Denmark)

    Wetterslev, Jørn; Thorlund, Kristian; Brok, Jesper

    2009-01-01

    an intervention effect suggested by trials with low-risk of bias. METHODS: Information size calculations need to consider the total model variance in a meta-analysis to control type I and type II errors. Here, we derive an adjusting factor for the required information size under any random-effects model meta......-analysis. RESULTS: We devise a measure of diversity (D2) in a meta-analysis, which is the relative variance reduction when the meta-analysis model is changed from a random-effects into a fixed-effect model. D2 is the percentage that the between-trial variability constitutes of the sum of the between...... and interpreted using several simulations and clinical examples. In addition we show mathematically that diversity is equal to or greater than inconsistency, that is D2 >or= I2, for all meta-analyses. CONCLUSION: We conclude that D2 seems a better alternative than I2 to consider model variation in any random...

  4. Meta-regression analyses, meta-analyses, and trial sequential analyses of the effects of supplementation with Beta-carotene, vitamin a, and vitamin e singly or in different combinations on all-cause mortality

    DEFF Research Database (Denmark)

    Bjelakovic, Goran; Nikolova, Dimitrinka; Gluud, Christian

    2013-01-01

    Evidence shows that antioxidant supplements may increase mortality. Our aims were to assess whether different doses of beta-carotene, vitamin A, and vitamin E affect mortality in primary and secondary prevention randomized clinical trials with low risk of bias.......Evidence shows that antioxidant supplements may increase mortality. Our aims were to assess whether different doses of beta-carotene, vitamin A, and vitamin E affect mortality in primary and secondary prevention randomized clinical trials with low risk of bias....

  5. Ain't necessarily so: review and critique of recent meta-analyses of behavioral medicine interventions in health psychology.

    Science.gov (United States)

    Coyne, James C; Thombs, Brett D; Hagedoorn, Mariet

    2010-03-01

    We examined four meta-analyses of behavioral interventions for adults (Dixon, Keefe, Scipio, Perri, & Abernethy, 2007; Hoffman, Papas, Chatkoff, & Kerns, 2007; Irwin, Cole, & Nicassio, 2006; and Jacobsen, Donovan, Vadaparampil, & Small, 2007) that have appeared in the Evidence Based Treatment Reviews section of Health Psychology. Narrative review. We applied the following criteria to each meta-analysis: (1) whether each meta-analysis was described accurately, adequately, and transparently in the article; (2) whether there was an adequate attempt to deal with methodological quality of the original trials; (3) the extent to which the meta-analysis depended on small, underpowered studies; and (4) the extent to which the meta-analysis provided valid and useful evidence-based recommendations. Across the four meta-analyses, we identified substantial problems with the transparency and completeness with which these meta-analyses were reported, as well as a dependence on small, underpowered trials of generally poor quality. Results of our exercise raise questions about the clinical validity and utility of the conclusions of these meta-analyses. Results should serve as a wake up call to prospective authors, reviewers, and end-users of meta-analyses now appearing in the literature. Copyright 2010 APA, all rights reserved.

  6. Methodological Quality Assessment of Meta-analyses in Endodontics.

    Science.gov (United States)

    Kattan, Sereen; Lee, Su-Min; Kohli, Meetu R; Setzer, Frank C; Karabucak, Bekir

    2018-01-01

    The objectives of this review were to assess the methodological quality of published meta-analyses related to endodontics using the assessment of multiple systematic reviews (AMSTAR) tool and to provide a follow-up to previously published reviews. Three electronic databases were searched for eligible studies according to the inclusion and exclusion criteria: Embase via Ovid, The Cochrane Library, and Scopus. The electronic search was amended by a hand search of 6 dental journals (International Endodontic Journal; Journal of Endodontics; Australian Endodontic Journal; Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology; Endodontics and Dental Traumatology; and Journal of Dental Research). The searches were conducted to include articles published after July 2009, and the deadline for inclusion of the meta-analyses was November 30, 2016. The AMSTAR assessment tool was used to evaluate the methodological quality of all included studies. A total of 36 reports of meta-analyses were included. The overall quality of the meta-analyses reports was found to be medium, with an estimated mean overall AMSTAR score of 7.25 (95% confidence interval, 6.59-7.90). The most poorly assessed areas were providing an a priori design, the assessment of the status of publication, and publication bias. In recent publications in the field of endodontics, the overall quality of the reported meta-analyses is medium according to AMSTAR. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  7. Surrogate endpoints for overall survival in chemotherapy and radiotherapy trials in operable and locally advanced lung cancer: a re-analysis of meta-analyses of individual patients' data

    NARCIS (Netherlands)

    Mauguen, Audrey; Pignon, Jean-Pierre; Burdett, Sarah; Domerg, Caroline; Fisher, David; Paulus, Rebecca; Mandrekar, Samithra J.; Belani, Chandra P.; Shepherd, Frances A.; Eisen, Tim; Pang, Herbert; Collette, Laurence; Sause, William T.; Dahlberg, Suzanne E.; Crawford, Jeffrey; O'Brien, Mary; Schild, Steven E.; Parmar, Mahesh; Tierney, Jayne F.; Le Pechoux, Cécile; Michiels, Stefan; Burdett, S.; Fisher, D.; Le Péchoux, C.; Mauguen, A.; Michiels, S.; Pignon, J. P.; Tierney, J. F.; Belani, C. P.; Collette, L.; Dahlberg, S.; Eisen, T.; Mandrekar, S.; O'Brien, M.; Parmar, M.; Pang, H.; Paulus, R.; Crawford, J.; Sause, W.; Schild, S. E.; Shepherd, F.; Arriagada, R.; Atagi, S.; Auperin, A.; Ball, D.; Baumann, M.; Behrendt, K.; Belderbos, J.; Koning, C. C. E.; Uitterhoeve, A.

    2013-01-01

    The gold standard endpoint in clinical trials of chemotherapy and radiotherapy for lung cancer is overall survival. Although reliable and simple to measure, this endpoint takes years to observe. Surrogate endpoints that would enable earlier assessments of treatment effects would be useful. We

  8. Reporting of Positive Results in Randomized Controlled Trials of Mindfulness-Based Mental Health Interventions.

    Directory of Open Access Journals (Sweden)

    Stephanie Coronado-Montoya

    Full Text Available A large proportion of mindfulness-based therapy trials report statistically significant results, even in the context of very low statistical power. The objective of the present study was to characterize the reporting of "positive" results in randomized controlled trials of mindfulness-based therapy. We also assessed mindfulness-based therapy trial registrations for indications of possible reporting bias and reviewed recent systematic reviews and meta-analyses to determine whether reporting biases were identified.CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS databases were searched for randomized controlled trials of mindfulness-based therapy. The number of positive trials was described and compared to the number that might be expected if mindfulness-based therapy were similarly effective compared to individual therapy for depression. Trial registries were searched for mindfulness-based therapy registrations. CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS were also searched for mindfulness-based therapy systematic reviews and meta-analyses.108 (87% of 124 published trials reported ≥1 positive outcome in the abstract, and 109 (88% concluded that mindfulness-based therapy was effective, 1.6 times greater than the expected number of positive trials based on effect size d = 0.55 (expected number positive trials = 65.7. Of 21 trial registrations, 13 (62% remained unpublished 30 months post-trial completion. No trial registrations adequately specified a single primary outcome measure with time of assessment. None of 36 systematic reviews and meta-analyses concluded that effect estimates were overestimated due to reporting biases.The proportion of mindfulness-based therapy trials with statistically significant results may overstate what would occur in practice.

  9. Publication bias in dermatology systematic reviews and meta-analyses.

    Science.gov (United States)

    Atakpo, Paul; Vassar, Matt

    2016-05-01

    Systematic reviews and meta-analyses in dermatology provide high-level evidence for clinicians and policy makers that influence clinical decision making and treatment guidelines. One methodological problem with systematic reviews is the under representation of unpublished studies. This problem is due in part to publication bias. Omission of statistically non-significant data from meta-analyses may result in overestimation of treatment effect sizes which may lead to clinical consequences. Our goal was to assess whether systematic reviewers in dermatology evaluate and report publication bias. Further, we wanted to conduct our own evaluation of publication bias on meta-analyses that failed to do so. Our study considered systematic reviews and meta-analyses from ten dermatology journals from 2006 to 2016. A PubMed search was conducted, and all full-text articles that met our inclusion criteria were retrieved and coded by the primary author. 293 articles were included in our analysis. Additionally, we formally evaluated publication bias in meta-analyses that failed to do so using trim and fill and cumulative meta-analysis by precision methods. Publication bias was mentioned in 107 articles (36.5%) and was formally evaluated in 64 articles (21.8%). Visual inspection of a funnel plot was the most common method of evaluating publication bias. Publication bias was present in 45 articles (15.3%), not present in 57 articles (19.5%) and not determined in 191 articles (65.2%). Using the trim and fill method, 7 meta-analyses (33.33%) showed evidence of publication bias. Although the trim and fill method only found evidence of publication bias in 7 meta-analyses, the cumulative meta-analysis by precision method found evidence of publication bias in 15 meta-analyses (71.4%). Many of the reviews in our study did not mention or evaluate publication bias. Further, of the 42 articles that stated following PRISMA reporting guidelines, 19 (45.2%) evaluated for publication bias. In

  10. Features of Computer-Based Decision Aids: Systematic Review, Thematic Synthesis, and Meta-Analyses.

    Science.gov (United States)

    Syrowatka, Ania; Krömker, Dörthe; Meguerditchian, Ari N; Tamblyn, Robyn

    2016-01-26

    Patient information and education, such as decision aids, are gradually moving toward online, computer-based environments. Considerable research has been conducted to guide content and presentation of decision aids. However, given the relatively new shift to computer-based support, little attention has been given to how multimedia and interactivity can improve upon paper-based decision aids. The first objective of this review was to summarize published literature into a proposed classification of features that have been integrated into computer-based decision aids. Building on this classification, the second objective was to assess whether integration of specific features was associated with higher-quality decision making. Relevant studies were located by searching MEDLINE, Embase, CINAHL, and CENTRAL databases. The review identified studies that evaluated computer-based decision aids for adults faced with preference-sensitive medical decisions and reported quality of decision-making outcomes. A thematic synthesis was conducted to develop the classification of features. Subsequently, meta-analyses were conducted based on standardized mean differences (SMD) from randomized controlled trials (RCTs) that reported knowledge or decisional conflict. Further subgroup analyses compared pooled SMDs for decision aids that incorporated a specific feature to other computer-based decision aids that did not incorporate the feature, to assess whether specific features improved quality of decision making. Of 3541 unique publications, 58 studies met the target criteria and were included in the thematic synthesis. The synthesis identified six features: content control, tailoring, patient narratives, explicit values clarification, feedback, and social support. A subset of 26 RCTs from the thematic synthesis was used to conduct the meta-analyses. As expected, computer-based decision aids performed better than usual care or alternative aids; however, some features performed better than

  11. Features of Computer-Based Decision Aids: Systematic Review, Thematic Synthesis, and Meta-Analyses

    Science.gov (United States)

    Krömker, Dörthe; Meguerditchian, Ari N; Tamblyn, Robyn

    2016-01-01

    Background Patient information and education, such as decision aids, are gradually moving toward online, computer-based environments. Considerable research has been conducted to guide content and presentation of decision aids. However, given the relatively new shift to computer-based support, little attention has been given to how multimedia and interactivity can improve upon paper-based decision aids. Objective The first objective of this review was to summarize published literature into a proposed classification of features that have been integrated into computer-based decision aids. Building on this classification, the second objective was to assess whether integration of specific features was associated with higher-quality decision making. Methods Relevant studies were located by searching MEDLINE, Embase, CINAHL, and CENTRAL databases. The review identified studies that evaluated computer-based decision aids for adults faced with preference-sensitive medical decisions and reported quality of decision-making outcomes. A thematic synthesis was conducted to develop the classification of features. Subsequently, meta-analyses were conducted based on standardized mean differences (SMD) from randomized controlled trials (RCTs) that reported knowledge or decisional conflict. Further subgroup analyses compared pooled SMDs for decision aids that incorporated a specific feature to other computer-based decision aids that did not incorporate the feature, to assess whether specific features improved quality of decision making. Results Of 3541 unique publications, 58 studies met the target criteria and were included in the thematic synthesis. The synthesis identified six features: content control, tailoring, patient narratives, explicit values clarification, feedback, and social support. A subset of 26 RCTs from the thematic synthesis was used to conduct the meta-analyses. As expected, computer-based decision aids performed better than usual care or alternative aids; however

  12. Altered Brain Activity in Unipolar Depression Revisited: Meta-analyses of Neuroimaging Studies.

    Science.gov (United States)

    Müller, Veronika I; Cieslik, Edna C; Serbanescu, Ilinca; Laird, Angela R; Fox, Peter T; Eickhoff, Simon B

    2017-01-01

    During the past 20 years, numerous neuroimaging experiments have investigated aberrant brain activation during cognitive and emotional processing in patients with unipolar depression (UD). The results of those investigations, however, vary considerably; moreover, previous meta-analyses also yielded inconsistent findings. To readdress aberrant brain activation in UD as evidenced by neuroimaging experiments on cognitive and/or emotional processing. Neuroimaging experiments published from January 1, 1997, to October 1, 2015, were identified by a literature search of PubMed, Web of Science, and Google Scholar using different combinations of the terms fMRI (functional magnetic resonance imaging), PET (positron emission tomography), neural, major depression, depression, major depressive disorder, unipolar depression, dysthymia, emotion, emotional, affective, cognitive, task, memory, working memory, inhibition, control, n-back, and Stroop. Neuroimaging experiments (using fMRI or PET) reporting whole-brain results of group comparisons between adults with UD and healthy control individuals as coordinates in a standard anatomic reference space and using an emotional or/and cognitive challenging task were selected. Coordinates reported to show significant activation differences between UD and healthy controls during emotional or cognitive processing were extracted. By using the revised activation likelihood estimation algorithm, different meta-analyses were calculated. Meta-analyses tested for brain regions consistently found to show aberrant brain activation in UD compared with controls. Analyses were calculated across all emotional processing experiments, all cognitive processing experiments, positive emotion processing, negative emotion processing, experiments using emotional face stimuli, experiments with a sex discrimination task, and memory processing. All meta-analyses were calculated across experiments independent of reporting an increase or decrease of activity in

  13. Systematic review and meta-analyses of psychosocial interventions for veterans of the military

    Directory of Open Access Journals (Sweden)

    Neil J. Kitchiner

    2012-12-01

    Full Text Available Background: The efficacy of psychosocial therapies for common mental health disorders in veterans is unclear and requires further examination. Method: Systematic review and meta-analyses of randomised controlled trials (RCTs. Twenty databases were searched. Studies were included if they reported a psychosocial intervention designed to treat or reduce common mental health symptoms in veterans identified as being symptomatic at the time they entered the study. Studies of substance dependency disorders and psychosis were excluded. Eligible studies were assessed against methodological quality criteria and data were extracted and analysed. Results: Twenty-nine RCTs were identified. There was evidence for the use of trauma-focused therapies for post-traumatic stress disorder (PTSD and some evidence for psychological interventions in the treatment of borderline personality disorder, depression, insomnia, and panic disorder co-morbid to PTSD. However, methodological quality of many of the studies was less than optimal. Conclusions: Trauma-focused psychological therapies are likely to be effective for combat-related PTSD but there is a need for more research to determine the efficacy of psychological treatments for other mental health disorders in veterans.

  14. Disagreements in meta-analyses using outcomes measured on continuous or rating scales: observer agreement study

    DEFF Research Database (Denmark)

    Tendal, Britta; Higgins, Julian P T; Jüni, Peter

    2009-01-01

    difference (SMD), the protocols for the reviews and the trial reports (n=45) were retrieved. DATA EXTRACTION: Five experienced methodologists and five PhD students independently extracted data from the trial reports for calculation of the first SMD result in each review. The observers did not have access...... to the reviews but to the protocols, where the relevant outcome was highlighted. The agreement was analysed at both trial and meta-analysis level, pairing the observers in all possible ways (45 pairs, yielding 2025 pairs of trials and 450 pairs of meta-analyses). Agreement was defined as SMDs that differed less...... than 0.1 in their point estimates or confidence intervals. RESULTS: The agreement was 53% at trial level and 31% at meta-analysis level. Including all pairs, the median disagreement was SMD=0.22 (interquartile range 0.07-0.61). The experts agreed somewhat more than the PhD students at trial level (61...

  15. Effects of parenting interventions for at-risk parents with infants: a systematic review and meta-analyses.

    Science.gov (United States)

    Rayce, Signe B; Rasmussen, Ida S; Klest, Sihu K; Patras, Joshua; Pontoppidan, Maiken

    2017-12-27

    Infancy is a critical stage of life, and a secure relationship with caring and responsive caregivers is crucial for healthy infant development. Early parenting interventions aim to support families in which infants are at risk of developmental harm. Our objective is to systematically review the effects of parenting interventions on child development and on parent-child relationship for at-risk families with infants aged 0-12 months. This is a systematic review and meta-analyses. We extracted publications from 10 databases in June 2013, January 2015 and June 2016, and supplemented with grey literature and hand search. We assessed risk of bias, calculated effect sizes and conducted meta-analyses. (1) Randomised controlled trials of structured psychosocial interventions offered to at-risk families with infants aged 0-12 months in Western Organisation for Economic Co-operation and Development (OECD) countries, (2) interventions with a minimum of three sessions and at least half of these delivered postnatally and (3) outcomes reported for child development or parent-child relationship. Sixteen studies were included. Meta-analyses were conducted on seven outcomes represented in 13 studies. Parenting interventions significantly improved child behaviour ( d =0.14; 95% CI 0.03 to 0.26), parent-child relationship ( d =0.44; 95% CI 0.09 to 0.80) and maternal sensitivity ( d =0.46; 95% CI 0.26 to 0.65) postintervention. There were no significant effects on cognitive development ( d= 0.13; 95% CI -0.08 to 0.41), internalising behaviour ( d= 0.16; 95% CI -0.03 to 0.33) or externalising behaviour ( d= 0.16; 95% CI -0.01 to 0.30) post-intervention. At long-term follow-up we found no significant effect on child behaviour ( d= 0.15; 95% CI -0.03 to 0.31). Interventions offered to at-risk families in the first year of the child's life appear to improve child behaviour, parent-child relationship and maternal sensitivity post-intervention, but not child cognitive

  16. Identifying null meta-analyses that are ripe for updating

    Directory of Open Access Journals (Sweden)

    Fang Manchun

    2003-07-01

    Full Text Available Abstract Background As an increasingly large number of meta-analyses are published, quantitative methods are needed to help clinicians and systematic review teams determine when meta-analyses are not up to date. Methods We propose new methods for determining when non-significant meta-analytic results might be overturned, based on a prediction of the number of participants required in new studies. To guide decision making, we introduce the "new participant ratio", the ratio of the actual number of participants in new studies to the predicted number required to obtain statistical significance. A simulation study was conducted to study the performance of our methods and a real meta-analysis provides further evidence. Results In our three simulation configurations, our diagnostic test for determining whether a meta-analysis is out of date had sensitivity of 55%, 62%, and 49% with corresponding specificity of 85%, 80%, and 90% respectively. Conclusions Simulations suggest that our methods are able to detect out-of-date meta-analyses. These quick and approximate methods show promise for use by systematic review teams to help decide whether to commit the considerable resources required to update a meta-analysis. Further investigation and evaluation of the methods is required before they can be recommended for general use.

  17. Preferred Reporting Items for Systematic Review and Meta-Analyses of individual participant data: the PRISMA-IPD Statement.

    Science.gov (United States)

    Stewart, Lesley A; Clarke, Mike; Rovers, Maroeska; Riley, Richard D; Simmonds, Mark; Stewart, Gavin; Tierney, Jayne F

    2015-04-28

    Systematic reviews and meta-analyses of individual participant data (IPD) aim to collect, check, and reanalyze individual-level data from all studies addressing a particular research question and are therefore considered a gold standard approach to evidence synthesis. They are likely to be used with increasing frequency as current initiatives to share clinical trial data gain momentum and may be particularly important in reviewing controversial therapeutic areas. To develop PRISMA-IPD as a stand-alone extension to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Statement, tailored to the specific requirements of reporting systematic reviews and meta-analyses of IPD. Although developed primarily for reviews of randomized trials, many items will apply in other contexts, including reviews of diagnosis and prognosis. Development of PRISMA-IPD followed the EQUATOR Network framework guidance and used the existing standard PRISMA Statement as a starting point to draft additional relevant material. A web-based survey informed discussion at an international workshop that included researchers, clinicians, methodologists experienced in conducting systematic reviews and meta-analyses of IPD, and journal editors. The statement was drafted and iterative refinements were made by the project, advisory, and development groups. The PRISMA-IPD Development Group reached agreement on the PRISMA-IPD checklist and flow diagram by consensus. Compared with standard PRISMA, the PRISMA-IPD checklist includes 3 new items that address (1) methods of checking the integrity of the IPD (such as pattern of randomization, data consistency, baseline imbalance, and missing data), (2) reporting any important issues that emerge, and (3) exploring variation (such as whether certain types of individual benefit more from the intervention than others). A further additional item was created by reorganization of standard PRISMA items relating to interpreting results. Wording

  18. Psychological interventions for the management of glycemic and psychological outcomes of type 2 diabetes mellitus in China: A systematic review and meta-analyses of randomized controlled trials

    OpenAIRE

    Anna eChapman; Anna eChapman; Shuo eLiu; Stephanie eMerkouris; Stephanie eMerkouris; Joanne C Enticott; Joanne C Enticott; Hui eYang; Colette Joy Browning; Colette Joy Browning; Shane Andrew Thomas

    2015-01-01

    IntroductionChina has the largest number of type 2 diabetes mellitus (T2DM) cases globally and T2DM management has become a critical public health issue in China. Individuals with T2DM have an increased risk of developing mental health disorders, psychological disturbances and functional problems associated with living with their condition. Previous systematic reviews have demonstrated that, generally, psychological interventions are effective in the management of T2DM related outcomes; howev...

  19. Manual therapy for unsettled, distressed and excessively crying infants: a systematic review and meta-analyses.

    Science.gov (United States)

    Carnes, Dawn; Plunkett, Austin; Ellwood, Julie; Miles, Clare

    2018-01-24

    To conduct a systematic review and meta-analyses to assess the effect of manual therapy interventions for healthy but unsettled, distressed and excessively crying infants and to provide information to help clinicians and parents inform decisions about care. We reviewed published peer-reviewed primary research articles in the last 26 years from nine databases (Medline Ovid, Embase, Web of Science, Physiotherapy Evidence Database, Osteopathic Medicine Digital Repository , Cochrane (all databases), Index of Chiropractic Literature, Open Access Theses and Dissertations and Cumulative Index to Nursing and Allied Health Literature). Our inclusion criteria were: manual therapy (by regulated or registered professionals) of unsettled, distressed and excessively crying infants who were otherwise healthy and treated in a primary care setting. Outcomes of interest were: crying, feeding, sleep, parent-child relations, parent experience/satisfaction and parent-reported global change. Nineteen studies were selected for full review: seven randomised controlled trials, seven case series, three cohort studies, one service evaluation study and one qualitative study.We found moderate strength evidence for the effectiveness of manual therapy on: reduction in crying time (favourable: -1.27 hours per day (95% CI -2.19 to -0.36)), sleep (inconclusive), parent-child relations (inconclusive) and global improvement (no effect). The risk of reported adverse events was low: seven non-serious events per 1000 infants exposed to manual therapy (n=1308) and 110 per 1000 in those not exposed. Some small benefits were found, but whether these are meaningful to parents remains unclear as does the mechanisms of action. Manual therapy appears relatively safe. CRD42016037353. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  20. Effect of Risk of Bias on the Effect Size of Meta-Analytic Estimates in Randomized Controlled Trials in Periodontology and Implant Dentistry

    Science.gov (United States)

    Faggion, Clovis Mariano; Wu, Yun-Chun; Scheidgen, Moritz; Tu, Yu-Kang

    2015-01-01

    Background Risk of bias (ROB) may threaten the internal validity of a clinical trial by distorting the magnitude of treatment effect estimates, although some conflicting information on this assumption exists. Objective The objective of this study was evaluate the effect of ROB on the magnitude of treatment effect estimates in randomized controlled trials (RCTs) in periodontology and implant dentistry. Methods A search for Cochrane systematic reviews (SRs), including meta-analyses of RCTs published in periodontology and implant dentistry fields, was performed in the Cochrane Library in September 2014. Random-effect meta-analyses were performed by grouping RCTs with different levels of ROBs in three domains (sequence generation, allocation concealment, and blinding of outcome assessment). To increase power and precision, only SRs with meta-analyses including at least 10 RCTs were included. Meta-regression was performed to investigate the association between ROB characteristics and the magnitudes of intervention effects in the meta-analyses. Results Of the 24 initially screened SRs, 21 SRs were excluded because they did not include at least 10 RCTs in the meta-analyses. Three SRs (two from periodontology field) generated information for conducting 27 meta-analyses. Meta-regression did not reveal significant differences in the relationship of the ROB level with the size of treatment effect estimates, although a trend for inflated estimates was observed in domains with unclear ROBs. Conclusion In this sample of RCTs, high and (mainly) unclear risks of selection and detection biases did not seem to influence the size of treatment effect estimates, although several confounders might have influenced the strength of the association. PMID:26422698

  1. Meta-analyses of the 5-HTTLPR polymorphisms and post-traumatic stress disorder.

    Science.gov (United States)

    Navarro-Mateu, Fernando; Escámez, Teresa; Koenen, Karestan C; Alonso, Jordi; Sánchez-Meca, Julio

    2013-01-01

    To conduct a meta-analysis of all published genetic association studies of 5-HTTLPR polymorphisms performed in PTSD cases. Potential studies were identified through PubMed/MEDLINE, EMBASE, Web of Science databases (Web of Knowledge, WoK), PsychINFO, PsychArticles and HuGeNet (Human Genome Epidemiology Network) up until December 2011. Published observational studies reporting genotype or allele frequencies of this genetic factor in PTSD cases and in non-PTSD controls were all considered eligible for inclusion in this systematic review. Two reviewers selected studies for possible inclusion and extracted data independently following a standardized protocol. A biallelic and a triallelic meta-analysis, including the total S and S' frequencies, the dominant (S+/LL and S'+/L'L') and the recessive model (SS/L+ and S'S'/L'+), was performed with a random-effect model to calculate the pooled OR and its corresponding 95% CI. Forest plots and Cochran's Q-Statistic and I(2) index were calculated to check for heterogeneity. Subgroup analyses and meta-regression were carried out to analyze potential moderators. Publication bias and quality of reporting were also analyzed. 13 studies met our inclusion criteria, providing a total sample of 1874 patients with PTSD and 7785 controls in the biallelic meta-analyses and 627 and 3524, respectively, in the triallelic. None of the meta-analyses showed evidence of an association between 5-HTTLPR and PTSD but several characteristics (exposure to the same principal stressor for PTSD cases and controls, adjustment for potential confounding variables, blind assessment, study design, type of PTSD, ethnic distribution and Total Quality Score) influenced the results in subgroup analyses and meta-regression. There was no evidence of potential publication bias. Current evidence does not support a direct effect of 5-HTTLPR polymorphisms on PTSD. Further analyses of gene-environment interactions, epigenetic modulation and new studies with large samples

  2. Airway management education: simulation based training versus non-simulation based training-A systematic review and meta-analyses.

    Science.gov (United States)

    Sun, Yanxia; Pan, Chuxiong; Li, Tianzuo; Gan, Tong J

    2017-02-01

    Simulation-based training (SBT) has become a standard for medical education. However, the efficacy of simulation based training in airway management education remains unclear. The aim of this study was to evaluate all published evidence comparing the effectiveness of SBT for airway management versus non-simulation based training (NSBT) on learner and patient outcomes. Systematic review with meta-analyses were used. Data were derived from PubMed, EMBASE, CINAHL, Scopus, the Cochrane Controlled Trials Register and Cochrane Database of Systematic Reviews from inception to May 2016. Published comparative trials that evaluated the effect of SBT on airway management training in compared with NSBT were considered. The effect sizes with 95% confidence intervals (CI) were calculated for outcomes measures. Seventeen eligible studies were included. SBT was associated with improved behavior performance [standardized mean difference (SMD):0.30, 95% CI: 0.06 to 0.54] in comparison with NSBT. However, the benefits of SBT were not seen in time-skill (SMD:-0.13, 95% CI: -0.82 to 0.52), written examination score (SMD: 0.39, 95% CI: -0.09 to 0.86) and success rate of procedure completion on patients [relative risk (RR): 1.26, 95% CI: 0.96 to 1.66]. SBT may be not superior to NSBT on airway management training.

  3. Association between rs3087243 and rs231775 polymorphism within the cytotoxic T-lymphocyte antigen 4 gene and Graves' disease: a case/control study combined with meta-analyses

    Science.gov (United States)

    Dai, Yu; Zeng, Tianshu; Xiao, Fei; Chen, Lulu; Kong, Wen

    2017-01-01

    We conducted a case/control study to assess the impact of SNP rs3087243 and rs231775 within the CTLA4 gene, on the susceptibility to Graves' disease (GD) in a Chinese Han dataset (271 cases and 298 controls). The frequency of G allele for rs3087243 and rs231775 was observed to be significantly higher in subjects with GD than in control subjects (p = 0.005 and p = 0.000, respectively). After logistic regression analysis, a significant association was detected between SNP rs3087243 and GD in the additive and recessive models. Similarly, association for the SNP rs231775 could also be detected in the additive model, dominant model and recessive model. A meta-analysis, including 27 published datasets along with the current dataset, was performed to further confirm the association. Consistent with our case/control results, rs3087243 and rs231775 showed a significant association with GD in all genetic models. Of note, ethnic stratification revealed that these two SNPs were associated with susceptibility to GD in populations of both Asian and European descent. In conclusion, our data support that the rs3087243 and rs231775 polymorphisms within the CTLA4 gene confer genetic susceptibility to GD. PMID:29299173

  4. The interrelation between hypothyroidism and glaucoma: a critical review and meta-analyses.

    Science.gov (United States)

    Thvilum, Marianne; Brandt, Frans; Brix, Thomas Heiberg; Hegedüs, Laszlo

    2017-12-01

    Data on the association between hypothyroidism and glaucoma are conflicting. We sought to shed light on this by conducting a critical review and meta-analyses. The meta-analyses were conducted in adherence with the widely accepted MOOSE guidelines. Using the Medical Subject Heading (MeSH) terms: hypothyroidism, myxoedema and glaucoma or intraocular pressure, case-control studies, cohort studies and cross-sectional studies were identified (PubMed) and reviewed. Using meta-analysis, the relative risk (RR) of coexistence of glaucoma and hypothyroidism was calculated. Based on the literature search, thirteen studies fulfilled the inclusion criteria and could be categorized into two groups based on the exposure. The designs of the studies varied considerably, and there was heterogeneity related to lack of power, weak phenotype classifications and length of follow-up. Eight studies had glaucoma (5757 patients) as exposure and hypothyroidism as outcome. Among these, we found a non-significantly increased risk of hypothyroidism associated with glaucoma (RR 1.65; 95% confidence interval [CI]: 0.97-2.82). Based on five studies (168 006 patients) with hypothyroidism as exposure and glaucoma as outcome, we found the risk of glaucoma to be significantly increased (RR 1.33; 95% CI: 1.13-1.58). Based on these meta-analyses, there seems to be an association between hypothyroidism and glaucoma, which does not seem to be the case between glaucoma and hypothyroidism. However, larger scale studies with better phenotype classification, longer follow-up and taking comorbidity and other biases into consideration are needed to address a potential causal relationship. © 2017 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  5. Variables associated with achievement in higher education: A systematic review of meta-analyses.

    Science.gov (United States)

    Schneider, Michael; Preckel, Franzis

    2017-06-01

    The last 2 decades witnessed a surge in empirical studies on the variables associated with achievement in higher education. A number of meta-analyses synthesized these findings. In our systematic literature review, we included 38 meta-analyses investigating 105 correlates of achievement, based on 3,330 effect sizes from almost 2 million students. We provide a list of the 105 variables, ordered by the effect size, and summary statistics for central research topics. The results highlight the close relation between social interaction in courses and achievement. Achievement is also strongly associated with the stimulation of meaningful learning by presenting information in a clear way, relating it to the students, and using conceptually demanding learning tasks. Instruction and communication technology has comparably weak effect sizes, which did not increase over time. Strong moderator effects are found for almost all instructional methods, indicating that how a method is implemented in detail strongly affects achievement. Teachers with high-achieving students invest time and effort in designing the microstructure of their courses, establish clear learning goals, and employ feedback practices. This emphasizes the importance of teacher training in higher education. Students with high achievement are characterized by high self-efficacy, high prior achievement and intelligence, conscientiousness, and the goal-directed use of learning strategies. Barring the paucity of controlled experiments and the lack of meta-analyses on recent educational innovations, the variables associated with achievement in higher education are generally well investigated and well understood. By using these findings, teachers, university administrators, and policymakers can increase the effectivity of higher education. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  6. Association Between the 20210G>A Prothrombin Gene Polymorphism and Arterial Ischemic Stroke in Children and Young Adults-Two Meta-analyses of 3586 Cases and 6440 Control Subjects in Total.

    Science.gov (United States)

    Sarecka-Hujar, Beata; Kopyta, Ilona; Skrzypek, Michal; Sordyl, Joanna

    2017-04-01

    Previous data have shown that the 20210G>A polymorphism of the Factor II gene is related to an increased prothrombin level, which may in turn lead to a procoagulant state. The heterogeneous and multifactorial character of arterial ischemic stroke often results in contradictory reports describing the association between the 20210G>A polymorphism and arterial ischemic stroke in different populations. We performed a meta-analysis of available data addressing the relation between the FII 20210G>A polymorphism and arterial ischemic stroke, both in young adults and children. We searched PubMed using appropriate keywords. The inclusion criteria for the study were as follows: case-control study, study population consisting of children, study population consisting of young adults, arterial ischemic stroke confirmed by magnetic resonance imaging or computed tomography, and English language. The exclusion criteria included lack of genotype or allele frequencies, study design other than a case-control study, outcome definition other than arterial ischemic stroke, and previously overlapped patient groups. Finally, 30 case-control studies (14 in children and 16 in young adults) were included. Statistical analyses were conducted using R software. Heterogeneity between the studies was evaluated using the Dersimonian and Laird's Q test. In the case of significant between-studies heterogeneity, the pooled odds ratio was estimated with a random-effects model, otherwise a fixed-effects model was used. The pooled analysis showed that carriers of 20210A allele (GA+AA genotypes) of the prothrombin gene are more common in arterial ischemic stroke patients, both in children and young adults, than in control subjects (P = 0.006; odds ratio, 1.83; 95% confidence interval, 1.19 to 2.80 and P = 0.001; odds ratio, 1.69; 95% confidence interval, 1.25 to 2.28, respectively). The results of the present meta-analysis have proven that the FII 20210G>A polymorphism is associated with arterial

  7. Efficacy and acceptability of very low energy diets in overweight and obese people with Type 2 diabetes mellitus: a systematic review with meta-analyses.

    Science.gov (United States)

    Rehackova, L; Arnott, B; Araujo-Soares, V; Adamson, A A; Taylor, R; Sniehotta, F F

    2016-05-01

    To explore the efficacy and acceptability of very low energy diets in overweight or obese adults with Type 2 diabetes. Controlled trials and qualitative studies of individuals with Type 2 diabetes that compared very low energy diets with standard care, minimal interventions, other weight loss interventions, less intensive very low energy diet interventions and very low energy diets with additional components were eligible for inclusion. Meta-analyses of changes in weight, blood glucose levels and attrition rates were performed. Acceptability of very low energy diets was assessed by attrition rates, number and severity of side effects, and by qualitative evaluations of the interventions. Four randomized, five non-randomized controlled trials and no qualitative studies (21 references, 9 studies, 346 participants) were identified. Meta-analyses showed that very low energy diets induced greater weight losses than minimal interventions, standard care or low energy diets at 3 and 6 months. No conclusive evidence for differences in outcomes between very low energy diets and Roux-en-Y gastric bypass surgery was found. Greater differences in energy prescription between intervention and comparator arms were associated with greater differences in weight loss and fasting blood glucose levels at 3 months. Attrition rates did not differ between the very low energy diets and the comparator arms at any measurement point. Very low energy diets are effective in substantial weight loss among people with Type 2 diabetes. Levels of adherence to very low energy diets in controlled studies appear to be high, although details about behaviour support provided are usually poorly described. © 2015 Diabetes UK.

  8. The Effectiveness of Smartphone Apps for Lifestyle Improvement in Noncommunicable Diseases: Systematic Review and Meta-Analyses.

    Science.gov (United States)

    Lunde, Pernille; Nilsson, Birgitta Blakstad; Bergland, Astrid; Kværner, Kari Jorunn; Bye, Asta

    2018-05-04

    Noncommunicable diseases (NCDs) account for 70% of all deaths in a year globally. The four main NCDs are cardiovascular diseases, cancers, chronic pulmonary diseases, and diabetes mellitus. Fifty percent of persons with NCD do not adhere to prescribed treatment; in fact, adherence to lifestyle interventions is especially considered as a major challenge. Smartphone apps permit structured monitoring of health parameters, as well as the opportunity to receive feedback. The aim of this study was to review and assess the effectiveness of app-based interventions, lasting at least 3 months, to promote lifestyle changes in patients with NCDs. In February 2017, a literature search in five databases (EMBASE, MEDLINE, CINAHL, Academic Research Premier, and Cochrane Reviews and Trials) was conducted. Inclusion criteria was quantitative study designs including randomized and nonrandomized controlled trials that included patients aged 18 years and older diagnosed with any of the four main NCDs. Lifestyle outcomes were physical activity, physical fitness, modification of dietary habits, and quality of life. All included studies were assessed for risk of bias using the Cochrane Collaboration`s risk of bias tool. Meta-analyses were conducted for one of the outcomes (glycated hemoglobin, HbA 1c ) by using the estimate of effect of mean post treatment with SD or CI. Heterogeneity was tested using the I 2 test. All studies included in the meta-analyses were graded. Of the 1588 records examined, 9 met the predefined criteria. Seven studies included diabetes patients only, one study included heart patients only, and another study included both diabetes and heart patients. Statistical significant effect was shown in HbA 1c in 5 of 8 studies, as well in body weight in one of 5 studies and in waist circumference in one of 3 studies evaluating these outcomes. Seven of the included studies were included in the meta-analyses and demonstrated significantly overall effect on HbA 1c on a short

  9. Conducting Meta-Analyses Based on p Values

    Science.gov (United States)

    van Aert, Robbie C. M.; Wicherts, Jelte M.; van Assen, Marcel A. L. M.

    2016-01-01

    Because of overwhelming evidence of publication bias in psychology, techniques to correct meta-analytic estimates for such bias are greatly needed. The methodology on which the p-uniform and p-curve methods are based has great promise for providing accurate meta-analytic estimates in the presence of publication bias. However, in this article, we show that in some situations, p-curve behaves erratically, whereas p-uniform may yield implausible estimates of negative effect size. Moreover, we show that (and explain why) p-curve and p-uniform result in overestimation of effect size under moderate-to-large heterogeneity and may yield unpredictable bias when researchers employ p-hacking. We offer hands-on recommendations on applying and interpreting results of meta-analyses in general and p-uniform and p-curve in particular. Both methods as well as traditional methods are applied to a meta-analysis on the effect of weight on judgments of importance. We offer guidance for applying p-uniform or p-curve using R and a user-friendly web application for applying p-uniform. PMID:27694466

  10. The Limited Informativeness of Meta-Analyses of Media Effects.

    Science.gov (United States)

    Valkenburg, Patti M

    2015-09-01

    In this issue of Perspectives on Psychological Science, Christopher Ferguson reports on a meta-analysis examining the relationship between children's video game use and several outcome variables, including aggression and attention deficit symptoms (Ferguson, 2015, this issue). In this commentary, I compare Ferguson's nonsignificant effects sizes with earlier meta-analyses on the same topics that yielded larger, significant effect sizes. I argue that Ferguson's choice for partial effects sizes is unjustified on both methodological and theoretical grounds. I then plead for a more constructive debate on the effects of violent video games on children and adolescents. Until now, this debate has been dominated by two camps with diametrically opposed views on the effects of violent media on children. However, even the earliest media effects studies tell us that children can react quite differently to the same media content. Thus, if researchers truly want to understand how media affect children, rather than fight for the presence or absence of effects, they need to adopt a perspective that takes differential susceptibility to media effects more seriously. © The Author(s) 2015.

  11. Weighing Evidence "Steampunk" Style via the Meta-Analyser.

    Science.gov (United States)

    Bowden, Jack; Jackson, Chris

    2016-10-01

    The funnel plot is a graphical visualization of summary data estimates from a meta-analysis, and is a useful tool for detecting departures from the standard modeling assumptions. Although perhaps not widely appreciated, a simple extension of the funnel plot can help to facilitate an intuitive interpretation of the mathematics underlying a meta-analysis at a more fundamental level, by equating it to determining the center of mass of a physical system. We used this analogy to explain the concepts of weighing evidence and of biased evidence to a young audience at the Cambridge Science Festival, without recourse to precise definitions or statistical formulas and with a little help from Sherlock Holmes! Following on from the science fair, we have developed an interactive web-application (named the Meta-Analyser) to bring these ideas to a wider audience. We envisage that our application will be a useful tool for researchers when interpreting their data. First, to facilitate a simple understanding of fixed and random effects modeling approaches; second, to assess the importance of outliers; and third, to show the impact of adjusting for small study bias. This final aim is realized by introducing a novel graphical interpretation of the well-known method of Egger regression.

  12. Meta-Analyses of Predictors of Hope in Adolescents.

    Science.gov (United States)

    Yarcheski, Adela; Mahon, Noreen E

    2016-03-01

    The purposes of this study were to identify predictors of hope in the literature reviewed, to use meta-analysis to determine the mean effect size (ES) across studies between each predictor and hope, and to examine four moderators on each predictor-hope relationship. Using preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines for the literature reviewed, 77 published studies or doctoral dissertations completed between 1990 and 2012 met the inclusion criteria. Eleven predictors of hope were identified and each predictor in relation to hope was subjected to meta-analysis. Five predictors (positive affect, life satisfaction, optimism, self-esteem, and social support) of hope had large mean ESs, 1 predictor (depression) had a medium ES, 4 predictors (negative affect, stress, academic achievement, and violence) had small ESs, and 1 predictor (gender) had a trivial ES. Findings are interpreted for the 11 predictors in relation to hope. Limitations and conclusions are addressed; future studies are recommended. © The Author(s) 2014.

  13. Meta-analyses of the 5-HTTLPR polymorphisms and post-traumatic stress disorder.

    Directory of Open Access Journals (Sweden)

    Fernando Navarro-Mateu

    Full Text Available OBJECTIVE: To conduct a meta-analysis of all published genetic association studies of 5-HTTLPR polymorphisms performed in PTSD cases. METHODS DATA SOURCES: Potential studies were identified through PubMed/MEDLINE, EMBASE, Web of Science databases (Web of Knowledge, WoK, PsychINFO, PsychArticles and HuGeNet (Human Genome Epidemiology Network up until December 2011. STUDY SELECTION: Published observational studies reporting genotype or allele frequencies of this genetic factor in PTSD cases and in non-PTSD controls were all considered eligible for inclusion in this systematic review. DATA EXTRACTION: Two reviewers selected studies for possible inclusion and extracted data independently following a standardized protocol. STATISTICAL ANALYSIS: A biallelic and a triallelic meta-analysis, including the total S and S' frequencies, the dominant (S+/LL and S'+/L'L' and the recessive model (SS/L+ and S'S'/L'+, was performed with a random-effect model to calculate the pooled OR and its corresponding 95% CI. Forest plots and Cochran's Q-Statistic and I(2 index were calculated to check for heterogeneity. Subgroup analyses and meta-regression were carried out to analyze potential moderators. Publication bias and quality of reporting were also analyzed. RESULTS: 13 studies met our inclusion criteria, providing a total sample of 1874 patients with PTSD and 7785 controls in the biallelic meta-analyses and 627 and 3524, respectively, in the triallelic. None of the meta-analyses showed evidence of an association between 5-HTTLPR and PTSD but several characteristics (exposure to the same principal stressor for PTSD cases and controls, adjustment for potential confounding variables, blind assessment, study design, type of PTSD, ethnic distribution and Total Quality Score influenced the results in subgroup analyses and meta-regression. There was no evidence of potential publication bias. CONCLUSIONS: Current evidence does not support a direct effect of 5-HTTLPR

  14. Suicidality and aggression during antidepressant treatment: systematic review and meta-analyses based on clinical study reports.

    Science.gov (United States)

    Sharma, Tarang; Guski, Louise Schow; Freund, Nanna; Gøtzsche, Peter C

    2016-01-27

    To study serious harms associated with selective serotonin and serotonin-norepinephrine reuptake inhibitors.Design Systematic review and meta-analysis. Mortality and suicidality. Secondary outcomes were aggressive behaviour and akathisia. Clinical study reports for duloxetine, fluoxetine, paroxetine, sertraline, and venlafaxine obtained from the European and UK drug regulators, and summary trial reports for duloxetine and fluoxetine from Eli Lilly's website. Double blind placebo controlled trials that contained any patient narratives or individual patient listings of harms. Two researchers extracted data independently; the outcomes were meta-analysed by Peto's exact method (fixed effect model). We included 70 trials (64,381 pages of clinical study reports) with 18,526 patients. These trials had limitations in the study design and discrepancies in reporting, which may have led to serious under-reporting of harms. For example, some outcomes appeared only in individual patient listings in appendices, which we had for only 32 trials, and we did not have case report forms for any of the trials. Differences in mortality (all deaths were in adults, odds ratio 1.28, 95% confidence interval 0.40 to 4.06), suicidality (1.21, 0.84 to 1.74), and akathisia (2.04, 0.93 to 4.48) were not significant, whereas patients taking antidepressants displayed more aggressive behaviour (1.93, 1.26 to 2.95). For adults, the odds ratios were 0.81 (0.51 to 1.28) for suicidality, 1.09 (0.55 to 2.14) for aggression, and 2.00 (0.79 to 5.04) for akathisia. The corresponding values for children and adolescents were 2.39 (1.31 to 4.33), 2.79 (1.62 to 4.81), and 2.15 (0.48 to 9.65). In the summary trial reports on Eli Lilly's website, almost all deaths were noted, but all suicidal ideation events were missing, and the information on the remaining outcomes was incomplete. Because of the shortcomings identified and having only partial access to appendices with no access to case report forms, the harms

  15. Network meta-analysis incorporating randomized controlled trials and non-randomized comparative cohort studies for assessing the safety and effectiveness of medical treatments: challenges and opportunities

    OpenAIRE

    Cameron, Chris; Fireman, Bruce; Hutton, Brian; Clifford, Tammy; Coyle, Doug; Wells, George; Dormuth, Colin R.; Platt, Robert; Toh, Sengwee

    2015-01-01

    Network meta-analysis is increasingly used to allow comparison of multiple treatment alternatives simultaneously, some of which may not have been compared directly in primary research studies. The majority of network meta-analyses published to date have incorporated data from randomized controlled trials (RCTs) only; however, inclusion of non-randomized studies may sometimes be considered. Non-randomized studies can complement RCTs or address some of their limitations, such as short follow-up...

  16. Sleep Characteristics in Children with Attention Deficit Hyperactivity Disorder: Systematic Review and Meta-Analyses.

    Science.gov (United States)

    Díaz-Román, Amparo; Hita-Yáñez, Eva; Buela-Casal, Gualberto

    2016-05-15

    Sleep disturbances have been associated with attention deficit hyperactivity disorder (ADHD), but such relationship is still unclear. The results from the studies conducted do not provide enough evidence to support a sleep physiology inherent to ADHD. This study tries to determine if that sleep physiology really exists by comparing children with ADHD and control children in some sleep parameters. A search was conducted in several databases (Web of Science, Scopus, Pubmed and PsycINFO), and a manual search, to retrieve all the articles available from 1987 until March 2014. Of 8,678 non-duplicate studies retrieved, 11 studies met the inclusion and methodological quality criteria. Two meta-analyses were performed with eight of those studies, depending on data provided by them: polysomnographic or actigraphic. A fixed-effects model, and the standardized mean difference (SMD) as the index of effect size, were used in both meta-analyses. Significant differences were found only in the meta-analysis with polysomnography as outcome. Children with ADHD were found to spend more time in stage 1 sleep than controls (pooled SMD = 0.32, 95% CI = 0.08-0.55, p value = 0.009). Although few differences in sleep between children with ADHD and controls have been found in this review, further studies are required on this matter. Those studies should consider some variables discussed in this review, in order to obtain useful and reliable conclusions for research and clinical practice. Particularly, the influence of assessment criteria and ADHD subtypes in the sleep characteristics of children with ADHD should be addressed. © 2016 American Academy of Sleep Medicine.

  17. Methodologic quality of meta-analyses and systematic reviews on the Mediterranean diet and cardiovascular disease outcomes: a review.

    Science.gov (United States)

    Huedo-Medina, Tania B; Garcia, Marissa; Bihuniak, Jessica D; Kenny, Anne; Kerstetter, Jane

    2016-03-01

    Several systematic reviews/meta-analyses published within the past 10 y have examined the associations of Mediterranean-style diets (MedSDs) on cardiovascular disease (CVD) risk. However, these reviews have not been evaluated for satisfying contemporary methodologic quality standards. This study evaluated the quality of recent systematic reviews/meta-analyses on MedSD and CVD risk outcomes by using an established methodologic quality scale. The relation between review quality and impact per publication value of the journal in which the article had been published was also evaluated. To assess compliance with current standards, we applied a modified version of the Assessment of Multiple Systematic Reviews (AMSTARMedSD) quality scale to systematic reviews/meta-analyses retrieved from electronic databases that had met our selection criteria: 1) used systematic or meta-analytic procedures to review the literature, 2) examined MedSD trials, and 3) had MedSD interventions independently or combined with other interventions. Reviews completely satisfied from 8% to 75% of the AMSTARMedSD items (mean ± SD: 31.2% ± 19.4%), with those published in higher-impact journals having greater quality scores. At a minimum, 60% of the 24 reviews did not disclose full search details or apply appropriate statistical methods to combine study findings. Only 5 of the reviews included participant or study characteristics in their analyses, and none evaluated MedSD diet characteristics. These data suggest that current meta-analyses/systematic reviews evaluating the effect of MedSD on CVD risk do not fully comply with contemporary methodologic quality standards. As a result, there are more research questions to answer to enhance our understanding of how MedSD affects CVD risk or how these effects may be modified by the participant or MedSD characteristics. To clarify the associations between MedSD and CVD risk, future meta-analyses and systematic reviews should not only follow methodologic

  18. Comment on: "Cell Therapy for Heart Disease: Trial Sequential Analyses of Two Cochrane Reviews"

    DEFF Research Database (Denmark)

    Castellini, Greta; Nielsen, Emil Eik; Gluud, Christian

    2017-01-01

    Trial Sequential Analysis is a frequentist method to help researchers control the risks of random errors in meta-analyses (1). Fisher and colleagues used Trial Sequential Analysis on cell therapy for heart diseases (2). The present article discusses the usefulness of Trial Sequential Analysis and...

  19. Comprehensive research synopsis and systematic meta-analyses in Parkinson's disease genetics: The PDGene database.

    Directory of Open Access Journals (Sweden)

    Christina M Lill

    Full Text Available More than 800 published genetic association studies have implicated dozens of potential risk loci in Parkinson's disease (PD. To facilitate the interpretation of these findings, we have created a dedicated online resource, PDGene, that comprehensively collects and meta-analyzes all published studies in the field. A systematic literature screen of -27,000 articles yielded 828 eligible articles from which relevant data were extracted. In addition, individual-level data from three publicly available genome-wide association studies (GWAS were obtained and subjected to genotype imputation and analysis. Overall, we performed meta-analyses on more than seven million polymorphisms originating either from GWAS datasets and/or from smaller scale PD association studies. Meta-analyses on 147 SNPs were supplemented by unpublished GWAS data from up to 16,452 PD cases and 48,810 controls. Eleven loci showed genome-wide significant (P < 5 × 10(-8 association with disease risk: BST1, CCDC62/HIP1R, DGKQ/GAK, GBA, LRRK2, MAPT, MCCC1/LAMP3, PARK16, SNCA, STK39, and SYT11/RAB25. In addition, we identified novel evidence for genome-wide significant association with a polymorphism in ITGA8 (rs7077361, OR 0.88, P  =  1.3 × 10(-8. All meta-analysis results are freely available on a dedicated online database (www.pdgene.org, which is cross-linked with a customized track on the UCSC Genome Browser. Our study provides an exhaustive and up-to-date summary of the status of PD genetics research that can be readily scaled to include the results of future large-scale genetics projects, including next-generation sequencing studies.

  20. Early Versus Delayed Motion After Rotator Cuff Repair: A Systematic Review of Overlapping Meta-analyses.

    Science.gov (United States)

    Houck, Darby A; Kraeutler, Matthew J; Schuette, Hayden B; McCarty, Eric C; Bravman, Jonathan T

    2017-10-01

    Previous meta-analyses have been conducted to compare outcomes of early versus delayed motion after rotator cuff repair. To conduct a systematic review of overlapping meta-analyses comparing early versus delayed motion rehabilitation protocols after rotator cuff repair to determine which meta-analyses provide the best available evidence. Systematic review. A systematic review was performed by searching PubMed and Cochrane Library databases. Search terms included "rotator cuff repair," "early passive motion," "immobilization," "rehabilitation protocol," and "meta-analysis." Results were reviewed to determine study eligibility. Patient outcomes and structural healing were extracted from these meta-analyses. Meta-analysis quality was assessed using the Oxman-Guyatt and Quality of Reporting of Meta-analyses (QUOROM) systems. The Jadad decision algorithm was then used to determine which meta-analyses provided the best level of evidence. Seven meta-analyses containing a total of 5896 patients met the eligibility criteria (1 Level I evidence, 4 Level II evidence, 2 Level III evidence). None of these meta-analyses found immobilization to be superior to early motion; however, most studies suggested that early motion would increase range of motion (ROM), thereby reducing time of recovery. Three of these studies suggested that tear size contributed to the choice of rehabilitation to ensure proper healing of the shoulder. A study by Chan et al in 2014 received the highest QUOROM and Oxman-Guyatt scores, and therefore this meta-analysis appeared to have the highest level of evidence. Additionally, a study by Riboh and Garrigues in 2014 was selected as the highest quality study in this systematic review according to the Jadad decision algorithm. The current, best available evidence suggests that early motion improves ROM after rotator cuff repair but increases the risk of rotator cuff retear. Lower quality meta-analyses indicate that tear size may provide a better strategy in

  1. Twenty years of meta-analyses in orthopaedic surgery: has quality kept up with quantity?

    Science.gov (United States)

    Dijkman, Bernadette G; Abouali, Jihad A K; Kooistra, Bauke W; Conter, Henry J; Poolman, Rudolf W; Kulkarni, Abhaya V; Tornetta, Paul; Bhandari, Mohit

    2010-01-01

    As the number of studies in the literature is increasing, orthopaedic surgeons highly depend on meta-analyses as their primary source of scientific evidence. The objectives of this review were to assess the scientific quality and number of published meta-analyses on orthopaedics-related topics over time. We conducted, in duplicate and independently, a systematic review of published meta-analyses in orthopaedics in the years 2005 and 2008 and compared them with a previous systematic review of meta-analyses from 1969 to 1999. A search of electronic databases (MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews) was performed to identify meta-analyses published in 2005 and 2008. We searched bibliographies and contacted content experts to identify additional relevant studies. Two investigators independently assessed the quality of the studies, using the Oxman and Guyatt index, and abstracted relevant data. We included forty-five and forty-four meta-analyses from 2005 and 2008, respectively. While the number of meta-analyses increased fivefold from 1999 to 2008, the mean quality score did not change significantly over time (p = 0.067). In the later years, a significantly lower proportion of meta-analyses had methodological flaws (56% in 2005 and 68% in 2008) compared with meta-analyses published prior to 2000 (88%) (p = 0.006). In 2005 and 2008, respectively, 18% and 30% of the meta-analyses had major to extensive flaws in their methodology. Studies from 2008 with positive conclusions used and described appropriate criteria for the validity assessment less often than did those with negative results. The use of random-effects and fixed-effects models as pooling methods became more popular toward 2008. Although the methodological quality of orthopaedic meta-analyses has increased in the past twenty years, a substantial proportion continues to show major to extensive flaws. As the number of published meta-analyses is increasing, a routine checklist for

  2. Effects οf Yoga οn cancer patients: Secondary analysis οf Systematic Reviews/Meta-Analyses

    Directory of Open Access Journals (Sweden)

    Dimos Mastrogiannis

    2016-09-01

    Full Text Available Introduction: Western medicine’s model has been enriched with alternative management and treatment methods. Yoga is a technique that incorporates physical exercises, breathing methods, meditation and relaxation which has been proposed to have positive effects on cancer patients. Aim: The aim of the present study is to critically review findings of systematic reviews/meta-analyses that are available in the international literature, regarding the effects of yoga on cancer patients. Methodology: Literature review was performed in five (5 databases: PubMed, Scopus, EMBASE, Web of Science and Cochrane Database of systematic Reviews. Authors adopted the Preferred Reporting Items for Systematic Reviews and Meta-Analysis model in order to perform a critical review of the existing literature. Methodological assessment of papers under review was performed according to criteria of the Assessment of Multiple Systematic Reviews instrument. Inclusion criteria were the English language, research undertaken in adults and evaluation of effects of yoga as the primary intervention. Results: Although there is a lack of guidelines regarding the assessment of systematic reviews using the above mentioned instruments, 16 papers were included in the present study. Findings are confounding, even though there is evidence supporting the use of yoga in certain types of cancer. Specifically, improvements in quality of life and psychological wellbeing, anxiety, however, not pain reduction, have been reported in women suffering from breast cancer, however, no statistically significant effect has been documented in patients with haematological malignancies. Conclusions: The majority of studies about the effects of yoga on quality of life, fatigue, sleep quality, anxiety, and depression have small samples. There is a trend towards an overall quality of life improvement, nonetheless, the lack of sufficiently powered randomized controlled trials prevents the extraction of a safe

  3. Characteristics of meta-analyses and their component studies in the Cochrane Database of Systematic Reviews: a cross-sectional, descriptive analysis

    Directory of Open Access Journals (Sweden)

    Davey Jonathan

    2011-11-01

    Full Text Available Abstract Background Cochrane systematic reviews collate and summarise studies of the effects of healthcare interventions. The characteristics of these reviews and the meta-analyses and individual studies they contain provide insights into the nature of healthcare research and important context for the development of relevant statistical and other methods. Methods We classified every meta-analysis with at least two studies in every review in the January 2008 issue of the Cochrane Database of Systematic Reviews (CDSR according to the medical specialty, the types of interventions being compared and the type of outcome. We provide descriptive statistics for numbers of meta-analyses, numbers of component studies and sample sizes of component studies, broken down by these categories. Results We included 2321 reviews containing 22,453 meta-analyses, which themselves consist of data from 112,600 individual studies (which may appear in more than one meta-analysis. Meta-analyses in the areas of gynaecology, pregnancy and childbirth (21%, mental health (13% and respiratory diseases (13% are well represented in the CDSR. Most meta-analyses address drugs, either with a control or placebo group (37% or in a comparison with another drug (25%. The median number of meta-analyses per review is six (inter-quartile range 3 to 12. The median number of studies included in the meta-analyses with at least two studies is three (inter-quartile range 2 to 6. Sample sizes of individual studies range from 2 to 1,242,071, with a median of 91 participants. Discussion It is clear that the numbers of studies eligible for meta-analyses are typically very small for all medical areas, outcomes and interventions covered by Cochrane reviews. This highlights the particular importance of suitable methods for the meta-analysis of small data sets. There was little variation in number of studies per meta-analysis across medical areas, across outcome data types or across types of

  4. Effect of calcium from dairy and dietary supplements on faecal fat excretion: a meta-analysis of randomized controlled trials

    DEFF Research Database (Denmark)

    Christensen, R.; Lorenzen, Janne Kunchel; Svith, Carina Roholm

    2009-01-01

    Observational studies have found that dietary calcium intake is inversely related to body weight and body fat mass. One explanatory mechanism is that dietary calcium increases faecal fat excretion. To examine the effect of calcium from dietary supplements or dairy products on quantitative faecal...... fat excretion, we performed a systematic review with meta-analysis. We included randomized, controlled trials of calcium (supplements or dairy) in healthy subjects, where faecal fat excretion was measured. Meta-analyses used random-effects models with changes in faecal fat excreted expressed...

  5. How Effective Are Active Videogames Among the Young and the Old? Adding Meta-analyses to Two Recent Systematic Reviews.

    Science.gov (United States)

    van 't Riet, Jonathan; Crutzen, Rik; Lu, Amy Shirong

    2014-10-01

    Two recent systematic reviews have surveyed the existing evidence for the effectiveness of active videogames in children/adolescents and in elderly people. In the present study, effect sizes were added to these systematic reviews, and meta-analyses were performed. All reviewed studies were considered for inclusion in the meta-analyses, but only studies were included that investigated the effectiveness of active videogames, used an experimental design, and used actual health outcomes as the outcome measures (body mass index for children/adolescents [k=5] and functional balance for the elderly [k=6]). The average effect of active videogames in children and adolescents was small and nonsignificant: Hedges' g=0.20 (95 percent confidence interval, -0.08 to 0.48). Limited heterogeneity was observed, and no moderator analyses were performed. For the effect of active videogames on functional balance in the elderly, the analyses revealed a medium-sized and significant effect of g=0.68 (95 percent confidence interval, 0.13-1.24). For the elderly studies, substantial heterogeneity was observed. Moderator analyses showed that there were no significant effects of using a no-treatment control group versus an alternative treatment control group or of using games that were especially created for health-promotion purposes versus off-the-shelf games. Also, intervention duration and frequency, sample size, study quality, and dropout did not significantly moderate the effect of active videogames. The results of these meta-analyses provide preliminary evidence that active videogames can have positive effects on relevant outcome measures in children/adolescents and elderly individuals.

  6. The ecologic validity of fructose feeding trials: Supraphysiological feeding of fructose in human trials requires careful consideration when drawing conclusions on cardiometabolic risk

    OpenAIRE

    Vivian L Choo; Vivian L Choo; John L Sievenpiper; John L Sievenpiper; John L Sievenpiper

    2015-01-01

    Background: Select trials of fructose overfeeding have been used to implicate fructose as a driver of cardiometabolic risk.Objective: We examined temporal trends of fructose dose in human controlled feeding trials of fructose and cardiometabolic risk.Methods: We combined studies from eight meta-analyses on fructose and cardiometabolic risk to assess the average fructose dose used in these trials. Two types of trials were identified: 1) substitution trials, in which energy from fructose was e...

  7. The Ecologic Validity of Fructose Feeding Trials: Supraphysiological Feeding of Fructose in Human Trials Requires Careful Consideration When Drawing Conclusions on Cardiometabolic Risk

    OpenAIRE

    Choo, Vivian L.; Sievenpiper, John L.

    2015-01-01

    Background Select trials of fructose overfeeding have been used to implicate fructose as a driver of cardiometabolic risk. Objective We examined temporal trends of fructose dose in human controlled feeding trials of fructose and cardiometabolic risk. Methods We combined studies from eight meta-analyses on fructose and cardiometabolic risk to assess the average fructose dose used in these trials. Two types of trials were identified: (1) substitution trials, in which energy f...

  8. Age and sex as moderators of the placebo response – an evaluation of systematic reviews and meta-analyses across medicine.

    Science.gov (United States)

    Weimer, Katja; Colloca, Luana; Enck, Paul

    2015-01-01

    Predictors of the placebo response (PR) in randomized controlled trials (RCT) have been searched for ever since RCT have become the standard for testing novel therapies and age and gender are routinely documented data in all trials irrespective of the drug tested, its indication, and the primary and secondary end points chosen. To evaluate whether age and gender have been found to be reliable predictors of the PR across medical subspecialties, we extracted 75 systematic reviews, meta-analyses, and meta-regressions performed in major medical areas (neurology, psychiatry, internal medicine) known for high PR rates. The literature database used contains approximately 2,500 papers on various aspects of the genuine PR. These ‘meta-analyses’ were screened for statistical predictors of the PR across multiple RCT, including age and gender, but also other patient-based and design-based predictors of higher PR rates. Retrieved papers were sorted for areas and disease categories. Only 15 of the 75 analyses noted an effect of younger age to be associated with higher PR, and this was predominantly in psychiatric conditions but not in depression, and internal medicine but not in gastroenterology. Female gender was associated with higher PR in only 3 analyses. Among the patient-based predictors, the most frequently noted factor was lower symptom severity at baseline, and among the design- based factors, it was a randomization ratio that selected more patients to drugs than to placebo, more frequent study visits, and more recent trials that were associated with higher PR rates. While younger age may contribute to the PR in some conditions, sex does not. There is currently no evidence that the PR is different in the elderly. PR are, however, markedly influenced by the symptom severity at baseline, and by the likelihood of receiving active treatment in placebo- controlled trials. © 2014 S. Karger AG, Basel.

  9. Less is less: a systematic review of graph use in meta-analyses.

    Science.gov (United States)

    Schild, Anne H E; Voracek, Martin

    2013-09-01

    Graphs are an essential part of scientific communication. Complex datasets, of which meta-analyses are textbook examples, benefit the most from visualization. Although a number of graph options for meta-analyses exist, the extent to which these are used was hitherto unclear. A systematic review on graph use in meta-analyses in three disciplines (medicine, psychology, and business) and nine journals was conducted. Interdisciplinary differences, which are mirrored in the respective journals, were revealed, that is, graph use correlates with external factors rather than methodological considerations. There was only limited variation in graph types (with forest plots as the most important representatives), and diagnostic plots were very rare. Although an increase in graph use over time could be observed, it is unlikely that this phenomenon is specific to meta-analyses. There is a gaping discrepancy between available graphic methods and their application in meta-analyses. This may be rooted in a number of factors, namely, (i) insufficient dissemination of new developments, (ii) unsatisfactory implementation in software packages, and (iii) minor attention on graphics in meta-analysis reporting guidelines. Using visualization methods to their full capacity is a further step in using meta-analysis to its full potential. Copyright © 2013 John Wiley & Sons, Ltd.

  10. Motivational power of future time perspective: Meta-analyses in education, work, and health.

    Directory of Open Access Journals (Sweden)

    Lucija Andre

    Full Text Available Future time perspective (FTP may predict individual attitudes and behaviors. However, FTP research includes different FTP conceptualizations and outcomes which hinder generalizing its findings. To solve the inconsistencies in FTP research and generalize the magnitude of FTP as a driver of motivation and behavior, we conducted the first systematical synthesis of FTP relationships in three crucial life domains. Our meta-analyses of FTP studies in education (k = 28, work (k = 17, and health (k = 32 involved N = 31,558 participants, and used a conceptual model for grouping FTP constructs. To address different outcome types, we applied the Theory of Planned Behavior when coding the studies. FTP relationships with outcomes were small-to-medium, were generalizable across domains, and were strongest when the FTP construct included a mixture of cognition, behavioral intention, and affect and, in education, when the FTP measure was domain specific rather than general. There were cross-cultural differences in FTP-outcome relationships. The strength of the FTP-outcome types relationship varied for attitudes, perceived behavioral control, behavioral intention, and behaviors. The lowest effect sizes were found for FTP predicting actual behaviors in education, work, and health and between FTP and health attitudes. Theoretical implications of the findings and future research directions are discussed.

  11. Effect size calculation in meta-analyses of psychotherapy outcome research.

    Science.gov (United States)

    Hoyt, William T; Del Re, A C

    2018-05-01

    Meta-analysis of psychotherapy intervention research normally examines differences between treatment groups and some form of comparison group (e.g., wait list control; alternative treatment group). The effect of treatment is normally quantified as a standardized mean difference (SMD). We describe procedures for computing unbiased estimates of the population SMD from sample data (e.g., group Ms and SDs), and provide guidance about a number of complications that may arise related to effect size computation. These complications include (a) incomplete data in research reports; (b) use of baseline data in computing SMDs and estimating the population standard deviation (σ); (c) combining effect size data from studies using different research designs; and (d) appropriate techniques for analysis of data from studies providing multiple estimates of the effect of interest (i.e., dependent effect sizes). Clinical or Methodological Significance of this article: Meta-analysis is a set of techniques for producing valid summaries of existing research. The initial computational step for meta-analyses of research on intervention outcomes involves computing an effect size quantifying the change attributable to the intervention. We discuss common issues in the computation of effect sizes and provide recommended procedures to address them.

  12. Motivational power of future time perspective: Meta-analyses in education, work, and health.

    Science.gov (United States)

    Andre, Lucija; van Vianen, Annelies E M; Peetsma, Thea T D; Oort, Frans J

    2018-01-01

    Future time perspective (FTP) may predict individual attitudes and behaviors. However, FTP research includes different FTP conceptualizations and outcomes which hinder generalizing its findings. To solve the inconsistencies in FTP research and generalize the magnitude of FTP as a driver of motivation and behavior, we conducted the first systematical synthesis of FTP relationships in three crucial life domains. Our meta-analyses of FTP studies in education (k = 28), work (k = 17), and health (k = 32) involved N = 31,558 participants, and used a conceptual model for grouping FTP constructs. To address different outcome types, we applied the Theory of Planned Behavior when coding the studies. FTP relationships with outcomes were small-to-medium, were generalizable across domains, and were strongest when the FTP construct included a mixture of cognition, behavioral intention, and affect and, in education, when the FTP measure was domain specific rather than general. There were cross-cultural differences in FTP-outcome relationships. The strength of the FTP-outcome types relationship varied for attitudes, perceived behavioral control, behavioral intention, and behaviors. The lowest effect sizes were found for FTP predicting actual behaviors in education, work, and health and between FTP and health attitudes. Theoretical implications of the findings and future research directions are discussed.

  13. Motivational power of future time perspective: Meta-analyses in education, work, and health

    Science.gov (United States)

    2018-01-01

    Future time perspective (FTP) may predict individual attitudes and behaviors. However, FTP research includes different FTP conceptualizations and outcomes which hinder generalizing its findings. To solve the inconsistencies in FTP research and generalize the magnitude of FTP as a driver of motivation and behavior, we conducted the first systematical synthesis of FTP relationships in three crucial life domains. Our meta-analyses of FTP studies in education (k = 28), work (k = 17), and health (k = 32) involved N = 31,558 participants, and used a conceptual model for grouping FTP constructs. To address different outcome types, we applied the Theory of Planned Behavior when coding the studies. FTP relationships with outcomes were small-to-medium, were generalizable across domains, and were strongest when the FTP construct included a mixture of cognition, behavioral intention, and affect and, in education, when the FTP measure was domain specific rather than general. There were cross-cultural differences in FTP-outcome relationships. The strength of the FTP-outcome types relationship varied for attitudes, perceived behavioral control, behavioral intention, and behaviors. The lowest effect sizes were found for FTP predicting actual behaviors in education, work, and health and between FTP and health attitudes. Theoretical implications of the findings and future research directions are discussed. PMID:29364917

  14. Evaluation of European Schizophrenia GWAS Loci in Asian Populations via Comprehensive Meta-Analyses.

    Science.gov (United States)

    Xiao, Xiao; Luo, Xiong-Jian; Chang, Hong; Liu, Zichao; Li, Ming

    2017-08-01

    Schizophrenia is a severe and highly heritable neuropsychiatric disorder. Recent genetic analyses including genome-wide association studies (GWAS) have implicated multiple genome-wide significant variants for schizophrenia among European populations. However, many of these risk variants were not largely validated in other populations of different ancestry such as Asians. To validate whether these European GWAS significant loci are associated with schizophrenia in Asian populations, we conducted a systematic literature search and meta-analyses on 19 single nucleotide polymorphisms (SNPs) in Asian populations by combining all available case-control and family-based samples, including up to 30,000 individuals. We employed classical fixed (or random) effects inverse variance weighted methods to calculate summary odds ratios (ORs) and 95 % confidence intervals (CIs). Among the 19 GWAS loci, we replicated the risk associations of nine markers (e.g., SNPs at VRK2, ITIH3/4, NDST3, NOTCH4) surpassing significance level (two-tailed P Asian replication samples and initial European GWAS findings, and the successful replications of these GWAS loci in a different ethnic group provide stronger evidence for their clinical associations with schizophrenia. Further studies, focusing on the molecular mechanisms of these GWAS significant loci, will become increasingly important for understanding of the pathogenesis to schizophrenia.

  15. The influence of emotional cues on prospective memory: a systematic review with meta-analyses.

    Science.gov (United States)

    Hostler, Thomas J; Wood, Chantelle; Armitage, Christopher J

    2018-01-10

    Remembering to perform a behaviour in the future, prospective memory, is essential to ensuring that people fulfil their intentions. Prospective memory involves committing to memory a cue to action (encoding), and later recognising and acting upon the cue in the environment (retrieval). Prospective memory performance is believed to be influenced by the emotionality of the cues, however the literature is fragmented and inconsistent. We conducted a systematic search to synthesise research on the influence of emotion on prospective memory. Sixty-seven effect sizes were extracted from 17 articles and hypothesised effects tested using three meta-analyses. Overall, prospective memory was enhanced when positively-valenced rather than neutral cues were presented (d = 0.32). In contrast, negatively-valenced cues did not enhance prospective memory overall (d = 0.07), but this effect was moderated by the timing of the emotional manipulation. Prospective memory performance was improved when negatively-valenced cues were presented during both encoding and retrieval (d = 0.40), but undermined when presented only during encoding (d = -0.25). Moderating effects were also found for cue-focality and whether studies controlled for the arousal level of the cues. The principal finding is that positively-valenced cues improve prospective memory performance and that timing of the manipulation can moderate emotional effects on prospective memory. We offer a new agenda for future empirical work and theorising in this area.

  16. Reporting characteristics of meta-analyses in orthodontics: methodological assessment and statistical recommendations.

    Science.gov (United States)

    Papageorgiou, Spyridon N; Papadopoulos, Moschos A; Athanasiou, Athanasios E

    2014-02-01

    Ideally meta-analyses (MAs) should consolidate the characteristics of orthodontic research in order to produce an evidence-based answer. However severe flaws are frequently observed in most of them. The aim of this study was to evaluate the statistical methods, the methodology, and the quality characteristics of orthodontic MAs and to assess their reporting quality during the last years. Electronic databases were searched for MAs (with or without a proper systematic review) in the field of orthodontics, indexed up to 2011. The AMSTAR tool was used for quality assessment of the included articles. Data were analyzed with Student's t-test, one-way ANOVA, and generalized linear modelling. Risk ratios with 95% confidence intervals were calculated to represent changes during the years in reporting of key items associated with quality. A total of 80 MAs with 1086 primary studies were included in this evaluation. Using the AMSTAR tool, 25 (27.3%) of the MAs were found to be of low quality, 37 (46.3%) of medium quality, and 18 (22.5%) of high quality. Specific characteristics like explicit protocol definition, extensive searches, and quality assessment of included trials were associated with a higher AMSTAR score. Model selection and dealing with heterogeneity or publication bias were often problematic in the identified reviews. The number of published orthodontic MAs is constantly increasing, while their overall quality is considered to range from low to medium. Although the number of MAs of medium and high level seems lately to rise, several other aspects need improvement to increase their overall quality.

  17. Auto-titrating versus fixed continuous positive airway pressure for the treatment of obstructive sleep apnea: a systematic review with meta-analyses

    Directory of Open Access Journals (Sweden)

    Ip Stanley

    2012-03-01

    Full Text Available Abstract Background Obstructive sleep apnea is a relatively common disorder that can lead to lost productivity and cardiovascular disease. The form of positive airway treatment that should be offered is unclear. Methods MEDLINE and the Cochrane Central Trials registry were searched for English language randomized controlled trials comparing auto-titrating positive airway pressure (APAP with continuous positive airway pressure (CPAP in adults with obstructive sleep apnea (inception through 9/2010. Six researchers extracted information on study design, potential bias, patient characteristics, interventions and outcomes. Data for each study were extracted by one reviewer and confirmed by another. Random effects model meta-analyses were performed for selected outcomes. Results Twenty-four randomized controlled trials met the inclusion criteria. In individual studies, APAP and fixed CPAP resulted in similar changes from baseline in the apnea-hypopnea index, most other sleep study measures and quality of life. By meta-analysis, APAP improved compliance by 11 minutes per night (95% CI, 3 to 19 minutes and reduced sleepiness as measured by the Epworth Sleepiness Scale by 0.5 points (95% CI, 0.8 to 0.2 point reduction compared with fixed CPAP. Fixed CPAP improved minimum oxygen saturation by 1.3% more than APAP (95% CI, 0.4 to 2.2%. Studies had relatively short follow-up and generally excluded patients with significant comorbidities. No study reported on objective clinical outcomes. Conclusions Statistically significant differences were found but clinical importance is unclear. Because the treatment effects are similar between APAP and CPAP, the therapy of choice may depend on other factors such as patient preference, specific reasons for non-compliance and cost.

  18. The effects of 'ecstasy' (MDMA) on visuospatial memory performance: findings from a systematic review with meta-analyses.

    Science.gov (United States)

    Murphy, Philip N; Bruno, Raimondo; Ryland, Ida; Wareing, Michele; Fisk, John E; Montgomery, Catharine; Hilton, Joanne

    2012-03-01

    To review, with meta-analyses where appropriate, performance differences between ecstasy (3,4-methylenedioxymethamphetamine) users and non-users on a wider range of visuospatial tasks than previously reviewed. Such tasks have been shown to draw upon working memory executive resources. Abstract databases were searched using the United Kingdom National Health Service Evidence Health Information Resource. Inclusion criteria were publication in English language peer-reviewed journals and the reporting of new findings regarding human ecstasy-users' performance on visuospatial tasks. Data extracted included specific task requirements to provide a basis for meta-analyses for categories of tasks with similar requirements. Fifty-two studies were identified for review, although not all were suitable for meta-analysis. Significant weighted mean effect sizes indicating poorer performance by ecstasy users compared with matched controls were found for tasks requiring recall of spatial stimulus elements, recognition of figures and production/reproduction of figures. There was no evidence of a linear relationship between estimated ecstasy consumption and effect sizes. Given the networked nature of processing for spatial and non-spatial visual information, future scanning and imaging studies should focus on brain activation differences between ecstasy users and non-users in the context of specific tasks to facilitate identification of loci of potentially compromised activity in users. Copyright © 2012 John Wiley & Sons, Ltd.

  19. Clinical Research That Matters: Designing Outcome-Based Research for Older Adults to Qualify for Systematic Reviews and Meta-Analyses.

    Science.gov (United States)

    Lee, Jeannie K; Fosnight, Susan M; Estus, Erica L; Evans, Paula J; Pho, Victoria B; Reidt, Shannon; Reist, Jeffrey C; Ruby, Christine M; Sibicky, Stephanie L; Wheeler, Janel B

    2018-01-01

    Though older adults are more sensitive to the effects of medications than their younger counterparts, they are often excluded from manufacturer-based clinical studies. Practice-based research is a practical method to identify medication-related effects in older patients. This research also highlights the role of a pharmacist in improving care in this population. A single study rarely has strong enough evidence to change geriatric practice, unless it is a large-scale, multisite, randomized controlled trial that specifically targets older adults. It is important to design studies that may be used in systematic reviews or meta-analyses that build a stronger evidence base. Recent literature has documented a gap in advanced pharmacist training pertaining to research skills. In this paper, we hope to fill some of the educational gaps related to research in older adults. We define best practices when deciding on the type of study, inclusion and exclusion criteria, design of the intervention, how outcomes are measured, and how results are reported. Well-designed studies increase the pool of available data to further document the important role that pharmacists have in optimizing care of older patients.

  20. Limitations and risks of meta-analyses of longevity studies

    DEFF Research Database (Denmark)

    Sebastiani, Paola; Bae, Harold; Gurinovich, Anastasia

    2017-01-01

    Searching for genetic determinants of human longevity has been challenged by the rarity of data sets with large numbers of individuals who have reached extreme old age, inconsistent definitions of the phenotype, and the difficulty of defining appropriate controls. Meta-analysis - a statistical...... method to summarize results from different studies - has become a common tool in genetic epidemiology to accrue large sample sizes for powerful genetic association studies. In conducting a meta-analysis of studies of human longevity however, particular attention must be made to the definition of cases...... and controls (including their health status) and on the effect of possible confounders such as sex and ethnicity upon the genetic effect to be estimated. We will show examples of how a meta-analysis can inflate the false negative rates of genetic association studies or it can bias estimates of the association...

  1. Meta-analyses triggered by previous (false-)significant findings : Problems and solutions

    NARCIS (Netherlands)

    Schuit, Ewoud; Roes, Kit C B; Mol, Ben W J; Kwee, Anneke; Moons, Karel G M; Groenwold, Rolf H H

    2015-01-01

    BACKGROUND: Meta-analyses are typically triggered by a (potentially false-significant) finding in one of the preceding primary studies. We studied consequences of meta-analysis investigating effects when primary studies that triggered such meta-analysis are also included. METHODS: We analytically

  2. An Introduction to Systematic Reviews and Meta-Analyses for Exotic Animal Practitioners

    NARCIS (Netherlands)

    Meursinge Reynders, Reint

    2017-01-01

    Developing and conducting systematic reviews and meta-analyses is a complex process that requires many judgments and the input from a wide variety of stakeholders. This article presents an introduction on how to develop, conduct, and report these research studies. Veterinary clinicians should seek

  3. Genome-wide meta-analyses identify multiple loci associated with smoking behavior

    NARCIS (Netherlands)

    H. Furberg (Helena); Y. Kim (Yunjung); J. Dackor (Jennifer); E.A. Boerwinkle (Eric); N. Franceschini (Nora); D. Ardissino (Diego); L. Bernardinelli (Luisa); P.M. Mannucci (Pier); F. Mauri (Francesco); P.A. Merlini (Piera); D. Absher (Devin); T.L. Assimes (Themistocles); S.P. Fortmann (Stephen); C. Iribarren (Carlos); J.W. Knowles (Joshua); T. Quertermous (Thomas); L. Ferrucci (Luigi); T. Tanaka (Toshiko); J.C. Bis (Joshua); T. Haritunians (Talin); B. McKnight (Barbara); B.M. Psaty (Bruce); K.D. Taylor (Kent); E.L. Thacker (Evan); P. Almgren (Peter); L. Groop (Leif); C. Ladenvall (Claes); M. Boehnke (Michael); A.U. Jackson (Anne); K.L. Mohlke (Karen); H.M. Stringham (Heather); J. Tuomilehto (Jaakko); E.J. Benjamin (Emelia); S.J. Hwang; D. Levy (Daniel); S.R. Preis; R.S. Vasan (Ramachandran Srini); J. Duan (Jubao); P.V. Gejman (Pablo); D.F. Levinson (Douglas); A.R. Sanders (Alan); J. Shi (Jianxin); E.H. Lips (Esther); J.D. McKay (James); A. Agudo (Antonio); L. Barzan (Luigi); V. Bencko (Vladimir); S. Benhamou (Simone); X. Castellsagué (Xavier); C. Canova (Cristina); D.I. Conway (David); E. Fabianova (Eleonora); L. Foretova (Lenka); V. Janout (Vladimir); C.M. Healy (Claire); I. Holcátová (Ivana); K. Kjaerheim (Kristina); P. Lagiou; J. Lissowska (Jolanta); R. Lowry (Ray); T.V. MacFarlane (Tatiana); D. Mates (Dana); L. Richiardi (Lorenzo); P. Rudnai (Peter); N. Szeszenia-Dabrowska (Neonilia); D. Zaridze; A. Znaor (Ariana); M. Lathrop (Mark); P. Brennan (Paul); S. Bandinelli (Stefania); T.M. Frayling (Timothy); J.M. Guralnik (Jack); Y. Milaneschi (Yuri); J.R.B. Perry (John); D. Altshuler (David); R. Elosua (Roberto); S. Kathiresan (Sekar); G. Lucas (Gavin); O. Melander (Olle); V. Salomaa (Veikko); S.M. Schwartz (Stephen); B.F. Voight (Benjamin); B.W.J.H. Penninx (Brenda); J.H. Smit (Johannes); N. Vogelzangs (Nicole); D.I. Boomsma (Dorret); E.J.C. de Geus (Eco); J.M. Vink (Jacqueline); G.A.H.M. Willemsen (Gonneke); S.J. Chanock (Stephen); F. Gu (Fangyi); S.E. Hankinson (Susan); D. Hunter (David); A. Hofman (Albert); H.W. Tiemeier (Henning); A.G. Uitterlinden (André); P. Tikka-Kleemola (Päivi); S. Walter (Stefan); D.I. Chasman (Daniel); B.M. Everett (Brendan); G. Pare (Guillaume); P.M. Ridker (Paul); M.D. Li (Ming); H.H. Maes (Hermine); J. Audrain-Mcgovern (Janet); D. Posthuma (Danielle); L.M. Thornton (Laura); C. Lerman (Caryn); J. Kaprio (Jaakko); J.E. Rose (Jed); J.P.A. Ioannidis (John); P. Kraft (Peter); D.Y. Lin (Dan); P.F. Sullivan (Patrick); C.J. O'Donnell (Christopher)

    2010-01-01

    textabstractConsistent but indirect evidence has implicated genetic factors in smoking behavior. We report meta-analyses of several smoking phenotypes within cohorts of the Tobacco and Genetics Consortium (n = 74,053). We also partnered with the European Network of Genetic and Genomic Epidemiology

  4. Network meta-analyses performed by contracting companies and commissioned by industry

    NARCIS (Netherlands)

    Schuit, Ewoud; Ioannidis, John P A

    2016-01-01

    Background: Industry commissions contracting companies to perform network meta-analysis for health technology assessment (HTA) and reimbursement submissions. Our objective was to estimate the number of network meta-analyses performed by consulting companies contracted by industry, to assess whether

  5. New Blood Pressure-Associated Loci Identified in Meta-Analyses of 475 000 Individuals

    DEFF Research Database (Denmark)

    Kraja, Aldi T.; Cook, James P.; Warren, Helen R.

    2017-01-01

    Background - Genome-wide association studies have recently identified >400 loci that harbor DNA sequence variants that influence blood pressure (BP). Our earlier studies identified and validated 56 single nucleotide variants (SNVs) associated with BP from meta-analyses of exome chip genotype data...

  6. Cooper's Taxonomy of Literature Reviews Applied to Meta-Analyses in Educational Achievement.

    Science.gov (United States)

    Sipe, Theresa Ann; Stallings, William M.

    H. M. Cooper (1988) has developed a taxonomy that classified literature reviews based on six characteristics: (1) focus of attention; (2) goal of the synthesis; (3) perspective on the literature; (4) coverage of the literature; (5) organization of the perspective; and (6) intended audience. One hundred and three meta-analyses identified from the…

  7. Meta-analyses of workplace physical activity and dietary behaviour interventions on weight outcomes

    NARCIS (Netherlands)

    Verweij, L.M.; Coffeng, J.; Mechelen, W. van; Proper, K.I.

    2011-01-01

    This meta-analytic review critically examines the effectiveness of workplace interventions targeting physical activity, dietary behaviour or both on weight outcomes. Data could be extracted from 22 studies published between 1980 and November 2009 for meta-analyses. The GRADE approach was used to

  8. How can my research paper be useful for future meta-analyses on forest restoration practices?

    Science.gov (United States)

    Enrique Andivia; Pedro Villar‑Salvador; Juan A. Oliet; Jaime Puertolas; R. Kasten Dumroese

    2018-01-01

    Statistical meta-analysis is a powerful and useful tool to quantitatively synthesize the information conveyed in published studies on a particular topic. It allows identifying and quantifying overall patterns and exploring causes of variation. The inclusion of published works in meta-analyses requires, however, a minimum quality standard of the reported data and...

  9. The prevalence of child maltreatment across the globe: Review of a series of meta-analyses.

    NARCIS (Netherlands)

    Stoltenborgh, M.; Bakermans-Kranenburg, M.J.; Alink, L.R.A.; van IJzendoorn, M.H.

    2015-01-01

    In this review, we combine and compare the results of a series of meta-analyses on the prevalence of child sexual, physical and emotional abuse and physical and emotional neglect, including 244 publications and 551 prevalence rates for the various types of maltreatment. Child maltreatment research

  10. Meta-Analyses of Human Cell-Based Cardiac Regeneration Therapies

    DEFF Research Database (Denmark)

    Gyöngyösi, Mariann; Wojakowski, Wojciech; Navarese, Eliano P

    2016-01-01

    In contrast to multiple publication-based meta-analyses involving clinical cardiac regeneration therapy in patients with recent myocardial infarction, a recently published meta-analysis based on individual patient data reported no effect of cell therapy on left ventricular function or clinical...

  11. Cognitive dysfunction in bipolar disorder and schizophrenia: a systematic review of meta-analyses

    Directory of Open Access Journals (Sweden)

    Bortolato B

    2015-12-01

    Full Text Available Beatrice Bortolato,1 Kamilla W Miskowiak,2 Cristiano A Köhler,3 Eduard Vieta,4 André F Carvalho3 1Department of Mental Health, ULSS 10 “Veneto Orientale”, Venice, Italy; 2Psychiatric Centre Copenhagen, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; 3Translational Psychiatry Research Group and Department of Clinical Medicine, Faculty of Medicine, Federal University of Ceará, Fortaleza, CE, Brazil; 4Bipolar Disorders Program, Institute of Neuroscience, Hospital Clínic Barcelona, IDIBAPS, CIBERSAM, University of Barcelona, Catalonia, Spain Abstract: Cognitive impairment is a core feature of schizophrenia (SZ and bipolar disorder (BD. A neurocognitive profile characterized by widespread cognitive deficits across multiple domains in the context of substantial intellectual impairment, which appears to antedate illness onset, is a replicated finding in SZ. There is no specific neuropsychological signature that can facilitate the diagnostic differentiation of SZ and BD, notwithstanding, neuropsychological deficits appear more severe in SZ. The literature in this field has provided contradictory results due to methodological differences across studies. Meta-analytic techniques may offer an opportunity to synthesize findings and to control for potential sources of heterogeneity. Here, we performed a systematic review of meta-analyses of neuropsychological findings in SZ and BD. While there is no conclusive evidence for progressive cognitive deterioration in either SZ or BD, some findings point to more severe cognitive deficits in patients with early illness onset across both disorders. A compromised pattern of cognitive functioning in individuals at familiar and/or clinical risk to psychosis as well as in first-degree relatives of BD patients suggests that early neurodevelopmental factors may play a role in the emergence of cognitive deficits in both disorders. Premorbid intellectual impairment in SZ and at least in a

  12. A literature review and meta-analyses of cannabis use and suicidality.

    Science.gov (United States)

    Borges, Guilherme; Bagge, Courtney L; Orozco, Ricardo

    2016-05-01

    We lack a review of the epidemiological literature on cannabis use (acute use and chronic-usual quantity/frequency and heavy use) and suicidality (suicide death, suicide ideation, suicide attempt). The English language literature on Medline, PsychInfo, Google Scholar, and public-use databases was searched for original articles, critical review reports, and public use data on cannabis use and suicide for the period ranging from 1990-2015 (February). Odds ratios (OR) from random effects in meta-analyses for any cannabis use and heavy cannabis use were calculated. The acute cannabis-suicidality literature mostly includes descriptive toxicology reports. In terms of death by suicide, the average positive cannabis rate was 9.50% for studies sampling from all suicides, with higher cannabis detection rates amongst suicide decedents by non-overdose methods. We found only 4 studies providing estimates for any chronic cannabis use and death by suicide (OR=2.56 (1.25-5.27)). After deleting duplicates we found 6 studies on any cannabis use and suicide ideation (OR=1.43 (1.13-1.83)), 5 studies on heavy cannabis use and suicide ideation (OR=2.53 (1.00-6.39)), 6 studies on any cannabis use and suicide attempt (OR=2.23 (1.24-4.00)) and 6 studies on heavy cannabis use and suicide attempt (OR=3.20 (1.72-5.94)). We currently lack evidence that acute cannabis use increases imminent risk for suicidality. The evidence tends to support that chronic cannabis use can predict suicidality, but the lack of homogeneity in the measurement of cannabis exposure and, in some instances, the lack of systematic control for known risk factors tempered this finding. Copyright © 2016 Elsevier B.V. All rights reserved.

  13. Geriatric characteristics in randomised controlled trials on antidepressant drugs for older adults: a systematic review

    NARCIS (Netherlands)

    Benraad, Carolien E. M.; Kamerman-Celie, Floor; van Munster, Barbara C.; Oude Voshaar, Richard C.; Spijker, Jan; Olde Rikkert, Marcel G. M.

    2016-01-01

    Objective: Meta-analyses of antidepressant drug treatment trials have found that increasing age is associated with a less favourable outcome. Because the prevalence of geriatric characteristics, like disability, medical co-morbidity, malnutrition, cognitive (dys) function and frailty increase with

  14. Geriatric characteristics in randomised controlled trials on antidepressant drugs for older adults : a systematic review

    NARCIS (Netherlands)

    Benraad, Carolien E. M.; Kamerman-Celie, Floor; van Munster, Barbara C.; Oude Voshaar, Richard C.; Spijker, Jan; Rikkert, Marcel G. M. Olde

    Objective: Meta-analyses of antidepressant drug treatment trials have found that increasing age is associated with a less favourable outcome. Because the prevalence of geriatric characteristics, like disability, medical co-morbidity, malnutrition, cognitive (dys) function and frailty increase with

  15. Massage therapy for fibromyalgia: a systematic review and meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Yan-hui Li

    Full Text Available BACKGROUND: Although some studies evaluated the effectiveness of massage therapy for fibromyalgia (FM, the role of massage therapy in the management of FM remained controversial. OBJECTIVE: The purpose of this systematic review is to evaluate the evidence of massage therapy for patients with FM. METHODS: Electronic databases (up to June 2013 were searched to identify relevant studies. The main outcome measures were pain, anxiety, depression, and sleep disturbance. Two reviewers independently abstracted data and appraised risk of bias. The risk of bias of eligible studies was assessed based on Cochrane tools. Standardised mean difference (SMD and 95% confidence intervals (CI were calculated by more conservative random-effects model. And heterogeneity was assessed based on the I(2 statistic. RESULTS: Nine randomized controlled trials involving 404 patients met the inclusion criteria. The meta-analyses showed that massage therapy with duration ≥ 5 weeks significantly improved pain (SMD, 0.62; 95% CI 0.05 to 1.20; p = 0.03, anxiety (SMD, 0.44; 95% CI 0.09 to 0.78; p = 0.01, and depression (SMD, 0.49; 95% CI 0.15 to 0.84; p = 0.005 in patients with FM, but not on sleep disturbance (SMD, 0.19; 95% CI -0.38 to 0.75; p = 0.52. CONCLUSION: Massage therapy with duration ≥ 5 weeks had beneficial immediate effects on improving pain, anxiety, and depression in patients with FM. Massage therapy should be one of the viable complementary and alternative treatments for FM. However, given fewer eligible studies in subgroup meta-analyses and no evidence on follow-up effects, large-scale randomized controlled trials with long follow-up are warrant to confirm the current findings.

  16. Massage therapy for fibromyalgia: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Li, Yan-hui; Wang, Feng-yun; Feng, Chun-qing; Yang, Xia-feng; Sun, Yi-hua

    2014-01-01

    Although some studies evaluated the effectiveness of massage therapy for fibromyalgia (FM), the role of massage therapy in the management of FM remained controversial. The purpose of this systematic review is to evaluate the evidence of massage therapy for patients with FM. Electronic databases (up to June 2013) were searched to identify relevant studies. The main outcome measures were pain, anxiety, depression, and sleep disturbance. Two reviewers independently abstracted data and appraised risk of bias. The risk of bias of eligible studies was assessed based on Cochrane tools. Standardised mean difference (SMD) and 95% confidence intervals (CI) were calculated by more conservative random-effects model. And heterogeneity was assessed based on the I(2) statistic. Nine randomized controlled trials involving 404 patients met the inclusion criteria. The meta-analyses showed that massage therapy with duration ≥ 5 weeks significantly improved pain (SMD, 0.62; 95% CI 0.05 to 1.20; p = 0.03), anxiety (SMD, 0.44; 95% CI 0.09 to 0.78; p = 0.01), and depression (SMD, 0.49; 95% CI 0.15 to 0.84; p = 0.005) in patients with FM, but not on sleep disturbance (SMD, 0.19; 95% CI -0.38 to 0.75; p = 0.52). Massage therapy with duration ≥ 5 weeks had beneficial immediate effects on improving pain, anxiety, and depression in patients with FM. Massage therapy should be one of the viable complementary and alternative treatments for FM. However, given fewer eligible studies in subgroup meta-analyses and no evidence on follow-up effects, large-scale randomized controlled trials with long follow-up are warrant to confirm the current findings.

  17. Sugars, obesity, and cardiovascular disease: results from recent randomized control trials.

    Science.gov (United States)

    Rippe, James M; Angelopoulos, Theodore J

    2016-11-01

    The relationship between sugar consumption and various health-related sequelas is controversial. Some investigators have argued that excessive sugar consumption is associated with increased risk of obesity, coronary heart disease, diabetes (T2D), metabolic syndrome, non-alcoholic fatty liver disease, and stimulation of reward pathways in the brain potentially causing excessive caloric consumption. These concerns have influenced organizations such as the World Health Organization, the Scientific Advisory Committee on Nutrition in England not to exceed 5 % of total energy and the Dietary Guidelines for Americans Advisory Committee 2015 to recommend upper limits of sugar consumption not to exceed 10 % of calories. Data from many randomized control trials (RCTs) do not support linkages between sugar consumption at normal levels within the human diet and various adverse metabolic and health-related effects. Fructose and glucose are typically consumed together in roughly equal proportions from high-fructose corn syrup (also known as isoglucose in Europe) or sucrose. The purpose of this review is to present data from recent RCTs and findings from recent systematic reviews and meta-analyses related to sugar consumption and its putative health effects. This review evaluates findings from recent randomized controlled trials, systematic reviews and meta-analyses into the relationship of sugar consumption and a range of health-related issues including energy-regulating hormones, obesity, cardiovascular disease, diabetes, and accumulation of liver fat and neurologic responses. Data from these sources do not support linkages between sugar consumption at normal levels within the human diet and various adverse metabolic and health-related effects.

  18. Meta-analyses of the Association of Sleep Apnea with Insulin Resistance, and the Effects of CPAP on HOMA-IR, Adiponectin, and Visceral Adipose Fat.

    Science.gov (United States)

    Iftikhar, Imran H; Hoyos, Camilla M; Phillips, Craig L; Magalang, Ulysses J

    2015-04-15

    We sought to conduct an updated meta-analysis of randomized controlled trials (RCTs) on the effect of continuous positive airway pressure (CPAP) on insulin resistance, as measured by homeostasis model assessment of insulin resistance (HOMA-IR), visceral abdominal fat (VAF), and adiponectin. Additionally, we performed a separate meta-analysis and meta-regression of studies on the association of insulin resistance and obstructive sleep apnea (OSA). All included studies were searched from PubMed (from conception to March 15, 2014). Data were pooled across all included RCTs as the mean difference in HOMA-IR and VAF, and as the standardized mean difference in the case of adiponectin analysis. From the included case-control studies, data on the difference of HOMA-IR between cases and controls were pooled across all studies, as the standardized mean difference (SMD). There was a significant difference in HOMA-IR (-0.43 [95% CIs: -0.75 to -0.11], p = 0.008) between CPAP treated and non CPAP treated participants. However, there was no significant difference in VAF or adiponectin; (-47.93 [95% CI: -112.58 to 16.72], p = 0.14) and (-0.06 [95% CI: -0.28 to 0.15], p = 0.56), respectively. Meta-analysis of 16 case-control studies showed a pooled SMD in HOMA-IR of 0.51 (95% CI: 0.28 to 0.75), p ≤ 0.001, between cases and controls. The results of our meta-analyses show that CPAP has a favorable effect on insulin resistance. This effect is not associated with any significant changes in total adiponectin levels or amount of VAF. Our findings also confirm a significant association between OSA and insulin resistance. © 2015 American Academy of Sleep Medicine.

  19. Locomotor activity measures in the diagnosis of Attention Deficit Hyperactivity Disorder: Meta-analyses and new findings

    Science.gov (United States)

    Murillo, Lourdes García; Cortese, Samuele; Anderson, David; Martino, Adriana Di; Castellanos, Francisco Xavier

    2015-01-01

    Introduction Our aim was to assess differences in movement measures in Attention-Deficit/Hyperactivity Disorder (ADHD) vs. typically developing (TD) controls. Methods We performed meta-analyses of published studies on motion measures contrasting ADHD with controls. We also conducted a case-control study with children/adolescents (n=61 TD, n=62 ADHD) and adults (n=30 TD, n=19 ADHD) using the McLean Motion Activity Test, semi-structured diagnostic interviews and the Behavior Rating Inventory of Executive Function and Conners (Parent, Teacher; Self) Rating Scales. Results Meta-analyses revealed medium-to-large effect sizes for actigraph (standardized mean difference [SMD]: 0.64, 95% Confidence interval (CI): 0.43, 0.85) and motion tracking systems (SDM: 0.92, 95% CI: 0.65, 1.20) measures in differentiating individuals with ADHD from controls. Effects sizes were similar in studies of children/adolescents ([SMD]:0.75, 95% CI: 0.50, 1.01) and of adults ([SMD]: 0.73, 95% CI: 0.46, 1.00). In our sample, ADHD groups differed significantly in number of Head Movements (p=0.02 in children; p=0.002 in adults), Displacement (p=0.009/pADHD (d=0.45, 95% CI: 0.08, 0.82). In the concurrent go/no-go task, reaction time variability was significantly greater in ADHD (pADHD even in adults. Our results suggest that objective locomotion measures may be particularly useful in evaluating adults with possible ADHD. PMID:25770940

  20. DeLLITE Depression in late life: an intervention trial of exercise. Design and recruitment of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Keeling Sally

    2008-05-01

    Full Text Available Abstract Background Physical activity shows potential in combating the poor outcomes associated with depression in older people. Meta-analyses show gaps in the research with poor trial design compromising certainty in conclusions and few programmes showing sustained effects. Methods/design The Depression in Late Life: an Intervention Trial of Exercise (DeLLITE is a 12 month randomised controlled trial of a physical activity intervention to increase functional status in people aged 75 years and older with depressive symptoms. The intervention involves an individualised activity programme based on goal setting and progression of difficulty of activities delivered by a trained nurse during 8 home visits over 6 months. The control group received time matched home visits to discuss social contacts and networks. Baseline, 6 and 12 months measures were assessed in face to face visits with the primary outcome being functional status (SPPB, NEADL. Secondary outcomes include depressive symptoms (Geriatric Depression Scale, quality of life (SF-36, physical activity (AHS Physical Activity Questionnaire and falls (self report. Discussion Due to report in 2008 the DeLLITE study has recruited 70% of those eligible and tests the efficacy of a home based, goal setting physical activity programme in improving function, mood and quality of life in older people with depressive symptomatology. If successful in improving function and mood this trial could prove for the first time that there are long term health benefit of physical activity, independent of social activity, in this high risk group who consume excess health related costs. Trial registration Australian and New Zealand Clinical Trials Register ACTRN12605000475640

  1. Economic evaluation of adult rehabilitation: a systematic review and meta-analysis of randomized controlled trials in a variety of settings.

    Science.gov (United States)

    Brusco, Natasha Kareem; Taylor, Nicholas F; Watts, Jennifer J; Shields, Nora

    2014-01-01

    To report if there is a difference in costs from a societal perspective between adults receiving rehabilitation in an inpatient rehabilitation setting versus an alternative setting. If there are cost differences, to report whether opting for the least expensive program setting adversely affects patient outcomes. Electronic databases from the earliest possible date until May 2011. All languages were included. Multiple reviewers identified randomized controlled trials with a full economic evaluation that compared adult inpatient rehabilitation with an alternative. There were 29 included trials with 6746 participants. Multiple observers extracted data independently. Trial appraisal included a risk of bias assessment and a checklist to report the strength of the economic evaluation. Results were synthesized using standardized mean differences (SMDs) and meta-analyses for the primary outcome of cost. The Grading of Recommendations Assessment, Development, and Evaluation was applied to assess for risk of bias across studies for meta-analyses. There was high-quality evidence that cost was significantly reduced for rehabilitation in the home versus inpatient rehabilitation in a meta-analysis of 732 patients poststroke (pooled SMD [δ]=-.28; 95% confidence interval [CI], -.47 to -.09), without compromise to patient outcomes. Results of individual trials in other patient groups (orthopedic, rheumatoid arthritis, and geriatric) receiving rehabilitation in the home or community were generally consistent with the meta-analysis. There was moderate quality evidence that cost was significantly reduced for inpatient rehabilitation (stroke unit) versus general acute care in a meta-analysis of 463 patients poststroke (δ=.31; 95% CI, .15-.48), with improvement to patient outcomes. These results were not replicated in 2 individual trials with a geriatric and a mixed cohort, where costs did not differ between general acute care and inpatient rehabilitation. Three of the 4 individual

  2. a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    MS Yıldırım

    2016-02-01

    Full Text Available The aim of this study was to compare the effects of static stretching, proprioceptive neuromuscular facilitation (PNF stretching and Mulligan technique on hip flexion range of motion (ROM in subjects with bilateral hamstring tightness. A total of 40 students (mean age: 21.5±1.3 years, mean body height: 172.8±8.2 cm, mean body mass index: 21.9±3.0 kg • m-2 with bilateral hamstring tightness were enrolled in this randomized trial, of whom 26 completed the study. Subjects were divided into 4 groups performing (I typical static stretching, (II PNF stretching, (III Mulligan traction straight leg raise (TSLR technique, (IV no intervention. Hip flexion ROM was measured using a digital goniometer with the passive straight leg raise test before and after 4 weeks by two physiotherapists blinded to the groups. 52 extremities of 26 subjects were analyzed. Hip flexion ROM increased in all three intervention groups (p<0.05 but not in the no-intervention group after 4 weeks. A statistically significant change in initial–final assessment differences of hip flexion ROM was found between groups (p<0.001 in favour of PNF stretching and Mulligan TSLR technique in comparison to typical static stretching (p=0.016 and p=0.02, respectively. No significant difference was found between Mulligan TSLR technique and PNF stretching (p=0.920. The initial–final assessment difference of hip flexion ROM was similar in typical static stretching and no intervention (p=0.491. A 4-week stretching intervention is beneficial for increasing hip flexion ROM in bilateral hamstring tightness. However, PNF stretching and Mulligan TSLR technique are superior to typical static stretching. These two interventions can be alternatively used for stretching in hamstring tightness.

  3. The Efficacy of Psychological Therapies in Reducing Weight and Binge Eating in People with Bulimia Nervosa and Binge Eating Disorder Who Are Overweight or Obese—A Critical Synthesis and Meta-Analyses

    Science.gov (United States)

    Palavras, Marly Amorim; Hay, Phillipa; dos Santos Filho, Celso Alves; Claudino, Angélica

    2017-01-01

    Recurrent binge eating episodes, the core feature of Bulimia Nervosa (BN) and Binge Eating Disorder (BED), are frequently comorbid with obesity. Psychological interventions, notably Cognitive Behavioural Therapy (CBT), are effective for binge eating reduction in BED or BN but less so for weight loss. Behavioural Weight Loss Therapy (BWLT) shows effectiveness for binge eating reduction and weight loss but the latter appears poorly sustained over time. Our aim was to review evidence for efficacy of psychological therapies for BN/BED associated with overweight or obesity in reducing binge frequency and weight. A systematic search for randomized controlled trials with adult samples who had BN or BED was conducted considering articles in English, French, Spanish and Portuguese with no restrictions for the timeline publication ending in March 2016. A quality appraisal of the trials and meta-analyses comparing BWLT to CBT were done. This review identified 2248 articles for screening and 19 published articles were selected. No trials of BN were identified. This review found CBT was favoured compared to BWLT with regard to short-term binge eating reduction. However, insufficient evidence was found for superiority for BWLT efficacy compared to CBT considering binge eating remission, reduction of binge eating frequency and weight loss. More research is needed to test the efficacy of psychological treatments for BED or BN with co-morbid overweight or obesity, including trials evaluating binge eating remission and weight loss in the long-term. PMID:28304341

  4. The Efficacy of Psychological Therapies in Reducing Weight and Binge Eating in People with Bulimia Nervosa and Binge Eating Disorder Who Are Overweight or Obese-A Critical Synthesis and Meta-Analyses.

    Science.gov (United States)

    Palavras, Marly Amorim; Hay, Phillipa; Filho, Celso Alves Dos Santos; Claudino, Angélica

    2017-03-17

    Recurrent binge eating episodes, the core feature of Bulimia Nervosa (BN) and Binge Eating Disorder (BED), are frequently comorbid with obesity. Psychological interventions, notably Cognitive Behavioural Therapy (CBT), are effective for binge eating reduction in BED or BN but less so for weight loss. Behavioural Weight Loss Therapy (BWLT) shows effectiveness for binge eating reduction and weight loss but the latter appears poorly sustained over time. Our aim was to review evidence for efficacy of psychological therapies for BN/BED associated with overweight or obesity in reducing binge frequency and weight. A systematic search for randomized controlled trials with adult samples who had BN or BED was conducted considering articles in English, French, Spanish and Portuguese with no restrictions for the timeline publication ending in March 2016. A quality appraisal of the trials and meta-analyses comparing BWLT to CBT were done. This review identified 2248 articles for screening and 19 published articles were selected. No trials of BN were identified. This review found CBT was favoured compared to BWLT with regard to short-term binge eating reduction. However, insufficient evidence was found for superiority for BWLT efficacy compared to CBT considering binge eating remission, reduction of binge eating frequency and weight loss. More research is needed to test the efficacy of psychological treatments for BED or BN with co-morbid overweight or obesity, including trials evaluating binge eating remission and weight loss in the long-term.

  5. Environmental risk factors of pregnancy outcomes: a summary of recent meta-analyses of epidemiological studies.

    Science.gov (United States)

    Nieuwenhuijsen, Mark J; Dadvand, Payam; Grellier, James; Martinez, David; Vrijheid, Martine

    2013-01-15

    Various epidemiological studies have suggested associations between environmental exposures and pregnancy outcomes. Some studies have tempted to combine information from various epidemiological studies using meta-analysis. We aimed to describe the methodologies used in these recent meta-analyses of environmental exposures and pregnancy outcomes. Furthermore, we aimed to report their main findings. We conducted a bibliographic search with relevant search terms. We obtained and evaluated 16 recent meta-analyses. The number of studies included in each reported meta-analysis varied greatly, with the largest number of studies available for environmental tobacco smoke. Only a small number of the studies reported having followed meta-analysis guidelines or having used a quality rating system. Generally they tested for heterogeneity and publication bias. Publication bias did not occur frequently.The meta-analyses found statistically significant negative associations between environmental tobacco smoke and stillbirth, birth weight and any congenital anomalies; PM2.5 and preterm birth; outdoor air pollution and some congenital anomalies; indoor air pollution from solid fuel use and stillbirth and birth weight; polychlorinated biphenyls (PCB) exposure and birth weight; disinfection by-products in water and stillbirth, small for gestational age and some congenital anomalies; occupational exposure to pesticides and solvents and some congenital anomalies; and agent orange and some congenital anomalies. The number of meta-analyses of environmental exposures and pregnancy outcomes is small and they vary in methodology. They reported statistically significant associations between environmental exposures such as environmental tobacco smoke, air pollution and chemicals and pregnancy outcomes.

  6. Environmental risk factors of pregnancy outcomes: a summary of recent meta-analyses of epidemiological studies

    Directory of Open Access Journals (Sweden)

    Nieuwenhuijsen Mark J

    2013-01-01

    Full Text Available Abstract Background Various epidemiological studies have suggested associations between environmental exposures and pregnancy outcomes. Some studies have tempted to combine information from various epidemiological studies using meta-analysis. We aimed to describe the methodologies used in these recent meta-analyses of environmental exposures and pregnancy outcomes. Furthermore, we aimed to report their main findings. Methods We conducted a bibliographic search with relevant search terms. We obtained and evaluated 16 recent meta-analyses. Results The number of studies included in each reported meta-analysis varied greatly, with the largest number of studies available for environmental tobacco smoke. Only a small number of the studies reported having followed meta-analysis guidelines or having used a quality rating system. Generally they tested for heterogeneity and publication bias. Publication bias did not occur frequently. The meta-analyses found statistically significant negative associations between environmental tobacco smoke and stillbirth, birth weight and any congenital anomalies; PM2.5 and preterm birth; outdoor air pollution and some congenital anomalies; indoor air pollution from solid fuel use and stillbirth and birth weight; polychlorinated biphenyls (PCB exposure and birth weight; disinfection by-products in water and stillbirth, small for gestational age and some congenital anomalies; occupational exposure to pesticides and solvents and some congenital anomalies; and agent orange and some congenital anomalies. Conclusions The number of meta-analyses of environmental exposures and pregnancy outcomes is small and they vary in methodology. They reported statistically significant associations between environmental exposures such as environmental tobacco smoke, air pollution and chemicals and pregnancy outcomes.

  7. Oral Chinese proprietary medicine for angina pectoris: an overview of systematic reviews/meta-analyses.

    Science.gov (United States)

    Luo, Jing; Xu, Hao; Yang, Guoyan; Qiu, Yu; Liu, Jianping; Chen, Keji

    2014-08-01

    Oral Chinese proprietary medicine (CPM) is commonly used to treat angina pectoris, and many relevant systematic reviews/meta-analyses are available. However, these reviews have not been systematically summarized and evaluated. We conducted an overview of these reviews, and explored their methodological and reporting quality to inform both practice and further research. We included systematic reviews/meta-analyses on oral CPM in treating angina until March 2013 by searching PubMed, Embase, the Cochrane Library and four Chinese databases. We extracted data according to a pre-designed form, and assessed the methodological and reporting characteristics of the reviews in terms of AMSTAR and PRISMA respectively. Most of the data analyses were descriptive. 36 systematic reviews/meta-analyses involving over 82,105 participants with angina reviewing 13 kinds of oral CPM were included. The main outcomes assessed in the reviews were surrogate outcomes (34/36, 94.4%), adverse events (31/36, 86.1%), and symptoms (30/36, 83.3%). Six reviews (6/36, 16.7%) drew definitely positive conclusions, while the others suggested potential benefits in the symptoms, electrocardiogram, and adverse events. The overall methodological and reporting quality of the reviews was limited, with many serious flaws such as the lack of review protocol and incomprehensive literature searches. Though many systematic reviews/meta-analyses on oral CPM for angina suggested potential benefits or definitely positive effects, stakeholders should interpret the findings of these reviews with caution, considering the overall limited methodological and reporting quality. We recommend further studies should be appropriately conducted and systematic reviews reported according to PRISMA standard. Copyright © 2014 Elsevier Ltd. All rights reserved.

  8. The Traditional Chinese Medicine and Relevant Treatment for the Efficacy and Safety of Atopic Dermatitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    Science.gov (United States)

    Shi, Zhao-feng; Song, Tie-bing; Xie, Juan; Yan, Yi-quan

    2017-01-01

    Background Atopic dermatitis (AD) has become a common skin disease that requires systematic and comprehensive treatment to achieve adequate clinical control. Traditional Chinese medicines and related treatments have shown clinical effects for AD in many studies. But the systematic reviews and meta-analyses for them are lacking. Objective The systematic review and meta-analysis based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement were conducted to evaluate the efficacy and safety of traditional Chinese medicines and related treatments for AD treatment. Methods Randomized controlled trials (RCTs) were searched based on standardized searching rules in eight medical databases from the inception up to December 2016 and a total of 24 articles with 1,618 patients were enrolled in this meta-analysis. Results The results revealed that traditional Chinese medicines and related treatments did not show statistical differences in clinical effectiveness, SCORAD amelioration, and SSRI amelioration for AD treatment compared with control group. However, EASI amelioration of traditional Chinese medicines and related treatments for AD was superior to control group. Conclusion We need to make conclusion cautiously for the efficacy and safety of traditional Chinese medicine and related treatment on AD therapy. More standard, multicenter, double-blind randomized controlled trials (RCTs) of traditional Chinese medicine and related treatment for AD were required to be conducted for more clinical evidences providing in the future. PMID:28713436

  9. Meta-Analyses of the Effects of Habitual Running on Indices of Health in Physically Inactive Adults.

    Science.gov (United States)

    Hespanhol Junior, Luiz Carlos; Pillay, Julian David; van Mechelen, Willem; Verhagen, Evert

    2015-10-01

    In order to implement running to promote physical activity, it is essential to quantify the extent to which running improves health. The aim was to summarise the literature on the effects of endurance running on biomedical indices of health in physically inactive adults. Electronic searches were conducted in October 2014 on PubMed, Embase, CINAHL, SPORTDiscus, PEDro, the Cochrane Library and LILACS, with no limits of date and language of publication. Randomised controlled trials (with a minimum of 8 weeks of running training) that included physically inactive but healthy adults (18-65 years) were selected. The studies needed to compare intervention (i.e. endurance running) and control (i.e., no intervention) groups. Two authors evaluated study eligibility, extracted data, and assessed risk of bias; a third author resolved any uncertainties. Random-effects meta-analyses were performed to summarise the estimates for length of training and sex. A dose-response analysis was performed with random-effects meta-regression in order to investigate the relationship between running characteristics and effect sizes. After screening 22,380 records, 49 articles were included, of which 35 were used to combine data on ten biomedical indices of health. On average the running programs were composed of 3.7 ± 0.9 sessions/week, 2.3 ± 1.0 h/week, 14.4 ± 5.4 km/week, at 60-90% of the maximum heart rate, and lasted 21.5 ± 16.8 weeks. After 1 year of training, running was effective in reducing body mass by 3.3 kg [95% confidence interval (CI) 4.1-2.5], body fat by 2.7% (95% CI 5.1-0.2), resting heart rate by 6.7 min(-1) (95% CI 10.3-3.0) and triglycerides by 16.9 mg dl(-1) (95% CI 28.1-5.6). Also, running significantly increased maximal oxygen uptake (VO2max) by 7.1 ml min(-1) kg(-1) (95% CI 5.0-9.1) and high-density lipoprotein (HDL) cholesterol by 3.3 mg dl(-1) (95% CI 1.2-5.4). No significant effect was found for lean body mass, body mass index, total cholesterol and low

  10. Ain't Necessarily So : Review and Critique of Recent Meta-Analyses of Behavioral Medicine Interventions in Health Psychology

    NARCIS (Netherlands)

    Coyne, James C.; Thombs, Brett D.; Hagedoorn, Mariet

    Objective: We examined four meta-analyses of behavioral interventions for adults (Dixon, Keefe, Scipio, Perri, & Abernethy, 2007; Hoffman, Papas, Chatkoff, & Kerns, 2007; Irwin, Cole, & Nicassio, 2006; and Jacobsen, Donovan, Vadaparampil, & Small, 2007) that have appeared in the Evidence Based

  11. Aspirin in the Treatment of Cancer: Reductions in Metastatic Spread and in Mortality: A Systematic Review and Meta-Analyses of Published Studies

    Science.gov (United States)

    Elwood, Peter C.

    2016-01-01

    Background Low-dose aspirin has been shown to reduce the incidence of cancer, but its role in the treatment of cancer is uncertain. Objectives We conducted a systematic search of the scientific literature on aspirin taken by patients following a diagnosis of cancer, together with appropriate meta-analyses. Methods Searches were completed in Medline and Embase in December 2015 using a pre-defined search strategy. References and abstracts of all the selected papers were scanned and expert colleagues were contacted for additional studies. Two reviewers applied pre-determined eligibility criteria (cross-sectional, cohort and controlled studies, and aspirin taken after a diagnosis of cancer), assessed study quality and extracted data on cancer cause-specific deaths, overall mortality and incidence of metastases. Random effects meta-analyses and planned sub-group analyses were completed separately for observational and experimental studies. Heterogeneity and publication bias were assessed in sensitivity analyses and appropriate omissions made. Papers were examined for any reference to bleeding and authors of the papers were contacted and questioned. Results Five reports of randomised trials were identified, together with forty two observational studies: sixteen on colorectal cancer, ten on breast and ten on prostate cancer mortality. Pooling of eleven observational reports of the effect of aspirin on cause-specific mortality from colon cancer, after the omission of one report identified on the basis of sensitivity analyses, gave a hazard ratio (HR) of 0.76 (95% CI 0.66, 0.88) with reduced heterogeneity (P = 0.04). The cause specific mortality in five reports of patients with breast cancer showed significant heterogeneity (Paspirin, and in five the effect is statistically significant. There were no significant differences between the pooled HRs for the three main cancers and after the omission of three reports already identified in sensitivity analyses heterogeneity was

  12. Quality of meta-analyses in major leading gastroenterology and hepatology journals: A systematic review.

    Science.gov (United States)

    Liu, Pengfei; Qiu, Yuanyu; Qian, Yuting; Chen, Xiao; Wang, Yiran; Cui, Jin; Zhai, Xiao

    2017-01-01

    To appraise the current reporting methodological quality of meta-analyses in five leading gastroenterology and hepatology journals, and to identify the variables associated with the reporting quality. We systematically searched the literature of meta-analyses in Gastroenterology, Gut, Hepatology, Journal of Hepatology (J HEPATOL) and American Journal of Gastroenterology (AM J GASTROENTEROL) from 2006 to 2008 and from 2012 to 2014. Characteristics were extracted based on the PRISMA statement and the AMSTAR tool. Country, number of patients, funding source were also revealed and descriptively reported. A total of 127 meta-analyses were enrolled in this study and were compared among journals, study years, and other characters. Compliances with the PRISMA statement and the AMSTAR checklist were 20.8 ± 4.2 out of a maximum of 27 and 7.6 ± 2.4 out of a maximum of 11, respectively. Some domains were poorly reported including describing a protocol and/or registration (item 5, 0.0%), describing methods, and giving results of additional analyses (item 16, 45.7% and item 23, 48.0%) for PRISMA and duplicating study selection and data extraction (item 2, 53.5%), and providing a list of included and excluded studies (item 5, 14.2%) for AMSTAR. Publication in recent years showed a significantly better methodological quality than those published in previous years. This study shows that methodological reporting quality of MAs in the major gastroenterology and hepatology journals has improved in recent years after the publication of the developed PRISMA statement, and it can be further improved. © 2016 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

  13. Management of hepatocellular carcinoma: an overview of major findings from meta-analyses

    Science.gov (United States)

    Guo, Xiaozhong; Han, Guohong

    2016-01-01

    This paper aims to systematically review the major findings from meta-analyses comparing different treatment options for hepatocellular carcinoma (HCC). A total of 153 relevant papers were searched via the PubMed, EMBASE, and Cochrane library databases. They were classified according to the mainstay treatment modalities (i.e., liver transplantation, surgical resection, radiofrequency ablation, transarterial embolization or chemoembolization, sorafenib, and others). The primary outcome data, such as overall survival, diseases-free survival or recurrence-free survival, progression-free survival, and safety, were summarized. The recommendations and uncertainties regarding the treatment of HCC were also proposed. PMID:27167195

  14. Post-licence driver education for the prevention of road traffic crashes: a systematic review of randomised controlled trials.

    Science.gov (United States)

    Ker, Katharine; Roberts, Ian; Collier, Timothy; Beyer, Fiona; Bunn, Frances; Frost, Chris

    2005-03-01

    The effectiveness of post-licence driver education for preventing road traffic crashes was quantified using a systematic review and meta-analyses of randomised controlled trials. Searches of appropriate electronic databases, the Internet and reference lists of relevant papers were conducted. The searches were not restricted by language or publication status. Data were pooled from 21 randomised controlled trials, including over 300,000 full licence-holding drivers of all ages. Nineteen trials reported subsequent traffic offences, with a pooled relative risk of 0.96 (95% confidence interval 0.94, 0.98). Fifteen trials reported traffic crashes with a pooled relative risk of 0.98 (0.96, 1.01). Four trials reported injury crashes with a pooled relative risk of 1.12 (0.88, 1.41). The results provide no evidence that post-licence driver education is effective in preventing road injuries or crashes. Although the results are compatible with a small reduction in the occurrence of traffic crashes, this may be due to selection biases or bias in the included trials.

  15. What is the level of evidence for the amnestic effects of sedatives in pediatric patients? A systematic review and meta-analyses.

    Directory of Open Access Journals (Sweden)

    Karolline Alves Viana

    Full Text Available Studies have suggested that benzodiazepines are amnestic drug par excellence, but when taken together, what level of evidence do they generate? Are other sedatives as amnestic as benzodiazepines? The aim of this study was to assess the level of scientific evidence for the amnestic effect of sedatives in pediatric patients who undergo health procedures.The literature was searched to identify randomized controlled trials that evaluated anterograde and retrograde amnesia in 1-19-year-olds who received sedative drugs during health procedures. Electronic databases, including PubMed, Scopus and Cochrane Library besides clinical trial registries and grey literature were searched. Two independent reviewers performed data extraction and risk of bias assessment using the Cochrane Collaboration's Tool. The meta-analyses were performed by calculating relative risk (RR to 95% confidence intervals (CI. The quality of the evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation approach.Fifty-four studies were included (4,168 participants. A higher occurrence of anterograde amnesia was observed when benzodiazepines, the most well-studied sedatives (n = 47, were used than when placebo was used (n = 12 (RR = 3.10; 95% CI: 2.30-4.19, P<0.001; I2 = 14%, with a moderate level of evidence. Higher doses of alpha2-adrenergic agonists (clonidine/dexmedetomidine produced more anterograde amnesia than lower doses (n = 2 (RR = 1.83; 95% CI: 1.03-3.25; P = 0.038; I2 = 0%, with a low level of evidence; benzodiazepines' amnestic effects were not dose-dependent (n = 3 (RR = 1.54; 95% CI: 0.96-2.49; P = 0.07; I2 = 12% but the evidence was low. A qualitative analysis showed that retrograde amnesia did not occur in 8 out of 10 studies.In children, moderate evidence support that benzodiazepines induce anterograde amnesia, whereas the evidence for other sedatives is weak and based on isolated and small studies. Further clinical trials focused

  16. Examining the associations between HIV-related stigma and health outcomes in people living with HIV/AIDS: a series of meta-analyses

    Science.gov (United States)

    Mitra, Sanjana; Chen, Shiyi; Gogolishvili, David; Globerman, Jason; Chambers, Lori; Wilson, Mike; Logie, Carmen H; Shi, Qiyun; Morassaei, Sara; Rourke, Sean B

    2016-01-01

    Objective To conduct a systematic review and series of meta-analyses on the association between HIV-related stigma and health among people living with HIV. Data sources A structured search was conducted on 6 electronic databases for journal articles reporting associations between HIV-related stigma and health-related outcomes published between 1996 and 2013. Study eligibility criteria Controlled studies, cohort studies, case-control studies and cross-sectional studies in people living with HIV were considered for inclusion. Outcome measures Mental health (depressive symptoms, emotional and mental distress, anxiety), quality of life, physical health, social support, adherence to antiretroviral therapy, access to and usage of health/social services and risk behaviours. Results 64 studies were included in our meta-analyses. We found significant associations between HIV-related stigma and higher rates of depression, lower social support and lower levels of adherence to antiretroviral medications and access to and usage of health and social services. Weaker relationships were observed between HIV-related stigma and anxiety, quality of life, physical health, emotional and mental distress and sexual risk practices. While risk of bias assessments revealed overall good quality related to how HIV stigma and health outcomes were measured on the included studies, high risk of bias among individual studies was observed in terms of appropriate control for potential confounders. Additional research should focus on elucidating the mechanisms behind the negative relationship between stigma and health to better inform interventions to reduce the impact of stigma on the health and well-being of people with HIV. Conclusions This systematic review and series of meta-analyses support the notion that HIV-related stigma has a detrimental impact on a variety of health-related outcomes in people with HIV. This review can inform the development of multifaceted, intersectoral interventions to

  17. An umbrella review of meta-analyses of interventions to improve maternal outcomes for teen mothers.

    Science.gov (United States)

    SmithBattle, Lee; Loman, Deborah G; Chantamit-O-Pas, Chutima; Schneider, Joanne Kraenzle

    2017-08-01

    The purpose of this study was to perform an umbrella review of meta-analyses of intervention studies designed to improve outcomes of pregnant or parenting teenagers. An extensive search retrieved nine reports which provided 21 meta-analyses analyses. Data were extracted by two reviewers. Methodological quality was assessed using the AMSTAR Instrument. Most effect sizes were small but high quality studies showed significant outcomes for reduced low birth weight (RR = 0.60), repeat pregnancies/births (OR = 0.47-0.62), maternal education (OR = 1.21-1.83), and maternal employment (OR = 1.26). Several parenting outcomes (parent-child teaching interaction post-intervention [SMD = -0.91] and at follow-up [SMD = -1.07], and parent-child relationship post-intervention [SMD = -0.71] and at follow-up [SMD = -0.90]) were significant, but sample sizes were very small. Many reports did not include moderator analyses. Behavioral interventions offer limited resources and occur too late to mitigate the educational and social disparities that precede teen pregnancy. Future intervention research and policies that redress the social determinants of early childbearing are recommended. Copyright © 2017 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.

  18. Novel citation-based search method for scientific literature: application to meta-analyses.

    Science.gov (United States)

    Janssens, A Cecile J W; Gwinn, M

    2015-10-13

    Finding eligible studies for meta-analysis and systematic reviews relies on keyword-based searching as the gold standard, despite its inefficiency. Searching based on direct citations is not sufficiently comprehensive. We propose a novel strategy that ranks articles on their degree of co-citation with one or more "known" articles before reviewing their eligibility. In two independent studies, we aimed to reproduce the results of literature searches for sets of published meta-analyses (n = 10 and n = 42). For each meta-analysis, we extracted co-citations for the randomly selected 'known' articles from the Web of Science database, counted their frequencies and screened all articles with a score above a selection threshold. In the second study, we extended the method by retrieving direct citations for all selected articles. In the first study, we retrieved 82% of the studies included in the meta-analyses while screening only 11% as many articles as were screened for the original publications. Articles that we missed were published in non-English languages, published before 1975, published very recently, or available only as conference abstracts. In the second study, we retrieved 79% of included studies while screening half the original number of articles. Citation searching appears to be an efficient and reasonably accurate method for finding articles similar to one or more articles of interest for meta-analysis and reviews.

  19. Efficacy and safety of ginger in osteoarthritis patients: a meta-analysis of randomized placebo-controlled trials.

    Science.gov (United States)

    Bartels, E M; Folmer, V N; Bliddal, H; Altman, R D; Juhl, C; Tarp, S; Zhang, W; Christensen, R

    2015-01-01

    The aim of this study was to assess the clinical efficacy and safety of oral ginger for symptomatic treatment of osteoarthritis (OA) by carrying out a systematic literature search followed by meta-analyses on selected studies. Inclusion criteria were randomized controlled trials (RCTs) comparing oral ginger treatment with placebo in OA patients aged >18 years. Outcomes were reduction in pain and reduction in disability. Harm was assessed as withdrawals due to adverse events. The efficacy effect size was estimated using Hedges' standardized mean difference (SMD), and safety by risk ratio (RR). Standard random-effects meta-analysis was used, and inconsistency was evaluated by the I-squared index (I(2)). Out of 122 retrieved references, 117 were discarded, leaving five trials (593 patients) for meta-analyses. The majority reported relevant randomization procedures and blinding, but an inadequate intention-to-treat (ITT) analysis. Following ginger intake, a statistically significant pain reduction SMD = -0.30 ([95% CI: [(-0.50, -0.09)], P = 0.005]) with a low degree of inconsistency among trials (I(2) = 27%), and a statistically significant reduction in disability SMD = -0.22 ([95% CI: ([-0.39, -0.04)]; P = 0.01; I(2) = 0%]) were seen, both in favor of ginger. Patients given ginger were more than twice as likely to discontinue treatment compared to placebo ([RR = 2.33; 95% CI: (1.04, 5.22)]; P = 0.04; I(2) = 0%]). Ginger was modestly efficacious and reasonably safe for treatment of OA. We judged the evidence to be of moderate quality, based on the small number of participants and inadequate ITT populations. Prospero: CRD42011001777. Copyright © 2014 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  20. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients

    NARCIS (Netherlands)

    Baigent, C; Sudlow, C; Collins, R; Peto, R

    2002-01-01

    Objective To determine the effects of antiplatelet therapy among patients at high risk of occlusive vascular events. Design Collaborative meta-analyses (systematic overviews). Inclusion criteria Randomised trials of an antiplatelet regimen versus control or of one antiplatelet regimen versus another

  1. A systematic review, and meta-analyses, of the impact of health-related claims on dietary choices.

    Science.gov (United States)

    Kaur, Asha; Scarborough, Peter; Rayner, Mike

    2017-07-11

    Health-related claims are statements regarding the nutritional content of a food (nutrition claims) and/or indicate that a relationship exists between a food and a health outcome (health claims). Their impact on food purchasing or consumption decisions is unclear. This systematic review measured the effect of health-related claims, on pre-packaged foods in retail settings, on adult purchasing decisions (real and perceived). In September 2016, we searched MEDLINE, EMBASE, PsychINFO, CAB abstracts, Business Source Complete, and Web of Science/Science Citation Index & Social Science Citation Index for articles in English published in peer-review journals. Studies were included if they were controlled experiments where the experimental group(s) included a health-related claim and the control group involved an identical product without a health-related claim. Included studies measured (at an individual or population level); actual or intended choice, purchases, and/or consumption. The primary outcome was product choices and purchases, the secondary outcome was food consumption and preference. Results were standardised through calculating odds ratios and 95% confidence intervals (CI) for the likelihood of choosing a product when a health-related claim was present. Results were combined in a random-effects meta-analysis. Thirty-one papers were identified, 17 of which were included for meta-analyses. Most studies were conducted in Europe (n = 17) and the USA (n = 7). Identified studies were choice experiments that measured the likelihood of a product being chosen when a claim was present compared to when a claim was not present, (n = 16), 15 studies were experiments that measured either; intent-rating scale outcomes (n = 8), consumption (n = 6), a combination of the two (n = 1), or purchase data (n = 1). Overall, 20 studies found that claims increase purchasing and/or consumption, eight studies had mixed results, and two studies found consumption

  2. Long-Term Efficacy of Maintenance Therapy for Multiple Myeloma: A Quantitative Synthesis of 22 Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Jie-Li Li

    2018-04-01

    Full Text Available We aimed to quantitatively synthesize data from randomized controlled trials (RCTs concerning maintenance for multiple myeloma (MM. We searched electronic literature databases and conference proceedings to identify relevant RCTs. We selected eligible RCTs using predefined selection criteria. We conducted meta-analysis comparing maintenance containing new agents and conventional maintenance, and subgroup analysis by transplantation status and mainstay agent as well. We performed trial sequential analysis (TSA to determine adequacy of sample size for overall and subgroup meta-analyses. We performed network meta-analysis (NMA to compare and rank included regimens. A total of 22 RCTs involving 9,968 MM patients and 15 regimens were included, the overall quality of which was adequate. Significant heterogeneity was detected for progression-free survival (PFS but not overall survival (OS. Meta-analyses showed that maintenance containing new agents significantly improved PFS but not OS [PFS: Hazard Ratio (HR = 0.59, 95% Confidence Interval (CI = 0.54 to 0.64; OS: HR = 0.93, 95% CI = 0.87 to 1.00], compared with controls. Subgroup analyses revealed lenalidomide (Len-based therapies better than thalidomide-based ones (HR = 0.50 and 0.66, respectively; P = 0.001. NMA revealed that most of the maintenance regimens containing new agents were significantly better than simple observation in terms of PFS but not OS. Len single agent was the most effective, considering PFS and OS both. We concluded that conventional maintenance has very limited effect. Maintenance containing new agents is highly effective in improving PFS, but has very limited effect on OS. Maintenance with Len may have the largest survival benefits. Emerging strategies may further change the landscape of maintenance of MM.

  3. Systematic literature reviews and meta-analyses: part 6 of a series on evaluation of scientific publications.

    Science.gov (United States)

    Ressing, Meike; Blettner, Maria; Klug, Stefanie J

    2009-07-01

    Because of the rising number of scientific publications, it is important to have a means of jointly summarizing and assessing different studies on a single topic. Systematic literature reviews, meta-analyses of published data, and meta-analyses of individual data (pooled reanalyses) are now being published with increasing frequency. We here describe the essential features of these methods and discuss their strengths and weaknesses. This article is based on a selective literature search. The different types of review and meta-analysis are described, the methods used in each are outlined so that they can be evaluated, and a checklist is given for the assessment of reviews and meta-analyses of scientific articles. Systematic literature reviews provide an overview of the state of research on a given topic and enable an assessment of the quality of individual studies. They also allow the results of different studies to be evaluated together when these are inconsistent. Meta-analyses additionally allow calculation of pooled estimates of an effect. The different types of review and meta-analysis are discussed with examples from the literature on one particular topic. Systematic literature reviews and meta-analyses enable the research findings and treatment effects obtained in different individual studies to be summed up and evaluated.

  4. Effectiveness and cost-effectiveness of ehealth interventions in somatic diseases: a systematic review of systematic reviews and meta-analyses.

    Science.gov (United States)

    Elbert, Niels J; van Os-Medendorp, Harmieke; van Renselaar, Wilco; Ekeland, Anne G; Hakkaart-van Roijen, Leona; Raat, Hein; Nijsten, Tamar E C; Pasmans, Suzanne G M A

    2014-04-16

    evidence is at least promising (65% vs 62%). Reviews focusing primarily on children or family caregivers still remained scarce. Although a pooled (subgroup) analysis of aggregate data from randomized studies was performed in a higher percentage of more recently published reviews (45% vs 27%), data on economic outcome measures were less frequently reported (65% vs 85%). The number of reviews and meta-analyses on eHealth interventions in patients with somatic diseases has increased considerably in recent years. Most articles show eHealth is effective/cost-effective or at least suggest evidence is promising, which is consistent with previous findings. Although many researchers advocate larger, well-designed, controlled studies, we believe attention should be given to the development and evaluation of strategies to implement effective/cost-effective eHealth initiatives in daily practice, rather than to further strengthen current evidence.

  5. The change of adjacent segment after cervical disc arthroplasty compared with anterior cervical discectomy and fusion: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Dong, Liang; Xu, Zhengwei; Chen, Xiujin; Wang, Dongqi; Li, Dichen; Liu, Tuanjing; Hao, Dingjun

    2017-10-01

    Many meta-analyses have been performed to study the efficacy of cervical disc arthroplasty (CDA) compared with anterior cervical discectomy and fusion (ACDF); however, there are few data referring to adjacent segment within these meta-analyses, or investigators are unable to arrive at the same conclusion in the few meta-analyses about adjacent segment. With the increased concerns surrounding adjacent segment degeneration (ASDeg) and adjacent segment disease (ASDis) after anterior cervical surgery, it is necessary to perform a comprehensive meta-analysis to analyze adjacent segment parameters. To perform a comprehensive meta-analysis to elaborate adjacent segment motion, degeneration, disease, and reoperation of CDA compared with ACDF. Meta-analysis of randomized controlled trials (RCTs). PubMed, Embase, and Cochrane Library were searched for RCTs comparing CDA and ACDF before May 2016. The analysis parameters included follow-up time, operative segments, adjacent segment motion, ASDeg, ASDis, and adjacent segment reoperation. The risk of bias scale was used to assess the papers. Subgroup analysis and sensitivity analysis were used to analyze the reason for high heterogeneity. Twenty-nine RCTs fulfilled the inclusion criteria. Compared with ACDF, the rate of adjacent segment reoperation in the CDA group was significantly lower (panalysis. There was no statistically significant difference in ASDeg between CDA and ACDF within the 24-month follow-up period; however, the rate of ASDeg in CDA was significantly lower than that of ACDF with the increase in follow-up time (p.05). Cervical disc arthroplasty provided a lower adjacent segment range of motion (ROM) than did ACDF, but the difference was not statistically significant. Compared with ACDF, the advantages of CDA were lower ASDeg and adjacent segment reoperation. However, there was no statistically significant difference in ASDis and adjacent segment ROM. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. How Efficacious is Danshen (Salvia miltiorrhiza) Dripping Pill in Treating Angina Pectoris? Evidence Assessment for Meta-Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Jia, Yongliang; Leung, Siu-Wai

    2017-09-01

    More than 230 randomized controlled trials (RCTs) of danshen dripping pill (DSP) and isosorbide dinitrate (ISDN) in treating angina pectoris after the first preferred reporting items for systematic reviews and meta-analyses-compliant comprehensive meta-analysis were published in 2010. Other meta-analyses had flaws in study selection, statistical meta-analysis, and evidence assessment. This study completed the meta-analysis with an extensive assessment of the evidence. RCTs published from 1994 to 2016 on DSP and ISDN in treating angina pectoris for at least 4 weeks were included. The risk of bias (RoB) of included RCTs was assessed with the Cochrane's tool for assessing RoB. Meta-analyses based on a random-effects model were performed on two outcome measures: symptomatic (SYM) and electrocardiography (ECG) improvements. Subgroup analysis, sensitivity analysis, metaregression, and publication bias analysis were also conducted. The evidence strength was evaluated with the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) method. Among the included 109 RCTs with 11,973 participants, 49 RCTs and 5042 participants were new (after 2010). The RoB of included RCTs was high in randomization and blinding. Overall effect sizes in odds ratios for DSP over ISDN were 2.94 (95% confidence interval [CI]: 2.53-3.41) on SYM (n = 108) and 2.37 (95% CI: 2.08-2.69) by ECG (n = 81) with significant heterogeneities (I 2  = 41%, p < 0.0001 on SYM and I 2  = 44%, p < 0.0001 on ECG). Subgroup, sensitivity, and metaregression analyses showed consistent results without publication bias. However, the evidence strength was low in GRADE. The efficacy of DSP was still better than ISDN in treating angina pectoris, but the confidence decreased due to high RoB and heterogeneities.

  7. Effect of soya protein on blood pressure: a meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Dong, Jia-Yi; Tong, Xing; Wu, Zhi-Wei; Xun, Peng-Cheng; He, Ka; Qin, Li-Qiang

    2011-08-01

    Observational studies have indicated that soya food consumption is inversely associated with blood pressure (BP). Evidence from randomised controlled trials (RCT) on the BP-lowering effects of soya protein intake is inconclusive. We aimed to evaluate the effectiveness of soya protein intake in lowering BP. The PubMed database was searched for published RCT in the English language through to April 2010, which compared a soya protein diet with a control diet. We conducted a random-effects meta-analysis to examine the effects of soya protein on BP. Subgroup and meta-regression analyses were performed to explore possible explanations for heterogeneity among trials. Meta-analyses of twenty-seven RCT showed a mean decrease of 2·21 mmHg (95 % CI - 4·10, - 0·33; P = 0·021) for systolic BP (SBP) and 1·44 mmHg (95 % CI - 2·56, - 0·31; P = 0·012) for diastolic BP (DBP), comparing the participants in the soya protein group with those in the control group. Soya protein consumption significantly reduced SBP and DBP in both hypertensive and normotensive subjects, and the reductions were markedly greater in hypertensive subjects. Significant and greater BP reductions were also observed in trials using carbohydrate, but not milk products, as the control diet. Meta-regression analyses further revealed a significantly inverse association between pre-treatment BP and the level of BP reductions. In conclusion, soya protein intake, compared with a control diet, significantly reduces both SBP and DBP, but the BP reductions are related to pre-treatment BP levels of subjects and the type of control diet used as comparison.

  8. Visible learning a synthesis of over 800 meta-analyses relating to achievement

    CERN Document Server

    Hattie, John A C

    2009-01-01

    This unique and ground-breaking book is the result of 15 years research and synthesises over 800 meta-analyses on the influences on achievement in school-aged students. It builds a story about the power of teachers, feedback, and a model of learning and understanding. The research involves many millions of students and represents the largest ever evidence based research into what actually works in schools to improve learning. Areas covered include the influence of the student, home, school, curricula, teacher, and teaching strategies. A model of teaching and learning is developed based on the notion of visible teaching and visible learning. A major message is that what works best for students is similar to what works best for teachers - an attention to setting challenging learning intentions, being clear about what success means, and an attention to learning strategies for developing conceptual understanding about what teachers and students know and understand. Although the current evidence based fad has turn...

  9. Thirty years of Alzheimer's disease genetics: the implications of systematic meta-analyses.

    Science.gov (United States)

    Bertram, Lars; Tanzi, Rudolph E

    2008-10-01

    The genetic underpinnings of Alzheimer's disease (AD) remain largely elusive despite early successes in identifying three genes that cause early-onset familial AD (those that encode amyloid precursor protein (APP) and the presenilins (PSEN1 and PSEN2)), and one genetic risk factor for late-onset AD (the gene that encodes apolipoprotein E (APOE)). A large number of studies that aimed to help uncover the remaining disease-related loci have been published in recent decades, collectively proposing or refuting the involvement of over 500 different gene candidates. Systematic meta-analyses of these studies currently highlight more than 20 loci that have modest but significant effects on AD risk. This Review discusses the putative pathogenetic roles and common biochemical pathways of some of the most genetically and biologically compelling of these potential AD risk factors.

  10. Conducting meta-analyses of HIV prevention literatures from a theory-testing perspective.

    Science.gov (United States)

    Marsh, K L; Johnson, B T; Carey, M P

    2001-09-01

    Using illustrations from HIV prevention research, the current article advocates approaching meta-analysis as a theory-testing scientific method rather than as merely a set of rules for quantitative analysis. Like other scientific methods, meta-analysis has central concerns with internal, external, and construct validity. The focus of a meta-analysis should only rarely be merely describing the effects of health promotion, but rather should be on understanding and explaining phenomena and the processes underlying them. The methodological decisions meta-analysts make in conducting reviews should be guided by a consideration of the underlying goals of the review (e.g., simply effect size estimation or, preferably theory testing). From the advocated perspective that a health behavior meta-analyst should test theory, the authors present a number of issues to be considered during the conduct of meta-analyses.

  11. Maternal Colonization With Group B Streptococcus and Serotype Distribution Worldwide: Systematic Review and Meta-analyses.

    Science.gov (United States)

    Russell, Neal J; Seale, Anna C; O'Driscoll, Megan; O'Sullivan, Catherine; Bianchi-Jassir, Fiorella; Gonzalez-Guarin, Juan; Lawn, Joy E; Baker, Carol J; Bartlett, Linda; Cutland, Clare; Gravett, Michael G; Heath, Paul T; Le Doare, Kirsty; Madhi, Shabir A; Rubens, Craig E; Schrag, Stephanie; Sobanjo-Ter Meulen, Ajoke; Vekemans, Johan; Saha, Samir K; Ip, Margaret

    2017-11-06

    Maternal rectovaginal colonization with group B Streptococcus (GBS) is the most common pathway for GBS disease in mother, fetus, and newborn. This article, the second in a series estimating the burden of GBS, aims to determine the prevalence and serotype distribution of GBS colonizing pregnant women worldwide. We conducted systematic literature reviews (PubMed/Medline, Embase, Latin American and Caribbean Health Sciences Literature [LILACS], World Health Organization Library Information System [WHOLIS], and Scopus), organized Chinese language searches, and sought unpublished data from investigator groups. We applied broad inclusion criteria to maximize data inputs, particularly from low- and middle-income contexts, and then applied new meta-analyses to adjust for studies with less-sensitive sampling and laboratory techniques. We undertook meta-analyses to derive pooled estimates of maternal GBS colonization prevalence at national and regional levels. The dataset regarding colonization included 390 articles, 85 countries, and a total of 299924 pregnant women. Our adjusted estimate for maternal GBS colonization worldwide was 18% (95% confidence interval [CI], 17%-19%), with regional variation (11%-35%), and lower prevalence in Southern Asia (12.5% [95% CI, 10%-15%]) and Eastern Asia (11% [95% CI, 10%-12%]). Bacterial serotypes I-V account for 98% of identified colonizing GBS isolates worldwide. Serotype III, associated with invasive disease, accounts for 25% (95% CI, 23%-28%), but is less frequent in some South American and Asian countries. Serotypes VI-IX are more common in Asia. GBS colonizes pregnant women worldwide, but prevalence and serotype distribution vary, even after adjusting for laboratory methods. Lower GBS maternal colonization prevalence, with less serotype III, may help to explain lower GBS disease incidence in regions such as Asia. High prevalence worldwide, and more serotype data, are relevant to prevention efforts. © The Author 2017. Published by

  12. Meta-Analyses of the Associations of Respiratory Health Effectswith Dampness and Mold in Homes

    Energy Technology Data Exchange (ETDEWEB)

    Fisk, William J.; Lei-Gomez, Quanhong; Mendell, Mark J.

    2006-01-01

    The Institute of Medicine (IOM) of the National Academy of Sciences recently completed a critical review of the scientific literature pertaining to the association of indoor dampness and mold contamination with adverse health effects. In this paper, we report the results of quantitative meta-analysis of the studies reviewed in the IOM report. We developed point estimates and confidence intervals (CIs) to summarize the association of several respiratory and asthma-related health outcomes with the presence of dampness and mold in homes. The odds ratios and confidence intervals from the original studies were transformed to the log scale and random effect models were applied to the log odds ratios and their variance. Models were constructed both accounting for the correlation between multiple results within the studies analyzed and ignoring such potential correlation. Central estimates of ORs for the health outcomes ranged from 1.32 to 2.10, with most central estimates between 1.3 and 1.8. Confidence intervals (95%) excluded unity except in two of 28 instances, and in most cases the lower bound of the CI exceeded 1.2. In general, the two meta-analysis methods produced similar estimates for ORs and CIs. Based on the results of the meta-analyses, building dampness and mold are associated with approximately 30% to 80% increases in a variety of respiratory and asthma-related health outcomes. The results of these meta-analyses reinforce the IOM's recommendation that actions be taken to prevent and reduce building dampness problems.

  13. Benefits of Exercise Training For Computer-Based Staff: A Meta Analyses

    Directory of Open Access Journals (Sweden)

    Mothna Mohammed

    2017-04-01

    Full Text Available Background: Office workers sit down to work for approximately 8 hours a day and, as a result, many of them do not have enough time for any form of physical exercise. This can lead to musculoskeletal discomforts, especially low back pain and recently, many researchers focused on home/office-based exercise training for prevention/treatment of low back pain among this population. Objective: This Meta analyses paper tried to discuss about the latest suggested exercises for the office workers based on the mechanisms and theories behind low back pain among office workers. Method: In this Meta analyses the author tried to collect relevant papers which were published previously on the subject. Google Scholar, Scopus, and PubMed were used as sources to find the articles. Only articles that were published using the same methodology, including office workers, musculoskeletal discomforts, low back pain, and exercise training keywords, were selected. Studies that failed to report sufficient sample statistics, or lacked a substantial review of past academic scholarship and/or clear methodologies, were excluded. Results: Limited evidence regarding the prevention of, and treatment methods for, musculoskeletal discomfort, especially those in the low back, among office workers, is available. The findings showed that training exercises had a significant effect (p<0.05 on low back pain discomfort scores and decreased pain levels in response to office-based exercise training. Conclusion: Office-based exercise training can affect pain/discomfort scores among office workers through positive effects on flexibility and strength of muscles. As such, it should be suggested to occupational therapists as a practical way for the treatment/prevention of low back pain among office workers.

  14. [Considerations on the use of meta-analyses in the orientation of knowledge and decisions in Occupational Medicine].

    Science.gov (United States)

    Catalani, Simona; Berra, Alessandro; Tomasi, Cesare; Romano, Canzio; Pira, Enrico; Garzaro, Giacomo; Apostoli, Pietro

    2015-01-01

    In recent years, due to the need to elaborate the amount of information available from the scientific literature, the meta-analyses and systematic reviews have become very numerous. The meta-analyses are carried out to evaluate the association between two events when single researches haven't provided comprehensive data. On the other hand, a good meta-analysis must satisfy certain criteria, from the selection of the studies until the evaluation of the outcomes; to this purpose, the application of methods for quality assessment is a crucial point to obtain data of adequate reliability. The aim of this review is to give some introductory tools for a critical approach to meta-analyses and systematic reviews, which have become useful instruments also in occupational medicine.

  15. Circulating biomarkers for predicting cardiovascular disease risk; a systematic review and comprehensive overview of meta-analyses.

    Directory of Open Access Journals (Sweden)

    Thijs C van Holten

    Full Text Available BACKGROUND: Cardiovascular disease is one of the major causes of death worldwide. Assessing the risk for cardiovascular disease is an important aspect in clinical decision making and setting a therapeutic strategy, and the use of serological biomarkers may improve this. Despite an overwhelming number of studies and meta-analyses on biomarkers and cardiovascular disease, there are no comprehensive studies comparing the relevance of each biomarker. We performed a systematic review of meta-analyses on levels of serological biomarkers for atherothrombosis to compare the relevance of the most commonly studied biomarkers. METHODS AND FINDINGS: Medline and Embase were screened on search terms that were related to "arterial ischemic events" and "meta-analyses". The meta-analyses were sorted by patient groups without pre-existing cardiovascular disease, with cardiovascular disease and heterogeneous groups concerning general populations, groups with and without cardiovascular disease, or miscellaneous. These were subsequently sorted by end-point for cardiovascular disease or stroke and summarized in tables. We have identified 85 relevant full text articles, with 214 meta-analyses. Markers for primary cardiovascular events include, from high to low result: C-reactive protein, fibrinogen, cholesterol, apolipoprotein B, the apolipoprotein A/apolipoprotein B ratio, high density lipoprotein, and vitamin D. Markers for secondary cardiovascular events include, from high to low result: cardiac troponins I and T, C-reactive protein, serum creatinine, and cystatin C. For primary stroke, fibrinogen and serum uric acid are strong risk markers. Limitations reside in that there is no acknowledged search strategy for prognostic studies or meta-analyses. CONCLUSIONS: For primary cardiovascular events, markers with strong predictive potential are mainly associated with lipids. For secondary cardiovascular events, markers are more associated with ischemia. Fibrinogen is a

  16. Author-paper affiliation network architecture influences the methodological quality of systematic reviews and meta-analyses of psoriasis.

    Directory of Open Access Journals (Sweden)

    Juan Luis Sanz-Cabanillas

    Full Text Available Moderate-to-severe psoriasis is associated with significant comorbidity, an impaired quality of life, and increased medical costs, including those associated with treatments. Systematic reviews (SRs and meta-analyses (MAs of randomized clinical trials are considered two of the best approaches to the summarization of high-quality evidence. However, methodological bias can reduce the validity of conclusions from these types of studies and subsequently impair the quality of decision making. As co-authorship is among the most well-documented forms of research collaboration, the present study aimed to explore whether authors' collaboration methods might influence the methodological quality of SRs and MAs of psoriasis. Methodological quality was assessed by two raters who extracted information from full articles. After calculating total and per-item Assessment of Multiple Systematic Reviews (AMSTAR scores, reviews were classified as low (0-4, medium (5-8, or high (9-11 quality. Article metadata and journal-related bibliometric indices were also obtained. A total of 741 authors from 520 different institutions and 32 countries published 220 reviews that were classified as high (17.2%, moderate (55%, or low (27.7% methodological quality. The high methodological quality subnetwork was larger but had a lower connection density than the low and moderate methodological quality subnetworks; specifically, the former contained relatively fewer nodes (authors and reviews, reviews by authors, and collaborators per author. Furthermore, the high methodological quality subnetwork was highly compartmentalized, with several modules representing few poorly interconnected communities. In conclusion, structural differences in author-paper affiliation network may influence the methodological quality of SRs and MAs on psoriasis. As the author-paper affiliation network structure affects study quality in this research field, authors who maintain an appropriate balance

  17. Effect of CPAP Withdrawal on BP in OSA: Data from Three Randomized Controlled Trials.

    Science.gov (United States)

    Schwarz, Esther I; Schlatzer, Christian; Rossi, Valentina A; Stradling, John R; Kohler, Malcolm

    2016-12-01

    Based on meta-analyses, the BP-lowering effect of CPAP therapy in patients with OSA is reported to be approximately 2 to 3 mm Hg. This figure is derived from heterogeneous trials, which are often limited by poor CPAP adherence, and thus the treatment effect may possibly be underestimated. We analyzed morning BP data from three randomized controlled CPAP withdrawal trials, which included only patients with optimal CPAP compliance. Within the three trials, 149 patients with OSA who were receiving CPAP were randomized to continue therapeutic CPAP (n = 65) or to withdraw CPAP (n = 84) for 2 weeks. Morning BP was measured at home before and after sleep studies in the hospital. CPAP withdrawal was associated with a return of OSA (apnea-hypopnea index [AHI] at a baseline of 2.8/h and at follow-up of 33.2/h). Office systolic BP (SBP) increased in the CPAP withdrawal group compared with the CPAP continuation group by +5.4 mm Hg (95% CI, 1.8-8.9 mm Hg; P = .003) and in the home SBP group by +9.0 mm Hg (95% CI, 5.7-12.3 mm Hg; P CPAP withdrawal results in a clinically relevant increase in BP, which is considerably higher than in conventional CPAP trials; it is also underestimated when office BP is used. Greater OSA severity is associated with a higher BP rise in response to CPAP withdrawal. ClinicalTrials.gov; No.: NCT01332175 and NCT01797653) URL: www.clinicaltrials.gov and ISRCTN registry (ISRCTN 93153804) URL: http://www.isrctn.com/. Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

  18. Acceptance and Commitment Therapy (ACT) for Chronic Pain: A Systematic Review and Meta-Analyses.

    Science.gov (United States)

    Hughes, Laura S; Clark, Jodi; Colclough, Janette A; Dale, Elizabeth; McMillan, Dean

    2017-06-01

    Chronic pain places a burden on individuals and the economy. Although there is evidence for the effectiveness of cognitive-behavior therapy, it is recognized that the effects are limited. Acceptance and Commitment Therapy (ACT), which aims to increase valued action in the presence of pain, has been suggested as an alternative approach. The objective of this review was to determine the clinical effectiveness of ACT for chronic pain in adults when compared with control conditions and other active treatments. The searches of this systematic review were conducted in the Cochrane library, MEDLINE, EMBASE, CINAHL Plus (EBSCO), and PsycINFO. Grey literature, reference list, and reverse citation searches were also completed. Eleven trials were included. ACT was favored over controls (no alternative intervention or treatment as usual). Significant, medium to large effect sizes were found for measures of pain acceptance and psychological flexibility, which are typically considered processes of ACT. Significant small to medium effect sizes were found for measures of functioning, anxiety, and depression. Measures of pain intensity and quality of life were not significantly different than zero. Generally effect sizes were smaller at follow-up. ACT was more clinically effective than controls on a number of outcomes. It is possible that methodological limitations, some of which are common to psychological trials, may have led to overestimated effects. Only a few studies compared ACT to active treatments and while the evidence is promising for ACT in the treatment of chronic pain, further methodologically robust trials are required.

  19. The effects of rhythm control strategies versus rate control strategies for atrial fibrillation and atrial flutter

    DEFF Research Database (Denmark)

    Sethi, Naqash J; Feinberg, Joshua; Nielsen, Emil E

    2017-01-01

    -effect meta-analysis and chose the most conservative result as our primary result. We used Trial Sequential Analysis (TSA) to control for random errors. Statistical heterogeneity was assessed by visual inspection of forest plots and by calculating inconsistency (I2) for traditional meta-analyses and diversity...... (D2) for TSA. Sensitivity analyses and subgroup analyses were conducted to explore the reasons for substantial statistical heterogeneity. We assessed the risk of publication bias in meta-analyses consisting of 10 trials or more with tests for funnel plot asymmetry. We used GRADE to assess the quality...... of the body of evidence. RESULTS: 25 randomized clinical trials (n = 9354 participants) were included, all of which were at high risk of bias. Meta-analysis showed that rhythm control strategies versus rate control strategies significantly increased the risk of a serious adverse event (risk ratio (RR), 1...

  20. Uptake of systematic reviews and meta-analyses based on individual participant data in clinical practice guidelines: descriptive study

    NARCIS (Netherlands)

    Vale, C.L.; Rydzewska, L.H.; Rovers, M.M.; Emberson, J.R.; Gueyffier, F.; Stewart, L.A.

    2015-01-01

    OBJECTIVE: To establish the extent to which systematic reviews and meta-analyses of individual participant data (IPD) are being used to inform the recommendations included in published clinical guidelines. DESIGN: Descriptive study. SETTING: Database maintained by the Cochrane IPD Meta-analysis

  1. Dietary supplement use and colorectal cancer risk: A systematic review and meta-analyses of prospective cohort studies

    NARCIS (Netherlands)

    Heine-Bröring, R.C.; Winkels, R.M.; Renkema, J.M.S.; Kragt, L.; Orten-Luiten, van A.C.B.; Tigchelaar, E.F.; Chan, D.S.M.; Norat, T.; Kampman, E.

    2015-01-01

    Use of dietary supplements is rising in countries where colorectal cancer is prevalent. We conducted a systematic literature review and meta-analyses of prospective cohort studies on dietary supplement use and colorectal cancer risk. We identified relevant studies in Medline, Embase and Cochrane up

  2. Genome-wide meta-analyses of multiancestry cohorts identify multiple new susceptibility loci for refractive error and myopia

    NARCIS (Netherlands)

    Verhoeven, Virginie J. M.; Hysi, Pirro G.; Wojciechowski, Robert; Fan, Qiao; Guggenheim, Jeremy A.; Höhn, René; Macgregor, Stuart; Hewitt, Alex W.; Nag, Abhishek; Cheng, Ching-Yu; Yonova-Doing, Ekaterina; Zhou, Xin; Ikram, M. Kamran; Buitendijk, Gabriëlle H. S.; McMahon, George; Kemp, John P.; Pourcain, Beate St; Simpson, Claire L.; Mäkelä, Kari-Matti; Lehtimäki, Terho; Kähönen, Mika; Paterson, Andrew D.; Hosseini, S. Mohsen; Wong, Hoi Suen; Xu, Liang; Jonas, Jost B.; Pärssinen, Olavi; Wedenoja, Juho; Yip, Shea Ping; Ho, Daniel W. H.; Pang, Chi Pui; Chen, Li Jia; Burdon, Kathryn P.; Craig, Jamie E.; Klein, Barbara E. K.; Klein, Ronald; Haller, Toomas; Metspalu, Andres; Khor, Chiea-Chuen; Tai, E.-Shyong; Aung, Tin; Vithana, Eranga; Tay, Wan-Ting; Barathi, Veluchamy A.; Chen, Peng; Li, Ruoying; Liao, Jiemin; Zheng, Yingfeng; Bergen, Arthur A. B.; Chen, Wei

    2013-01-01

    Refractive error is the most common eye disorder worldwide and is a prominent cause of blindness. Myopia affects over 30% of Western populations and up to 80% of Asians. The CREAM consortium conducted genome-wide meta-analyses, including 37,382 individuals from 27 studies of European ancestry and

  3. The PRISMA extension statement for reporting of systematic reviews incorporating network meta-analyses of health care interventions

    DEFF Research Database (Denmark)

    Hutton, Brian; Salanti, Georgia; Caldwell, Deborah M

    2015-01-01

    The PRISMA statement is a reporting guideline designed to improve the completeness of reporting of systematic reviews and meta-analyses. Authors have used this guideline worldwide to prepare their reviews for publication. In the past, these reports typically compared 2 treatment alternatives. Wit...

  4. Investigation of publication bias in meta-analyses of diagnostic test accuracy: a meta-epidemiological study

    NARCIS (Netherlands)

    van Enst, W. Annefloor; Ochodo, Eleanor; Scholten, Rob J. P. M.; Hooft, Lotty; Leeflang, Mariska M.

    2014-01-01

    The validity of a meta-analysis can be understood better in light of the possible impact of publication bias. The majority of the methods to investigate publication bias in terms of small study-effects are developed for meta-analyses of intervention studies, leaving authors of diagnostic test

  5. How effective are active videogames among the young and the old? Adding meta-analyses to two recent systematic reviews

    NARCIS (Netherlands)

    Riet, J.P. van 't; Crutzen, R.M.M.; Lu, A.S.

    2014-01-01

    Objective: Two recent systematic reviews have surveyed the existing evidence for the effectiveness of active videogames in children/adolescents and in elderly people. In the present study, effect sizes were added to these systematic reviews, and meta-analyses were performed. Materials and Methods:

  6. The role of host genetic factors in respiratory tract infectious diseases: systematic review, meta-analyses and field synopsis

    NARCIS (Netherlands)

    Patarčić, Inga; Gelemanović, Andrea; Kirin, Mirna; Kolčić, Ivana; Theodoratou, Evropi; Baillie, Kenneth J.; de Jong, Menno D.; Rudan, Igor; Campbell, Harry; Polašek, Ozren

    2015-01-01

    Host genetic factors have frequently been implicated in respiratory infectious diseases, often with inconsistent results in replication studies. We identified 386 studies from the total of 24,823 studies identified in a systematic search of four bibliographic databases. We performed meta-analyses of

  7. Wet cupping therapy for treatment of herpes zoster: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Cao, Huijuan; Zhu, Chenjun; Liu, Jianping

    2010-01-01

    Wet cupping is a traditional Chinese medicine therapy commonly used in treating herpes zoster in China, and clinical studies have shown that wet cupping may have beneficial effect on herpes zoster compared with Western medication. We included randomized controlled trials (RCTs) on wet cupping for herpes zoster. We searched PubMed, the Cochrane Library (Issue 3, 2008), China Network Knowledge Infrastructure (CNKI), Chinese Scientific Journals Fulltext Database VIP, and Wan Fang Database. All searches ended in February 2009. Two authors extracted data and assessed the trials' quality independently. RevMan 5.0.18 software (The Cochrane Collaboration, The Nordic Cochrane Centre, Copenhagen, Denmark) was used for data analysis with effect estimate presented as relative risk (RR) and mean difference (MD) with a 95% confidence interval (CI). Eight RCTs involving 651 patients were included, and the methodological quality of trials was generally fair in terms of randomization, blinding, and intention-to-treat analysis. Meta-analyses showed wet cupping was superior to medication in the number of cured patients (RR 2.49, 95% CI 1.91 to 3.24, P cupping plus medication was significantly better than medication alone on number of cured patients (RR 1.93, 95% CI 1.23 to 3.04, P = .005) but demonstrated no difference in symptom improvement (RR 1.00, 95% CI 0.92 to 1.08, P = .98). There were no serious adverse effects related to wet cupping therapy in the included trials. Wet cupping appears to be effective in the treatment of herpes zoster. However, further large, rigorously designed

  8. Intraoperative and postoperative feasibility and safety of total tubeless, tubeless, small-bore tube, and standard percutaneous nephrolithotomy: a systematic review and network meta-analysis of 16 randomized controlled trials.

    Science.gov (United States)

    Lee, Joo Yong; Jeh, Seong Uk; Kim, Man Deuk; Kang, Dong Hyuk; Kwon, Jong Kyou; Ham, Won Sik; Choi, Young Deuk; Cho, Kang Su

    2017-06-27

    Percutaneous nephrolithotomy (PCNL) is performed to treat relatively large renal stones. Recent publications indicate that tubeless and total tubeless (stentless) PCNL is safe in selected patients. We performed a systematic review and network meta-analysis to evaluate the feasibility and safety of different PCNL procedures, including total tubeless, tubeless with stent, small-bore tube, and large-bore tube PCNLs. PubMed, Cochrane Central Register of Controlled Trials, and EMBASE™ databases were searched to identify randomized controlled trials published before December 30, 2013. One researcher examined all titles and abstracts found by the searches. Two investigators independently evaluated the full-text articles to determine whether those met the inclusion criteria. Qualities of included studies were rated with Cochrane's risk-of-bias assessment tool. Sixteen studies were included in the final syntheses including pairwise and network meta-analyses. Operation time, pain scores, and transfusion rates were not significantly different between PCNL procedures. Network meta-analyses demonstrated that for hemoglobin changes, total tubeless PCNL may be superior to standard PCNL (mean difference [MD] 0.65, 95% CI 0.14-1.13) and tubeless PCNLs with stent (MD -1.14, 95% CI -1.65--0.62), and small-bore PCNL may be superior to tubeless PCNL with stent (MD 1.30, 95% CI 0.27-2.26). Network meta-analyses also showed that for length of hospital stay, total tubeless (MD 1.33, 95% CI 0.23-2.43) and tubeless PCNLs with stent (MD 0.99, 95% CI 0.19-1.79) may be superior to standard PCNL. In rank probability tests, small-bore tube and total tubeless PCNLs were superior for operation time, pain scores, and hemoglobin changes. For hemoglobin changes, total tubeless and small-bore PCNLs may be superior to other methods. For hospital stay, total tubeless and tubeless PCNLs with stent may be superior to other procedures.

  9. Reporting the results of meta-analyses: a plea for incorporating clinical relevance referring to an example.

    Science.gov (United States)

    Bartels, Ronald H M A; Donk, Roland D; Verhagen, Wim I M; Hosman, Allard J F; Verbeek, André L M

    2017-11-01

    The results of meta-analyses are frequently reported, but understanding and interpreting them is difficult for both clinicians and patients. Statistical significances are presented without referring to values that imply clinical relevance. This study aimed to use the minimal clinically important difference (MCID) to rate the clinical relevance of a meta-analysis. This study is a review of the literature. This study is a review of meta-analyses relating to a specific topic, clinical results of cervical arthroplasty. The outcome measure used in the study was the MCID. We performed an extensive literature search of a series of meta-analyses evaluating a similar subject as an example. We searched in Pubmed and Embase through August 9, 2016, and found articles concerning meta-analyses of the clinical outcome of cervical arthroplasty compared with that of anterior cervical discectomy with fusion in cases of cervical degenerative disease. We evaluated the analyses for statistical significance and their relation to MCID. MCID was defined based on results in similar patient groups and a similar disease entity reported in the literature. We identified 21 meta-analyses, only one of which referred to MCID. However, the researchers used an inappropriate measurement scale and, therefore, an incorrect MCID. The majority of the conclusions were based on statistical results without mentioning clinical relevance. The majority of the articles we reviewed drew conclusions based on statistical differences instead of clinical relevance. We recommend introducing the concept of MCID while reporting the results of a meta-analysis, as well as mentioning the explicit scale of the analyzed measurement. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. Effects of exercise training using resistance bands on glycaemic control and strength in type 2 diabetes mellitus: a meta-analysis of randomised controlled trials.

    Science.gov (United States)

    McGinley, Samantha K; Armstrong, Marni J; Boulé, Normand G; Sigal, Ronald J

    2015-04-01

    Resistance exercise using free weights or weight machines improves glycaemic control and strength in people with type 2 diabetes. Resistance band training is potentially less expensive and more accessible, but the effects of resistance band training on glycaemic control and strength in this population are not well understood. This paper aims to systematically review and meta-analyse the effect of resistance band training on haemoglobin A1c (HbA1c) and strength in adults with type 2 diabetes. Database searches were performed in August 2013 (MEDLINE, SPORTDiscus, EMBASE, and CINAHL). Reference lists of eligible articles were hand-searched for additional studies. Randomised trials evaluating the effects of resistance band training in adults with type 2 diabetes on HbA1c or objectively measured strength were selected. Baseline and post-intervention HbA1c and strength were extracted for the intervention and control groups. Details of the exercise interventions and methodological quality were collected. Seven trials met inclusion criteria. Post-intervention-weighted mean HbA1c was nonsignificantly lower in exercise groups compared to control groups [weighted mean difference (WMD) = -0.18 percentage points (-1.91 mmol/mol); P = 0.27]. Post-intervention strength was significantly higher in the exercise groups compared to the control groups in the lower extremities (WMD = 21.90 kg; P diabetes.

  11. Use and misuse of temperature normalisation in meta-analyses of thermal responses of biological traits

    Directory of Open Access Journals (Sweden)

    Dimitrios - Georgios Kontopoulos

    2018-02-01

    Full Text Available There is currently unprecedented interest in quantifying variation in thermal physiology among organisms, especially in order to understand and predict the biological impacts of climate change. A key parameter in this quantification of thermal physiology is the performance or value of a rate, across individuals or species, at a common temperature (temperature normalisation. An increasingly popular model for fitting thermal performance curves to data—the Sharpe-Schoolfield equation—can yield strongly inflated estimates of temperature-normalised rate values. These deviations occur whenever a key thermodynamic assumption of the model is violated, i.e., when the enzyme governing the performance of the rate is not fully functional at the chosen reference temperature. Using data on 1,758 thermal performance curves across a wide range of species, we identify the conditions that exacerbate this inflation. We then demonstrate that these biases can compromise tests to detect metabolic cold adaptation, which requires comparison of fitness or rate performance of different species or genotypes at some fixed low temperature. Finally, we suggest alternative methods for obtaining unbiased estimates of temperature-normalised rate values for meta-analyses of thermal performance across species in climate change impact studies.

  12. HOW HEALTHY IS THE BEHAVIOR OF YOUNG ATHLETES? A SYSTEMATIC LITERATURE REVIEW AND META-ANALYSES

    Directory of Open Access Journals (Sweden)

    Katharina Diehl

    2012-06-01

    Full Text Available Participation in sports during adolescence is considered a healthy behavior. The extent to which adolescent athletes engage in other healthful (or risky behaviors is less clear, however. We conducted a systematic literature review following the PRISMA Statement to assess the frequency of risky behaviors among athletes in this age group. We searched the PubMed, PsycINFO and SCA Sociological Abstracts databases for observational studies published in English over the last twenty years on the frequency of selected risk behaviors (alcohol consumption, smoking behavior, use of illicit drugs, unhealthy nutrition, and doping in adolescent athletes. Two independent reviewers selected articles following the PRISMA Statement. Behavior frequency was assessed as was comparability of study design and methods. When possible, meta- analyses were performed using data from subgroups of studies in which operational indicators were comparable. Seventy-eight articles met eligibility criteria. Although report of risky behaviors varied across studies, we observed overall, that studies tend to report higher alcohol use, less smoking, less recreational drug use, and more smokeless tobacco use in (high-involved athletes. Considerable heterogeneity was noted in study design, definition of target groups and use of operational indicators (I² ranged from 93.2% to 100%. Especially the higher prevalence of using alcohol and smokeless tobacco needs more attention in interventions targeted to this group. Overall, greater consensus on methods used to assess risky behaviors in adolescent athletes

  13. Systematic Comparison of Brain Imaging Meta-Analyses of ToM with vPT.

    Science.gov (United States)

    Arora, Aditi; Schurz, Matthias; Perner, Josef

    2017-01-01

    In visual perspective taking (vPT) one has to concern oneself with what other people see and how they see it. Since seeing is a mental state, developmental studies have discussed vPT within the domain of "theory of mind (ToM)" but imaging studies have not treated it as such. Based on earlier results from several meta-analyses, we tested for the overlap of visual perspective taking studies with 6 different kinds of ToM studies: false belief, trait judgments, strategic games, social animations, mind in the eyes, and rational actions. Joint activation was observed between the vPT task and some kinds of ToM tasks in regions involving the left temporoparietal junction (TPJ), anterior precuneus, left middle occipital gyrus/extrastriate body area (EBA), and the left inferior frontal and precentral gyrus. Importantly, no overlap activation was found for the vPT tasks with the joint core of all six kinds of ToM tasks. This raises the important question of what the common denominator of all tasks that fall under the label of "theory of mind" is supposed to be if visual perspective taking is not one of them.

  14. Antipsychotic polypharmacy in clozapine resistant schizophrenia: a randomized controlled trial of tapering antipsychotic co-treatment

    Directory of Open Access Journals (Sweden)

    Jari Tiihonen

    2012-01-01

    Full Text Available There is a considerable disparity between clinical practice and recommendations based on meta-analyses of antipsychotic polypharmacy in clozapine resistant schizophrenia. For this reason, we investigated the clinical response to reducing the use olanzapine that had been previously added on clozapine treatment among seriously ill hospitalized patients. In a randomized controlled trial with crossover design, we studied volunteer patients (N = 15 who had olanzapine added on to clozapine in a state mental hospital. Clozapine monotherapy was just as effective as clozapine-olanzapine therapy, according to results from Clinical Global Impression Scale and Global Assessment of Functioning as primary outcome measures. Polypharmacy is widely used in treating schizophrenia, and usually, add-on medications are started because of worsening of the clinical state. A major confounding feature of these add-ons is whether observed improvements are caused by the medication or explained by the natural fluctuating course of the disorder. The present study, in spite of its small size, indicates the necessity of reconsidering the value of polypharmacy in treating schizophrenia.

  15. Examining the associations between HIV-related stigma and health outcomes in people living with HIV/AIDS: a series of meta-analyses.

    Science.gov (United States)

    Rueda, Sergio; Mitra, Sanjana; Chen, Shiyi; Gogolishvili, David; Globerman, Jason; Chambers, Lori; Wilson, Mike; Logie, Carmen H; Shi, Qiyun; Morassaei, Sara; Rourke, Sean B

    2016-07-13

    To conduct a systematic review and series of meta-analyses on the association between HIV-related stigma and health among people living with HIV. A structured search was conducted on 6 electronic databases for journal articles reporting associations between HIV-related stigma and health-related outcomes published between 1996 and 2013. Controlled studies, cohort studies, case-control studies and cross-sectional studies in people living with HIV were considered for inclusion. Mental health (depressive symptoms, emotional and mental distress, anxiety), quality of life, physical health, social support, adherence to antiretroviral therapy, access to and usage of health/social services and risk behaviours. 64 studies were included in our meta-analyses. We found significant associations between HIV-related stigma and higher rates of depression, lower social support and lower levels of adherence to antiretroviral medications and access to and usage of health and social services. Weaker relationships were observed between HIV-related stigma and anxiety, quality of life, physical health, emotional and mental distress and sexual risk practices. While risk of bias assessments revealed overall good quality related to how HIV stigma and health outcomes were measured on the included studies, high risk of bias among individual studies was observed in terms of appropriate control for potential confounders. Additional research should focus on elucidating the mechanisms behind the negative relationship between stigma and health to better inform interventions to reduce the impact of stigma on the health and well-being of people with HIV. This systematic review and series of meta-analyses support the notion that HIV-related stigma has a detrimental impact on a variety of health-related outcomes in people with HIV. This review can inform the development of multifaceted, intersectoral interventions to reduce the impact of HIV-related stigma on the health and well-being of people living

  16. A Meta-Meta-Analysis: Empirical Review of Statistical Power, Type I Error Rates, Effect Sizes, and Model Selection of Meta-Analyses Published in Psychology

    Science.gov (United States)

    Cafri, Guy; Kromrey, Jeffrey D.; Brannick, Michael T.

    2010-01-01

    This article uses meta-analyses published in "Psychological Bulletin" from 1995 to 2005 to describe meta-analyses in psychology, including examination of statistical power, Type I errors resulting from multiple comparisons, and model choice. Retrospective power estimates indicated that univariate categorical and continuous moderators, individual…

  17. Glycemic Control: A Combination of Lifestyle Management and the Use of Drugs

    OpenAIRE

    Standl, Eberhard; Erbach, Michael; Schnell, Oliver

    2012-01-01

    Some 30% of contemporary cardiology patients have coexisting known diabetes, and another 40% have either undiagnosed diabetes or prediabetes. There is still no final conclusive evidence of cardiovascular benefit by good glycemic control in type 2 diabetes, although studies like the United Kingdom Prospective Diabetes Study (UKPDS) and the Prospective Pioglitazone Clinical Trial in Macrovascular Events, and meta-analyses based on these and other randomized controlled trials of blood glucose-lo...

  18. TEACCH-based group social skills training for children with high-functioning autism: a pilot randomized controlled trial.

    Science.gov (United States)

    Ichikawa, Kayoko; Takahashi, Yoshimitsu; Ando, Masahiko; Anme, Tokie; Ishizaki, Tatsuro; Yamaguchi, Hinako; Nakayama, Takeo

    2013-10-01

    Although social skills training programs for people with high-functioning autism (HFA) are widely practiced, the standardization of curricula, the examination of clinical effectiveness, and the evaluation of the feasibility of future trials have yet to be done in Asian countries. To compensate for this problem, a Japanese pilot randomized controlled trial (RCT) of the Treatment and Education of Autistic and Related Communication Handicapped Children (TEACCH)-based group social skills training for children with HFA and their mothers was conducted. Eleven children with HFA, aged 5-6 years, and their mothers were randomly assigned to the TEACCH program (n=5) or a waiting-list control group (n=6). The program involved comprehensive group intervention and featured weekly 2-hour sessions, totaling 20 sessions over six months. The adaptive behaviors and social reciprocity of the children, parenting stress, and parent-child interactions were assessed using the Strengths and Difficulties Questionnaire (SDQ), Parenting Stress Index (PSI), Beck depression inventory-II (BDI-II), and Interaction Rating Scale (IRS). Through this pilot trial, the intervention and evaluation of the program has been shaped. There were no dropouts from the program and the mothers' satisfaction was high. The outcome measurements improved more in the program group than in the control group, with moderate effect sizes (SDQ, 0.71; PSI, 0.58; BDI-II, 0.40; and IRS, 0.69). This pilot trial also implied that this program is more beneficial for high IQ children and mothers with low stress than for those who are not. We have standardized the TEACCH program, confirmed the feasibility of a future trial, and successfully estimated the positive effect size. These findings will contribute to a larger trial in the future and to forthcoming systematic reviews with meta-analyses. UMIN000004560.

  19. The effect of funding sources on donepezil randomised controlled trial outcome: a meta-analysis.

    Science.gov (United States)

    Killin, Lewis O J; Russ, Tom C; Starr, John M; Abrahams, Sharon; Della Sala, Sergio

    2014-04-07

    To investigate whether there is a difference in the treatment effect of donepezil on cognition in Alzheimer disease between industry-funded and independent randomised controlled trials. Fixed effects meta-analysis of standardised effects of donepezil on cognition as measured by the Mini Mental State Examination and the Alzheimer's Disease Assessment Scale-cognitive subscale. Studies included in the meta-analyses reported in the National Institute for Health and Care Excellence (NICE) technical appraisal 217 updated with new studies through a PubMed search. Inclusion criteria were double-blind, placebo-controlled trials of any length comparing patients diagnosed with probable Alzheimer disease (according to the NINCDS-ADRDA/DSM-III/IV criteria) taking any dosage of donepezil. Studies of combination therapies (eg, donepezil and memantine) were excluded, as were studies that enrolled patients with a diagnosis of Alzheimer disease associated with other disorders (eg, Parkinson's disease and Down's syndrome). Our search strategy identified 14 relevant trials (4 independent) with suitable data. Trials sponsored by pharmaceutical companies reported a larger effect of donepezil on standardised cognitive tests than trials published by independent research groups (standardised mean difference (SMD)=0.46, 95% CI 0.37 to 0.55 vs SMD=0.33, 95% CI 0.18 to 0.48, respectively). This difference remained when only data representing change up to 12 weeks from baseline were analysed (industry SMD=0.44, 95% CI 0.34 to 0.53 vs independent SMD=0.35, 95% CI 0.18 to 0.52). Analysis revealed that the effect of funding as a moderator variable of study heterogeneity was not statistically significant at either time point. The effect size of donepezil on cognition is larger in industry-funded than independent trials and this is not explained by the longer duration of industry-funded trials. The lack of a statistically significant moderator effect may indicate that the differences are due to

  20. [Principles of controlled clinical trials].

    Science.gov (United States)

    Martini, P

    1962-01-01

    The recovery of the patient should be facilitated as the result of therapeutic research. The basic rule for every therapeutic-clinical trial mist involve a comparison of therapeutic approaches. In acute conditions, such as acute infectious diseases, infarcts, etc., comparisons should be made between two or more groups: the collective therapeutic comparison = the between patients trial. The formation of groups, to be compared one with the other can be justified only if one is reasonably sure that a pathogenic condition indeed exists. In chronic diseases, which extend essentially unchanged over a lengthy period but are nevertheless reversible, therapeutic comparisons may be made between two or more time intervals within the course of the disease in the same individual. This type of therapeutic trial rests primarily upon a (refined!) type of specious reasoning and secondarily, upon modified statistics: the individual therapeutic comparison = the within patient trial. The collective therapeutic comparison, on the one hand, and the individual therapeutic comparison on the other, overlap somewhat in scope. The immediate therapeutic effect is not always an indication of its true value, which may become evident only upon long-term treatment. The short-term trials of therapeutic regimens in an individual must, therefore, be frequently supplemented by long-term trials which can only be carried out by comparing two groups. For many clinical investigations, therefore, the joint efforts of numerous hospitals are absolutely necessary. The second basic rule of therapeutic research is the elimination of secondary causes. The difficulties introduced by these secondary considerations are far greater in therapeutic trials carried out on ambulatory patients than has been hitherto realized. In order to remove subjective secondary causes, the author demanded, in 1931, the use of hidden or illusory media (placebos, dummies) that is, unconscious causative agents. The double blind

  1. Genome-wide meta-analyses identify multiple loci associated with smoking behavior.

    LENUS (Irish Health Repository)

    2010-05-01

    Consistent but indirect evidence has implicated genetic factors in smoking behavior. We report meta-analyses of several smoking phenotypes within cohorts of the Tobacco and Genetics Consortium (n = 74,053). We also partnered with the European Network of Genetic and Genomic Epidemiology (ENGAGE) and Oxford-GlaxoSmithKline (Ox-GSK) consortia to follow up the 15 most significant regions (n > 140,000). We identified three loci associated with number of cigarettes smoked per day. The strongest association was a synonymous 15q25 SNP in the nicotinic receptor gene CHRNA3 (rs1051730[A], beta = 1.03, standard error (s.e.) = 0.053, P = 2.8 x 10(-73)). Two 10q25 SNPs (rs1329650[G], beta = 0.367, s.e. = 0.059, P = 5.7 x 10(-10); and rs1028936[A], beta = 0.446, s.e. = 0.074, P = 1.3 x 10(-9)) and one 9q13 SNP in EGLN2 (rs3733829[G], beta = 0.333, s.e. = 0.058, P = 1.0 x 10(-8)) also exceeded genome-wide significance for cigarettes per day. For smoking initiation, eight SNPs exceeded genome-wide significance, with the strongest association at a nonsynonymous SNP in BDNF on chromosome 11 (rs6265[C], odds ratio (OR) = 1.06, 95% confidence interval (Cl) 1.04-1.08, P = 1.8 x 10(-8)). One SNP located near DBH on chromosome 9 (rs3025343[G], OR = 1.12, 95% Cl 1.08-1.18, P = 3.6 x 10(-8)) was significantly associated with smoking cessation.

  2. Epidemiology, quality and reporting characteristics of meta-analyses of observational studies published in Chinese journals.

    Science.gov (United States)

    Zhang, Zhe-wen; Cheng, Juan; Liu, Zhuan; Ma, Ji-chun; Li, Jin-long; Wang, Jing; Yang, Ke-hu

    2015-12-07

    The aim of this study was to examine the epidemiological and reporting characteristics as well as the methodological quality of meta-analyses (MAs) of observational studies published in Chinese journals. 5 Chinese databases were searched for MAs of observational studies published from January 1978 to May 2014. Data were extracted into Excel spreadsheets, and Meta-analysis of Observational Studies in Epidemiology (MOOSE) and Assessment of Multiple Systematic Reviews (AMSTAR) checklists were used to assess reporting characteristics and methodological quality, respectively. A total of 607 MAs were included. Only 52.2% of the MAs assessed the quality of the included primary studies, and the retrieval information was not comprehensive in more than half (85.8%) of the MAs. In addition, 50 (8.2%) MAs did not search any Chinese databases, while 126 (20.8%) studies did not search any English databases. Approximately 41.2% of the MAs did not describe the statistical methods in sufficient details, and most (95.5%) MAs did not report on conflicts of interest. However, compared with the before publication of the MOOSE Checklist, the quality of reporting improved significantly for 20 subitems after publication of the MOOSE Checklist, and 7 items of the included MAs demonstrated significant improvement after publication of the AMSTAR Checklist (pstudies have been published in Chinese journals, the reporting quality is questionable. Thus, there is an urgent need to increase the use of reporting guidelines and methodological tools in China; we recommend that Chinese journals adopt the MOOSE and AMSTAR criteria. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  3. Meta-analyses of workplace physical activity and dietary behaviour interventions on weight outcomes.

    Science.gov (United States)

    Verweij, L M; Coffeng, J; van Mechelen, W; Proper, K I

    2011-06-01

    This meta-analytic review critically examines the effectiveness of workplace interventions targeting physical activity, dietary behaviour or both on weight outcomes. Data could be extracted from 22 studies published between 1980 and November 2009 for meta-analyses. The GRADE approach was used to determine the level of evidence for each pooled outcome measure. Results show moderate quality of evidence that workplace physical activity and dietary behaviour interventions significantly reduce body weight (nine studies; mean difference [MD]-1.19 kg [95% CI -1.64 to -0.74]), body mass index (BMI) (11 studies; MD -0.34 kg m⁻² [95% CI -0.46 to -0.22]) and body fat percentage calculated from sum of skin-folds (three studies; MD -1.12% [95% CI -1.86 to -0.38]). There is low quality of evidence that workplace physical activity interventions significantly reduce body weight and BMI. Effects on percentage body fat calculated from bioelectrical impedance or hydrostatic weighing, waist circumference, sum of skin-folds and waist-hip ratio could not be investigated properly because of a lack of studies. Subgroup analyses showed a greater reduction in body weight of physical activity and diet interventions containing an environmental component. As the clinical relevance of the pooled effects may be substantial on a population level, we recommend workplace physical activity and dietary behaviour interventions, including an environment component, in order to prevent weight gain. © 2010 The Authors. obesity reviews © 2010 International Association for the Study of Obesity.

  4. Serum Lipid Profiles and Cancer Risk in the Context of Obesity: Four Meta-Analyses

    International Nuclear Information System (INIS)

    Melvin, J. C.; Holmberg, L.; Hemelrijck, M. V.

    2013-01-01

    The objective here was to summarize the evidence for, and quantify the link between, serum markers of lipid metabolism and risk of obesity-related cancers. Pub Med and Embase were searched using predefined inclusion criteria to conduct meta-analyses on the association between serum levels of TG, TC, HDL, ApoA-I, and risk of 11 obesity-related cancers. Pooled relative risks (RRs) and 95% confidence intervals were estimated using random-effects analyses. 28 studies were included. Associations between abnormal lipid components and risk of obesity-related cancers when using clinical cut points ( TC ≥ 6.50; TG ≥ 1.71; HDL ≤ 1.03; ApoA-I ≤ 1.05 mmol/L) were apparent in all models. RRs were 1.18 (95% CI: 1.08-1.29) for TC, 1.20 (1.07-1.35) for TG, 1.15 (1.01-1.32) for HDL, and 1.42 (1.17-1.74) for ApoA-I. High levels of TC and TG, as well as low levels of HDL and ApoA-I, were consistently associated with increased risk of obesity-related cancers. The modest RRs suggest serum lipids to be associated with the risk of cancer, but indicate it is likely that other markers of the metabolism and/or lifestyle factors may also be involved. Future intervention studies involving lifestyle modification would provide insight into the potential biological role of lipid metabolism in tumorigenesis.

  5. [Meta-analyses on measurement precision of non-invasive hemodynamic monitoring technologies in adults].

    Science.gov (United States)

    Pestel, G; Fukui, K; Higashi, M; Schmidtmann, I; Werner, C

    2018-06-01

    An ideal non-invasive monitoring system should provide accurate and reproducible measurements of clinically relevant variables that enables clinicians to guide therapy accordingly. The monitor should be rapid, easy to use, readily available at the bedside, operator-independent, cost-effective and should have a minimal risk and side effect profile for patients. An example is the introduction of pulse oximetry, which has become established for non-invasive monitoring of oxygenation worldwide. A corresponding non-invasive monitoring of hemodynamics and perfusion could optimize the anesthesiological treatment to the needs in individual cases. In recent years several non-invasive technologies to monitor hemodynamics in the perioperative setting have been introduced: suprasternal Doppler ultrasound, modified windkessel function, pulse wave transit time, radial artery tonometry, thoracic bioimpedance, endotracheal bioimpedance, bioreactance, and partial CO 2 rebreathing have been tested for monitoring cardiac output or stroke volume. The photoelectric finger blood volume clamp technique and respiratory variation of the plethysmography curve have been assessed for monitoring fluid responsiveness. In this manuscript meta-analyses of non-invasive monitoring technologies were performed when non-invasive monitoring technology and reference technology were comparable. The primary evaluation criterion for all studies screened was a Bland-Altman analysis. Experimental and pediatric studies were excluded, as were all studies without a non-invasive monitoring technique or studies without evaluation of cardiac output/stroke volume or fluid responsiveness. Most studies found an acceptable bias with wide limits of agreement. Thus, most non-invasive hemodynamic monitoring technologies cannot be considered to be equivalent to the respective reference method. Studies testing the impact of non-invasive hemodynamic monitoring technologies as a trend evaluation on outcome, as well as

  6. Methotrexate-induced toxicity pharmacogenetics: an umbrella review of systematic reviews and meta-analyses.

    Science.gov (United States)

    Campbell, Jared M; Bateman, Emma; Stephenson, Matthew D; Bowen, Joanne M; Keefe, Dorothy M; Peters, Micah D J

    2016-07-01

    Methotrexate chemotherapy is associated with various toxicities which can result in the interruption or discontinuation of treatment and a subsequently raised risk of relapse. This umbrella systematic review was conducted to synthesize the results of all existing systematic reviews that investigate the pharmacogenetics of methotrexate-induced toxicity, with the aim of developing a comprehensive reference for personalized medicine. Databases searched were PubMed, Embase, JBI Database of Systematic Reviews and Implementation Reports, DARE, and ProQuest. Papers were critically appraised by two reviewers, and data were extracted using a standardized tool. Three systematic reviews on methotrexate-induced toxicity were included in the review. Meta-analyses were reported across Asian, Caucasian, pediatric and adult patients for the MTHFR C677T and A1298C polymorphisms. Toxicity outcomes included different forms of hematologic, ectodermal and hepatic toxicities. Results varied considerably depending on the patient groups and subgroups investigated in the different systematic reviews, as well as the genetic models utilized. However, significant associations were found between the MTHFR C677T allele and; hepatic toxicity, myelosuppression, oral mucositis, gastrointestinal toxicity, and skin toxicity. Additionally, limited evidence suggests that the MTHFR A1298C polymorphism may be associated with decreased risk of skin toxicity and leukopenia. This umbrella systematic review has synthesized the best available evidence on the pharmacogenetics of methotrexate toxicity. The next step in making personalized medicine for methotrexate therapy a clinical reality is research on the effectiveness and cost-effectiveness of MTHFR genotype testing to enable the close monitoring of at-risk patients for the timely initiation of rescue therapies.

  7. Stillbirth With Group B Streptococcus Disease Worldwide: Systematic Review and Meta-analyses.

    Science.gov (United States)

    Seale, Anna C; Blencowe, Hannah; Bianchi-Jassir, Fiorella; Embleton, Nicholas; Bassat, Quique; Ordi, Jaume; Menéndez, Clara; Cutland, Clare; Briner, Carmen; Berkley, James A; Lawn, Joy E; Baker, Carol J; Bartlett, Linda; Gravett, Michael G; Heath, Paul T; Ip, Margaret; Le Doare, Kirsty; Rubens, Craig E; Saha, Samir K; Schrag, Stephanie; Meulen, Ajoke Sobanjo-Ter; Vekemans, Johan; Madhi, Shabir A

    2017-11-06

    There are an estimated 2.6 million stillbirths each year, many of which are due to infections, especially in low- and middle-income contexts. This paper, the eighth in a series on the burden of group B streptococcal (GBS) disease, aims to estimate the percentage of stillbirths associated with GBS disease. We conducted systematic literature reviews (PubMed/Medline, Embase, Literatura Latino-Americana e do Caribe em Ciências da Saúde, World Health Organization Library Information System, and Scopus) and sought unpublished data from investigator groups. Studies were included if they reported original data on stillbirths (predominantly ≥28 weeks' gestation or ≥1000 g, with GBS isolated from a sterile site) as a percentage of total stillbirths. We did meta-analyses to derive pooled estimates of the percentage of GBS-associated stillbirths, regionally and worldwide for recent datasets. We included 14 studies from any period, 5 with recent data (after 2000). There were no data from Asia. We estimated that 1% (95% confidence interval [CI], 0-2%) of all stillbirths in developed countries and 4% (95% CI, 2%-6%) in Africa were associated with GBS. GBS is likely an important cause of stillbirth, especially in Africa. However, data are limited in terms of geographic spread, with no data from Asia, and cases worldwide are probably underestimated due to incomplete case ascertainment. More data, using standardized, systematic methods, are critical, particularly from low- and middle-income contexts where the highest burden of stillbirths occurs. These data are essential to inform interventions, such as maternal GBS vaccination. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

  8. Efficacy of group psychotherapy for social anxiety disorder: A meta-analysis of randomized-controlled trials.

    Science.gov (United States)

    Barkowski, Sarah; Schwartze, Dominique; Strauss, Bernhard; Burlingame, Gary M; Barth, Jürgen; Rosendahl, Jenny

    2016-04-01

    Group psychotherapy for social anxiety disorder (SAD) is an established treatment supported by findings from primary studies and earlier meta-analyses. However, a comprehensive summary of the recent evidence is still pending. This meta-analysis investigates the efficacy of group psychotherapy for adult patients with SAD. A literature search identified 36 randomized-controlled trials examining 2171 patients. Available studies used mainly cognitive-behavioral group therapies (CBGT); therefore, quantitative analyses were done for CBGT. Medium to large positive effects emerged for wait list-controlled trials for specific symptomatology: g=0.84, 95% CI [0.72; 0.97] and general psychopathology: g=0.62, 95% CI [0.36; 0.89]. Group psychotherapy was also superior to common factor control conditions in alleviating symptoms of SAD, but not in improving general psychopathology. No differences appeared for direct comparisons of group psychotherapy and individual psychotherapy or pharmacotherapy. Hence, group psychotherapy for SAD is an efficacious treatment, equivalent to other treatment formats. Copyright © 2016 Elsevier Ltd. All rights reserved.

  9. Evaluating Study Withdrawal Among Biologics and Immunomodulators in Treating Ulcerative Colitis: A Meta-analysis of Controlled Clinical Trials.

    Science.gov (United States)

    Shah, Eric D; Siegel, Corey A; Chong, Kelly; Melmed, Gil Y

    2016-04-01

    We conducted a systematic review and meta-analysis to evaluate the efficacy and adverse event (AE)-associated tolerability of treatment with immunomodulators and biologics in ulcerative colitis clinical trials. We performed a literature search of PubMed and the Cochrane databases to identify randomized placebo-controlled trials of immunomodulators and biologics. Tolerability was defined through study withdrawal due to AEs and efficacy through clinical response in induction trials and clinical remission in maintenance trials. We performed meta-analyses using a random-effects model to determine relative risks (RRs) of efficacy and study withdrawal. Number needed to treat (NNT) and number needed to stop (NNS) were determined. The ratio of NNS/NNT was calculated, with a higher ratio indicating a greater number of patients in remission for every AE study discontinuation. We examined 13 single-agent trials representing biologics (infliximab, adalimumab, golimumab, and vedolizumab) and immunomodulators (tacrolimus and azathioprine). Induction therapy did not result in excess study withdrawal with immunomodulators (RR = 0.9, 95% CI 0.1-12.0) or biologics (RR = 0.7, 95% CI 0.3-1.8), therefore the NNS/NNT ratio could not be assessed because of high tolerability. Maintenance immunomodulator therapy resulted in a NNS of 14 (RR = 2.8, 95% CI 0.7-10.5) and NNS/NNT ratio of 2.4 in 2 trials. Biologics did not result in excess study withdrawal in maintenance (RR = 0.7, 95% CI 0.3-1.7) or combined induction-and-maintenance (RR = 0.6, 95% CI 0.4-1.0) trials. Biologics were not associated with a higher RR of study withdrawal due to AE than placebo. There were insufficient data to compare these results with immunomodulators.

  10. Association between Adult Height and Risk of Colorectal, Lung, and Prostate Cancer: Results from Meta-analyses of Prospective Studies and Mendelian Randomization Analyses

    Science.gov (United States)

    Khankari, Nikhil K.; Shu, Xiao-Ou; Wen, Wanqing; Kraft, Peter; Lindström, Sara; Peters, Ulrike; Schildkraut, Joellen; Schumacher, Fredrick; Bofetta, Paolo; Risch, Angela; Bickeböller, Heike; Amos, Christopher I.; Easton, Douglas; Gruber, Stephen B.; Haiman, Christopher A.; Hunter, David J.; Chanock, Stephen J.; Pierce, Brandon L.; Zheng, Wei

    2016-01-01

    Background Observational studies examining associations between adult height and risk of colorectal, prostate, and lung cancers have generated mixed results. We conducted meta-analyses using data from prospective cohort studies and further carried out Mendelian randomization analyses, using height-associated genetic variants identified in a genome-wide association study (GWAS), to evaluate the association of adult height with these cancers. Methods and Findings A systematic review of prospective studies was conducted using the PubMed, Embase, and Web of Science databases. Using meta-analyses, results obtained from 62 studies were summarized for the association of a 10-cm increase in height with cancer risk. Mendelian randomization analyses were conducted using summary statistics obtained for 423 genetic variants identified from a recent GWAS of adult height and from a cancer genetics consortium study of multiple cancers that included 47,800 cases and 81,353 controls. For a 10-cm increase in height, the summary relative risks derived from the meta-analyses of prospective studies were 1.12 (95% CI 1.10, 1.15), 1.07 (95% CI 1.05, 1.10), and 1.06 (95% CI 1.02, 1.11) for colorectal, prostate, and lung cancers, respectively. Mendelian randomization analyses showed increased risks of colorectal (odds ratio [OR] = 1.58, 95% CI 1.14, 2.18) and lung cancer (OR = 1.10, 95% CI 1.00, 1.22) associated with each 10-cm increase in genetically predicted height. No association was observed for prostate cancer (OR = 1.03, 95% CI 0.92, 1.15). Our meta-analysis was limited to published studies. The sample size for the Mendelian randomization analysis of colorectal cancer was relatively small, thus affecting the precision of the point estimate. Conclusions Our study provides evidence for a potential causal association of adult height with the risk of colorectal and lung cancers and suggests that certain genetic factors and biological pathways affecting adult height may also affect the

  11. Cancer and central nervous system disorders: protocol for an umbrella review of systematic reviews and updated meta-analyses of observational studies.

    Science.gov (United States)

    Catalá-López, Ferrán; Hutton, Brian; Driver, Jane A; Page, Matthew J; Ridao, Manuel; Valderas, José M; Alonso-Arroyo, Adolfo; Forés-Martos, Jaume; Martínez, Salvador; Gènova-Maleras, Ricard; Macías-Saint-Gerons, Diego; Crespo-Facorro, Benedicto; Vieta, Eduard; Valencia, Alfonso; Tabarés-Seisdedos, Rafael

    2017-04-04

    The objective of this study will be to synthesize the epidemiological evidence and evaluate the validity of the associations between central nervous system disorders and the risk of developing or dying from cancer. We will perform an umbrella review of systematic reviews and conduct updated meta-analyses of observational studies (cohort and case-control) investigating the association between central nervous system disorders and the risk of developing or dying from any cancer or specific types of cancer. Searches involving PubMed/MEDLINE, EMBASE, SCOPUS and Web of Science will be used to identify systematic reviews and meta-analyses of observational studies. In addition, online databases will be checked for observational studies published outside the time frames of previous reviews. Eligible central nervous system disorders will be Alzheimer's disease, anorexia nervosa, amyotrophic lateral sclerosis, autism spectrum disorders, bipolar disorder, depression, Down's syndrome, epilepsy, Huntington's disease, multiple sclerosis, Parkinson's disease and schizophrenia. The primary outcomes will be cancer incidence and cancer mortality in association with a central nervous system disorder. Secondary outcome measures will be site-specific cancer incidence and mortality, respectively. Two reviewers will independently screen references identified by the literature search, as well as potentially relevant full-text articles. Data will be abstracted, and study quality/risk of bias will be appraised by two reviewers independently. Conflicts at all levels of screening and abstraction will be resolved through discussion. Random-effects meta-analyses of primary observational studies will be conducted where appropriate. Parameters for exploring statistical heterogeneity are pre-specified. The World Cancer Research Fund (WCRF)/American Institute for Cancer Research (AICR) criteria and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach will be used

  12. An Overview of Meta-Analyses of Danhong Injection for Unstable Angina

    Directory of Open Access Journals (Sweden)

    Xiaoxia Zhang

    2015-01-01

    Full Text Available Objective. To systematically collect evidence and evaluate the effects of Danhong injection (DHI for unstable angina (UA. Methods. A comprehensive search was conducted in seven electronic databases up to January 2015. The methodological and reporting quality of included studies was assessed by using AMSTAR and PRISMA. Result. Five articles were included. The conclusions suggest that DHI plus conventional medicine treatment was effective for UA pectoris treatment, could alleviate symptoms of angina and ameliorate electrocardiograms. Flaws of the original studies and systematic reviews weaken the strength of evidence. Limitations of the methodology quality include performing an incomprehensive literature search, lacking detailed characteristics, ignoring clinical heterogeneity, and not assessing publication bias and other forms of bias. The flaws of reporting systematic reviews included the following: not providing a structured summary, no standardized search strategy. For the pooled findings, researchers took statistical heterogeneity into consideration, but clinical and methodology heterogeneity were ignored. Conclusion. DHI plus conventional medicine treatment generally appears to be effective for UA treatment. However, the evidence is not hard enough due to methodological flaws in original clinical trials and systematic reviews. Furthermore, rigorous designed randomized controlled trials are also needed. The methodology and reporting quality of systematic reviews should be improved.

  13. An Overview of Meta-Analyses of Danhong Injection for Unstable Angina.

    Science.gov (United States)

    Zhang, Xiaoxia; Wang, Hui; Chang, Yanxu; Wang, Yuefei; Lei, Xiang; Fu, Shufei; Zhang, Junhua

    2015-01-01

    Objective. To systematically collect evidence and evaluate the effects of Danhong injection (DHI) for unstable angina (UA). Methods. A comprehensive search was conducted in seven electronic databases up to January 2015. The methodological and reporting quality of included studies was assessed by using AMSTAR and PRISMA. Result. Five articles were included. The conclusions suggest that DHI plus conventional medicine treatment was effective for UA pectoris treatment, could alleviate symptoms of angina and ameliorate electrocardiograms. Flaws of the original studies and systematic reviews weaken the strength of evidence. Limitations of the methodology quality include performing an incomprehensive literature search, lacking detailed characteristics, ignoring clinical heterogeneity, and not assessing publication bias and other forms of bias. The flaws of reporting systematic reviews included the following: not providing a structured summary, no standardized search strategy. For the pooled findings, researchers took statistical heterogeneity into consideration, but clinical and methodology heterogeneity were ignored. Conclusion. DHI plus conventional medicine treatment generally appears to be effective for UA treatment. However, the evidence is not hard enough due to methodological flaws in original clinical trials and systematic reviews. Furthermore, rigorous designed randomized controlled trials are also needed. The methodology and reporting quality of systematic reviews should be improved.

  14. Systematic assessment of environmental risk factors for bipolar disorder: an umbrella review of systematic reviews and meta-analyses.

    Science.gov (United States)

    Bortolato, Beatrice; Köhler, Cristiano A; Evangelou, Evangelos; León-Caballero, Jordi; Solmi, Marco; Stubbs, Brendon; Belbasis, Lazaros; Pacchiarotti, Isabella; Kessing, Lars V; Berk, Michael; Vieta, Eduard; Carvalho, André F

    2017-03-01

    The pathophysiology of bipolar disorder is likely to involve both genetic and environmental risk factors. In our study, we aimed to perform a systematic search of environmental risk factors for BD. In addition, we assessed possible hints of bias in this literature, and identified risk factors supported by high epidemiological credibility. We searched the Pubmed/MEDLINE, EMBASE and PsycInfo databases up to 7 October 2016 to identify systematic reviews and meta-analyses of observational studies that assessed associations between putative environmental risk factors and BD. For each meta-analysis, we estimated its summary effect size by means of both random- and fixed-effects models, 95% confidence intervals (CIs), the 95% prediction interval, and heterogeneity. Evidence of small-study effects and excess of significance bias was also assessed. Sixteen publications met the inclusion criteria (seven meta-analyses and nine qualitative systematic reviews). Fifty-one unique environmental risk factors for BD were evaluated. Six meta-analyses investigated associations with a risk factor for BD. Only irritable bowel syndrome (IBS) emerged as a risk factor for BD supported by convincing evidence (k=6; odds ratio [OR]=2.48; 95% CI=2.35-2.61; P<.001), and childhood adversity was supported by highly suggestive evidence. Asthma and obesity were risk factors for BD supported by suggestive evidence, and seropositivity to Toxoplasma gondii and a history of head injury were supported by weak evidence. Notwithstanding that several environmental risk factors for BD were identified, few meta-analyses of observational studies were available. Therefore, further well-designed and adequately powered studies are necessary to map the environmental risk factors for BD. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  15. Neurofeedback for Attention-Deficit/Hyperactivity Disorder: Meta-Analysis of Clinical and Neuropsychological Outcomes From Randomized Controlled Trials.

    Science.gov (United States)

    Cortese, Samuele; Ferrin, Maite; Brandeis, Daniel; Holtmann, Martin; Aggensteiner, Pascal; Daley, David; Santosh, Paramala; Simonoff, Emily; Stevenson, Jim; Stringaris, Argyris; Sonuga-Barke, Edmund J S

    2016-06-01

    We performed meta-analyses of randomized controlled trials to examine the effects of neurofeedback on attention-deficit/hyperactivity disorder (ADHD) symptoms and neuropsychological deficits in children and adolescents with ADHD. We searched PubMed, Ovid, Web of Science, ERIC, and CINAHAL through August 30, 2015. Random-effects models were employed. Studies were evaluated with the Cochrane Risk of Bias tool. We included 13 trials (520 participants with ADHD). Significant effects were found on ADHD symptoms rated by assessors most proximal to the treatment setting, that is, the least blinded outcome measure (standardized mean difference [SMD]: ADHD total symptoms = 0.35, 95% CI = 0.11-0.59; inattention = 0.36, 95% CI = 0.09-0.63; hyperactivity/impulsivity = 0.26, 95% CI = 0.08-0.43). Effects were not significant when probably blinded ratings were the outcome or in trials with active/sham controls. Results were similar when only frequency band training trials, the most common neurofeedback approach, were analyzed separately. Effects on laboratory measures of inhibition (SMD = 0.30, 95% CI = -0.10 to 0.70) and attention (SMD = 0.13, 95% CI = -0.09 to 0.36) were not significant. Only 4 studies directly assessed whether learning occurred after neurofeedback training. The risk of bias was unclear for many Cochrane Risk of Bias domains in most studies. Evidence from well-controlled trials with probably blinded outcomes currently fails to support neurofeedback as an effective treatment for ADHD. Future efforts should focus on implementing standard neurofeedback protocols, ensuring learning, and optimizing clinically relevant transfer. Copyright © 2016 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

  16. Contour plot assessment of existing meta-analyses confirms robust association of statin use and acute kidney injury risk.

    Science.gov (United States)

    Chevance, Aurélie; Schuster, Tibor; Steele, Russell; Ternès, Nils; Platt, Robert W

    2015-10-01

    Robustness of an existing meta-analysis can justify decisions on whether to conduct an additional study addressing the same research question. We illustrate the graphical assessment of the potential impact of an additional study on an existing meta-analysis using published data on statin use and the risk of acute kidney injury. A previously proposed graphical augmentation approach is used to assess the sensitivity of the current test and heterogeneity statistics extracted from existing meta-analysis data. In addition, we extended the graphical augmentation approach to assess potential changes in the pooled effect estimate after updating a current meta-analysis and applied the three graphical contour definitions to data from meta-analyses on statin use and acute kidney injury risk. In the considered example data, the pooled effect estimates and heterogeneity indices demonstrated to be considerably robust to the addition of a future study. Supportingly, for some previously inconclusive meta-analyses, a study update might yield statistically significant kidney injury risk increase associated with higher statin exposure. The illustrated contour approach should become a standard tool for the assessment of the robustness of meta-analyses. It can guide decisions on whether to conduct additional studies addressing a relevant research question. Copyright © 2015 Elsevier Inc. All rights reserved.

  17. The Evaluation of Bivariate Mixed Models in Meta-analyses of Diagnostic Accuracy Studies with SAS, Stata and R.

    Science.gov (United States)

    Vogelgesang, Felicitas; Schlattmann, Peter; Dewey, Marc

    2018-05-01

    Meta-analyses require a thoroughly planned procedure to obtain unbiased overall estimates. From a statistical point of view not only model selection but also model implementation in the software affects the results. The present simulation study investigates the accuracy of different implementations of general and generalized bivariate mixed models in SAS (using proc mixed, proc glimmix and proc nlmixed), Stata (using gllamm, xtmelogit and midas) and R (using reitsma from package mada and glmer from package lme4). Both models incorporate the relationship between sensitivity and specificity - the two outcomes of interest in meta-analyses of diagnostic accuracy studies - utilizing random effects. Model performance is compared in nine meta-analytic scenarios reflecting the combination of three sizes for meta-analyses (89, 30 and 10 studies) with three pairs of sensitivity/specificity values (97%/87%; 85%/75%; 90%/93%). The evaluation of accuracy in terms of bias, standard error and mean squared error reveals that all implementations of the generalized bivariate model calculate sensitivity and specificity estimates with deviations less than two percentage points. proc mixed which together with reitsma implements the general bivariate mixed model proposed by Reitsma rather shows convergence problems. The random effect parameters are in general underestimated. This study shows that flexibility and simplicity of model specification together with convergence robustness should influence implementation recommendations, as the accuracy in terms of bias was acceptable in all implementations using the generalized approach. Schattauer GmbH.

  18. The Reporting Quality of Systematic Reviews and Meta-Analyses in Industrial and Organizational Psychology: A Systematic Review.

    Science.gov (United States)

    Schalken, Naomi; Rietbergen, Charlotte

    2017-01-01

    Objective: The goal of this systematic review was to examine the reporting quality of the method section of quantitative systematic reviews and meta-analyses from 2009 to 2016 in the field of industrial and organizational psychology with the help of the Meta-Analysis Reporting Standards (MARS), and to update previous research, such as the study of Aytug et al. (2012) and Dieckmann et al. (2009). Methods: A systematic search for quantitative systematic reviews and meta-analyses was conducted in the top 10 journals in the field of industrial and organizational psychology between January 2009 and April 2016. Data were extracted on study characteristics and items of the method section of MARS. A cross-classified multilevel model was analyzed, to test whether publication year and journal impact factor (JIF) were associated with the reporting quality scores of articles. Results: Compliance with MARS in the method section was generally inadequate in the random sample of 120 articles. Variation existed in the reporting of items. There were no significant effects of publication year and journal impact factor (JIF) on the reporting quality scores of articles. Conclusions: The reporting quality in the method section of systematic reviews and meta-analyses was still insufficient, therefore we recommend researchers to improve the reporting in their articles by using reporting standards like MARS.

  19. Interpreting trial results following use of different intention-to-treat approaches for preventing attrition bias

    DEFF Research Database (Denmark)

    Dossing, Anna; Tarp, Simon; Furst, Daniel E

    2014-01-01

    10 biological and targeted drugs based on collections of trials that would correspond to 10 individual meta-analyses. ETHICS AND DISSEMINATION: This study will enhance transparency for evaluating mITT treatment effects described in meta-analyses. The intended audience will include healthcare...... concerns when executing different mITT approaches in meta-analyses. METHODS AND ANALYSIS: Using meta-epidemiology on randomised trials considered less prone to bias (ie, good internal validity) and assessing biological or targeted agents in patients with rheumatoid arthritis, we will meta-analyse data from...

  20. Does the use of consumer health information technology improve outcomes in the patient self-management of diabetes? A meta-analysis and narrative review of randomized controlled trials.

    Science.gov (United States)

    Or, Calvin K L; Tao, Da

    2014-05-01

    To assess whether the use of consumer health information technologies (CHITs) improves outcomes in the patient self-management of diabetes. The evidence from randomized controlled trials (RCTs) on the effects of CHITs on patient outcomes was analyzed using either meta-analysis or a narrative synthesis approach. A systematic search of seven electronic databases was conducted to identify relevant reports of RCTs for the analysis. In the meta-analyses, standardized mean differences in patient outcomes were calculated and random-effects models were applied in cases where the heterogeneity of the results was moderate or high, otherwise fixed-effects models were used. Sixty-two studies, representing 67 RCTs, met the inclusion criteria. The results of the meta-analyses showed that the use of CHITs was associated with significant reductions in HbA1c, blood pressure, total cholesterol, and triglycerides levels when compared with the usual care. The findings from the narrative synthesis indicated that only a small proportion of the trials reported positive effects of CHITs on patient outcomes. The use of CHITs in supporting diabetes self-management appears to have potential benefits for patients' self-management of diabetes. However, the effectiveness of the technologies in improving patient outcomes still awaits confirmation in future studies. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  1. Meta-analyses of the proportion of Japanese encephalitis virus infection in vectors and vertebrate hosts.

    Science.gov (United States)

    Oliveira, Ana R S; Cohnstaedt, Lee W; Strathe, Erin; Hernández, Luciana Etcheverry; McVey, D Scott; Piaggio, José; Cernicchiaro, Natalia

    2017-09-07

    Japanese encephalitis (JE) is a zoonosis in Southeast Asia vectored by mosquitoes infected with the Japanese encephalitis virus (JEV). Japanese encephalitis is considered an emerging exotic infectious disease with potential for introduction in currently JEV-free countries. Pigs and ardeid birds are reservoir hosts and play a major role on the transmission dynamics of the disease. The objective of the study was to quantitatively summarize the proportion of JEV infection in vectors and vertebrate hosts from data pertaining to observational studies obtained in a systematic review of the literature on vector and host competence for JEV, using meta-analyses. Data gathered in this study pertained to three outcomes: proportion of JEV infection in vectors, proportion of JEV infection in vertebrate hosts, and minimum infection rate (MIR) in vectors. Random-effects subgroup meta-analysis models were fitted by species (mosquito or vertebrate host species) to estimate pooled summary measures, as well as to compute the variance between studies. Meta-regression models were fitted to assess the association between different predictors and the outcomes of interest and to identify sources of heterogeneity among studies. Predictors included in all models were mosquito/vertebrate host species, diagnostic methods, mosquito capture methods, season, country/region, age category, and number of mosquitos per pool. Mosquito species, diagnostic method, country, and capture method represented important sources of heterogeneity associated with the proportion of JEV infection; host species and region were considered sources of heterogeneity associated with the proportion of JEV infection in hosts; and diagnostic and mosquito capture methods were deemed important contributors of heterogeneity for the MIR outcome. Our findings provide reference pooled summary estimates of vector competence for JEV for some mosquito species, as well as of sources of variability for these outcomes. Moreover, this

  2. Types, frequencies, and burden of nonspecific adverse events of drugs: analysis of randomized placebo-controlled clinical trials.

    Science.gov (United States)

    Mahr, Alfred; Golmard, Clara; Pham, Emilie; Iordache, Laura; Deville, Laure; Faure, Pierre

    2017-07-01

    Scarce studies analyzing adverse event (AE) data from randomized placebo-controlled clinical trials (RPCCTs) of selected illnesses suggested that a substantial proportion of collected AEs are unrelated to the drug taken. This study analyzed the nonspecific AEs occurring with active-drug exposure in RPCCTs for a large range of medical conditions. Randomized placebo-controlled clinical trials published in five prominent medical journals during 2006-2012 were searched. Only trials that evaluated orally or parenterally administered active drugs versus placebo in a head-to-head setting were selected. For AEs reported from ≥10 RPCCTs, Pearson's correlation coefficients (r) were calculated to determine the relationship between AE rates in placebo and active-drug recipients. Random-effects meta-analyses were used to compute proportions of nonspecific AEs, which were truncated at a maximum of 100%, in active-drug recipients. We included 231 trials addressing various medical domains or healthy participants. For the 88 analyzed AE variables, AE rates for placebo and active-drug recipients were in general strongly correlated (r > 0.50) or very strongly correlated (r > 0.80). The pooled proportions of nonspecific AEs for the active-drug recipients were 96.8% (95%CI: 95.5-98.1) for any AEs, 100% (97.9-100) for serious AEs, and 77.7% (72.7-83.2) for drug-related AEs. Results were similar for individual medical domains and healthy participants. The pooled proportion of nonspecificity of 82 system organ class and individual AE types ranged from 38% to 100%. The large proportion of nonspecific AEs reported in active-drug recipients of RPCCTs, including serious and drug-related AEs, highlights the limitations of clinical trial data to determine the tolerability of drugs. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  3. Comparative clinical effectiveness of management strategies for sciatica: systematic review and network meta-analyses.

    Science.gov (United States)

    Lewis, Ruth A; Williams, Nefyn H; Sutton, Alex J; Burton, Kim; Din, Nafees Ud; Matar, Hosam E; Hendry, Maggie; Phillips, Ceri J; Nafees, Sadia; Fitzsimmons, Deborah; Rickard, Ian; Wilkinson, Clare

    2015-06-01

    There are numerous treatment approaches for sciatica. Previous systematic reviews have not compared all these strategies together. To compare the clinical effectiveness of different treatment strategies for sciatica simultaneously. Systematic review and network meta-analysis. We searched 28 electronic databases and online trial registries, along with bibliographies of previous reviews for comparative studies evaluating any intervention to treat sciatica in adults, with outcome data on global effect or pain intensity. Network meta-analysis methods were used to simultaneously compare all treatment strategies and allow indirect comparisons of treatments between studies. The study was funded by the UK National Institute for Health Research Health Technology Assessment program; there are no potential conflict of interests. We identified 122 relevant studies; 90 were randomized controlled trials (RCTs) or quasi-RCTs. Interventions were grouped into 21 treatment strategies. Internal and external validity of included studies was very low. For overall recovery as the outcome, compared with inactive control or conventional care, there was a statistically significant improvement following disc surgery, epidural injections, nonopioid analgesia, manipulation, and acupuncture. Traction, percutaneous discectomy, and exercise therapy were significantly inferior to epidural injections or surgery. For pain as the outcome, epidural injections and biological agents were significantly better than inactive control, but similar findings for disc surgery were not statistically significant. Biological agents were significantly better for pain reduction than bed rest, nonopioids, and opioids. Opioids, education/advice alone, bed rest, and percutaneous discectomy were inferior to most other treatment strategies; although these findings represented large effects, they were statistically equivocal. For the first time, many different treatment strategies for sciatica have been compared in the

  4. Trial Sequential Analysis in systematic reviews with meta-analysis

    Directory of Open Access Journals (Sweden)

    Jørn Wetterslev

    2017-03-01

    Full Text Available Abstract Background Most meta-analyses in systematic reviews, including Cochrane ones, do not have sufficient statistical power to detect or refute even large intervention effects. This is why a meta-analysis ought to be regarded as an interim analysis on its way towards a required information size. The results of the meta-analyses should relate the total number of randomised participants to the estimated required meta-analytic information size accounting for statistical diversity. When the number of participants and the corresponding number of trials in a meta-analysis are insufficient, the use of the traditional 95% confidence interval or the 5% statistical significance threshold will lead to too many false positive conclusions (type I errors and too many false negative conclusions (type II errors. Methods We developed a methodology for interpreting meta-analysis results, using generally accepted, valid evidence on how to adjust thresholds for significance in randomised clinical trials when the required sample size has not been reached. Results The Lan-DeMets trial sequential monitoring boundaries in Trial Sequential Analysis offer adjusted confidence intervals and restricted thresholds for statistical significance when the diversity-adjusted required information size and the corresponding number of required trials for the meta-analysis have not been reached. Trial Sequential Analysis provides a frequentistic approach to control both type I and type II errors. We define the required information size and the corresponding number of required trials in a meta-analysis and the diversity (D2 measure of heterogeneity. We explain the reasons for using Trial Sequential Analysis of meta-analysis when the actual information size fails to reach the required information size. We present examples drawn from traditional meta-analyses using unadjusted naïve 95% confidence intervals and 5% thresholds for statistical significance. Spurious conclusions in

  5. Interactions among Candidate Genes Selected by Meta-Analyses Resulting in Higher Risk of Ischemic Stroke in a Chinese Population.

    Directory of Open Access Journals (Sweden)

    Man Luo

    Full Text Available Ischemic stroke (IS is a multifactorial disorder caused by both genetic and environmental factors. The combined effects of multiple susceptibility genes might result in a higher risk for IS than a single gene. Therefore, we investigated whether interactions among multiple susceptibility genes were associated with an increased risk of IS by evaluating gene polymorphisms identified in previous meta-analyses, including methylenetetrahydrofolate reductase (MTHFR C677T, beta fibrinogen (FGB, β-FG A455G and T148C, apolipoprotein E (APOE ε2-4, angiotensin-converting enzyme (ACE insertion/deletion (I/D, and endothelial nitric oxide synthase (eNOS G894T. In order to examine these interactions, 712 patients with IS and 774 controls in a Chinese Han population were genotyped using the SNaPshot method, and multifactor dimensionality reduction analysis was used to detect potential interactions among the candidate genes. The results of this study found that ACE I/D and β-FG T148C were significant synergistic contributors to IS. In particular, the ACE DD + β-FG 148CC, ACE DD + β-FG 148CT, and ACE ID + β-FG 148CC genotype combinations resulted in higher risk of IS. After adjusting for potential confounding IS risk factors (age, gender, family history of IS, hypertension history and history of diabetes mellitus using a logistic analysis, a significant correlation between the genotype combinations and IS patients persisted (overall stroke: adjusted odds ratio [OR] = 1.57, 95% confidence interval [CI]: 1.22-2.02, P < 0.001, large artery atherosclerosis subtype: adjusted OR = 1.50, 95% CI: 1.08-2.07, P = 0.016, small-artery occlusion subtype: adjusted OR = 2.04, 95% CI: 1.43-2.91, P < 0.001. The results of this study indicate that the ACE I/D and β-FG T148C combination may result in significantly higher risk of IS in this Chinese population.

  6. Definitions and methods of measuring and reporting on injurious falls in randomised controlled fall prevention trials: a systematic review

    Directory of Open Access Journals (Sweden)

    Schwenk Michael

    2012-04-01

    Full Text Available Abstract Background The standardisation of the assessment methodology and case definition represents a major precondition for the comparison of study results and the conduction of meta-analyses. International guidelines provide recommendations for the standardisation of falls methodology; however, injurious falls have not been targeted. The aim of the present article was to review systematically the range of case definitions and methods used to measure and report on injurious falls in randomised controlled trials (RCTs on fall prevention. Methods An electronic literature search of selected comprehensive databases was performed to identify injurious falls definitions in published trials. Inclusion criteria were: RCTs on falls prevention published in English, study population ≥ 65 years, definition of injurious falls as a study endpoint by using the terms "injuries" and "falls". Results The search yielded 2089 articles, 2048 were excluded according to defined inclusion criteria. Forty-one articles were included. The systematic analysis of the methodology applied in RCTs disclosed substantial variations in the definition and methods used to measure and document injurious falls. The limited standardisation hampered comparability of study results. Our results also highlight that studies which used a similar, standardised definition of injurious falls showed comparable outcomes. Conclusions No standard for defining, measuring, and documenting injurious falls could be identified among published RCTs. A standardised injurious falls definition enhances the comparability of study results as demonstrated by a subgroup of RCTs used a similar definition. Recommendations for standardising the methodology are given in the present review.

  7. Efficacy of Auricular Acupressure for Chronic Low Back Pain: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Li-Hua Yang

    2017-01-01

    Full Text Available Objectives. To identify the efficacy of auricular acupressure on pain and disability for chronic LBP by systematic review. Methods. A search of randomized controlled trials was conducted in four English medical electronic databases and three Chinese databases. Two reviewers independently retrieved related studies, assessed the methodological quality, and extracted data with a standardized data form. Meta-analyses were performed using all time-points meta-analysis. Results. A total of 7 trials met the inclusion criteria, of which 4 had the low risk of bias. The findings of this study showed that, for the immediate effect, auricular acupressure had large, significant effects in improving pain within 12 weeks. As for the follow-up effect, the pooled estimates also showed promising effect at 4-week follow-up after 4-week intervention (standardized mean difference = −1.13, 95% CI (-1.70, -0.56, P<0.001. But, for the disability level, the therapeutic effect was not significant (mean difference = −1.99, 95% CI (-4.93, 0.95, P=0.18. No serious adverse effects were recorded. Conclusions. The encouraging evidence of this study indicates that it is recommended to provide auricular acupressure to patients with chronic low back pain. However, a more accurate estimate of the effect will require further rigorously designed large-scale RCTs on chronic LBP for improving pain and disability.

  8. Meta-analyses of Theory use in Medication Adherence Intervention Research

    Science.gov (United States)

    Conn, Vicki S.; Enriquez, Maithe; Ruppar, Todd M.; Chan, Keith C.

    2016-01-01

    Objective This systematic review applied meta-analytic procedures to integrate primary research that examined theory- or model-linked medication adherence interventions. Methods Extensive literature searching strategies were used to locate trials testing interventions with medication adherence behavior outcomes measured by electronic event monitoring, pharmacy refills, pill counts, and self-reports. Random-effects model analysis was used to calculate standardized mean difference effect sizes for medication adherence outcomes. Results Codable data were extracted from 146 comparisons with 19,348 participants. The most common theories and models were social cognitive theory and motivational interviewing. The overall weighted effect size for all interventions comparing treatment and control participants was 0.294. The effect size for interventions based on single-theories was 0.323 and for multiple-theory interventions was 0.214. Effect sizes for individual theories and models ranged from 0.041 to 0.447. The largest effect sizes were for interventions based on the health belief model (0.477) and adult learning theory (0.443). The smallest effect sizes were for interventions based on PRECEDE (0.041) and self-regulation (0.118). Conclusion These findings suggest that theory- and model-linked interventions have a significant but modest effect on medication adherence outcomes. PMID:26931748

  9. Preterm Birth Associated With Group B Streptococcus Maternal Colonization Worldwide: Systematic Review and Meta-analyses.

    Science.gov (United States)

    Bianchi-Jassir, Fiorella; Seale, Anna C; Kohli-Lynch, Maya; Lawn, Joy E; Baker, Carol J; Bartlett, Linda; Cutland, Clare; Gravett, Michael G; Heath, Paul T; Ip, Margaret; Le Doare, Kirsty; Madhi, Shabir A; Saha, Samir K; Schrag, Stephanie; Sobanjo-Ter Meulen, Ajoke; Vekemans, Johan; Rubens, Craig E

    2017-11-06

    Preterm birth complications are the leading cause of deaths among children birth in order to inform estimates of the burden of GBS. We conducted systematic literature reviews (PubMed/Medline, Embase, Latin American and Caribbean Health Sciences Literature [LILACS], World Health Organization Library Information System [WHOLIS], and Scopus) and sought unpublished data from investigator groups on the association of preterm birth (birth with maternal GBS colonization to be 1.21 (95% confidence interval [CI], .99-1.48; P = .061) in cohort and cross-sectional studies, and the odds ratio to be 1.85 (95% CI, 1.24-2.77; P = .003) in case-control studies. Preterm birth was associated with GBS bacteriuria in cohort studies (RR, 1.98 [95% CI, 1.45-2.69]; P birth is associated with maternal GBS colonization, especially where there is evidence of ascending infection (bacteriuria). Several biases reduce the chance of detecting an effect. Equally, however, results, including evidence for the association, may be due to confounding, which is rarely addressed in studies. Assessment of any effect on preterm delivery should be included in future maternal GBS vaccine trials. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

  10. Association between Adult Height and Risk of Colorectal, Lung, and Prostate Cancer : Results from Meta-analyses of Prospective Studies and Mendelian Randomization Analyses

    NARCIS (Netherlands)

    Khankari, Nikhil K.; Shu, Xiao Ou; Wen, Wanqing; Kraft, Peter; Lindström, Sara; Peters, Ulrike; Schildkraut, Joellen; Schumacher, Fredrick; Bofetta, Paolo; Risch, Angela; Bickeböller, Heike; Amos, Christopher I.; Easton, Douglas; Eeles, Rosalind A.; Gruber, Stephen B.; Haiman, Christopher A.; Hunter, David J.; Chanock, Stephen J.; Pierce, Brandon L.; Zheng, Wei; Blalock, Kendra; Campbell, Peter T.; Casey, Graham; Conti, David V.; Edlund, Christopher K.; Figueiredo, Jane; James Gauderman, W.; Gong, Jian; Green, Roger C.; Harju, John F.; Harrison, Tabitha A.; Jacobs, Eric J.; Jenkins, Mark A.; Jiao, Shuo; Li, Li; Lin, Yi; Manion, Frank J.; Moreno, Victor; Mukherjee, Bhramar; Raskin, Leon; Schumacher, Fredrick R.; Seminara, Daniela; Severi, Gianluca; Stenzel, Stephanie L.; Thomas, Duncan C.; Hopper, John L.; Southey, Melissa C.; Makalic, Enes; Schmidt, Daniel F.; Fletcher, Olivia; Peto, Julian; Gibson, Lorna; dos Santos Silva, Isabel; Ahsan, Habib; Whittemore, Alice; Waisfisz, Quinten; Meijers-Heijboer, Hanne; Adank, Muriel; van der Luijt, Rob B.; Uitterlinden, Andre G.; Hofman, Albert; Meindl, Alfons; Schmutzler, Rita K.; Müller-Myhsok, Bertram; Lichtner, Peter; Nevanlinna, Heli; Muranen, Taru A.; Aittomäki, Kristiina; Blomqvist, Carl; Chang-Claude, Jenny; Hein, Rebecca; Dahmen, Norbert; Beckman, Lars; Crisponi, Laura; Hall, Per; Czene, Kamila; Irwanto, Astrid; Liu, Jianjun; Easton, Douglas F.; Turnbull, Clare; Rahman, Nazneen; Eeles, Rosalind; Kote-Jarai, Zsofia; Muir, Kenneth; Giles, Graham; Neal, David; Donovan, Jenny L.; Hamdy, Freddie C.; Wiklund, Fredrik; Gronberg, Henrik; Haiman, Christopher; Schumacher, Fred; Travis, Ruth; Riboli, Elio; Hunter, David; Gapstur, Susan; Berndt, Sonja; Chanock, Stephen; Han, Younghun; Su, Li; Wei, Yongyue; Hung, Rayjean J.; Brhane, Yonathan; McLaughlin, John; Brennan, Paul; McKay, James D.; Rosenberger, Albert; Houlston, Richard S.; Caporaso, Neil; Teresa Landi, Maria; Heinrich, Joachim; Wu, Xifeng; Ye, Yuanqing; Christiani, David C.

    2016-01-01

    Background: Observational studies examining associations between adult height and risk of colorectal, prostate, and lung cancers have generated mixed results. We conducted meta-analyses using data from prospective cohort studies and further carried out Mendelian randomization analyses, using

  11. Meta-analyses: does long-term PPI use increase the risk of gastric premalignant lesions?

    Science.gov (United States)

    Eslami, Layli; Nasseri-Moghaddam, Siavosh

    2013-08-01

    Proton pump inhibitors (PPIs) are the most effective agents available for reducing acid secretion. They are used for medical treatment of various acid-related disorders. PPIs are used extensively and for extended periods of time in gastroesophageal reflux disease (GERD). A troublesome issue regarding maintenance therapy has been the propensity of PPI-treated patients to develop chronic atrophic gastritis while on therapy that could theoretically lead to an increased incidence of gastric cancer. In addition, animal studies have raised concern for development of enterochromaffin-like cell hyperplasia and carcinoid tumors in the stomachs of mice receiving high dose PPIs. Current literature does not provide a clear-cut conclusion on the subject and the reports are sometimes contradictory. Therefore, this study is a systematic review of the available literature to address the safety of long-term PPI use and its relation to the development of malignant/premalignant gastric lesions. A literature search of biomedical databases was performed. The reference lists of retrieved articles were reviewed to further identify relevant trials. We hand-searched the abstracts of the American Digestive Disease Week (DDW) and the United European Gastroenterology Week (UEGW) from 1995 to 2013. Only randomized clinical trials (RCTs) that used PPIs as the primary treatment for at least six month versus no treatment, placebo, antacid or anti-reflux surgery (ARS) were included. Two reviewers independently extracted the data. Discrepancies in the interpretation were resolved by consensus. All analyses of outcomes were based on the intention-to-treat principle. We performed statistical analysis using Review Manager software. The effect measure of choice was relative risk (RR) for dichotomous data. Six RCTs with a total of 785 patients met the inclusion criteria. Two multicenter RCTs compared Esomeprazole with placebo. One RCT compared omeprazole with ARS. Two RCTs compared omeprazole with

  12. Exercise for depression in older adults: a meta-analysis of randomized controlled trials adjusting for publication bias

    Directory of Open Access Journals (Sweden)

    Felipe B. Schuch

    Full Text Available Objective: To evaluate the antidepressant effects of exercise in older adults, using randomized controlled trial (RCT data. Methods: We conducted a meta-analysis of exercise in older adults, addressing limitations of previous works. RCTs of exercise interventions in older people with depression (≥ 60 years comparing exercise vs. control were eligible. A random-effects meta-analysis calculating the standardized mean difference (SMD (95% confidence interval [95%CI], meta-regressions, and trim, fill, and fail-safe number analyses were conducted. Results: Eight RCTs were included, representing 138 participants in exercise arms and 129 controls. Exercise had a large and significant effect on depression (SMD = -0.90 [95%CI -0.29 to -1.51], with a fail-safe number of 71 studies. Significant effects were found for 1 mixed aerobic and anaerobic interventions, 2 at moderate intensity, 3 that were group-based, 4 that utilized mixed supervised and unsupervised formats, and 5 in people without other clinical comorbidities. Conclusion: Adjusting for publication bias increased the beneficial effects of exercise in three subgroup analysis, suggesting that previous meta-analyses have underestimated the benefits of exercise due to publication bias. We advocate that exercise be considered as a routine component of the management of depression in older adults.

  13. Low-protein diet for conservative management of chronic kidney disease: a systematic review and meta-analysis of controlled trials.

    Science.gov (United States)

    Rhee, Connie M; Ahmadi, Seyed-Foad; Kovesdy, Csaba P; Kalantar-Zadeh, Kamyar

    2018-04-01

    Recent data pose the question whether conservative management of chronic kidney disease (CKD) by means of a low-protein diet can be a safe and effective means to avoid or defer transition to dialysis therapy without causing protein-energy wasting or cachexia. We aimed to systematically review and meta-analyse the controlled clinical trials with adequate participants in each trial, providing rigorous contemporary evidence of the impact of a low-protein diet in the management of uraemia and its complications in patients with CKD. We searched MEDLINE (PubMed) and other sources for controlled trials on CKD to compare clinical management of CKD patients under various levels of dietary protein intake or to compare restricted protein intake with other interventions. Studies with similar patients, interventions, and outcomes were included in the meta-analyses. We identified 16 controlled trials of low-protein diet in CKD that met the stringent qualification criteria including having 30 or more participants. Compared with diets with protein intake of >0.8 g/kg/day, diets with restricted protein intake (disease, and a trend towards lower rates of all-cause death. In addition, very-low-protein diets (protein intake kidney function and reduction in the rate of progression to end-stage renal disease. Safety and adherence to a low-protein diet was not inferior to a normal protein diet, and there was no difference in the rate of malnutrition or protein-energy wasting. In this pooled analysis of moderate-size controlled trials, a low-protein diet appears to enhance the conservative management of non-dialysis-dependent CKD and may be considered as a potential option for CKD patients who wish to avoid or defer dialysis initiation and to slow down the progression of CKD, while the risk of protein-energy wasting and cachexia remains minimal. © 2017 The Authors. Journal of Cachexia, Sarcopenia and Muscle published by John Wiley & Sons Ltd on behalf of the Society on Sarcopenia

  14. Randomised controlled trials in Scandinavian educational research

    DEFF Research Database (Denmark)

    Pontoppidan, Maiken; Keilow, Maria; Dietrichson, Jens

    2018-01-01

    of this paper is to examine the history of randomised controlled trials in Scandinavian compulsory schools (grades 0–10; pupil ages 6-15). Specifically, we investigate drivers and barriers for randomised controlled trials in educational research and the differences between the three Scandinavian countries...... crucial for the implementation of RCTs and are likely more important in smaller countries such as the Scandinavian ones. Supporting institutions have now been established in all three countries, and we believe that the use of RCTs in Scandinavian educational research is likely to continue....... or more interventions were randomly assigned to groups of students and carried out in a school setting with the primary aim of improving the academic performance of children aged 6-15 in grades 0–10 in Denmark, Norway, or Sweden. We included both conducted and ongoing trials. Publications that seemed...

  15. Not all risks are created equal: A twin study and meta-analyses of risk taking across seven domains.

    Science.gov (United States)

    Wang, X T Xiao-Tian; Zheng, Rui; Xuan, Yan-Hua; Chen, Jie; Li, Shu

    2016-11-01

    Humans routinely deal with both traditional and novel risks. Different kinds of risks have been a driving force for both evolutionary adaptations and personal development. This study explored the genetic and environmental influences on human risk taking in different task domains. Our approach was threefold. First, we integrated several scales of domain-specific risk-taking propensity and developed a synthetic scale, including both evolutionarily typical and modern risks in the following 7 domains: cooperation/competition, safety, reproduction, natural/physical risk, moral risk, financial risk, and gambling. Second, we conducted a twin study using the scale to estimate the contributions of genes and environment to risk taking in each of these 7 domains. Third, we conducted a series of meta-analyses of extant twin studies across the 7 risk domains. The results showed that individual differences in risk-taking propensity and its consistency across domains were mainly regulated by additive genetic influences and individually unique environmental experiences. The heritability estimates from the meta-analyses ranged from 29% in financial risk taking to 55% in safety. Supporting the notion of risk-domain specificity, both the behavioral and genetic correlations among the 7 domains were generally low. Among the relatively few correlations between pairs of risk domains, our analysis revealed a common genetic factor that regulates moral, financial, and natural/physical risk taking. This is the first effort to separate genetic and environmental influences on risk taking across multiple domains in a single study and integrate the findings of extant twin studies via a series of meta-analyses conducted in different task domains. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  16. Hypnotherapy for insomnia: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Lam, Tak-Ho; Chung, Ka-Fai; Yeung, Wing-Fai; Yu, Branda Yee-Man; Yung, Kam-Ping; Ng, Tommy Ho-Yee

    2015-10-01

    To examine the efficacy and safety of hypnotherapy for insomnia as compared to placebo, pharmacological or non-pharmacological intervention, or no treatment. A systematic search on major electronic databases was conducted up until March 2014. Inclusion criteria are: (1) randomized controlled trials (RCTs) or quasi-RCTs; (2) intervention targeted at improving sleep; (3) hypnosis as an intervention; and (4) English language articles. Sleep diary variable is the primary outcome measure. Six RCTs of hypnotherapy and seven on autogenic training or guided imagery, comprising 502 subjects, were included. Eleven of the 13 studies had low methodological quality, as indicated by a modified Jadad score below 3, and high risks of bias in blinding and design of the control interventions. No adverse events related to hypnosis were reported, though seldom investigated. Meta-analyses found hypnotherapy significantly shortened sleep latency compared to waitlist (standardized mean difference, SMD=-0.88, 95% confidence interval (CI): -1.56, -0.19, P=0.01, I(2)=15%), but no difference compared to sham intervention (SMD: -1.08, 95% CI: -3.15, 0.09, P=0.31, I(2)=90%). Similar results were found for autogenic training or guided imagery (SMD with waitlist=-1.16, 95% CI: -1.92, -0.40, P=0.003, I(2)=0%; SMD with sham intervention=-0.50, 95% CI: -1.19, 0.19, P=0.15, I(2)=0%). Generalizability of the positive results is doubtful due to the relatively small sample size and methodological limitations. Future studies with larger sample size and better study design and methodology are called for. Copyright © 2015 Elsevier Ltd. All rights reserved.

  17. a randomised controlled trial oftwo prostaglandin regitnens

    African Journals Online (AJOL)

    Design. A prospective randomised controlled trial. Setting. Department of Obstetrics and Gynae- ... hours after the original administration of either prostaglandin regimen. If abortion had not taken place 36 .... Tygerberg Hospital for permission to publish, and Upjohn. (Pry) Ltd for supplying the Prepidil gel used in the study. 1.

  18. Is the randomised controlled trial the best?

    African Journals Online (AJOL)

    The randomised controlled trial (RCT) is recog nised as the gold standard of research methods, particularly to test efficacy. The primary benefit of the RCT, as everyone knows, is to prevent patient selection bias. And it should also guarantee some rigour of research methodology. It is always prospective. In a nonrandomised ...

  19. [Placebo-controlled trials in schizophrenia].

    Science.gov (United States)

    Melamed, Yuval; Davidson, Michael; Bleich, Avi

    2004-03-01

    Clinical trials involving human subjects give rise to ethical and medico-legal dilemmas. Essential research of new drugs may potentially expose patients to ineffective medications or to placebo. The complexity of the problem increases when dealing with mentally ill patients, for whom, on the one hand there is no known cure for their disease, and on the other hand, it is sometimes questionable whether or not they are able to provide informed consent to participate in clinical trials. The Israel Psychiatric Association decided to develop a position paper on the subject of placebo-controlled clinical trials in schizophrenia patients. Discussion groups were established, and the available material in the professional literature was examined, with an emphasis on recent developments. The Declaration of Helsinki and its amendments were analyzed, and experts in the field were consulted. Clinical drug trials for development of new medications are essential in all fields of medicine, especially in psychiatry. The requirement for a placebo arm in pharmaceutical trials presents ethical and clinical dilemmas that are especially complicated with regard to mentally ill persons whose free choice and ability to provide informed consent may be questionable. However, we do not believe that this predicament justifies unconditional rejection of placebo use in psychiatry, when it may provide substantial benefit for some patients. Simultaneously, it is our duty to provide stringent restrictions that will enable strict supervision over the scientific, clinical and ethical aspects of the trials. We propose the following criteria for approval of pharmaceutical trials that include a placebo arm: scientific justification; clinical and ethical justification; provision of informed consent; recruitment of patients hospitalized voluntarily; prevention of harm; administration of additional potential therapeutic interventions; benefit to patients participating in the study; control and follow

  20. A systematic review of the quality of conduct and reporting of systematic reviews and meta-analyses in paediatric surgery.

    Directory of Open Access Journals (Sweden)

    Paul Stephen Cullis

    Full Text Available Our objective was to evaluate quality of conduct and reporting of published systematic reviews and meta-analyses in paediatric surgery. We also aimed to identify characteristics predictive of review quality.Systematic reviews summarise evidence by combining sources, but are potentially prone to bias. To counter this, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA was published to aid in reporting. Similarly, the Assessing the Methodological Quality of Systematic Reviews (AMSTAR measurement tool was designed to appraise methodology. The paediatric surgical literature has seen an increasing number of reviews over the past decade, but quality has not been evaluated.Adhering to PRISMA guidelines, we performed a systematic review with a priori design to identify systematic reviews and meta-analyses of interventions in paediatric surgery. From 01/2010 to 06/2016, we searched: MEDLINE, EMBASE, Cochrane, Centre for Reviews and Dissemination, Web of Science, Google Scholar, reference lists and journals. Two reviewers independently selected studies and extracted data. We assessed conduct and reporting using AMSTAR and PRISMA. Scores were calculated as the sum of reported items. We also extracted author, journal and article characteristics, and used them in exploratory analysis to determine which variables predict quality.112 articles fulfilled eligibility criteria (53 systematic reviews; 59 meta-analyses. Overall, 68% AMSTAR and 56.8% PRISMA items were reported adequately. Poorest scores were identified with regards a priori design, inclusion of structured summaries, including the grey literature, citing excluded articles and evaluating bias. 13 reviews were pre-registered and 6 in PRISMA-endorsing journals. The following predicted quality in univariate analysis:, word count, Cochrane review, journal h-index, impact factor, journal endorses PRISMA, PRISMA adherence suggested in author guidance, article mentions PRISMA

  1. A Systematic Review and Meta-Analyses of Nonsucrose Sweet Solutions for Pain Relief in Neonates

    Directory of Open Access Journals (Sweden)

    Mariana Bueno

    2013-01-01

    Full Text Available BACKGROUND: Sucrose has been demonstrated to provide analgesia for minor painful procedures in infants. However, results of trials investigating other sweet solutions for neonatal pain relief have not yet been synthesized.

  2. The Hawthorne Effect: a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    van Haselen Robbert

    2007-07-01

    Full Text Available Abstract Background The 'Hawthorne Effect' may be an important factor affecting the generalisability of clinical research to routine practice, but has been little studied. Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge, no attempt has been made to quantify them. Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia. Methods Participants in a dementia trial were randomised to intensive follow-up (with comprehensive assessment visits at baseline and two, four and six months post randomisation or minimal follow-up (with an abbreviated assessment at baseline and a full assessment at six months. Our primary outcomes were cognitive functioning (ADAS-Cog and participant and carer-rated quality of life (QOL-AD. Results We recruited 176 participants, mainly through general practices. The main analysis was based on Intention to treat (ITT, with available data. In the ANCOVA model with baseline score as a co-variate, follow-up group had a significant effect on outcome at six months on the ADAS-Cog score (n = 140; mean difference = -2.018; 95%CI -3.914, -0.121; p = 0.037 favouring the intensive follow-up group, and on participant-rated quality of life score (n = 142; mean difference = -1.382; 95%CI -2.642, -0.122; p = 0.032 favouring minimal follow-up group. There was no significant difference on carer quality of life. Conclusion We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia resulted in a better outcome than minimal follow-up, as measured by their cognitive functioning. Trial registration Current controlled trials: ISRCTN45577048

  3. [Dengzhan Xixin injection as an adjuvant treatment for angina pectoris: a systematic review and Meta-analysis of randomized controlled trials].

    Science.gov (United States)

    Wang, Feng-jiao; Xie, Yan-ming; Liao, Xing; Jia, Min

    2015-08-01

    The paper is to systematically evaluate the efficacy and safety of Deng Zhan Xi Xin injection ( DZXXI) as an adjuvant treatment for patients with angina pectoris. The Cochrane Library, Medline, EMbase, CBM, CNKI, VIP, and Wan fang Data base were searched. Randomized controlled trials (RCTs) of DZXXI combined with western medicine routine treatment versus western medicine routine treatment alone for angina pectoris patients were all included. All trials were assessed according to the Cochrane Reviewer' s Handbook 5.1 for Systematic Reviews of Intervention and Meta analyses were performed by RevMan 5. 2 Software. A total of 30RCTs (3 086 patients including 1 572 patients of treatment group and 1 514 patients of control group) were included. Meta-analysis of treatment group compared with control group showed superior effect over reducing cardiovascular events ( OR = 0.33; 95% CI: [0.16, 0.67], P = 0.002, improving effective rate of DZXXI as adjuvant treatment for angina pectoris patients (OR = 3.97; 95% CI: [3.15, 5.02]; P angina pectoris. But based on the limitations of the study, rigorous design with long follow up clinical trials are necessary for further evidence.

  4. Systematic Review of Infrapopliteal Drug-Eluting Stents: A Meta-Analysis of Randomized Controlled Trials

    Energy Technology Data Exchange (ETDEWEB)

    Katsanos, Konstantinos, E-mail: katsanos@med.upatras.gr [NHS Foundation Trust, King' s Health Partners, Department of Interventional Radiology, Guy' s and St. Thomas' Hospitals (United Kingdom); Spiliopoulos, Stavros [Patras University Hospital, Department of Interventional Radiology, School of Medicine (Greece); Diamantopoulos, Athanasios [NHS Foundation Trust, King' s Health Partners, Department of Interventional Radiology, Guy' s and St. Thomas' Hospitals (United Kingdom); Karnabatidis, Dimitris [Patras University Hospital, Department of Interventional Radiology, School of Medicine (Greece); Sabharwal, Tarun [NHS Foundation Trust, King' s Health Partners, Department of Interventional Radiology, Guy' s and St. Thomas' Hospitals (United Kingdom); Siablis, Dimitris [Patras University Hospital, Department of Interventional Radiology, School of Medicine (Greece)

    2013-06-15

    IntroductionDrug-eluting stents (DES) have been proposed for the treatment of infrapopliteal arterial disease. We performed a systematic review to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing infrapopliteal DES.Materials and MethodsPubMed (Medline), EMBASE (Excerpta Medical Database), AMED (Allied and Complementary medicine Database), Scopus, CENTRAL (Cochrane Central Register of Controlled Trials), online content, and abstract meetings were searched in September 2012 for eligible RCTs according to the preferred reporting items for systematic reviews and meta-analyses selection process. Risk of bias was assessed using the Cochrane Collaboration's tool. Primary endpoint was primary patency defined as absence of {>=}50 % vessel restenosis at 1 year. Secondary outcome measures included patient survival, limb amputations, change of Rutherford-Becker class, target lesion revascularization (TLR) events, complete wound healing, and event-free survival at 1 year. Risk ratio (RRs) were calculated using the Mantel-Haenszel fixed effects model, and number-needed-to-treat values are reported.ResultsThree RCTs involving 501 patients with focal infrapopliteal lesions were analyzed (YUKON-BTX, DESTINY, and ACHILLES trials). All three RCTs included relatively short and focal infrapopliteal lesions. At 1 year, there was clear superiority of infrapopliteal DES compared with control treatments in terms of significantly higher primary patency (80.0 vs. 58.5 %; pooled RR = 1.37, 95 % confidence interval [CI] = 1.18-1.58, p < 0.0001; number-needed-to-treat (NNT) value = 4.8), improvement of Rutherford-Becker class (79.0 vs. 69.6 %; pooled RR = 1.13, 95 % CI = 1.002-1.275, p = 0.045; NNT = 11.1), decreased TLR events (9.9 vs. 22.0 %; pooled RR = 0.45, 95 % CI = 0.28-0.73, p = 0.001; NNT = 8.3), improved wound healing (76.8 vs. 59.7 %; pooled RR = 1.29, 95 % CI = 1.02-1.62, p = 0.04; NNT = 5.9), and better overall

  5. Systematic Review of Infrapopliteal Drug-Eluting Stents: A Meta-Analysis of Randomized Controlled Trials

    International Nuclear Information System (INIS)

    Katsanos, Konstantinos; Spiliopoulos, Stavros; Diamantopoulos, Athanasios; Karnabatidis, Dimitris; Sabharwal, Tarun; Siablis, Dimitris

    2013-01-01

    IntroductionDrug-eluting stents (DES) have been proposed for the treatment of infrapopliteal arterial disease. We performed a systematic review to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing infrapopliteal DES.Materials and MethodsPubMed (Medline), EMBASE (Excerpta Medical Database), AMED (Allied and Complementary medicine Database), Scopus, CENTRAL (Cochrane Central Register of Controlled Trials), online content, and abstract meetings were searched in September 2012 for eligible RCTs according to the preferred reporting items for systematic reviews and meta-analyses selection process. Risk of bias was assessed using the Cochrane Collaboration’s tool. Primary endpoint was primary patency defined as absence of ≥50 % vessel restenosis at 1 year. Secondary outcome measures included patient survival, limb amputations, change of Rutherford–Becker class, target lesion revascularization (TLR) events, complete wound healing, and event-free survival at 1 year. Risk ratio (RRs) were calculated using the Mantel–Haenszel fixed effects model, and number-needed-to-treat values are reported.ResultsThree RCTs involving 501 patients with focal infrapopliteal lesions were analyzed (YUKON-BTX, DESTINY, and ACHILLES trials). All three RCTs included relatively short and focal infrapopliteal lesions. At 1 year, there was clear superiority of infrapopliteal DES compared with control treatments in terms of significantly higher primary patency (80.0 vs. 58.5 %; pooled RR = 1.37, 95 % confidence interval [CI] = 1.18–1.58, p < 0.0001; number-needed-to-treat (NNT) value = 4.8), improvement of Rutherford–Becker class (79.0 vs. 69.6 %; pooled RR = 1.13, 95 % CI = 1.002–1.275, p = 0.045; NNT = 11.1), decreased TLR events (9.9 vs. 22.0 %; pooled RR = 0.45, 95 % CI = 0.28–0.73, p = 0.001; NNT = 8.3), improved wound healing (76.8 vs. 59.7 %; pooled RR = 1.29, 95 % CI = 1.02–1.62, p = 0.04; NNT = 5.9), and better

  6. Incorporating uncertainty regarding applicability of evidence from meta-analyses into clinical decision making.

    Science.gov (United States)

    Kriston, Levente; Meister, Ramona

    2014-03-01

    Judging applicability (relevance) of meta-analytical findings to particular clinical decision-making situations remains challenging. We aimed to describe an evidence synthesis method that accounts for possible uncertainty regarding applicability of the evidence. We conceptualized uncertainty regarding applicability of the meta-analytical estimates to a decision-making situation as the result of uncertainty regarding applicability of the findings of the trials that were included in the meta-analysis. This trial-level applicability uncertainty can be directly assessed by the decision maker and allows for the definition of trial inclusion probabilities, which can be used to perform a probabilistic meta-analysis with unequal probability resampling of trials (adaptive meta-analysis). A case study with several fictitious decision-making scenarios was performed to demonstrate the method in practice. We present options to elicit trial inclusion probabilities and perform the calculations. The result of an adaptive meta-analysis is a frequency distribution of the estimated parameters from traditional meta-analysis that provides individually tailored information according to the specific needs and uncertainty of the decision maker. The proposed method offers a direct and formalized combination of research evidence with individual clinical expertise and may aid clinicians in specific decision-making situations. Copyright © 2014 Elsevier Inc. All rights reserved.

  7. Control groups in recent septic shock trials

    DEFF Research Database (Denmark)

    Pettilä, Ville; Hjortrup, Peter B; Jakob, Stephan M

    2016-01-01

    PURPOSE: The interpretation of septic shock trial data is profoundly affected by patients, control intervention, co-interventions and selected outcome measures. We evaluated the reporting of control groups in recent septic shock trials. METHODS: We searched for original articles presenting......, and mortality outcomes, and calculated a data completeness score to provide an overall view of quality of reporting. RESULTS: A total of 24 RCTs were included (mean n = 287 patients and 71 % of eligible patients were randomized). Of the 24 studies, 14 (58 %) presented baseline data on vasopressors and 58...... % the proportion of patients with elevated lactate values. Five studies (21 %) provided data to estimate the proportion of septic shock patients fulfilling the Sepsis-3 definition. The mean data completeness score was 19 out of 36 (range 8-32). Of 18 predefined control group characteristics, a mean of 8 (range 2...

  8. Potential effectiveness of Chinese herbal medicine Yu ping feng san for adult allergic rhinitis: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Luo, Qiulan; Zhang, Claire Shuiqing; Yang, Lihong; Zhang, Anthony Lin; Guo, Xinfeng; Xue, Charlie Changli; Lu, Chuanjian

    2017-11-06

    Chinese herbal medicine formula Yu ping feng san (YPFS) is commonly used for allergic rhinitis (AR). Previous review had summarized the effectiveness and safety of YPFS, however without any subgroup analysis performed to provide detailed evidence for guiding clinical practice. YPFS was recommended for the management of AR by Chinese medicine clinical practice guideline, but the treatment duration of YPFS was also not specified. The aim of this study is to evaluate the effectiveness and safety of YPFS in treating adult AR with the most recent evidence, and attempt to specify the duration of utilisation through subgroup meta-analyses. Seven databases were searched from their inceptions to September 2017. Randomized controlled trials (RCTs) evaluating YPFS for adult AR were included. Methodological quality of studies was assessed using the Cochrane risk of bias tool. Meta-analysis and subgroup meta-analyses were conducted for evaluating the effectiveness of YPFS. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used for rating the quality of evidence. Twenty-two RCTs involving 23 comparisons were included in this review. YPFS was compared to placebo, pharmacotherapy, and used as an add-on treatment compared to pharmacotherapy. Meta-analyses were feasible for the outcomes of four individual nasal symptom scores and "effective rate". Four individual nasal symptom scores decreased after YPFS' combination treatment: itchy nose (MD-0.46, 95% CI[-0.50, -0.42]), sneezing (MD-0.41, 95% CI[-0.47, -0.35]), blocked nose (MD-0.46, 95% CI[-0.54, -0.39]) and runny nose (MD-0.42, 95% CI[-0.58, -0.26]). Based on "effective rate", meta-analysis showed that YPFS did not achieve better effect than pharmacotherapy (RR1.07, 95%CI [0.94, 1.22), but its combination with pharmacotherapy seemed more effective than pharmacotherapy alone (RR1.27, 95%CI [1.19, 1.34]) (low quality). Subgroup analysis suggested that YPFS was not superior to the second

  9. Relationship between Long Chain n-3 Polyunsaturated Fatty Acids and Autism Spectrum Disorder: Systematic Review and Meta-Analysis of Case-Control and Randomised Controlled Trials

    Directory of Open Access Journals (Sweden)

    Hajar Mazahery

    2017-02-01

    Full Text Available Omega-3 long chain polyunsaturated fatty acid supplementation (n-3 LCPUFA for treatment of Autism Spectrum Disorder (ASD is popular. The results of previous systematic reviews and meta-analyses of n-3 LCPUFA supplementation on ASD outcomes were inconclusive. Two meta-analyses were conducted; meta-analysis 1 compared blood levels of LCPUFA and their ratios arachidonic acid (ARA to docosahexaenoic acid (DHA, ARA to eicosapentaenoic acid (EPA, or total n-6 to total n-3 LCPUFA in ASD to those of typically developing individuals (with no neurodevelopmental disorders, and meta-analysis 2 compared the effects of n-3 LCPUFA supplementation to placebo on symptoms of ASD. Case-control studies and randomised controlled trials (RCTs were identified searching electronic databases up to May, 2016. Mean differences were pooled and analysed using inverse variance models. Heterogeneity was assessed using I2 statistic. Fifteen case-control studies (n = 1193 were reviewed. Compared with typically developed, ASD populations had lower DHA (−2.14 [95% CI −3.22 to −1.07]; p < 0.0001; I2 = 97%, EPA (−0.72 [95% CI −1.25 to −0.18]; p = 0.008; I2 = 88%, and ARA (−0.83 [95% CI, −1.48 to −0.17]; p = 0.01; I2 = 96% and higher total n-6 LCPUFA to n-3 LCPUFA ratio (0.42 [95% CI 0.06 to 0.78]; p = 0.02; I2 = 74%. Four RCTs were included in meta-analysis 2 (n = 107. Compared with placebo, n-3 LCPUFA improved social interaction (−1.96 [95% CI −3.5 to −0.34]; p = 0.02; I2 = 0 and repetitive and restricted interests and behaviours (−1.08 [95% CI −2.17 to −0.01]; p = 0.05; I2 = 0. Populations with ASD have lower n-3 LCPUFA status and n-3 LCPUFA supplementation can potentially improve some ASD symptoms. Further research with large sample size and adequate study duration is warranted to confirm the efficacy of n-3 LCPUFA.

  10. Efficacy and safety of corticosteroid injections and other injections for management of tendinopathy: a systematic review of randomised controlled trials.

    Science.gov (United States)

    Coombes, Brooke K; Bisset, Leanne; Vicenzino, Bill

    2010-11-20

    Few evidence-based treatment guidelines for tendinopathy exist. We undertook a systematic review of randomised trials to establish clinical efficacy and risk of adverse events for treatment by injection. We searched eight databases without language, publication, or date restrictions. We included randomised trials assessing efficacy of one or more peritendinous injections with placebo or non-surgical interventions for tendinopathy, scoring more than 50% on the modified physiotherapy evidence database scale. We undertook meta-analyses with a random-effects model, and estimated relative risk and standardised mean differences (SMDs). The primary outcome of clinical efficacy was protocol-defined pain score in the short term (4 weeks, range 0-12), intermediate term (26 weeks, 13-26), or long term (52 weeks, ≥52). Adverse events were also reported. 3824 trials were identified and 41 met inclusion criteria, providing data for 2672 participants. We showed consistent findings between many high-quality randomised controlled trials that corticosteroid injections reduced pain in the short term compared with other interventions, but this effect was reversed at intermediate and long terms. For example, in pooled analysis of treatment for lateral epicondylalgia, corticosteroid injection had a large effect (defined as SMD>0·8) on reduction of pain compared with no intervention in the short term (SMD 1·44, 95% CI 1·17-1·71, ptendon rupture). By comparison with placebo, reductions in pain were reported after injections of sodium hyaluronate (short [3·91, 3·54-4·28, peffective than was eccentric exercise. Despite the effectiveness of corticosteroid injections in the short term, non-corticosteroid injections might be of benefit for long-term treatment of lateral epicondylalgia. However, response to injection should not be generalised because of variation in effect between sites of tendinopathy. None. Copyright © 2010 Elsevier Ltd. All rights reserved.

  11. Right-handers have negligibly higher IQ scores than left-handers: Systematic review and meta-analyses.

    Science.gov (United States)

    Ntolka, Eleni; Papadatou-Pastou, Marietta

    2018-01-01

    The relationship between intelligence and handedness remains a matter of debate. The present study is a systematic review of 36 studies (totaling 66,108 individuals), which have measured full IQ scores in different handedness groups. Eighteen of those studies were further included in three sets of meta-analyses (totaling 20,442 individuals), which investigated differences in standardized mean IQ scores in (i) left-handers, (ii) non-right-handers, and (iii) mixed-handers compared to right-handers. The bulk of the studies included in the systematic review reported no differences in IQ scores between left- and right-handers. In the meta-analyses, statistically significant differences in mean IQ scores were detected between right-handers and left-handers, but were marginal in magnitude (d=-0.07); the data sets were found to be homogeneous. Significance was lost when the largest study was excluded. No differences in mean IQ scores were found between right-handers and non-right-handers as well as between right-handers and mixed-handers. No sex differences were found. Overall, the intelligence differences between handedness groups in the general population are negligible. Copyright © 2017 Elsevier Ltd. All rights reserved.

  12. Brain areas associated with numbers and calculations in children: Meta-analyses of fMRI studies

    Directory of Open Access Journals (Sweden)

    Marie Arsalidou

    2018-04-01

    Full Text Available Children use numbers every day and typically receive formal mathematical training from an early age, as it is a main subject in school curricula. Despite an increase in children neuroimaging studies, a comprehensive neuropsychological model of mathematical functions in children is lacking. Using quantitative meta-analyses of functional magnetic resonance imaging (fMRI studies, we identify concordant brain areas across articles that adhere to a set of selection criteria (e.g., whole-brain analysis, coordinate reports and report brain activity to tasks that involve processing symbolic and non-symbolic numbers with and without formal mathematical operations, which we called respectively number tasks and calculation tasks. We present data on children 14 years and younger, who solved these tasks. Results show activity in parietal (e.g., inferior parietal lobule and precuneus and frontal (e.g., superior and medial frontal gyri cortices, core areas related to mental-arithmetic, as well as brain regions such as the insula and claustrum, which are not typically discussed as part of mathematical problem solving models. We propose a topographical atlas of mathematical processes in children, discuss findings within a developmental constructivist theoretical model, and suggest practical methodological considerations for future studies. Keywords: Mathematical cognition, Meta-analyses, fMRI, Children, Development, Insula

  13. On Conducting Construct Validity Meta-Analyses for the Rorschach: A Reply to Tibon Czopp and Zeligman (2016).

    Science.gov (United States)

    Mihura, Joni L; Meyer, Gregory J; Dumitrascu, Nicolae; Bombel, George

    2016-01-01

    We respond to Tibon Czopp and Zeligman's (2016) critique of our systematic reviews and meta-analyses of 65 Rorschach Comprehensive System (CS) variables published in Psychological Bulletin (2013). The authors endorsed our supportive findings but critiqued the same methodology when used for the 13 unsupported variables. Unfortunately, their commentary was based on significant misunderstandings of our meta-analytic method and results, such as thinking we used introspectively assessed criteria in classifying levels of support and reporting only a subset of our externally assessed criteria. We systematically address their arguments that our construct label and criterion variable choices were inaccurate and, therefore, meta-analytic validity for these 13 CS variables was artificially low. For example, the authors created new construct labels for these variables that they called "the customary CS interpretation," but did not describe their methodology nor provide evidence that their labels would result in better validity than ours. They cite studies they believe we should have included; we explain how these studies did not fit our inclusion criteria and that including them would have actually reduced the relevant CS variables' meta-analytic validity. Ultimately, criticisms alone cannot change meta-analytic support from negative to positive; Tibon Czopp and Zeligman would need to conduct their own construct validity meta-analyses.

  14. Methological quality of systematic reviews and meta-analyses on acupuncture for stroke: A review of review.

    Science.gov (United States)

    Chen, Xin-Lin; Mo, Chuan-Wei; Lu, Li-Ya; Gao, Ri-Yang; Xu, Qian; Wu, Min-Feng; Zhou, Qian-Yi; Hu, Yue; Zhou, Xuan; Li, Xian-Tao

    2017-11-01

    To assess the methodological quality of systematic reviews and meta-analyses regarding acupuncture intervention for stroke and the primary studies within them. Two researchers searched PubMed, Cumulative index to Nursing and Allied Health Literature, Embase, ISI Web of Knowledge, Cochrane, Allied and Complementary Medicine, Ovid Medline, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, Wanfang and Traditional Chinese Medical Database to identify systematic reviews and meta-analyses about acupuncture for stroke published from the inception to December 2016. Review characteristics and the criteria for assessing the primary studies within reviews were extracted. The methodological quality of the reviews was assessed using adapted Oxman and Guyatt Scale. The methodological quality of primary studies was also assessed. Thirty-two eligible reviews were identified, 15 in English and 17 in Chinese. The English reviews were scored higher than the Chinese reviews (P=0.025), especially in criteria for avoiding bias and the scope of search. All reviews used the quality criteria to evaluate the methodological quality of primary studies, but some criteria were not comprehensive. The primary studies, in particular the Chinese reviews, had problems with randomization, allocation concealment, blinding, dropouts and withdrawals, intent-to-treat analysis and adverse events. Important methodological flaws were found in Chinese systematic reviews and primary studies. It was necessary to improve the methodological quality and reporting quality of both the systematic reviews published in China and primary studies on acupuncture for stroke.

  15. Living on a farm, contact with farm animals and pets, and childhood acute lymphoblastic leukemia: pooled and meta-analyses from the Childhood Leukemia International Consortium.

    Science.gov (United States)

    Orsi, Laurent; Magnani, Corrado; Petridou, Eleni T; Dockerty, John D; Metayer, Catherine; Milne, Elizabeth; Bailey, Helen D; Dessypris, Nick; Kang, Alice Y; Wesseling, Catharina; Infante-Rivard, Claire; Wünsch-Filho, Victor; Mora, Ana M; Spector, Logan G; Clavel, Jacqueline

    2018-04-16

    The associations between childhood acute lymphoblastic leukemia (ALL) and several factors related to early stimulation of the immune system, that is, farm residence and regular contacts with farm animals (livestock, poultry) or pets in early childhood, were investigated using data from 13 case-control studies participating in the Childhood Leukemia International Consortium. The sample included 7847 ALL cases and 11,667 controls aged 1-14 years. In all studies, the data were obtained from case and control parents using standardized questionnaires. Pooled odds ratios (ORs) and 95% confidence intervals (CIs) were estimated by unconditional logistic regression adjusted for age, sex, study, maternal education, and maternal age. Contact with livestock in the first year of life was inversely associated with ALL (OR = 0.65, 95% CI: 0.50, 0.85). Inverse associations were also observed for contact with dogs (OR = 0.92, 95% CI: 0.86, 0.99) and cats (OR = 0.87, 95% CI: 0.80, 0.94) in the first year of life. There was no evidence of a significant association with farm residence in the first year of life. The findings of these large pooled and meta-analyses add additional evidence to the hypothesis that regular contact with animals in early childhood is inversely associated with childhood ALL occurrence which is consistent with Greaves' delayed infection hypothesis. © 2018 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

  16. Combined effects of NQO1 Pro187Ser or SULT1A1 Arg213His polymorphism and smoking on bladder cancer risk: Two meta-analyses

    Directory of Open Access Journals (Sweden)

    Xiao-Chun Wang

    2017-10-01

    Full Text Available Objectives: Objectives: Cigarette smoking is the major risk factor of bladder cancer via exposure to chemical carcinogens. Nicotinamide adenine dinucleotide phosphate (NADP+: quinine oxidoreductase 1 (NQO1 and sulfotransferase 1A1 (SULT1A1 have been reported to involve in the metabolism of polycyclic aromatic hydrocarbons (PAHs and aromatic amines. Therefore, the risk of bladder cancer (BC may be influenced by polymorphisms in the genes that modulate metabolic detoxification in particular by interacting with cigarette smoking. Considering the limited power by the individual studies with a relatively small sample size, especially when analyzing the combined effect of polymorphisms in NQO1 and SULT1A1 genes and smoking, these 2 meta-analyses have aimed to clarify the combined effects of them on BC risk by integrating related studies. Material and Methods: Two meta-analyses included 1341 cases and 1346 controls concerning NQO1 Pro187Ser and smoking, and 1921 cases and 1882 controls on SULT1A1 Arg213His and smoking were performed. Odds ratios (OR and 95% confidence intervals (CI were used for assessing the strength of the association. Results: The result has demonstrated that smokers with NQO1 Pro/Ser or Ser/Ser genotypes have a prominent association with the risk of BC as compared with non-smokers with NQO1 Pro/Pro genotype, with OR equal to 3.71 (95% CI: 2.87–4.78, pheterogeneity = 0.376. Besides, smokers carrying SULT1A1 Arg/Arg genotypes were observed to confer 2.38 fold increased risk of BC (95% CI: 1.44–3.93, pheterogeneity = 0.001 when compared with non-smokers with SULT1A1 Arg/Arg or His/His genotypes. Conclusions: These findings have suggested that the NQO1 Pro187Ser or SULT1A1 Arg213His polymorphism combination with smoking significantly confer susceptibility to BC. Int J Occup Med Environ Health 2017;30(5:791–802

  17. Combined effects of NQO1 Pro187Ser or SULT1A1 Arg213His polymorphism and smoking on bladder cancer risk: Two meta-analyses.

    Science.gov (United States)

    Wang, Xiao-Chun; Wang, Jian; Tao, Hui-Hui; Zhang, Chao; Xu, Li-Fa

    2017-07-14

    Objectives: Cigarette smoking is the major risk factor of bladder cancer via exposure to chemical carcinogens. Nicotinamide adenine dinucleotide phosphate (NADP+): quinine oxidoreductase 1 (NQO1) and sulfotransferase 1A1 (SULT1A1) have been reported to involve in the metabolism of polycyclic aromatic hydrocarbons (PAHs) and aromatic amines. Therefore, the risk of bladder cancer (BC) may be influenced by polymorphisms in the genes that modulate metabolic detoxification in particular by interacting with cigarette smoking. Considering the limited power by the individual studies with a relatively small sample size, especially when analyzing the combined effect of polymorphisms in NQO1 and SULT1A1 genes and smoking, these 2 meta-analyses have aimed to clarify the combined effects of them on BC risk by integrating related studies. Two meta-analyses included 1341 cases and 1346 controls concerning NQO1 Pro187Ser and smoking, and 1921 cases and 1882 controls on SULT1A1 Arg213His and smoking were performed. Odds ratios (OR) and 95% confidence intervals (CI) were used for assessing the strength of the association. The result has demonstrated that smokers with NQO1 Pro/Ser or Ser/Ser genotypes have a prominent association with the risk of BC as compared with non-smokers with NQO1 Pro/Pro genotype, with OR equal to 3.71 (95% CI: 2.87-4.78, pheterogeneity = 0.376). Besides, smokers carrying SULT1A1 Arg/Arg genotypes were observed to confer 2.38 fold increased risk of BC (95% CI: 1.44-3.93, pheterogeneity = 0.001) when compared with non-smokers with SULT1A1 Arg/Arg or His/His genotypes. These findings have suggested that the NQO1 Pro187Ser or SULT1A1 Arg213His polymorphism combination with smoking significantly confer susceptibility to BC. Int J Occup Med Environ Health 2017;30(5):791-802. This work is available in Open Access model and licensed under a CC BY-NC 3.0 PL license.

  18. Enhanced recovery programs in lung cancer surgery: systematic review and meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Li S

    2017-11-01

    Full Text Available Shuangjiang Li,1 Kun Zhou,1 Guowei Che,1 Mei Yang,1 Jianhua Su,2 Cheng Shen,1 Pengming Yu2 1Department of Thoracic Surgery, 2Department of Rehabilitation, Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, China Background: Enhanced recovery after surgery (ERAS program is an effective evidence-based multidisciplinary protocol of perioperative care, but its roles in thoracic surgery remain unclear. This systematic review of randomized controlled trials (RCTs aims to investigate the efficacy and safety of the ERAS programs for lung cancer surgery. Materials and methods: We searched the PubMed and EMBASE databases to identify the RCTs that implemented an ERAS program encompassing more than four care elements within at least two phases of perioperative care in lung cancer surgery. The heterogeneity levels between studies were estimated by the Cochrane Collaborations. A qualitative review was performed if considerable heterogeneity was revealed. Relative risk (RR and weighted mean difference served as the summarized statistics for the meta-analyses. Additional analyses were also performed to perceive potential bias risks. Results: A total of seven RCTs enrolling 486 patients were included. The meta-analysis indicated that the ERAS group patients had significantly lower morbidity rates (RR=0.64; p<0.001, especially the rates of pulmonary (RR=0.43; p<0.001 and surgical complications (RR=0.46; p=0.010, than those of control group patients. No significant reduction was found in the in-hospital mortality (RR=0.70; p=0.58 or cardiovascular complications (RR=1.46; p=0.25. In the qualitative review, most of the evidence reported significantly shortened length of hospital and intensive care unit stay and decreased hospitalization costs in the ERAS-treated patients. No significant publication bias was detected in the meta-analyses. Conclusion: Our review demonstrates that the implementation of an ERAS program for lung cancer

  19. The effectiveness of home-based HIV counseling and testing on reducing stigma and risky sexual behavior among adults and adolescents: A systematic review and meta-analyses.

    Science.gov (United States)

    Feyissa, Garumma Tolu; Lockwood, Craig; Munn, Zachary

    2015-07-17

    -analysis software provided by Joanna Briggs Institute. Effect sizes were calculated using fixed effects model. Where the findings could not be pooled using meta-analyses, results were presented in a narrative form. Nine studies were included in this review, five of them reporting on stigma and related outcomes, three of them on sexual behavior and four of them on clinical outcomes. Meta-analysis indicated that the risk of observing any stigmatizing behavior in the community was 16% (RR=0.84, 95% CI 0.79 to 0.89] lower among the participants exposed to home-based HCT when compared to the risk among those participants not exposed to home-based HCT. The risk of experiencing any stigmatizing behavior by HIV positive patients was 37% (RR 0.63, 95% CI 0.45 to 0.88) lower among the intervention population compared to the risk among the control population. The risk of intimate partner violence was 34% (RR 0.66, 95% CI 0.49 to 0.89) lower among participants exposed to home-based HCT when compared to the risk among participants in the control arm. Compared to the control arm, the risk of reporting more than one sexual partner was 58% (RR 0.42, 95% CI 0.31 to 0.58) lower among participants exposed to home-based HCT. The risk of having any casual sexual partner in the past three months was 51% (RR 0.49, 95% CI 0.40 to 0.59) lower among the population exposed to home-based HCT when compared to the risk among those participants not exposed to home-based HCT. The risk of having ever been forced for sex among participants exposed to home-based HCT was 20% (RR 0.8, 0.56 to 1.14) lower when compared to the risk among the control arm; however this result was not statistically significant and the wide confidence interval indicates that the risk estimate was imprecise. Home-based HCT is protective against intimate partner violence, stigmatizing behavior, having multiple sexual partners, and having casual sexual partners. The low quality of studies included makes it difficult to formulate clear

  20. Adrenaline for out-of-hospital cardiac arrest resuscitation: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Lin, Steve; Callaway, Clifton W; Shah, Prakesh S; Wagner, Justin D; Beyene, Joseph; Ziegler, Carolyn P; Morrison, Laurie J

    2014-06-01

    The evidence for adrenaline in out-of-hospital cardiac arrest (OHCA) resuscitation is inconclusive. We systematically reviewed the efficacy of adrenaline for adult OHCA. We searched in MEDLINE, EMBASE, and Cochrane Library from inception to July 2013 for randomized controlled trials (RCTs) evaluating standard dose adrenaline (SDA) to placebo, high dose adrenaline (HDA), or vasopressin (alone or combination) in adult OHCA patients. Meta-analyses were performed using random effects modeling. Subgroup analyses were performed stratified by cardiac rhythm and by number of drug doses. The primary outcome was survival to discharge and the secondary outcomes were return of spontaneous circulation (ROSC), survival to admission, and neurological outcome. Fourteen RCTs (n=12,246) met inclusion criteria: one compared SDA to placebo (n=534), six compared SDA to HDA (n=6174), six compared SDA to an adrenaline/vasopressin combination (n=5202), and one compared SDA to vasopressin alone (n=336). There was no survival to discharge or neurological outcome differences in any comparison group, including subgroup analyses. SDA showed improved ROSC (RR 2.80, 95%CI 1.78-4.41, padrenaline. There was no benefit of adrenaline in survival to discharge or neurological outcomes. There were improved rates of survival to admission and ROSC with SDA over placebo and HDA over SDA. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  1. Transversus abdominal plane block for postoperative analgesia: a systematic review and meta-analysis of randomized-controlled trials.

    Science.gov (United States)

    Brogi, Etrusca; Kazan, Roy; Cyr, Shantale; Giunta, Francesco; Hemmerling, Thomas M

    2016-10-01

    The transversus abdominal plane (TAP) block has been described as an effective pain control technique after abdominal surgery. We performed a systematic review and meta-analysis of randomized-controlled trials (RCTs) to account for the increasing number of TAP block studies appearing in the literature. The primary outcome we examined was the effect of TAP block on the postoperative pain score at six, 12, and 24 hr. The secondary outcome was 24-hr morphine consumption. We searched the United States National Library of Medicine database, the Excerpta Medica database, and the Cochrane Central Register of Controlled Clinical Studies and identified RCTs focusing on the analgesic efficacy of TAP block compared with a control group [i.e., placebo, epidural analgesia, intrathecal morphine (ITM), and ilioinguinal nerve block after abdominal surgery]. Meta-analyses were performed on postoperative pain scores at rest at six, 12, and 24 hr (visual analogue scale, 0-10) and on 24-hr opioid consumption. In the 51 trials identified, compared with placebo, TAP block reduced the VAS for pain at six hours by 1.4 (95% confidence interval [CI], -1.9 to -0.8; P consumption at 24 hr after surgery (mean difference, -14.7 mg; 95% CI, -18.4 to -11.0; P consumption in the TAP block group after gynecological surgery, appendectomy, inguinal surgery, bariatric surgery, and urological surgery. Nevertheless, separate analysis of the studies comparing ITM with TAP block revealed that ITM seemed to have a greater analgesic efficacy. The TAP block can play an important role in the management of pain after abdominal surgery by reducing both pain scores and 24-hr morphine consumption. It may have particular utility when neuraxial techniques or opioids are contraindicated.

  2. The efficacy of antibiotic prophylaxis at placement of dental implants: a Cochrane systematic review of randomised controlled clinical trials.

    Science.gov (United States)

    Esposito, Marco; Grusovin, Maria Gabriella; Coulthard, Paul; Oliver, Richard; Worthington, Helen V

    To assess the beneficial or harmful effects of systemic prophylactic antibiotics at dental implant placement versus no antibiotic/placebo administration and, if antibiotics are of benefit, to find which type, dosage and duration is the most effective. The Cochrane Oral Health Group's Trials Register, CENTRAL, MEDLINE and EMBASE were searched and several journals were handsearched with no language restriction up to January 2008. Randomised controlled trials (RCTs) with a follow up of at least 3 months comparing the administration of various prophylactic antibiotic regimens versus no antibiotics to patients undergoing dental implant placement were eligible. Screening of studies, quality assessment and data extraction were conducted in duplicate. Missing information was requested. Outcome measures were: prosthesis and implant failures, postoperative infections and adverse events (gastrointestinal, hypersensitivity, etc.). Two RCTs were identified: one comparing 2 g of preoperative amoxicillin versus placebo (316 patients) and the other comparing 2 g of preoperative amoxicillin + 500 mg four times a day for 2 days versus no antibiotics (80 patients). The meta-analyses of the two trials showed a statistically significant higher number of patients experiencing implant failures in the group not receiving antibiotics: RR = 0.22 (95% CI 0.06 to 0.86). The number needed to treat (NNT) to prevent one patient having an implant failure is 25 (95% CI 13 to 100), based on a patient implant failure rate of 6% in patients not receiving antibiotics. The other outcomes were not statistically significant, and only two minor adverse events were recorded, one of which was in the placebo group. There is some evidence suggesting that 2 g of amoxicillin given 1 hour preoperatively significantly reduce failures of dental implants placed in ordinary conditions. It remains unclear whether postoperative antibiotics are beneficial, and which is the most effective antibiotic. It might be

  3. Treatment of depressive disorders in primary care - protocol of a multiple treatment systematic review of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Linde Klaus

    2011-11-01

    Full Text Available Abstract Background Several systematic reviews have summarized the evidence for specific treatments of primary care patients suffering from depression. However, it is not possible to answer the question how the available treatment options compare with each other as review methods differ. We aim to systematically review and compare the available evidence for the effectiveness of pharmacological, psychological, and combined treatments for patients with depressive disorders in primary care. Methods/Design To be included, studies have to be randomized trials comparing antidepressant medication (tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs, hypericum extracts, other agents and/or psychological therapies (e.g. interpersonal psychotherapy, cognitive therapy, behavioural therapy, short dynamically-oriented psychotherapy with another active therapy, placebo or sham intervention, routine care or no treatment in primary care patients in the acute phase of a depressive episode. Main outcome measure is response after completion of acute phase treatment. Eligible studies will be identified from available systematic reviews, from searches in electronic databases (Medline, Embase and Central, trial registers, and citation tracking. Two reviewers will independently extract study data and assess the risk of bias using the Cochrane Collaboration's corresponding tool. Meta-analyses (random effects model, inverse variance weighting will be performed for direct comparisons of single interventions and for groups of similar interventions (e.g. SSRIs vs. tricyclics and defined time-windows (up to 3 months and above. If possible, a global analysis of the relative effectiveness of treatments will be estimated from all available direct and indirect evidence that is present in a network of treatments and comparisons. Discussion Practitioners do not only want to know whether there is evidence that a specific treatment is more effective than

  4. Randomised controlled trials: important but overrated?

    LENUS (Irish Health Repository)

    Boylan, J F

    2012-02-01

    Practising physicians individualise treatments, hoping to achieve optimal outcomes by tackling relevant patient variables. The randomised controlled trial (RCT) is universally accepted as the best means of comparison. Yet doctors sometimes wonder if particular patients might benefit more from treatments that fared worse in the RCT comparisons. Such clinicians may even feel ostracised by their peers for stepping outside treatments based on RCTs and guidelines. Are RCTs the only acceptable evaluations of how patient care can be assessed and delivered? In this controversy we explore the interpretation of RCT data for practising clinicians facing individualised patient choices. First, critical care anaesthetists John Boylan and Brian Kavanagh emphasise the dangers of bias and show how Bayesian approaches utilise prior probabilities to improve posterior (combined) probability estimates. Secondly, Jane Armitage, of the Clinical Trial Service Unit in Oxford, argues why RCTs remain essential and explores how the quality of randomisation can be improved through systematic reviews and by avoiding selective reporting.

  5. Efficacy and safety profile of antibiotic prophylaxis usage in clean and clean-contaminated plastic and reconstructive surgery: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Zhang, Yi; Dong, Jiasheng; Qiao, Yufei; He, Jinguang; Wang, Tao; Ma, Sunxiang

    2014-01-01

    There is no consensus with regard to antibiotic prophylaxis usage in clean and clean-contaminated plastic and reconstructive surgery. This meta-analysis sought to assess the efficacy and safety of antibiotic prophylaxis and to determine appropriate duration of prophylaxis. An English language literature search was conducted using PubMed and the Cochrane Collaboration for randomized controlled trials (RCTs) that evaluate the use of antibiotic prophylaxis to prevent postoperative surgical site infection (SSI) in patients undergoing clean and clean-contaminated plastic and reconstructive surgery. Data from intention-to-treat analyses were used where available. For the dichotomous data, results for each study were odds ratio (OR) with 95% confidence interval (CI) and combined for meta-analysis using the Mantel-Haenszel method or the DerSimonian and Laird method. Study quality was critically appraised by 2 reviewers using established criteria. STATA version 12 was used for meta-analyses. Twelve RCTs involving 2395 patients were included, of which 8 trials were considered to be of high methodological quality. Effect of antibiotic prophylaxis in plastic and reconstructive surgery was found favorable over placebo in SSI prevention (13 studies; 2449 participants; OR, 0.53; 95% CI, 0.4-0.7; P plastic surgeries with high-risk factors and clean-contaminated plastic surgeries. Besides, a short-course administration regimen seemed to be of adequate efficacy and safety. High-quality prospective trials on larger scale are needed to further confirm these findings.

  6. Are Youth Psychopathic Traits Related to Bullying? Meta-analyses on Callous-Unemotional Traits, Narcissism, and Impulsivity.

    Science.gov (United States)

    van Geel, Mitch; Toprak, Fatih; Goemans, Anouk; Zwaanswijk, Wendy; Vedder, Paul

    2017-10-01

    In the current manuscript meta-analyses are performed to analyze the relations between three aspects of psychopathy in youth, Callous-Unemotional (CU) traits, Narcissism, and Impulsivity, and bullying behaviors. The databases PsycINFO, MEDLINE, ERIC, Web of Science and Proquest were searched for relevant articles on bullying and CU traits, Narcissism, or Impulsivity in youth under 20 years of age. Two authors each independently screened 842 studies that were found in the literature search. Two authors independently coded ten studies on bullying and CU (N = 4115) traits, six studies on bullying and Narcissism (N = 3376) and 14 studies on bullying and Impulsivity (N = 33,574) that met the inclusion criteria. Significant correlations were found between bullying and CU traits, Narcissism, and Impulsivity. These results were not affected by publication bias. Anti-bullying interventions could potentially benefit from including elements that have been found effective in the treatment of youth psychopathy.

  7. Genome-wide Meta-analyses of Breast, Ovarian and Prostate Cancer Association Studies Identify Multiple New Susceptibility Loci Shared by At Least Two Cancer Types

    Science.gov (United States)

    Kar, Siddhartha P.; Beesley, Jonathan; Al Olama, Ali Amin; Michailidou, Kyriaki; Tyrer, Jonathan; Kote-Jarai, ZSofia; Lawrenson, Kate; Lindstrom, Sara; Ramus, Susan J.; Thompson, Deborah J.; Kibel, Adam S.; Dansonka-Mieszkowska, Agnieszka; Michael, Agnieszka; Dieffenbach, Aida K.; Gentry-Maharaj, Aleksandra; Whittemore, Alice S.; Wolk, Alicja; Monteiro, Alvaro; Peixoto, Ana; Kierzek, Andrzej; Cox, Angela; Rudolph, Anja; Gonzalez-Neira, Anna; Wu, Anna H.; Lindblom, Annika; Swerdlow, Anthony; Ziogas, Argyrios; Ekici, Arif B.; Burwinkel, Barbara; Karlan, Beth Y.; Nordestgaard, Børge G.; Blomqvist, Carl; Phelan, Catherine; McLean, Catriona; Pearce, Celeste Leigh; Vachon, Celine; Cybulski, Cezary; Slavov, Chavdar; Stegmaier, Christa; Maier, Christiane; Ambrosone, Christine B.; Høgdall, Claus K.; Teerlink, Craig C.; Kang, Daehee; Tessier, Daniel C.; Schaid, Daniel J.; Stram, Daniel O.; Cramer, Daniel W.; Neal, David E.; Eccles, Diana; Flesch-Janys, Dieter; Velez Edwards, Digna R.; Wokozorczyk, Dominika; Levine, Douglas A.; Yannoukakos, Drakoulis; Sawyer, Elinor J.; Bandera, Elisa V.; Poole, Elizabeth M.; Goode, Ellen L.; Khusnutdinova, Elza; Høgdall, Estrid; Song, Fengju; Bruinsma, Fiona; Heitz, Florian; Modugno, Francesmary; Hamdy, Freddie C.; Wiklund, Fredrik; Giles, Graham G.; Olsson, Håkan; Wildiers, Hans; Ulmer, Hans-Ulrich; Pandha, Hardev; Risch, Harvey A.; Darabi, Hatef; Salvesen, Helga B.; Nevanlinna, Heli; Gronberg, Henrik; Brenner, Hermann; Brauch, Hiltrud; Anton-Culver, Hoda; Song, Honglin; Lim, Hui-Yi; McNeish, Iain; Campbell, Ian; Vergote, Ignace; Gronwald, Jacek; Lubiński, Jan; Stanford, Janet L.; Benítez, Javier; Doherty, Jennifer A.; Permuth, Jennifer B.; Chang-Claude, Jenny; Donovan, Jenny L.; Dennis, Joe; Schildkraut, Joellen M.; Schleutker, Johanna; Hopper, John L.; Kupryjanczyk, Jolanta; Park, Jong Y.; Figueroa, Jonine; Clements, Judith A.; Knight, Julia A.; Peto, Julian; Cunningham, Julie M.; Pow-Sang, Julio; Batra, Jyotsna; Czene, Kamila; Lu, Karen H.; Herkommer, Kathleen; Khaw, Kay-Tee; Matsuo, Keitaro; Muir, Kenneth; Offitt, Kenneth; Chen, Kexin; Moysich, Kirsten B.; Aittomäki, Kristiina; Odunsi, Kunle; Kiemeney, Lambertus A.; Massuger, Leon F.A.G.; Fitzgerald, Liesel M.; Cook, Linda S.; Cannon-Albright, Lisa; Hooning, Maartje J.; Pike, Malcolm C.; Bolla, Manjeet K.; Luedeke, Manuel; Teixeira, Manuel R.; Goodman, Marc T.; Schmidt, Marjanka K.; Riggan, Marjorie; Aly, Markus; Rossing, Mary Anne; Beckmann, Matthias W.; Moisse, Matthieu; Sanderson, Maureen; Southey, Melissa C.; Jones, Michael; Lush, Michael; Hildebrandt, Michelle A. T.; Hou, Ming-Feng; Schoemaker, Minouk J.; Garcia-Closas, Montserrat; Bogdanova, Natalia; Rahman, Nazneen; Le, Nhu D.; Orr, Nick; Wentzensen, Nicolas; Pashayan, Nora; Peterlongo, Paolo; Guénel, Pascal; Brennan, Paul; Paulo, Paula; Webb, Penelope M.; Broberg, Per; Fasching, Peter A.; Devilee, Peter; Wang, Qin; Cai, Qiuyin; Li, Qiyuan; Kaneva, Radka; Butzow, Ralf; Kopperud, Reidun Kristin; Schmutzler, Rita K.; Stephenson, Robert A.; MacInnis, Robert J.; Hoover, Robert N.; Winqvist, Robert; Ness, Roberta; Milne, Roger L.; Travis, Ruth C.; Benlloch, Sara; Olson, Sara H.; McDonnell, Shannon K.; Tworoger, Shelley S.; Maia, Sofia; Berndt, Sonja; Lee, Soo Chin; Teo, Soo-Hwang; Thibodeau, Stephen N.; Bojesen, Stig E.; Gapstur, Susan M.; Kjær, Susanne Krüger; Pejovic, Tanja; Tammela, Teuvo L.J.; Dörk, Thilo; Brüning, Thomas; Wahlfors, Tiina; Key, Tim J.; Edwards, Todd L.; Menon, Usha; Hamann, Ute; Mitev, Vanio; Kosma, Veli-Matti; Setiawan, Veronica Wendy; Kristensen, Vessela; Arndt, Volker; Vogel, Walther; Zheng, Wei; Sieh, Weiva; Blot, William J.; Kluzniak, Wojciech; Shu, Xiao-Ou; Gao, Yu-Tang; Schumacher, Fredrick; Freedman, Matthew L.; Berchuck, Andrew; Dunning, Alison M.; Simard, Jacques; Haiman, Christopher A.; Spurdle, Amanda; Sellers, Thomas A.; Hunter, David J.; Henderson, Brian E.; Kraft, Peter; Chanock, Stephen J.; Couch, Fergus J.; Hall, Per; Gayther, Simon A.; Easton, Douglas F.; Chenevix-Trench, Georgia; Eeles, Rosalind; Pharoah, Paul D.P.; Lambrechts, Diether

    2016-01-01

    Breast, ovarian, and prostate cancers are hormone-related and may have a shared genetic basis but this has not been investigated systematically by genome-wide association (GWA) studies. Meta-analyses combining the largest GWA meta-analysis data sets for these cancers totaling 112,349 cases and 116,421 controls of European ancestry, all together and in pairs, identified at P cancer loci: three associated with susceptibility to all three cancers (rs17041869/2q13/BCL2L11; rs7937840/11q12/INCENP; rs1469713/19p13/GATAD2A), two breast and ovarian cancer risk loci (rs200182588/9q31/SMC2; rs8037137/15q26/RCCD1), and two breast and prostate cancer risk loci (rs5013329/1p34/NSUN4; rs9375701/6q23/L3MBTL3). Index variants in five additional regions previously associated with only one cancer also showed clear association with a second cancer type. Cell-type specific expression quantitative trait locus and enhancer-gene interaction annotations suggested target genes with potential cross-cancer roles at the new loci. Pathway analysis revealed significant enrichment of death receptor signaling genes near loci with P cancer meta-analysis. PMID:27432226

  8. Exercise interventions for the improvement of falls-related outcomes among older adults with diabetes mellitus: A systematic review and meta-analyses.

    Science.gov (United States)

    Chapman, Anna; Meyer, Claudia; Renehan, Emma; Hill, Keith D; Browning, Colette J

    2017-03-01

    Falls as a complication of diabetes mellitus (DM) can have a major impact on the health of older adults. Previous reviews have demonstrated that certain exercise interventions are effective at reducing falls in older people; however, no studies have quantified the effectiveness of exercise interventions on falls-related outcomes among older adults with DM. A systematic search for all years to September 2015 identified available literature. Eligibility criteria included: appropriate exercise intervention/s; assessed falls-related outcomes; older adults with DM. Effect sizes were pooled using a random effects model. Positive effect sizes favoured the intervention. Ten RCTs were eligible for the meta-analyses. Exercise interventions were more effective than the control condition for static balance (0.53, 95% CI: 0.13 to 0.93), lower-limb strength (0.63, 95% CI: 0.09 to 1.18), and gait (0.59, 95% CI: 0.22 to 0.96). No RCTs assessed falls-risk; one RCT reported 12month falls-rate, with no differential treatment effect observed. Exercise interventions can improve certain falls-related outcomes among older adults with DM. Substantial heterogeneity and limited numbers of studies should be considered when interpreting results. Among older adults, where DM burden is increasing, exercise interventions may provide promising approaches to assist the improvement of falls-related outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. Evidence from Meta-Analyses of the Facial Width-to-Height Ratio as an Evolved Cue of Threat.

    Directory of Open Access Journals (Sweden)

    Shawn N Geniole

    Full Text Available The facial width-to-height ratio (FWHR is the width of the face divided by the height of the upper face. There is mixed evidence for the hypothesis that the FWHR is a cue of threat and dominance in the human face. We conducted a systematic review and meta-analyses of all peer-reviewed studies (and 2 unpublished studies to estimate the magnitude of the sex difference in the FWHR, and the magnitude of the relationship between the FWHR and threatening and dominant behaviours and perceptions. Studies were eligible for inclusion if the authors reported an analysis involving the FWHR. Our analyses revealed that the FWHR was larger in men than in women (d = .11, n = 10,853, cued judgements of masculinity in men (r = .35, n of faces = 487; n of observers = 339, and was related to body mass index (r = .31, n = 2,506. Further, the FWHR predicted both threat behaviour in men (r = .16, n = 4,603 and dominance behaviour in both sexes (r = .12, n = 948 across a variety of indices. Individuals with larger FWHRs were judged by observers as more threatening (r = .46, n of faces = 1,691; n of observers = 2,076 and more dominant (r = .20, n of faces = 603; n of observers = 236 than those with smaller FWHRs. Individuals with larger FWHRs were also judged as less attractive (r = -.26, n of faces = 721; n of observers = 335, especially when women made the judgements. These findings provide some support for the hypothesis that the FWHR is part of an evolved cueing system of intra-sexual threat and dominance in men. A limitation of the meta-analyses on perceptions of threat and dominance were the low number of stimuli involving female and older adult faces.

  10. Meta-analyses of cognitive and motor function in youth aged 16 years and younger who subsequently develop schizophrenia.

    Science.gov (United States)

    Dickson, H; Laurens, K R; Cullen, A E; Hodgins, S

    2012-04-01

    Previous reviews have reported cognitive and motor deficits in childhood and adolescence among individuals who later develop schizophrenia. However, these reviews focused exclusively on studies of individuals with affected relatives or on population/birth cohorts, incorporated studies with estimated measures of pre-morbid intelligence, or included investigations that examined symptomatic at-risk participants or participants 18 years or older. Thus, it remains unclear whether cognitive and motor deficits constitute robust antecedents of schizophrenia. Meta-analyses were conducted on published studies that examined cognitive or motor function in youth aged 16 years or younger who later developed schizophrenia or a schizophrenia spectrum disorder (SSD) and those who did not. Twenty-three studies fulfilled the following inclusion criteria: (1) written in English; (2) prospective investigations of birth or genetic high-risk cohorts, or follow-back investigations of population samples; (3) objective measures of cognitive or motor performance at age 16 or younger; (4) results provided for individuals who did and who did not develop schizophrenia/SSD later in life; and (5) sufficient data to calculate effect sizes. Four domains of function were examined: IQ; Motor Function; General Academic Achievement; and Mathematics Achievement. Meta-analyses showed that, by age 16, individuals who subsequently developed schizophrenia/SSD displayed significant deficits in IQ (d=0.51) and motor function (d=0.56), but not in general academic achievement (d=0.25) or mathematics achievement (d=0.21). Subsidiary analysis indicated that the IQ deficit was present by age 13. These results demonstrate that deficits in IQ and motor performance precede the prodrome and the onset of illness.

  11. Systematic Review of Integrative Health Care Research: Randomized Control Trials, Clinical Controlled Trials, and Meta-Analysis

    Directory of Open Access Journals (Sweden)

    Raheleh Khorsan

    2011-01-01

    Full Text Available A systematic review was conducted to assess the level of evidence for integrative health care research. We searched PubMed, Allied and Complementary Medicine (AMED, BIOSIS Previews, EMBASE, the entire Cochrane Library, MANTIS, Social SciSearch, SciSearch Cited Ref Sci, PsychInfo, CINAHL, and NCCAM grantee publications listings, from database inception to May 2009, as well as searches of the “gray literature.” Available studies published in English language were included. Three independent reviewers rated each article and assessed the methodological quality of studies using the Scottish Intercollegiate Guidelines Network (SIGN 50. Our search yielded 11,891 total citations but 6 clinical studies, including 4 randomized, met our inclusion criteria. There are no available systematic reviews/meta-analyses published that met our inclusion criteria. The methodological quality of the included studies was assessed independently using quality checklists of the SIGN 50. Only a small number of RCTs and CCTs with a limited number of patients and lack of adequate control groups assessing integrative health care research are available. These studies provide limited evidence of effective integrative health care on some modalities. However, integrative health care regimen appears to be generally safe.

  12. Impact of food supplementation on weight loss in randomised-controlled dietary intervention trials: a systematic review and meta-analysis.

    Science.gov (United States)

    Wibisono, Cinthya; Probst, Yasmine; Neale, Elizabeth; Tapsell, Linda

    2016-04-01

    Dietary trials provide evidence for practice and policy guidelines, but poor adherence may confound results. Food supplementation may improve adherence to dietary interventions, but the impact of supplementation on study outcomes is not known. The aim of this review was to examine the impact of food supplementation on weight loss in dietary intervention trials. The databases Scopus, PubMed and the Cochrane Library were searched for dietary intervention trials published between January 2004 and March 2015 using the following keyword combinations: 'trial' OR 'intervention', 'food' OR 'diet', 'weight loss' and 'adherence' OR 'adherence'. Studies were included if food was provided to at least one study group and both 'weight change' and 'adherence' were reported. Random effects meta-analyses were conducted to assess weighted mean differences (WMD) in body weight (change or final mean values). The included studies formed two groups: trials involving an intervention group supplemented with a food and a control without food supplementation (food v. no food), and trials in which food was provided to all subjects (food v. food) (PROSPERO registration: CRD42015017563). In total, sixteen studies were included. Significant weight reduction was reported in the food v. no food studies (WMD -0·74 kg; 95 % CI -1·40, -0·08; P=0·03, I 2=63 %). A non-significant increase in weight was found among the food v. food studies (WMD 0·84 kg; 95 % CI -0·60, 2·27; P=0·25, I 2=0 %). Food supplementation appeared to result in greater weight loss in dietary trials. Energy restrictions and intensity of interventions were other significant factors influencing weight loss.

  13. Comparison of pharmacological and non-pharmacological interventions to prevent delirium in critically ill patients: a protocol for a systematic review incorporating network meta-analyses.

    Science.gov (United States)

    Burry, L D; Hutton, B; Guenette, M; Williamson, D; Mehta, S; Egerod, I; Kanji, S; Adhikari, N K; Moher, D; Martin, C M; Rose, L

    2016-09-08

    Delirium is characterized by acute changes in mental status including inattention, disorganized thinking, and altered level of consciousness, and is highly prevalent in critically ill adults. Delirium has adverse consequences for both patients and the healthcare system; however, at this time, no effective treatment exists. The identification of effective prevention strategies is therefore a clinical and research imperative. An important limitation of previous reviews of delirium prevention is that interventions were considered in isolation and only direct evidence was used. Our systematic review will synthesize all existing data using network meta-analysis, a powerful statistical approach that enables synthesis of both direct and indirect evidence. We will search Ovid MEDLINE, CINAHL, Embase, PsycINFO, and Web of Science from 1980 to March 2016. We will search the PROSPERO registry for protocols and the Cochrane Library for published systematic reviews. We will examine reference lists of pertinent reviews and search grey literature and the International Clinical Trials Registry Platform for unpublished studies and ongoing trials. We will include randomized and quasi-randomized trials of critically ill adults evaluating any pharmacological, non-pharmacological, or multi-component intervention for delirium prevention, administered in or prior to (i.e., peri-operatively) transfer to the ICU. Two authors will independently screen search results and extract data from eligible studies. Risk of bias assessments will be completed on all included studies. To inform our network meta-analysis, we will first conduct conventional pair-wise meta-analyses for primary and secondary outcomes using random-effects models. We will generate our network meta-analysis using a Bayesian framework, assuming a common heterogeneity parameter across all comparisons, and accounting for correlations in multi-arm studies. We will perform analyses using WinBUGS software. This systematic review

  14. Cardiovascular and Renal Outcomes of Renin-Angiotensin System Blockade in Adult Patients with Diabetes Mellitus: A Systematic Review with Network Meta-Analyses.

    Science.gov (United States)

    Catalá-López, Ferrán; Macías Saint-Gerons, Diego; González-Bermejo, Diana; Rosano, Giuseppe M; Davis, Barry R; Ridao, Manuel; Zaragoza, Abel; Montero-Corominas, Dolores; Tobías, Aurelio; de la Fuente-Honrubia, César; Tabarés-Seisdedos, Rafael; Hutton, Brian

    2016-03-01

    Medications aimed at inhibiting the renin-angiotensin system (RAS) have been used extensively for preventing cardiovascular and renal complications in patients with diabetes, but data that compare their clinical effectiveness are limited. We aimed to compare the effects of classes of RAS blockers on cardiovascular and renal outcomes in adults with diabetes. Eligible trials were identified by electronic searches in PubMed/MEDLINE and the Cochrane Database of Systematic Reviews (1 January 2004 to 17 July 2014). Interventions of interest were angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and direct renin (DR) inhibitors. The primary endpoints were cardiovascular mortality, myocardial infarction, and stroke-singly and as a composite endpoint, major cardiovascular outcome-and end-stage renal disease [ESRD], doubling of serum creatinine, and all-cause mortality-singly and as a composite endpoint, progression of renal disease. Secondary endpoints were angina pectoris and hospitalization for heart failure. In all, 71 trials (103,120 participants), with a total of 14 different regimens, were pooled using network meta-analyses. When compared with ACE inhibitor, no other RAS blocker used in monotherapy and/or combination was associated with a significant reduction in major cardiovascular outcomes: ARB (odds ratio [OR] 1.02; 95% credible interval [CrI] 0.90-1.18), ACE inhibitor plus ARB (0.97; 95% CrI 0.79-1.19), DR inhibitor plus ACE inhibitor (1.32; 95% CrI 0.96-1.81), and DR inhibitor plus ARB (1.00; 95% CrI 0.73-1.38). For the risk of progression of renal disease, no significant differences were detected between ACE inhibitor and each of the remaining therapies: ARB (OR 1.10; 95% CrI 0.90-1.40), ACE inhibitor plus ARB (0.97; 95% CrI 0.72-1.29), DR inhibitor plus ACE inhibitor (0.99; 95% CrI 0.65-1.57), and DR inhibitor plus ARB (1.18; 95% CrI 0.78-1.84). No significant differences were showed between ACE inhibitors and ARBs with

  15. Cardiovascular and Renal Outcomes of Renin-Angiotensin System Blockade in Adult Patients with Diabetes Mellitus: A Systematic Review with Network Meta-Analyses.

    Directory of Open Access Journals (Sweden)

    Ferrán Catalá-López

    2016-03-01

    Full Text Available Medications aimed at inhibiting the renin-angiotensin system (RAS have been used extensively for preventing cardiovascular and renal complications in patients with diabetes, but data that compare their clinical effectiveness are limited. We aimed to compare the effects of classes of RAS blockers on cardiovascular and renal outcomes in adults with diabetes.Eligible trials were identified by electronic searches in PubMed/MEDLINE and the Cochrane Database of Systematic Reviews (1 January 2004 to 17 July 2014. Interventions of interest were angiotensin-converting enzyme (ACE inhibitors, angiotensin receptor blockers (ARBs, and direct renin (DR inhibitors. The primary endpoints were cardiovascular mortality, myocardial infarction, and stroke-singly and as a composite endpoint, major cardiovascular outcome-and end-stage renal disease [ESRD], doubling of serum creatinine, and all-cause mortality-singly and as a composite endpoint, progression of renal disease. Secondary endpoints were angina pectoris and hospitalization for heart failure. In all, 71 trials (103,120 participants, with a total of 14 different regimens, were pooled using network meta-analyses. When compared with ACE inhibitor, no other RAS blocker used in monotherapy and/or combination was associated with a significant reduction in major cardiovascular outcomes: ARB (odds ratio [OR] 1.02; 95% credible interval [CrI] 0.90-1.18, ACE inhibitor plus ARB (0.97; 95% CrI 0.79-1.19, DR inhibitor plus ACE inhibitor (1.32; 95% CrI 0.96-1.81, and DR inhibitor plus ARB (1.00; 95% CrI 0.73-1.38. For the risk of progression of renal disease, no significant differences were detected between ACE inhibitor and each of the remaining therapies: ARB (OR 1.10; 95% CrI 0.90-1.40, ACE inhibitor plus ARB (0.97; 95% CrI 0.72-1.29, DR inhibitor plus ACE inhibitor (0.99; 95% CrI 0.65-1.57, and DR inhibitor plus ARB (1.18; 95% CrI 0.78-1.84. No significant differences were showed between ACE inhibitors and ARBs with

  16. Levo-α-acetylmethadol (LAAM induced QTc-prolongation - results from a controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Wieneke H

    2009-01-01

    Full Text Available Abstract Background Due to potential proarrhythmic side-effects levo-α-Acetylmethadol (LAAM is currently not available in EU countries as maintenance drug in the treatment of opiate addiction. However, recent studies and meta-analyses underline the clinical advantages of LAAM with respect to the reduction of heroin use. Thus a reappraisal of LAAM has been demanded. The aim of the present study was to evaluate the relative impact of LAAM on QTc-interval, as a measure of pro-arrhythmic risk, in comparison to methadone, the current standard in substitution therapy. Methods ECG recordings were analysed within a randomized, controlled clinical trial evaluating the efficacy and tolerability of maintenance treatment with LAAM compared with racemic methadone. Recordings were done at two points: 1 during a run-in period with all patients on methadone and 2 24 weeks after randomisation into methadone or LAAM treatment group. These ECG recordings were analysed with respect to QTc-values and QTc-dispersion. Mean values as well as individual changes compared to baseline parameters were evaluated. QTc-intervals were classified according to CPMP-guidelines. Results Complete ECG data sets could be obtained in 53 patients (31 LAAM-group, 22 methadone-group. No clinical cardiac complications were observed in either group. After 24 weeks, patients receiving LAAM showed a significant increase in QTc-interval (0.409 s ± 0.022 s versus 0.418 s ± 0.028 s, p = 0.046, whereas no significant changes could be observed in patients remaining on methadone. There was no statistically significant change in QTc-dispersion in either group. More patients with borderline prolonged and prolonged QTc-intervals were observed in the LAAM than in the methadone treatment group (n = 7 vs. n = 1; p = 0.1. Conclusions In this controlled trial LAAM induced QTc-prolongation in a higher degree than methadone. Given reports of severe arrhythmic events, careful ECG-monitoring is recommended

  17. Misoprostol versus ergometrine-oxytocin for preventing postpartum haemorrhage: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Tan, Jing; Cao, Qiao; He, Guo-Lin; Cai, Yu-Han; Yu, Jia-Jie; Sun, Xin; Li, You-Ping

    2016-11-01

    To compare the effects of misoprostol versus ergometrine-oxytocin for postpartum haemorrhage (PPH) prevention, and provide important evidence to choose optimal agents for preventing PPH in developing countries. The Cochrane Central Register of Controlled Trials, PubMed, EMbase, and ClinicalTrails.gov were searched from inception to 1st January 2016. Two authors independently extracted data and assessed risk of bias of studies according to Cochrane Handbook5.1.0. Meta-analysis was performed using RevMan5.2.4 software. A total of 4034 women from six randomized controlled trials (RCTs) were included. Meta-analyses showed that the PPH rate (7.6% vs. 4.2%, RR = 1.81, 95%CI (1.40, 2.35), P oxytocin group, respectively. But there was no significant difference of severe PPH rate between two groups (1.2% vs. 0.76%, RR = 1.55, 95%CI (0.78, 3.07), P = 0.21). The need for manual removal of placenta in misoprostol was only about one-third of ergometrine-oxytocin (0.5% vs. 1.4%, RR = 0.33, 95%CI (0.15, 0.76), P oxytocin could be deemed as alternative agent in low-resource setting due to recognized effect. As a result of limited evidence about these uterotonic agents, the more high-quality RCTs are needed to determine the potentials and harms of various uterotonic agents for preventing PPH in developing countries. © 2016 Chinese Cochrane Center, West China Hospital of Sichuan University and John Wiley & Sons Australia, Ltd.

  18. The clinical effectiveness of different parenting programmes for children with conduct problems: a systematic review of randomised controlled trials

    Directory of Open Access Journals (Sweden)

    Taylor Rod S

    2009-03-01

    Full Text Available Abstract Background Conduct problems are common, disabling and costly. The prognosis for children with conduct problems is poor, with outcomes in adulthood including criminal behaviour, alcoholism, drug abuse, domestic violence, child abuse and a range of psychiatric disorders. There has been a rapid expansion of group based parent-training programmes for the treatment of children with conduct problems in a number of countries over the past 10 years. Existing reviews of parent training have methodological limitations such as inclusion of non-randomised studies, the absence of investigation for heterogeneity prior to meta-analysis or failure to report confidence intervals. The objective of the current study was to systematically review randomised controlled trials of parenting programmes for the treatment of children with conduct problems. Methods Standard systematic review methods were followed including duplicate inclusion decisions, data extraction and quality assessment. Twenty electronic databases from the fields of medicine, psychology, social science and education were comprehensively searched for RCTs and systematic reviews to February 2006. Inclusion criteria were: randomised controlled trial; of structured, repeatable parenting programmes; for parents/carers of children up to the age of 18 with a conduct problem; and at least one measure of child behaviour. Meta-analysis and qualitative synthesis were used to summarise included studies. Results 57 RCTs were included. Studies were small with an average group size of 21. Meta-analyses using both parent (SMD -0.67; 95% CI: -0.91, -0.42 and independent (SMD -0.44; 95% CI: -0.66, -0.23 reports of outcome showed significant differences favouring the intervention group. There was insufficient evidence to determine the relative effectiveness of different approaches to delivering parenting programmes. Conclusion Parenting programmes are an effective treatment for children with conduct problems

  19. [Chromium supplementation in patients with type 2 diabetes and high risk of type 2 diabetes: a meta-analysis of randomized controlled trials].

    Science.gov (United States)

    San Mauro-Martin, Ismael; Ruiz-León, Ana María; Camina-Martín, María Alicia; Garicano-Vilar, Elena; Collado-Yurrita, Luis; Mateo-Silleras, Beatriz de; Redondo Del Río, María De Paz

    2016-02-16

    Chromium is an essential trace mineral for carbohydrate and lipid metabolism, which is currently prescribed to control diabetes mellitus. Results of previous systematic reviews and meta-analyses of chromium supplementation and metabolic profiles in diabetes have been inconsistent. The objective of this meta-analysis was to assess the effects on metabolic profiles and safety of chromium supplementation in type 2 diabetes mellitus and cholesterol. Literature searches in PubMed, Scopus and Web of Science were made by use of related terms-keywords and randomized clinical trials during the period of 2000-2014. Thirteen trials fulfilled the inclusion criteria and were included in this systematic review. Total doses of Cr supplementation and brewer's yeast ranged from 42 to 1,000 μg/day, and duration of supplementation ranged from 30 to 120 days. The analysis indicated that there was a significant effect of chromium supplementation in diabetics on fasting plasma glucose with a weighted average effect size of -29.26 mg/dL, p = 0.01, CI 95% = -52.4 to -6.09; and on total cholesterol with a weighted average effect size of -6.7 mg/dL, p = 0.01, CI 95% = -11.88 to -1.53. The available evidence suggests favourable effects of chromium supplementation on glycaemic control in patients with diabetes.

  20. The Effect of Omega-3 on Circulating Adiponectin in Adults with Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Bahreini, Mehdi; Ramezani, Amir-Hossein; Shishehbor, Farideh; Mansoori, Anahita

    2018-01-04

    Whether consumption of omega-3 affects circulating adiponectin has not been established. The objective of this study was to evaluate the effect of omega-3 (food or supplement) on circulating adiponectin in patients with type 2 diabetes through a systematic review of meta-analyses of randomized controlled trials. PubMed, Scopus and Web of Science were searched for relevant studies through May 2016. Two researchers screened and abstracted the literature independently. Pooled estimates were obtained using the random-effects models. Overall, omega-3 increased adiponectin by 0.57 µg/mL (95% confidence interval [CI] 0.15 to 1.31; p=0.01, I-square=74.2% p for heterogeneity omega-3 for more than 8 weeks. This systematic review and meta-analysis of randomized, placebo-controlled clinical trials suggests that omega-3 in patients with type 2 diabetes increases circulating adiponectin. These findings support the potentially beneficial effects of dietary omega-3 in patients with type 2 diabetes on pathways related to adiponectin metabolism. Copyright © 2017 Diabetes Canada. Published by Elsevier Inc. All rights reserved.

  1. Adjunctive Nutraceuticals for Depression: A Systematic Review and Meta-Analyses.

    Science.gov (United States)

    Sarris, Jerome; Murphy, Jenifer; Mischoulon, David; Papakostas, George I; Fava, Maurizio; Berk, Michael; Ng, Chee H

    2016-06-01

    There is burgeoning interest in augmentation strategies for improving inadequate response to antidepressants. The adjunctive use of standardized pharmaceutical-grade nutrients, known as nutraceuticals, has the potential to modulate several neurochemical pathways implicated in depression. While many studies have been conducted in this area, to date no specialized systematic review (or meta-analysis) has been conducted. A systematic search of PubMed, CINAHL, Cochrane Library, and Web of Science was conducted up to December 2015 for clinical trials using adjunctive nutrients for depression. Where sufficient data were available, a random-effects model analyzed the standard mean difference between treatment and placebo in the change from baseline to endpoint, combining the effect size data. Funnel plot and heterogeneity analyses were also performed. Primarily positive results were found for replicated studies testing S-adenosylmethionine (SAMe), methylfolate, omega-3 (primarily EPA or ethyl-EPA), and vitamin D, with positive isolated studies for creatine, folinic acid, and an amino acid combination. Mixed results were found for zinc, folic acid, vitamin C, and tryptophan, with nonsignificant results for inositol. No major adverse effects were noted in the studies (aside from minor digestive disturbance). A meta-analysis of adjunctive omega-3 versus placebo revealed a significant and moderate to strong effect in favor of omega-3. Conversely, a meta-analysis of folic acid revealed a nonsignificant difference from placebo. Marked study heterogeneity was found in a Higgins test for both omega-3 and folic acid studies; funnel plots also revealed asymmetry (reflecting potential study bias). Current evidence supports adjunctive use of SAMe, methylfolate, omega-3, and vitamin D with antidepressants to reduce depressive symptoms.

  2. Recent randomized controlled trials in otolaryngology.

    Science.gov (United States)

    Banglawala, Sarfaraz M; Lawrence, Lauren A; Franko-Tobin, Emily; Soler, Zachary M; Schlosser, Rodney J; Ioannidis, John

    2015-03-01

    To assess recent trends in the prevalence and quality of reporting of randomized controlled trials (RCTs) in 4 otolaryngology journals. Methodology and reporting analysis. Randomized controlled trials in 4 otolaryngology journals. All RCTs published from 2011 to 2013 in 4 major otolaryngology journals were examined for characteristics of study design, quality of design and reporting, and funding. Of 5279 articles published in 4 leading otolaryngology journals from 2011 to 2013, 189 (3.3%) were RCTs. The majority of RCTs were clinical studies (86%), with the largest proportion consisting of sinonasal topics (31%). Most interventions were medical (46%), followed by surgical (38%) and mixed (16%). In terms of quality, randomization method was reported in 54% of RCTs, blinding in 33%, and adverse events in 65%. Intention-to-treat analysis was used in 32%; P values were reported in 87% and confidence intervals in 10%. Research funding was most often absent or not reported (55%), followed by not-for-profit (25%). Based on review of 4 otolaryngology journals, RCTs are still a small proportion of all published studies in the field of otolaryngology. There seem to be trends toward improvement in quality of design and reporting of RCTs, although many quality features remain suboptimal. Practitioners both designing and interpreting RCTs should critically evaluate RCTs for quality. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.

  3. A systematic review and meta-analyses on C-reactive protein in relation to periodontitis.

    Science.gov (United States)

    Paraskevas, Spiros; Huizinga, John D; Loos, Bruno G

    2008-04-01

    Elevated plasma C-reactive protein (CRP) is regarded as a risk predictor for cardiovascular diseases. This systematic review explored the robustness of observations that CRP is elevated in periodontitis. Similarly, the effect of periodontal therapy on CRP levels was investigated. Selection of publications was based on: (1) cross-sectional (case-control) studies; (2) longitudinal (treatment) studies; (3) high-sensitivity CRP measurement; (4) median and/or mean (+/-SD) values presented; and (5) subjects with no systemic disorders. Screening of the initially 448 identified studies and reference checking resulted in 18 suitable papers. The majority of the studies showed that CRP levels are higher in patients than in controls. Often, studies showed that patients had CRP levels >2.1 mg/l. A meta-analysis of 10 cross-sectional studies showed that the weighted mean difference (WMD) of CRP between patients and controls was 1.56 mg/l (pperiodontal therapy. Eligible treatment studies in a meta-analysis demonstrated a WMD of reductions of CRP after therapy of 0.50 mg/L (95% CI 0.08-0.93) (p=0.02). There is strong evidence from cross-sectional studies that plasma CRP in periodontitis is elevated compared with controls. There is modest evidence on the effect of periodontal therapy in lowering the levels of CRP.

  4. A Systematic Review and Meta-Analysis of Baduanjin Qigong for Health Benefits: Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Liye Zou

    2017-01-01

    Full Text Available Objective. To investigate the effects of practicing Baduanjin Qigong on different health outcomes. Methods. Six electronic databases were used for literature search through entering the following key words: Baduanjin Qigong, quality of life, sleep quality, and health-related outcomes. Results. Nineteen randomized controlled trials were used for meta-analysis. The aggregated results from this systematic review have shown significant benefits in favour of Baduanjin Qigong on quality of life (SMD, −0.75; 95% CI −1.26 to −0.24; P=0.004, sleep quality (SMD, −0.55; 95% CI −0.97 to −0.12; P=0.01, balance (SMD, −0.94; 95% CI −1.59 to 0.30; P=0.004, handgrip strength (SMD, -0.69; 95% CI −1.2 to −0.19; P=0.007, trunk flexibility (SMD, −0.66; 95% CI −1.13 to −0.19; P=0.006, systolic (SMD, −0.60; 95% CI −0.94 to −0.27; P=0.0004 and diastolic blood pressure (SMD, −0.46; 95% CI −0.73 to −0.20; P=0.0005, and resting heart rate (SMD, −0.87; 95% CI −1.47 to −0.27; P=0.005. The aggregated results of meta-analyses examining the effect of Baduanjin Qigong on leg power, cardiopulmonary endurance, and pulmonary function remain unclear because of a small number of studies. Conclusions. The aggregated results from this systematic review show that Baduanjin Qigong practice is beneficial for quality of life, sleep quality, balance, handgrip strength, trunk flexibility, systolic and diastolic blood pressure, and resting heart rate. Further studies are necessary to confirm the effects of Baduanjin Qigong on leg power, cardiopulmonary endurance, and pulmonary function (e.g., vital capacity, while considering a long-term follow-up. Registration Number. This trial is registered with International Prospective Register of Systematic Reviews (PROSPERO: CRD42016036966.

  5. Treatment of depression with Chai Hu Shu Gan San: a systematic review and meta-analysis of 42 randomized controlled trials.

    Science.gov (United States)

    Sun, Yan; Xu, Xia; Zhang, Jinping; Chen, Yuanyuan

    2018-02-17

    Depression is a common mental disorder. Chai Hu Shu Gan San, a traditional Chinese medicine, is used to treat depression empirically. We present a systematic review and meta-analysis of the therapeutic efficacy and safety of Chai Hu Shu Gan San in treating depression. Several databases, including PubMed, China National Knowledge Internet, Wanfang, Chongqing VIP, and the Cochrane library, were systematically searched from their date of foundation to January 1, 2017. In this review, wehave included randomized control trials that compared Chai Hu Shu Gan San (or its combination with a regular Western medicine) with a regular Western medicine alone for the treatment of depression. Two investigators independently extracted and analyzed the data using RevMan 5.2.0 software. Mean difference (with a 95% confidence interval) was used as efficacy indices for outcomes. We included 42 studies involving 3234 patients with depression in 15 different types of diseases. Meta analyses showed better effect of Chai Hu Shu Gan San than fluoxetine for pure depression (MD = - 1.59, from - 2.82 to - 0.37, 4 trials, I 2  = 26%), for post-stroke depression (MD = - 4.20, from - 6.20 to - 2.19, 7 trials, I 2  = 96%), and for postpartum depression (MD = - 4.10, from - 7.48 to - 0.72 7 trials, I 2  = 86%). None of the articles reported severe adverse events of oral administration of Chai Hu Shu Gan San. Furthermore, any adverse effects of using Chai Hu Shu Gan San alone were fewer than those of regular Western medicines. This review found that Chai Hu Shu Gan San has some advantages in treating depression, especially post-stroke depression and post-partum depression. A meticulously designed and conducted randomized control trial is needed for further evaluation.

  6. Effects of extracted soy isoflavones alone on blood total and LDL cholesterol: Meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Kyoko Taku

    2008-07-01

    Full Text Available Kyoko Taku1, Keizo Umegaki1, Yoshiko Ishimi2, Shaw Watanabe31Information Center, National Institute of Health and Nutrition, Tokyo, Japan; 2Nutritional Epidemiology Program, National Institute of Health and Nutrition, Tokyo, Japan; 3Nutritional Education Program, National Institute of Health and Nutrition, Tokyo, JapanAbstract: When provided concurrently with soy protein for 1–3 months, soy isoflavones exert synergistic or additive cholesterol-lowering effects. This meta-analysis was performed to evaluate the effects of extracted soy isoflavones alone (not ingested concurrently with soy protein on total and low density lipoprotein (LDL cholesterol. MEDLINE (1966–2007, EMBASE (1966–2007, CENTRAL (1966–2007, ICHUSHI (1983–2008, and CNKI (1979–2007 were searched for randomized placebo-controlled trials published in English, Japanese, and Chinese, describing the changes in lipid profiles in adult humans resulting from ingestion of extracted soy isoflavones for 1–3 months. Reference lists of relevant systematic reviews and meta-analyses were hand-searched. Meta-analysis of 10 and 9 trials with usable information using REVMAN found that an average of 70 mg soy isoflavones/day (27–132 mg, as the aglycone form alone had a nonsignificant effect on total (0.01 mmol/L [95% CI: –0.12, 0.14]; P = 0.86 and LDL (0.03 mmol/L [95% CI: –0.11, 0.16]; P = 0.71 cholesterol in menopausal women, respectively. It is concluded that ingestion of about 70 mg extracted soy isoflavones/day alone for 1–3 months does not improve total and LDL cholesterol levels in normocholesterolemic menopausal women; further studies are needed to verify the effects of extracted soy isoflavones.Keywords: extracted soy isoflavones, lipid, total cholesterol, LDL cholesterol

  7. Repetitive Transcranial Magnetic Stimulation for Treatment-Resistant Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    Science.gov (United States)

    Sehatzadeh, Shayan; Tu, Hong Anh; Palimaka, Stefan; Yap, Belinda; O'Reilly, Daria; Bowen, Jim; Higgins, Caroline; Holubowich, Corinne

    2016-01-01

    Background To date, several randomized controlled trials (RCTs) have shown the efficacy of repetitive transcranial magnetic stimulation (rTMS) in the treatment of major depression. Objective This analysis examined the antidepressant efficacy of rTMS in patients with treatment-resistant unipolar depression. Methods A literature search was performed for RCTs published from January 1, 1994, to November 20, 2014. The search was updated on March 1, 2015. Two independent reviewers evaluated the abstracts for inclusion, reviewed full texts of eligible studies, and abstracted data. Meta-analyses were conducted to obtain summary estimates. The primary outcome was changes in depression scores measured by the Hamilton Rating Scale for Depression (HRSD), and we considered, a priori, the mean difference of 3.5 points to be a clinically important treatment effect. Remission and response to the treatment were secondary outcomes, and we calculated number needed to treat on the basis of these outcomes. We examined the possibility of publication bias by constructing funnel plots and by Begg's and Egger's tests. A meta-regression was undertaken to examine the effect of specific rTMS technical parameters on the treatment effects. Results Twenty-three RCTs compared rTMS with sham, and six RCTs compared rTMS with electroconvulsive therapy (ECT). Trials of rTMS versus sham showed a statistically significant improvement in depression scores with rTMS (weighted mean difference [WMD] 2.31, 95% CI 1.19–3.43; P transcranial magnetic stimulation had a small short-term effect for improving depression in comparison with sham, but follow-up studies did not show that the small effect will continue for longer periods. PMID:27099642

  8. Biogeochemical Responses and Feedbacks to Climate Change: Synthetic Meta-Analyses Relevant to Earth System Models

    Energy Technology Data Exchange (ETDEWEB)

    van Gestel, Natasja; Jan van Groenigen, Kees; Osenberg, Craig; Dukes, Jeffrey; Dijkstra, Paul

    2018-03-20

    This project examined the sensitivity of carbon in land ecosystems to environmental change, focusing on carbon contained in soil, and the role of carbon-nitrogen interactions in regulating ecosystem carbon storage. The project used a combination of empirical measurements, mathematical models, and statistics to partition effects of climate change on soil into processes enhancing soil carbon and processes through which it decomposes. By synthesizing results from experiments around the world, the work provided novel insight on ecological controls and responses across broad spatial and temporal scales. The project developed new approaches in meta-analysis using principles of element mass balance and large datasets to derive metrics of ecosystem responses to environmental change. The project used meta-analysis to test how nutrients regulate responses of ecosystems to elevated CO2 and warming, in particular responses of nitrogen fixation, critical for regulating long-term C balance.

  9. Relevance of randomised controlled trials in oncology.

    Science.gov (United States)

    Tannock, Ian F; Amir, Eitan; Booth, Christopher M; Niraula, Saroj; Ocana, Alberto; Seruga, Bostjan; Templeton, Arnoud J; Vera-Badillo, Francisco

    2016-12-01

    Well-designed randomised controlled trials (RCTs) can prevent bias in the comparison of treatments and provide a sound basis for changes in clinical practice. However, the design and reporting of many RCTs can render their results of little relevance to clinical practice. In this Personal View, we discuss the limitations of RCT data and suggest some ways to improve the clinical relevance of RCTs in the everyday management of patients with cancer. RCTs should ask questions of clinical rather than commercial interest, avoid non-validated surrogate endpoints in registration trials, and have entry criteria that allow inclusion of all patients who are fit to receive treatment. Furthermore, RCTs should be reported with complete accounting of frequency and management of toxicities, and with strict guidelines to ensure freedom from bias. Premature reporting of results should be avoided. The bar for clinical benefit should be raised for drug registration, which should require publication and review of mature data from RCTs, post-marketing health outcome studies, and value-based pricing. Copyright © 2016 Elsevier Ltd. All rights reserved.

  10. A systematic review and meta-Analyses show that carbapenem use and medical devices are the leading risk factors for carbapenem- resistant pseudomonas aeruginosa

    NARCIS (Netherlands)

    A.F. Voor (Anne); J.A. Severin (Juliëtte); E.M.E.H. Lesaffre (Emmanuel); M.C. Vos (Margreet)

    2014-01-01

    textabstractA systematic review and meta-Analyses were performed to identify the risk factors associated with carbapenem-resistant Pseudomonas aeruginosa and to identify sources and reservoirs for the pathogen. A systematic search of PubMed and Embase databases from 1 January 1987 until 27 January

  11. A systematic meta-review of evaluations of youth violence prevention programs: Common and divergent findings from 25 years of meta-analyses and systematic reviews☆

    Science.gov (United States)

    Matjasko, Jennifer L.; Vivolo-Kantor, Alana M.; Massetti, Greta M.; Holland, Kristin M.; Holt, Melissa K.; Cruz, Jason Dela

    2018-01-01

    Violence among youth is a pervasive public health problem. In order to make progress in reducing the burden of injury and mortality that result from youth violence, it is imperative to identify evidence-based programs and strategies that have a significant impact on violence. There have been many rigorous evaluations of youth violence prevention programs. However, the literature is large, and it is difficult to draw conclusions about what works across evaluations from different disciplines, contexts, and types of programs. The current study reviews the meta-analyses and systematic reviews published prior to 2009 that synthesize evaluations of youth violence prevention programs. This meta-review reports the findings from 37 meta-analyses and 15 systematic reviews; the included reviews were coded on measures of the social ecology, prevention approach, program type, and study design. A majority of the meta-analyses and systematic reviews were found to demonstrate moderate program effects. Meta-analyses yielded marginally smaller effect sizes compared to systematic reviews, and those that included programs targeting family factors showed marginally larger effects than those that did not. In addition, there are a wide range of individual/family, program, and study moderators of program effect sizes. Implications of these findings and suggestions for future research are discussed. PMID:29503594

  12. Serum BDNF concentrations as peripheral manifestations of depression : evidence from a systematic review and meta-analyses on 179 associations (N=9484)

    NARCIS (Netherlands)

    Molendijk, M. L.; Spinhoven, P.; Polak, M.; Bus, B. A. A.; Penninx, B. W. J. H.; Elzinga, B. M.

    Meta-analyses, published in 2008-2010, have confirmed abnormally low serum brain-derived neurotrophic factor (BDNF) concentrations in depressed patients and normalization of this by antidepressant treatment. These findings are believed to reflect peripheral manifestations of the neurotrophin

  13. Effectiveness of online mindfulness-based interventions in improving mental health: A review and meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Spijkerman, M P J; Pots, W T M; Bohlmeijer, E T

    2016-04-01

    Mindfulness-based interventions (MBIs) are increasingly being delivered through the Internet. Whereas numerous meta-analyses have investigated the effectiveness of face-to-face MBIs in the context of mental health and well-being, thus far a quantitative synthesis of the effectiveness of online MBIs is lacking. The aim of this meta-analysis was to estimate the overall effects of online MBIs on mental health. Fifteen randomised controlled trials were included in this study. A random effects model was used to compute pre-post between-group effect sizes, and the study quality of each of the included trials was rated. Results showed that online MBIs have a small but significant beneficial impact on depression (g=0.29), anxiety (g=0.22), well-being (g=0.23) and mindfulness (g=0.32). The largest effect was found for stress, with a moderate effect size (g=0.51). For stress and mindfulness, exploratory subgroup analyses demonstrated significantly higher effect sizes for guided online MBIs than for unguided online MBIs. In addition, meta-regression analysis showed that effect sizes for stress were significantly moderated by the number of intervention sessions. Effect sizes, however, were not significantly related to study quality. The findings indicate that online MBIs have potential to contribute to improving mental health outcomes, particularly stress. Limitations, directions for future research and practical implications are discussed. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  14. Machine learning for the meta-analyses of microbial pathogens' volatile signatures.

    Science.gov (United States)

    Palma, Susana I C J; Traguedo, Ana P; Porteira, Ana R; Frias, Maria J; Gamboa, Hugo; Roque, Ana C A

    2018-02-20

    Non-invasive and fast diagnostic tools based on volatolomics hold great promise in the control of infectious diseases. However, the tools to identify microbial volatile organic compounds (VOCs) discriminating between human pathogens are still missing. Artificial intelligence is increasingly recognised as an essential tool in health sciences. Machine learning algorithms based in support vector machines and features selection tools were here applied to find sets of microbial VOCs with pathogen-discrimination power. Studies reporting VOCs emitted by human microbial pathogens published between 1977 and 2016 were used as source data. A set of 18 VOCs is sufficient to predict the identity of 11 microbial pathogens with high accuracy (77%), and precision (62-100%). There is one set of VOCs associated with each of the 11 pathogens which can predict the presence of that pathogen in a sample with high accuracy and precision (86-90%). The implemented pathogen classification methodology supports future database updates to include new pathogen-VOC data, which will enrich the classifiers. The sets of VOCs identified potentiate the improvement of the selectivity of non-invasive infection diagnostics using artificial olfaction devices.

  15. Can smartphone mental health interventions reduce symptoms of anxiety? A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Firth, Joseph; Torous, John; Nicholas, Jennifer; Carney, Rebekah; Rosenbaum, Simon; Sarris, Jerome

    2017-08-15

    Various psychological interventions are effective for reducing symptoms of anxiety when used alone, or as an adjunct to anti-anxiety medications. Recent studies have further indicated that smartphone-supported psychological interventions may also reduce anxiety, although the role of mobile devices in the treatment and management of anxiety disorders has yet to be established. We conducted a systematic review and meta-analysis of all randomized clinical trials (RCTs) reporting the effects of psychological interventions delivered via smartphone on symptoms of anxiety (sub-clinical or diagnosed anxiety disorders). A systematic search of major electronic databases conducted in November 2016 identified 9 eligible RCTs, with 1837 participants. Random-effects meta-analyses were used to calculate the standardized mean difference (as Hedges' g) between smartphone interventions and control conditions. Significantly greater reductions in total anxiety scores were observed from smartphone interventions than control conditions (g=0.325, 95% C.I.=0.17-0.48, psmartphone interventions were significantly greater when compared to waitlist/inactive controls (g=0.45, 95% C.I.=0.30-0.61, psmartphone interventions can match (or exceed) the efficacy of recognised treatments for anxiety has yet to established. This meta-analysis shows that psychological interventions delivered via smartphone devices can reduce anxiety. Future research should aim to develop pragmatic methods for implementing smartphone-based support for people with anxiety, while also comparing the efficacy of these interventions to standard face-to-face psychological care. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  16. A Microsoft-Excel-based tool for running and critically appraising network meta-analyses--an overview and application of NetMetaXL.

    Science.gov (United States)

    Brown, Stephen; Hutton, Brian; Clifford, Tammy; Coyle, Doug; Grima, Daniel; Wells, George; Cameron, Chris

    2014-09-29

    The use of network meta-analysis has increased dramatically in recent years. WinBUGS, a freely available Bayesian software package, has been the most widely used software package to conduct network meta-analyses. However, the learning curve for WinBUGS can be daunting, especially for new users. Furthermore, critical appraisal of network meta-analyses conducted in WinBUGS can be challenging given its limited data manipulation capabilities and the fact that generation of graphical output from network meta-analyses often relies on different software packages than the analyses themselves. We developed a freely available Microsoft-Excel-based tool called NetMetaXL, programmed in Visual Basic for Applications, which provides an interface for conducting a Bayesian network meta-analysis using WinBUGS from within Microsoft Excel. . This tool allows the user to easily prepare and enter data, set model assumptions, and run the network meta-analysis, with results being automatically displayed in an Excel spreadsheet. It also contains macros that use NetMetaXL's interface to generate evidence network diagrams, forest plots, league tables of pairwise comparisons, probability plots (rankograms), and inconsistency plots within Microsoft Excel. All figures generated are publication quality, thereby increasing the efficiency of knowledge transfer and manuscript preparation. We demonstrate the application of NetMetaXL using data from a network meta-analysis published previously which compares combined resynchronization and implantable defibrillator therapy in left ventricular dysfunction. We replicate results from the previous publication while demonstrating result summaries generated by the software. Use of the freely available NetMetaXL successfully demonstrated its ability to make running network meta-analyses more accessible to novice WinBUGS users by allowing analyses to be conducted entirely within Microsoft Excel. NetMetaXL also allows for more efficient and transparent

  17. ArrayWiki: an enabling technology for sharing public microarray data repositories and meta-analyses

    Science.gov (United States)

    Stokes, Todd H; Torrance, JT; Li, Henry; Wang, May D

    2008-01-01

    Background A survey of microarray databases reveals that most of the repository contents and data models are heterogeneous (i.e., data obtained from different chip manufacturers), and that the repositories provide only basic biological keywords linking to PubMed. As a result, it is difficult to find datasets using research context or analysis parameters information beyond a few keywords. For example, to reduce the "curse-of-dimension" problem in microarray analysis, the number of samples is often increased by merging array data from different datasets. Knowing chip data parameters such as pre-processing steps (e.g., normalization, artefact removal, etc), and knowing any previous biological validation of the dataset is essential due to the heterogeneity of the data. However, most of the microarray repositories do not have meta-data information in the first place, and do not have a a mechanism to add or insert this information. Thus, there is a critical need to create "intelligent" microarray repositories that (1) enable update of meta-data with the raw array data, and (2) provide standardized archiving protocols to minimize bias from the raw data sources. Results To address the problems discussed, we have developed a community maintained system called ArrayWiki that unites disparate meta-data of microarray meta-experiments from multiple primary sources with four key features. First, ArrayWiki provides a user-friendly knowledge management interface in addition to a programmable interface using standards developed by Wikipedia. Second, ArrayWiki includes automated quality control processes (caCORRECT) and novel visualization methods (BioPNG, Gel Plots), which provide extra information about data quality unavailable in other microarray repositories. Third, it provides a user-curation capability through the familiar Wiki interface. Fourth, ArrayWiki provides users with simple text-based searches across all experiment meta-data, and exposes data to search engine crawlers

  18. Meta-analyses of the relationship between conformity to masculine norms and mental health-related outcomes.

    Science.gov (United States)

    Wong, Y Joel; Ho, Moon-Ho Ringo; Wang, Shu-Yi; Miller, I S Keino

    2017-01-01

    Despite theoretical postulations that individuals' conformity to masculine norms is differentially related to mental health-related outcomes depending on a variety of contexts, there has not been any systematic synthesis of the empirical research on this topic. Therefore, the authors of this study conducted meta-analyses of the relationships between conformity to masculine norms (as measured by the Conformity to Masculine Norms Inventory-94 and other versions of this scale) and mental health-related outcomes using 78 samples and 19,453 participants. Conformity to masculine norms was modestly and unfavorably associated with mental health as well as moderately and unfavorably related to psychological help seeking. The authors also identified several moderation effects. Conformity to masculine norms was more strongly correlated with negative social functioning than with psychological indicators of negative mental health. Conformity to the specific masculine norms of self-reliance, power over women, and playboy were unfavorably, robustly, and consistently related to mental health-related outcomes, whereas conformity to the masculine norm of primacy of work was not significantly related to any mental health-related outcome. These findings highlight the need for researchers to disaggregate the generic construct of conformity to masculine norms and to focus instead on specific dimensions of masculine norms and their differential associations with other outcomes. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  19. Working memory circuit as a function of increasing age in healthy adolescence: A systematic review and meta-analyses.

    Science.gov (United States)

    Andre, Julia; Picchioni, Marco; Zhang, Ruibin; Toulopoulou, Timothea

    2016-01-01

    Working memory ability matures through puberty and early adulthood. Deficits in working memory are linked to the risk of onset of neurodevelopmental disorders such as schizophrenia, and there is a significant temporal overlap between the peak of first episode psychosis risk and working memory maturation. In order to characterize the normal working memory functional maturation process through this critical phase of cognitive development we conducted a systematic review and coordinate based meta-analyses of all the available primary functional magnetic resonance imaging studies (n = 382) that mapped WM function in healthy adolescents (10-17 years) and young adults (18-30 years). Activation Likelihood Estimation analyses across all WM tasks revealed increased activation with increasing subject age in the middle frontal gyrus (BA6) bilaterally, the left middle frontal gyrus (BA10), the left precuneus and left inferior parietal gyri (BA7; 40). Decreased activation with increasing age was found in the right superior frontal (BA8), left junction of postcentral and inferior parietal (BA3/40), and left limbic cingulate gyrus (BA31). These results suggest that brain activation during adolescence increased with age principally in higher order cortices, part of the core working memory network, while reductions were detected in more diffuse and potentially more immature neural networks. Understanding the process by which the brain and its cognitive functions mature through healthy adulthood may provide us with new clues to understanding the vulnerability to neurodevelopmental disorders.

  20. Working memory circuit as a function of increasing age in healthy adolescence: A systematic review and meta-analyses

    Directory of Open Access Journals (Sweden)

    Julia Andre

    2016-01-01

    Full Text Available Working memory ability matures through puberty and early adulthood. Deficits in working memory are linked to the risk of onset of neurodevelopmental disorders such as schizophrenia, and there is a significant temporal overlap between the peak of first episode psychosis risk and working memory maturation. In order to characterize the normal working memory functional maturation process through this critical phase of cognitive development we conducted a systematic review and coordinate based meta-analyses of all the available primary functional magnetic resonance imaging studies (n = 382 that mapped WM function in healthy adolescents (10–17 years and young adults (18–30 years. Activation Likelihood Estimation analyses across all WM tasks revealed increased activation with increasing subject age in the middle frontal gyrus (BA6 bilaterally, the left middle frontal gyrus (BA10, the left precuneus and left inferior parietal gyri (BA7; 40. Decreased activation with increasing age was found in the right superior frontal (BA8, left junction of postcentral and inferior parietal (BA3/40, and left limbic cingulate gyrus (BA31. These results suggest that brain activation during adolescence increased with age principally in higher order cortices, part of the core working memory network, while reductions were detected in more diffuse and potentially more immature neural networks. Understanding the process by which the brain and its cognitive functions mature through healthy adulthood may provide us with new clues to understanding the vulnerability to neurodevelopmental disorders.

  1. Glucocerebrosidase mutations and neuropsychiatric phenotypes in Parkinson's disease and Lewy body dementias: Review and meta-analyses.

    Science.gov (United States)

    Creese, Byron; Bell, Emily; Johar, Iskandar; Francis, Paul; Ballard, Clive; Aarsland, Dag

    2018-03-01

    Heterozygous mutations in glucocerebrosidase gene (GBA) are a major genetic risk factor for Parkinson's disease (PD) and dementia with Lewy bodies (DLB). Recently, there has been a considerable focus on the relationship between GBA mutations and emergence of cognitive impairment and neuropsychiatric symptoms in these diseases. Here, we review the literature in this area, with a particular focus, including meta-analysis, on the key neuropsychiatric symptoms of cognitive impairment, psychosis, and depression in Parkinson's disease. Our meta-analysis demonstrated that GBA mutations are associated with a 2.4-fold increased risk of cognitive impairment. In addition, our novel meta-analyses of psychosis and depression showed a 1.8- and 2.2-fold increased risk respectively associated with GBA mutations, although due to possible bias and heterogeneity the depression findings should be interpreted with caution. While the precise mechanisms which increase susceptibility to neurodegeneration in GBA carriers are not known, evidence of greater cortical Lewy body pathology, reduced patterns of cortical activation, and hippocampal pathology in animal models are all consistent with a direct effect of GBA mutations on these symptoms. Extension of this work in DLB and individuals without neurodegeneration will be important in further characterizing how GBA mutations increase risk for PD and DLB and influence disease course. © 2017 Wiley Periodicals, Inc.

  2. Trial Sequential Analysis in systematic reviews with meta-analysis

    DEFF Research Database (Denmark)

    Wetterslev, Jørn; Jakobsen, Janus Christian; Gluud, Christian

    2017-01-01

    BACKGROUND: Most meta-analyses in systematic reviews, including Cochrane ones, do not have sufficient statistical power to detect or refute even large intervention effects. This is why a meta-analysis ought to be regarded as an interim analysis on its way towards a required information size...... from traditional meta-analyses using unadjusted naïve 95% confidence intervals and 5% thresholds for statistical significance. Spurious conclusions in systematic reviews with traditional meta-analyses can be reduced using Trial Sequential Analysis. Several empirical studies have demonstrated...

  3. Randomised controlled trial of mesalazine in IBS.

    Science.gov (United States)

    Barbara, Giovanni; Cremon, Cesare; Annese, Vito; Basilisco, Guido; Bazzoli, Franco; Bellini, Massimo; Benedetti, Antonio; Benini, Luigi; Bossa, Fabrizio; Buldrini, Paola; Cicala, Michele; Cuomo, Rosario; Germanà, Bastianello; Molteni, Paola; Neri, Matteo; Rodi, Marcello; Saggioro, Alfredo; Scribano, Maria Lia; Vecchi, Maurizio; Zoli, Giorgio; Corinaldesi, Roberto; Stanghellini, Vincenzo

    2016-01-01

    Low-grade intestinal inflammation plays a role in the pathophysiology of IBS. In this trial, we aimed at evaluating the efficacy and safety of mesalazine in patients with IBS. We conducted a phase 3, multicentre, tertiary setting, randomised, double-blind, placebo-controlled trial in patients with Rome III confirmed IBS. Patients were randomly assigned to either mesalazine, 800 mg, or placebo, three times daily for 12 weeks, and were followed for additional 12 weeks. The primary efficacy endpoint was satisfactory relief of abdominal pain/discomfort for at least half of the weeks of the treatment period. The key secondary endpoint was satisfactory relief of overall IBS symptoms. Supportive analyses were also performed classifying as responders patients with a percentage of affirmative answers of at least 75% or >75% of time. A total of 185 patients with IBS were enrolled from 21 centres. For the primary endpoint, the responder patients were 68.6% in the mesalazine group versus 67.4% in the placebo group (p=0.870; 95% CI -12.8 to 15.1). In explorative analyses, with the 75% rule or >75% rule, the percentage of responders was greater in the mesalazine group with a difference over placebo of 11.6% (p=0.115; 95% CI -2.7% to 26.0%) and 5.9% (p=0.404; 95% CI -7.8% to 19.4%), respectively, although these differences were not significant. For the key secondary endpoint, overall symptoms improved in the mesalazine group and reached a significant difference of 15.1% versus placebo (p=0.032; 95% CI 1.5% to 28.7%) with the >75% rule. Mesalazine treatment was not superior than placebo on the study primary endpoint. However, a subgroup of patients with IBS showed a sustained therapy response and benefits from a mesalazine therapy. ClincialTrials.gov number, NCT00626288. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  4. Do randomized controlled trials discuss healthcare costs?

    Directory of Open Access Journals (Sweden)

    G Michael Allan

    Full Text Available BACKGROUND: Healthcare costs, particularly pharmaceutical costs, are a dominant issue for most healthcare organizations, but it is unclear if randomized controlled trials (RCTs routinely discuss costs. Our objective was to assess the frequency and factors associated with the inclusion of costs in RCTs. METHODS AND FINDINGS: We randomly sampled 188 RCTs spanning three years (2003-2005 from six high impact journals. The sample size for RCTs was based on a calculation to estimate the inclusion of actual drug costs with a precision of +/-3%. Two reviewers independently extracted cost data and study characteristics. Frequencies were calculated and potential characteristics associated with the inclusion of costs were explored. Actual drug costs were included in 4.7% (9/188 of RCTs; any actual costs were included in 7.4% (14/188 of RCTs; and any mention of costs was included in 27.7% (52/188 of RCTs. As the amount of industry funding increased across RCTs, from non-profit to mixed to fully industry funded RCTs, there was a statistically significant reduction in the number of RCTs with any actual costs (Cochran-Armitage test, p = 0.005 and any mention of costs (Cochran-Armitage test, p = 0.02. Logistic regression analysis also indicated funding was associated with the inclusion of any actual cost (OR = 0.34, p = 0.009 or any mention of costs (OR = 0.63, p = 0.02. Journal, study conclusions, study location, primary author's country and product age were not associated with inclusion of cost information. CONCLUSION: While physicians are encouraged to consider costs when prescribing drugs for their patients, actual drug costs were provided in only 5% of RCTs and were not mentioned at all in 72% of RCTs. Industry funded trials were less likely to include cost information. No other factors were associated with the inclusion of cost information.

  5. Do randomized controlled trials discuss healthcare costs?

    Science.gov (United States)

    Allan, G Michael; Korownyk, Christina; LaSalle, Kate; Vandermeer, Ben; Ma, Victoria; Klein, Douglas; Manca, Donna

    2010-08-23

    Healthcare costs, particularly pharmaceutical costs, are a dominant issue for most healthcare organizations, but it is unclear if randomized controlled trials (RCTs) routinely discuss costs. Our objective was to assess the frequency and factors associated with the inclusion of costs in RCTs. We randomly sampled 188 RCTs spanning three years (2003-2005) from six high impact journals. The sample size for RCTs was based on a calculation to estimate the inclusion of actual drug costs with a precision of +/-3%. Two reviewers independently extracted cost data and study characteristics. Frequencies were calculated and potential characteristics associated with the inclusion of costs were explored. Actual drug costs were included in 4.7% (9/188) of RCTs; any actual costs were included in 7.4% (14/188) of RCTs; and any mention of costs was included in 27.7% (52/188) of RCTs. As the amount of industry funding increased across RCTs, from non-profit to mixed to fully industry funded RCTs, there was a statistically significant reduction in the number of RCTs with any actual costs (Cochran-Armitage test, p = 0.005) and any mention of costs (Cochran-Armitage test, p = 0.02). Logistic regression analysis also indicated funding was associated with the inclusion of any actual cost (OR = 0.34, p = 0.009) or any mention of costs (OR = 0.63, p = 0.02). Journal, study conclusions, study location, primary author's country and product age were not associated with inclusion of cost information. While physicians are encouraged to consider costs when prescribing drugs for their patients, actual drug costs were provided in only 5% of RCTs and were not mentioned at all in 72% of RCTs. Industry funded trials were less likely to include cost information. No other factors were associated with the inclusion of cost information.

  6. Influence of companion diagnostics on efficacy and safety of targeted anti-cancer drugs: systematic review and meta-analyses.

    Science.gov (United States)

    Ocana, Alberto; Ethier, Josee-Lyne; Díez-González, Laura; Corrales-Sánchez, Verónica; Srikanthan, Amirrtha; Gascón-Escribano, María J; Templeton, Arnoud J; Vera-Badillo, Francisco; Seruga, Bostjan; Niraula, Saroj; Pandiella, Atanasio; Amir, Eitan

    2015-11-24

    Companion diagnostics aim to identify patients that will respond to targeted therapies, therefore increasing the clinical efficacy of such drugs. Less is known about their influence on safety and tolerability of targeted anti-cancer agents. Randomized trials evaluating targeted agents for solid tumors approved by the US Food and Drug Administration since year 2000 were assessed. Odds ratios (OR) and and 95% confidence intervals (CI) were computed for treatment-related death, treatment-discontinuation related to toxicity and occurrence of any grade 3/4 adverse events (AEs). The 12 most commonly reported individual AEs were also explored. ORs were pooled in a meta-analysis. Analysis comprised 41 trials evaluating 28 targeted agents. Seventeen trials (41%) utilized companion diagnostics. Compared to control groups, targeted drugs in experimental arms were associated with increased odds of treatment discontinuation, grade 3/4 AEs, and toxic death irrespective of whether they utilized companion diagnostics or not. Compared to drugs without available companion diagnostics, agents with companion diagnostics had a lower magnitude of increased odds of treatment discontinuation (OR = 1.12 vs. 1.65, p diagnostics were greatest for diarrhea (OR = 1.29 vs. 2.43, p diagnostics are associated with improved safety, and tolerability. Differences were most marked for gastrointestinal, cutaneous and neurological toxicity.

  7. Bone Morphogenetic Protein for the Healing of Tibial Fracture: A Meta-Analysis of Randomized Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Jiezhi Dai

    Full Text Available To review the evidence from RCTs on clinical outcomes and benefit of acute tibial fracture and nonunion treated with and without BMPs.We searched multiple databases (MEDLINE, EMABSE, BIOSIS and Cochrane central as well as reference lists of articles and contacted authors. Evaluated outcomes included union rate, revision rate, hardware failure and infection. The weighted and standard mean difference (WMD and SMD or the relative risk (RR was calculated for continuous or dichotomous data respectively. The quality of the trial was assessed, and meta-analyses were performed with the Cochrane Collaboration's REVMAN 5.0 software.Eight RCTs involving 1113 patients were included. For acute tibial fracture, BMP group was associated with a higher rate of union (RR, 1.16; 95% CI, 1.04 to 1.30 and a lower rate of revision (RR, 0.68; 95% CI, 0.54 to 0.85 compared with control group. No significant differences were found in rate of hardware failure and infection. The pooled RR for achieving union for tibial fracture nonunion was 0.98 (95% CI, 0.86 to 1.13. There was no significant difference between the two groups in the rate of revision (RR, 0.48; 95% CI, 0.13 to 1.85 and infection (RR, 0.61; 95% CI, 0.37 to 1.02.Study on acute tibial fractures suggests that BMP is more effective that controls, for bone union and for decreasing the rate of surgical revision to achieve union. For the treatment of tibial fracture nonunion, BMP leads to similar results to as autogenous bone grafting. Finally, well-designed RCTs of BMP for tibial fracture treatment are also needed.

  8. Bleeding and pneumonia in intensive care patients given ranitidine and sucralfate for prevention of stress ulcer: meta-analysis of randomised controlled trials

    Science.gov (United States)

    Messori, A; Trippoli, S; Vaiani, M; Gorini, M; Corrado, A

    2000-01-01

    Objectives To determine the effectiveness of ranitidine and sucralfate in the prevention of stress ulcer in critical patients and to assess if these treatments affect the risk of nosocomial pneumonia. Design Published studies retrieved through Medline and other databases. Five meta-analyses evaluated effectiveness in terms of bleeding rates (A: ranitidine v placebo; B: sucralfate v placebo) and infectious complications in terms of incidence of nosocomial pneumonia (C: ranitidine v placebo; D: sucralfate v placebo; E: ranitidine v sucralfate). Trial quality was determined with an empirical ad hoc procedure. Main outcome measures Rates of clinically important gastrointestinal bleeding and nosocomial pneumonia (compared between the two study arms and expressed with odds ratios specific for individual studies and meta-analytic summary odds ratios). Results Meta-analysis A (five studies) comprised 398 patients; meta-analysis C (three studies) comprised 311 patients; meta-analysis D (two studies) comprised 226 patients: and meta-analysis E (eight studies) comprised 1825 patients. Meta-analysis B was not carried out as the literature search selected only one clinical trial. In meta-analysis A ranitidine was found to have the same effectiveness as placebo (odds ratio of bleeding 0.72, 95% confidence interval 0.30 to 1.70, P=0.46). In placebo controlled studies (meta-analyses C and D) ranitidine and sucralfate had no influence on the incidence of nosocomial pneumonia. In comparison with sucralfate, ranitidine significantly increased the incidence of nosocomial pneumonia (meta-analysis E: 1.35, 1.07 to 1.70, P=0.012). The mean quality score in the four analyses (on a 0 to 10 scale) ranged from 5.6 in meta-analysis E to 6.6 in meta-analysis A. Conclusions Ranitidine is ineffective in the prevention of gastrointestinal bleeding in patients in intensive care and might increase the risk of pneumonia. Studies on sucralfate do not provide conclusive results. These findings are

  9. Endorsement of PRISMA statement and quality of systematic reviews and meta-analyses published in nursing journals: a cross-sectional study

    Science.gov (United States)

    Tam, Wilson W S; Lo, Kenneth K H; Khalechelvam, Parames

    2017-01-01

    Objective Systematic reviews (SRs) often poorly report key information, thereby diminishing their usefulness. Previous studies evaluated published SRs and determined that they failed to meet explicit criteria or characteristics. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was recommended as a reporting guideline for SR and meta-analysis (MA), but previous studies showed that adherence to the statement was not high for SRs published in different medical fields. Thus, the aims of this study are twofold: (1) to investigate the number of nursing journals that have required or recommended the use of the PRISMA statement for reporting SR, and (2) to examine the adherence of SRs and/or meta-analyses to the PRISMA statement published in nursing journals. Design A cross-sectional study. Methods Nursing journals listed in the ISI journal citation report were divided into 2 groups based on the recommendation of PRISMA statement in their ‘Instruction for Authors’. SRs and meta-analyses published in 2014 were searched in 3 databases. 37 SRs and meta-analyses were randomly selected in each group. The adherence of each item to the PRISMA was examined and summarised using descriptive statistics. The quality of the SRs was assessed by Assessing the Methodological Quality of Systematic Reviews. The differences between the 2 groups were compared using the Mann-Whitney U test. Results Out of 107 nursing journals, 30 (28.0%) recommended or required authors to follow the PRISMA statement when they submit SRs or meta-analyses. The median rates of adherence to the PRISMA statement for reviews published in journals with and without PRISMA endorsement were 64.9% (IQR: 17.6–92.3%) and 73.0% (IQR: 59.5–94.6%), respectively. No significant difference was observed in any of the items between the 2 groups. Conclusions The median adherence of SRs and meta-analyses in nursing journals to PRISMA is low at 64.9% and 73.0%, respectively

  10. Endorsement of PRISMA statement and quality of systematic reviews and meta-analyses published in nursing journals: a cross-sectional study.

    Science.gov (United States)

    Tam, Wilson W S; Lo, Kenneth K H; Khalechelvam, Parames

    2017-02-07

    Systematic reviews (SRs) often poorly report key information, thereby diminishing their usefulness. Previous studies evaluated published SRs and determined that they failed to meet explicit criteria or characteristics. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was recommended as a reporting guideline for SR and meta-analysis (MA), but previous studies showed that adherence to the statement was not high for SRs published in different medical fields. Thus, the aims of this study are twofold: (1) to investigate the number of nursing journals that have required or recommended the use of the PRISMA statement for reporting SR, and (2) to examine the adherence of SRs and/or meta-analyses to the PRISMA statement published in nursing journals. A cross-sectional study. Nursing journals listed in the ISI journal citation report were divided into 2 groups based on the recommendation of PRISMA statement in their 'Instruction for Authors'. SRs and meta-analyses published in 2014 were searched in 3 databases. 37 SRs and meta-analyses were randomly selected in each group. The adherence of each item to the PRISMA was examined and summarised using descriptive statistics. The quality of the SRs was assessed by Assessing the Methodological Quality of Systematic Reviews. The differences between the 2 groups were compared using the Mann-Whitney U test. Out of 107 nursing journals, 30 (28.0%) recommended or required authors to follow the PRISMA statement when they submit SRs or meta-analyses. The median rates of adherence to the PRISMA statement for reviews published in journals with and without PRISMA endorsement were 64.9% (IQR: 17.6-92.3%) and 73.0% (IQR: 59.5-94.6%), respectively. No significant difference was observed in any of the items between the 2 groups. The median adherence of SRs and meta-analyses in nursing journals to PRISMA is low at 64.9% and 73.0%, respectively. Nonetheless, the adherence level of nursing journals to the

  11. Acupuncture and asthma: a review of controlled trials

    NARCIS (Netherlands)

    Kleijnen, J.; ter Riet, G.; Knipschild, P.

    1991-01-01

    BACKGROUND: Published controlled trials of acupuncture in asthma have often contained a small number of subjects and the results are contradictory. Controlled trials have been reviewed to determine whether clearer conclusions could be obtained by assessing as many studies as possible according to

  12. Opioid detoxification : from controlled clinical trial to clinical practice

    NARCIS (Netherlands)

    Dijkstra, Boukje A G; De Jong, Cor A J; Wensing, Michel; Krabbe, Paul F M; van der Staak, Cees P F

    2010-01-01

    Controlled clinical trials have high internal validity but suffer from difficulties in external validity. This study evaluates the generalizability of the results of a controlled clinical trial on rapid detoxification in the everyday clinical practice of two addiction treatment centers. The results

  13. Association of Helicobacter pylori infection with chronic atrophic gastritis: Meta-analyses according to type of disease definition.

    Science.gov (United States)

    Weck, Melanie N; Brenner, Hermann

    2008-08-15

    Helicobacter pylori is a major risk factor for chronic atrophic gastritis (CAG). A large variety of definitions of CAG have been used in epidemiologic studies in the past. The aim of this work was to systematically review and summarize estimates of the association between H. pylori infection and CAG according to the various definitions of CAG. Articles on the association between H. pylori infection and CAG published until July 2007 were identified. Separate meta-analyses were carried out for studies defining CAG based on gastroscopy with biopsy, serum pepsinogen I (PG I) only, the pepsinogen I/pepsinogen II ratio (PG I/PG II ratio) only, or a combination of PG I and the PG I/PG II ratio. Numbers of identified studies and summary odds ratios (OR) (95% confidence intervals) were as follows: gastroscopy with biopsy: n = 34, OR = 6.4 (4.0-10.1); PG I only: n = 13, OR = 0.9 (0.7-1.2); PG I/PG II ratio: n = 8, OR = 7.2 (3.1-16.8); combination of PG I and the PG I/PG II ratio: n = 20, OR = 5.7 (4.4-7.5). Studies with CAG definitions based on gastroscopy with biopsy or the PG I/PG II ratio (alone or in combination with PG I) yield similarly strong associations of H. pylori with CAG. The association is missed entirely in studies where CAG is defined by PG I only. (c) 2008 Wiley-Liss, Inc.

  14. Environmental risk factors for autism: an evidence-based review of systematic reviews and meta-analyses.

    Science.gov (United States)

    Modabbernia, Amirhossein; Velthorst, Eva; Reichenberg, Abraham

    2017-01-01

    According to recent evidence, up to 40-50% of variance in autism spectrum disorder (ASD) liability might be determined by environmental factors. In the present paper, we conducted a review of systematic reviews and meta-analyses of environmental risk factors for ASD. We assessed each review for quality of evidence and provided a brief overview of putative mechanisms of environmental risk factors for ASD. Current evidence suggests that several environmental factors including vaccination, maternal smoking, thimerosal exposure, and most likely assisted reproductive technologies are unrelated to risk of ASD. On the contrary, advanced parental age is associated with higher risk of ASD. Birth complications that are associated with trauma or ischemia and hypoxia have also shown strong links to ASD, whereas other pregnancy-related factors such as maternal obesity, maternal diabetes, and caesarian section have shown a less strong (but significant) association with risk of ASD. The reviews on nutritional elements have been inconclusive about the detrimental effects of deficiency in folic acid and omega 3, but vitamin D seems to be deficient in patients with ASD. The studies on toxic elements have been largely limited by their design, but there is enough evidence for the association between some heavy metals (most important inorganic mercury and lead) and ASD that warrants further investigation. Mechanisms of the association between environmental factors and ASD are debated but might include non-causative association (including confounding), gene-related effect, oxidative stress, inflammation, hypoxia/ischemia, endocrine disruption, neurotransmitter alterations, and interference with signaling pathways. Compared to genetic studies of ASD, studies of environmental risk factors are in their infancy and have significant methodological limitations. Future studies of ASD risk factors would benefit from a developmental psychopathology approach, prospective design, precise exposure

  15. The effect of grinding on the mechanical behavior of Y-TZP ceramics: A systematic review and meta-analyses.

    Science.gov (United States)

    Pereira, G K R; Fraga, S; Montagner, A F; Soares, F Z M; Kleverlaan, C J; Valandro, L F

    2016-10-01

    The aim of this study was to systematically review the literature to assess the effect of grinding on the mechanical properties, structural stability and superficial characteristics of Y-TZP ceramics. The MEDLINE via PubMed and Web of Science (ISI - Web of Knowledge) electronic databases were searched with included peer-reviewed publications in English language and with no publication year limit. From 342 potentially eligible studies, 73 were selected for full-text analysis, 30 were included in the systematic review with 20 considered in the meta-analysis. Two reviewers independently selected the studies, extracted the data, and assessed the risk of bias. Statistical analyses were performed using RevMan 5.1, with random effects model, at a significance level of 0.05. A descriptive analysis considering phase transformation, Y-TZP grain size, Vickers hardness, residual stress and aging of all included studies were executed. Four outcomes were considered in the meta-analyses (factor: grinding x as-sintered) in global and subgroups analyses (grinding tool, grit-size and cooling) for flexural strength and roughness (Ra) data. A significant difference (pgrinding; subgroup analyses revealed that different parameters also lead to different effects on roughness. High heterogeneity was found in some comparisons. Generally grinding promotes decrease in strength and increase in roughness of Y-TZP ceramics. However, the use of a grinding tool that allows greater accuracy of the movement (i.e. contra angle hand-pieces coupled to slowspeed turbines), small grit size (<50μm) and the use of plenty coolant seem to be the main factors to decrease the defect introduction and allow the occurrence of the toughening transformation mechanism, decreasing the risk of deleterious impact on Y-TZP mechanical properties. Copyright © 2016 Elsevier Ltd. All rights reserved.

  16. Is self-monitoring of blood glucose effective in improving glycaemic control in type 2 diabetes without insulin treatment: a meta-analysis of randomised controlled trials

    Science.gov (United States)

    Zhu, Hongmei; Zhu, Yanan; Leung, Siu-wai

    2016-01-01

    Objective The present study aimed to verify the effectiveness of self-monitoring of blood glucose (SMBG) in patients with non-insulin-treated type 2 diabetes (T2D). Methods A comprehensive literature search was conducted in PubMed, Cochrane Library, Web of Science, ScienceDirect and ClinicalTrials.gov from their respective inception dates to 26 October 2015. Eligible randomised controlled trials (RCTs) were included according to prespecified criteria. The quality of the included RCTs was evaluated according to the Cochrane risk of bias tool, and the evidence quality of meta-analyses was assessed by the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) criteria. A meta-analysis of primary and secondary outcome measures was performed. Sensitivity and subgroup analyses were carried out to evaluate the robustness and heterogeneity of the findings. Begg's and Egger's tests were used to quantify publication biases. Results A total of 15 RCTs, comprising 3383 patients with non-insulin-treated T2D, met the inclusion criteria. The SMBG intervention improved glycated haemoglobin (HbA1c) (mean difference −0.33; 95% CI −0.45 to −0.22; p=3.0730e−8; n=18), body mass index (BMI; −0.65; −1.18 to −0.12; p=0.0164; n=9) and total cholesterol (TC; −0.12; −0.20 to −0.04; p=0.0034; n=8) more effectively than the control in overall effect. The sensitivity analysis revealed little difference in overall effect, indicating the robustness of the results. SMBG moderated HbA1c levels better than the control in all subgroup analyses. Most of the RCTs had high risk of bias in blinding, while the overall quality of evidence for HbA1c was moderate according to the GRADE criteria. Publication bias was moderate for BMI. Conclusions SMBG improved HbA1c levels in the short term (≤6-month follow-up) and long term (≥12-month follow-up) in patients with T2D who were not using insulin. Trial registration number CRD42015019099. PMID:27591016

  17. Pain Control Interventions in Preterm Neonates: A Randomized Controlled Trial.

    Science.gov (United States)

    Shukla, Vivek V; Bansal, Satvik; Nimbalkar, Archana; Chapla, Apurva; Phatak, Ajay; Patel, Dipen; Nimbalkar, Somashekhar

    2018-04-15

    To compare individual efficacy and additive effects of pain control interventions in preterm neonates. Randomized controlled trial. Level-3 University affiliated neonatal intensive care unit. 200 neonates (26-36 wk gestational age) requiring heel-prick for bedside glucose assessment. Exclusion criteria were neurologic impairment and critical illness precluding study interventions. Neonates were randomly assigned to Kangaroo mother care with Music therapy, Music therapy, Kangaroo Mother care or Control (no additional intervention) groups. All groups received expressed breast milk with cup and spoon as a baseline pain control intervention. Assessment of pain using Premature Infant Pain Profile (PIPP) score on recorded videos. The mean (SD) birth weight and gestational age of the neonates was 1.9 (0.3) kg and 34 (2.3) wk, respectively. Analysis of variance showed significant difference in total PIPP score across groups (P<0.001). Post-hoc comparisons using Sheffe's test revealed that the mean (SD) total PIPP score was significantly lower in Kangaroo mother care group [7.7 (3.9) vs. 11.5 (3.4), 95% CI(-5.9, -1.7), P<0.001] as well as Kangaroo mother care with Music therapy group [8.5 (3.2) vs. 11.5 (3.4), 95%CI (-5.1, -0.9), P=0.001] as compared to Control group. PIPP score was not significantly different between Control group and Music therapy group. Kangaroo mother care with and without Music therapy (with expressed breast milk) significantly reduces pain on heel-prick as compared to expressed breast milk alone. Kangaroo mother care with expressed breast milk should be the first choice as a method for pain control in preterm neonates.

  18. The Effectiveness of Conservative Management for Acute Whiplash Associated Disorder (WAD II: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Taweewat Wiangkham

    Full Text Available To evaluate the effectiveness of conservative management (except drug therapy for acute Whiplash Associated Disorder (WAD II.Systematic review and meta-analysis of Randomised Controlled Trials (RCTs using a pre-defined protocol. Two independent reviewers searched information sources, decided eligibility of studies, and assessed risk of bias (RoB of included trials. Data were extracted by one reviewer and checked by the other. A third reviewer mediated any disagreements throughout. Qualitative trial and RoB data were summarised descriptively. Quantitative syntheses were conducted across trials for comparable interventions, outcome measures and assessment points. Meta-analyses compared effect sizes with random effects, using STATA version 12.PEDro, Medline, Embase, AMED, CINAHL, PsycINFO, and Cochrane Library with manual searching in key journals, reference lists, British National Bibliography for Report Literature, Center for International Rehabilitation Research Information & Exchange, and National Technical Information Service were searched from inception to 15th April 2015. Active researchers in the field were contacted to determine relevant studies.RCTs evaluating acute (10 days interventions, there were no statistically significant differences in all outcome measures between interventions at any time.Conservative and active interventions may be useful for pain reduction in patients with acute WADII. Additionally, cervical horizontal mobility could be improved by conservative intervention. The employment of a behavioural intervention (e.g. act-as-usual, education and self-care including regularly exercise could have benefits for pain reduction and improvement in cervical movement in the coronal and horizontal planes. The evidence was evaluated as low/very low level according to the Grading of Recommendations Assessment, Development and Evaluation system.

  19. Robotic Assisted Radical Cystectomy with Extracorporeal Urinary Diversion Does Not Show a Benefit over Open Radical Cystectomy: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Wei Shen Tan

    Full Text Available The number of robotic assisted radical cystectomy (RARC procedures is increasing despite the lack of Level I evidence showing any advantages over open radical cystectomy (ORC. However, several systematic reviews with meta-analyses including non-randomised studies, suggest an overall benefit for RARC compared to ORC. We performed a systematic review with meta-analysis of randomised controlled trials (RCTs to evaluate the perioperative morbidity and efficacy of RARC compared to ORC in patients with bladder cancer.Literature searches of Medline/Pubmed, Embase, Web of Science and clinicaltrials.gov databases up to 10th March 2016 were performed. The inclusion criteria for eligible studies were RCTs which compared perioperative outcomes of ORC and RARC for bladder cancer. Primary objective was perioperative and histopathological outcomes of RARC versus ORC while the secondary objective was quality of life assessment (QoL, oncological outcomes and cost analysis.Four RCTs (from 5 articles met the inclusion criteria, with a total of 239 patients all with extracorporeal urinary diversion. Patient demographics and clinical characteristics of RARC and ORC patients were evenly matched. There was no significant difference between groups in perioperative morbidity, length of stay, positive surgical margin, lymph node yield and positive lymph node status. RARC group had significantly lower estimated blood loss (p<0.001 and wound complications (p = 0.03 but required significantly longer operating time (p<0.001. QoL was not measured uniformly across trials and cost analysis was reported in one RCTs. A test for heterogeneity did highlight differences across operating time of trials suggesting that surgeon experience may influence outcomes.This study does not provide evidence to support a benefit for RARC compared to ORC. These results may not have inference for RARC with intracorporeal urinary diversion. Well-designed trials with appropriate endpoints conducted

  20. Oral administration of Chinese herbal medicine during gestation period for preventing hemolytic disease of the newborn due to ABO incompatibility: A systematic review of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Huijuan Cao

    Full Text Available About 85.3% of hemolytic disease of the newborn (HDN is caused by maternal-fetal ABO blood group incompatibility. However, there is currently no recommended "best" therapy for ABO incompatibility during pregnancy.To systematically assess the safety and effectiveness of oral Chinese herbal medicine (CHM for preventing HDN due to ABO incompatibility.The protocol of this review was registered on the PROSPERO website (No. CRD42016038637.Six databases were searched from inception to April 2016. Randomized controlled trials (RCTs of CHM for maternal-fetal ABO incompatibility were included. The primary outcome was incidence of HDN. The Cochrane risk of bias tool was used to assess the methodological quality of included trials. Risk ratios (RR and mean differences with 95% confidence interval were used as effect measures. Meta-analyses using Revman 5.3 software were conducted if there were sufficient trials without obvious clinical or statistical heterogeneity available.Totally 28 RCTs involving3413 women were included in the review. The majority of the trials had unclear or high risk of bias. Our study found that the rate of HDN and the incidence of neonatal jaundice might be 70% lower in the herbal medicine group compared with the usual care group (RR from 0.25 to 0.30.After treatment with herbal medicine, women were twice as likely to have antibody titers lower than 1:64 compared with women who received usual care(RR from 2.15 to 3.14 and the umbilical cord blood bilirubin level in the herbal medicine group was 4umol/L lower than in those receiving usual care. There was no difference in Apgar scores or birthweights between the two groups.This review found very low-quality evidence that CHM prevented HDN caused by maternal-fetal ABO incompatibility. No firm conclusions can be drawn regarding the effectiveness or safety of CHM for this condition.

  1. Oral administration of Chinese herbal medicine during gestation period for preventing hemolytic disease of the newborn due to ABO incompatibility: A systematic review of randomized controlled trials.

    Science.gov (United States)

    Cao, Huijuan; Wu, Ruohan; Han, Mei; Caldwell, Patrina Ha Yuen; Liu, Jian-Ping

    2017-01-01

    About 85.3% of hemolytic disease of the newborn (HDN) is caused by maternal-fetal ABO blood group incompatibility. However, there is currently no recommended "best" therapy for ABO incompatibility during pregnancy. To systematically assess the safety and effectiveness of oral Chinese herbal medicine (CHM) for preventing HDN due to ABO incompatibility. The protocol of this review was registered on the PROSPERO website (No. CRD42016038637).Six databases were searched from inception to April 2016. Randomized controlled trials (RCTs) of CHM for maternal-fetal ABO incompatibility were included. The primary outcome was incidence of HDN. The Cochrane risk of bias tool was used to assess the methodological quality of included trials. Risk ratios (RR) and mean differences with 95% confidence interval were used as effect measures. Meta-analyses using Revman 5.3 software were conducted if there were sufficient trials without obvious clinical or statistical heterogeneity available. Totally 28 RCTs involving3413 women were included in the review. The majority of the trials had unclear or high risk of bias. Our study found that the rate of HDN and the incidence of neonatal jaundice might be 70% lower in the herbal medicine group compared with the usual care group (RR from 0.25 to 0.30).After treatment with herbal medicine, women were twice as likely to have antibody titers lower than 1:64 compared with women who received usual care(RR from 2.15 to 3.14) and the umbilical cord blood bilirubin level in the herbal medicine group was 4umol/L lower than in those receiving usual care. There was no difference in Apgar scores or birthweights between the two groups. This review found very low-quality evidence that CHM prevented HDN caused by maternal-fetal ABO incompatibility. No firm conclusions can be drawn regarding the effectiveness or safety of CHM for this condition.

  2. Motivational Interviewing for encouraging quit attempts among unmotivated smokers: study protocol of a randomized, controlled, efficacy trial

    Directory of Open Access Journals (Sweden)

    Catley Delwyn

    2012-06-01

    Full Text Available Abstract Background Although the current Clinical Practice Guideline recommend Motivational Interviewing for use with smokers not ready to quit, the strength of evidence for its use is rated as not optimal. The purpose of the present study is to address key methodological limitations of previous studies by ensuring fidelity in the delivery of the Motivational Interviewing intervention, using an attention-matched control condition, and focusing on unmotivated smokers whom meta-analyses have indicated may benefit most from Motivational Interviewing. It is hypothesized that MI will be more effective at inducing quit attempts and smoking cessation at 6-month follow-up than brief advice to quit and an intensity-matched health education condition. Methods/Design A sample of adult community resident smokers (N = 255 who report low motivation and readiness to quit are being randomized using a 2:2:1 treatment allocation to Motivational Interviewing, Health Education, or Brief Advice. Over 6 months, participants in Motivational Interviewing and Health Education receive 4 individual counseling sessions and participants in Brief Advice receive one brief in-person individual session at baseline. Rigorous monitoring and independent verification of fidelity will assure the counseling approaches are distinct and delivered as planned. Participants complete surveys at baseline, week 12 and 6-month follow-up to assess demographics, smoking characteristics, and smoking outcomes. Participants who decide to quit are provided with a self-help guide to quitting, help with a quit plan, and free pharmacotherapy. The primary outcome is self-report of one or more quit attempts lasting at least 24 hours between randomization and 6-month follow-up. The secondary outcome is biochemically confirmed 7-day point prevalence cessation at 6-month follow-up. Hypothesized mediators of the presumed treatment effect on quit attempts are greater perceived autonomy support and

  3. Drooling in Parkinson's disease: A randomized controlled trial of incobotulinum toxin A and meta-analysis of Botulinum toxins.

    Science.gov (United States)

    Narayanaswami, Pushpa; Geisbush, Thomas; Tarulli, Andrew; Raynor, Elizabeth; Gautam, Shiva; Tarsy, Daniel; Gronseth, Gary

    2016-09-01

    Botulinum toxins are a therapeutic option for drooling in Parkinson's Disease (PD). The aims of this study were to: 1. evaluate the efficacy of incobotulinum toxin A for drooling in PD. 2. Perform a meta-analysis of studies of Botulinum toxins for drooling in PD. 1. Primary study: Randomized, double blind, placebo controlled, cross over trial. Incobotulinum toxin (100 units) or saline was injected into the parotid (20 units) and submandibular (30 units) glands. Subjects returned monthly for three evaluations after each injection. Outcome measures were saliva weight and Drooling Frequency and Severity Scale. 2. Systematic review of literature, followed by inverse variance meta-analyses using random effects models. 1. Primary Study: Nine of 10 subjects completed both arms. There was no significant change in the primary outcome of saliva weight one month after injection in the treatment period compared to placebo period (mean difference, gm ± SD: -0.194 ± 0.61, range: -1.28 to 0.97, 95% CI -0.71 to 0.32). Secondary outcomes also did not change. 2. Meta-analysis of six studies demonstrated significant benefit of Botulinum toxin on functional outcomes (effect size, Cohen's d: -1.32, CI -1.86 to -0.78). The other studies used a higher dose of Botulinum toxin A into the parotid glands. This study did not demonstrate efficacy of incobotulinum toxin A for drooling in PD, but lacked precision to exclude moderate benefit. The parotid/submandibular dose-ratio may have influenced results. Studies evaluating higher doses of incobotulinum toxin A into the parotid glands may be useful. Copyright © 2016 Elsevier Ltd. All rights reserved.

  4. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration

    DEFF Research Database (Denmark)

    Liberati, Alessandro; Altman, Douglas G; Tetzlaff, Jennifer

    2009-01-01

    Systematic reviews and meta-analyses are essential to summarize evidence relating to efficacy and safety of health care interventions accurately and reliably. The clarity and transparency of these reports, however, is not optimal. Poor reporting of systematic reviews diminishes their value...... to clinicians, policy makers, and other users. Since the development of the QUOROM (QUality Of Reporting Of Meta-analysis) Statement--a reporting guideline published in 1999--there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews...... and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realizing these issues, an international group that included experienced authors and methodologists developed PRISMA (Preferred Reporting Items for Systematic...

  5. Using meta-analytic path analysis to test theoretical predictions in health behavior: An illustration based on meta-analyses of the theory of planned behavior.

    Science.gov (United States)

    Hagger, Martin S; Chan, Derwin K C; Protogerou, Cleo; Chatzisarantis, Nikos L D

    2016-08-01

    Synthesizing research on social cognitive theories applied to health behavior is an important step in the development of an evidence base of psychological factors as targets for effective behavioral interventions. However, few meta-analyses of research on social cognitive theories in health contexts have conducted simultaneous tests of theoretically-stipulated pattern effects using path analysis. We argue that conducting path analyses of meta-analytic effects among constructs from social cognitive theories is important to test nomological validity, account for mediation effects, and evaluate unique effects of theory constructs independent of past behavior. We illustrate our points by conducting new analyses of two meta-analyses of a popular theory applied to health behaviors, the theory of planned behavior. We conducted meta-analytic path analyses of the theory in two behavioral contexts (alcohol and dietary behaviors) using data from the primary studies included in the original meta-analyses augmented to include intercorrelations among constructs and relations with past behavior missing from the original analysis. Findings supported the nomological validity of the theory and its hypotheses for both behaviors, confirmed important model processes through mediation analysis, demonstrated the attenuating effect of past behavior on theory relations, and provided estimates of the unique effects of theory constructs independent of past behavior. Our analysis illustrates the importance of conducting a simultaneous test of theory-stipulated effects in meta-analyses of social cognitive theories applied to health behavior. We recommend researchers adopt this analytic procedure when synthesizing evidence across primary tests of social cognitive theories in health. Copyright © 2016 Elsevier Inc. All rights reserved.

  6. Using meta-analytic path analysis to test theoretical predictions in health behavior: An illustration based on meta-analyses of the theory of planned behavior

    OpenAIRE

    Hagger, Martin; Chan, Dervin K. C.; Protogerou, Cleo; Chatzisarantis, Nikos L. D.

    2016-01-01

    Objective Synthesizing research on social cognitive theories applied to health behavior is an important step in the development of an evidence base of psychological factors as targets for effective behavioral interventions. However, few meta-analyses of research on social cognitive theories in health contexts have conducted simultaneous tests of theoretically-stipulated pattern effects using path analysis. We argue that conducting path analyses of meta-analytic effects among constructs fr...

  7. Comparison of intra-articular hyaluronic acid and methylprednisolone for pain management in knee osteoarthritis: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Ran, Jian; Yang, Xiaohui; Ren, Zheng; Wang, Jian; Dong, Hui

    2018-05-01

    We performed a meta-analysis of randomized controlled trials (RCTs) to compare the efficacy and safety of intra-articular methylprednisolone and hyaluronic acid (HA) in term of pain reduction and improvements of knee function in patients with knee osteoarthritis (OA). The PubMed, EMBASE, ScienceDirect, and Cochrane Library databases were systematically searched for literature up to January 2018. RCTs involving HA and methylprednisolone in knee OA were included. Two independent reviewers performed independent data abstraction. The I 2 statistic was used to assess heterogeneity. A fixed or random effects model was adopted for meta-analysis. All meta-analyses were performed by using STATA 14.0. Five RCTs with 1004 patients were included in the meta-analysis. The present meta-analysis indicated that there were no significant differences in terms of WOMAC pain, physical function and stiffness at 4 week, 12 weeks and 26 weeks between HA and methylprednisolone groups. No increased risk of adverse events were identified in both groups. Both HA and methylprednisolone injections were effective therapies for patients with knee OA. Methylprednisolone showed comparable efficacy in reducing pain and improving functional recovery to HA. And no significant difference was found in long-term of follow-up in terms of adverse effects. Copyright © 2018 IJS Publishing Group Ltd. All rights reserved.

  8. Pleiotropic Meta-Analyses of Longitudinal Studies Discover Novel Genetic Variants Associated with Age-Related Diseases

    Directory of Open Access Journals (Sweden)

    Liang He

    2016-10-01

    Full Text Available Age-related diseases may result from shared biological mechanisms in intrinsic processes of aging. Genetic effects on age-related diseases are often modulated by environmental factors due to their little contribution to fitness or are mediated through certain endophenotypes. Identification of genetic variants with pleiotropic effects on both common complex diseases and endophenotypes may reveal potential conflicting evolutionary pressures and deliver new insights into shared genetic contribution to healthspan and lifespan. Here, we performed pleiotropic meta-analyses of genetic variants using five NIH-funded datasets by integrating univariate summary statistics for age-related diseases and endophenotypes. We investigated three groups of traits: (1 endophenotypes such as blood glucose, blood pressure, lipids, hematocrit, and body mass index, (2 time-to-event outcomes such as the age-at-onset of diabetes mellitus (DM, cancer, cardiovascular diseases (CVDs and neurodegenerative diseases (NDs, and (3 both combined. In addition to replicating previous findings, we identify seven novel genome-wide significant loci (< 5e-08, out of which five are low-frequency variants. Specifically, from Group 2, we find rs7632505 on 3q21.1 in SEMA5B, rs460976 on 21q22.3 (1 kb from TMPRSS2 and rs12420422 on 11q24.1 predominantly associated with a variety of CVDs, rs4905014 in ITPK1 associated with stroke and heart failure, rs7081476 on 10p12.1 in ANKRD26 associated with multiple diseases including DM, CVDs, and NDs. From Group 3, we find rs8082812 on 18p11.22 and rs1869717 on 4q31.3 associated with both endophenotypes and CVDs. Our follow-up analyses show that rs7632505, rs4905014, and rs8082812 have age-dependent effects on coronary heart disease or stroke. Functional annotation suggests that most of these SNPs are within regulatory regions or DNase clusters and in linkage disequilibrium with expression quantitative trait loci, implying their potential regulatory

  9. Deep Sequencing of Three Loci Implicated in Large-Scale Genome-Wide Association Study Smoking Meta-Analyses.

    Science.gov (United States)

    Clark, Shaunna L; McClay, Joseph L; Adkins, Daniel E; Aberg, Karolina A; Kumar, Gaurav; Nerella, Sri; Xie, Linying; Collins, Ann L; Crowley, James J; Quakenbush, Corey R; Hillard, Christopher E; Gao, Guimin; Shabalin, Andrey A; Peterson, Roseann E; Copeland, William E; Silberg, Judy L; Maes, Hermine; Sullivan, Patrick F; Costello, Elizabeth J; van den Oord, Edwin J

    2016-05-01

    Genome-wide association study meta-analyses have robustly implicated three loci that affect susceptibility for smoking: CHRNA5\\CHRNA3\\CHRNB4, CHRNB3\\CHRNA6 and EGLN2\\CYP2A6. Functional follow-up studies of these loci are needed to provide insight into biological mechanisms. However, these efforts have been hampered by a lack of knowledge about the specific causal variant(s) involved. In this study, we prioritized variants in terms of the likelihood they account for the reported associations. We employed targeted capture of the CHRNA5\\CHRNA3\\CHRNB4, CHRNB3\\CHRNA6, and EGLN2\\CYP2A6 loci and flanking regions followed by next-generation deep sequencing (mean coverage 78×) to capture genomic variation in 363 individuals. We performed single locus tests to determine if any single variant accounts for the association, and examined if sets of (rare) variants that overlapped with biologically meaningful annotations account for the associations. In total, we investigated 963 variants, of which 71.1% were rare (minor allele frequency < 0.01), 6.02% were insertion/deletions, and 51.7% were catalogued in dbSNP141. The single variant results showed that no variant fully accounts for the association in any region. In the variant set results, CHRNB4 accounts for most of the signal with significant sets consisting of directly damaging variants. CHRNA6 explains most of the signal in the CHRNB3\\CHRNA6 locus with significant sets indicating a regulatory role for CHRNA6. Significant sets in CYP2A6 involved directly damaging variants while the significant variant sets suggested a regulatory role for EGLN2. We found that multiple variants implicating multiple processes explain the signal. Some variants can be prioritized for functional follow-up. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  10. Garlic powder intake and cardiovascular risk factors: a meta-analysis of randomized controlled clinical trials.

    Science.gov (United States)

    Kwak, Jin Sook; Kim, Ji Yeon; Paek, Ju Eun; Lee, You Jin; Kim, Haeng-Ran; Park, Dong-Sik; Kwon, Oran

    2014-12-01

    Although preclinical studies suggest that garlic has potential preventive effects on cardiovascular disease (CVD) risk factors, clinical trials and reports from systematic reviews or meta-analyses present inconsistent results. The contradiction might be attributed to variations in the manufacturing process that can markedly influence the composition of garlic products. To investigate this issue further, we performed a meta-analysis of the effects of garlic powder on CVD risk factors. We searched PubMed, Cochrane, Science Direct and EMBASE through May 2014. A random-effects meta-analysis was performed on 22 trials reporting total cholesterol (TC), 17 trials reporting LDL cholesterol (LDL-C), 18 trials reporting HDL cholesterol (HDL-C), 4 trials reporting fasting blood glucose (FBG), 9 trials reporting systolic blood pressure (SBP) and 10 trials reporting diastolic blood pressure (DBP). The overall garlic powder intake significantly reduced blood TC and LDL-C by -0.41 mmol/L (95% confidence interval [CI], -0.69, -0.12) (-15.83 mg/dL [95% CI, -26.64, -4.63]) and -0.21 mmol/L (95% CI, -0.40, -0.03) (-8.11 mg/dL [95% CI, -15.44, -1.16]), respectively. The mean difference in the reduction of FBG levels was -0.96 mmol/L (95% CI, -1.91, -0.01) (-17.30 mg/dL [95% CI, -34.41, -0.18]). Evidence for SBP and DBP reduction in the garlic supplementation group was also demonstrated by decreases of -4.34 mmHg (95% CI, -8.38, -0.29) and -2.36 mmHg (95% CI, -4.56, -0.15), respectively. This meta-analysis provides consistent evidence that garlic powder intake reduces the CVD risk factors of TC, LDL-C, FBG and BP.

  11. Systematic review finds that study data not published in full text articles have unclear impact on meta-analyses results in medical research.

    Science.gov (United States)

    Schmucker, Christine M; Blümle, Anette; Schell, Lisa K; Schwarzer, Guido; Oeller, Patrick; Cabrera, Laura; von Elm, Erik; Briel, Matthias; Meerpohl, Joerg J

    2017-01-01

    A meta-analysis as part of a systematic review aims to provide a thorough, comprehensive and unbiased statistical summary of data from the literature. However, relevant study results could be missing from a meta-analysis because of selective publication and inadequate dissemination. If missing outcome data differ systematically from published ones, a meta-analysis will be biased with an inaccurate assessment of the intervention effect. As part of the EU-funded OPEN project (www.open-project.eu) we conducted a systematic review that assessed whether the inclusion of data that were not published at all and/or published only in the grey literature influences pooled effect estimates in meta-analyses and leads to different interpretation. Systematic review of published literature (methodological research projects). Four bibliographic databases were searched up to February 2016 without restriction of publication year or language. Methodological research projects were considered eligible for inclusion if they reviewed a cohort of meta-analyses which (i) compared pooled effect estimates of meta-analyses of health care interventions according to publication status of data or (ii) examined whether the inclusion of unpublished or grey literature data impacts the result of a meta-analysis. Seven methodological research projects including 187 meta-analyses comparing pooled treatment effect estimates according to different publication status were identified. Two research projects showed that published data showed larger pooled treatment effects in favour of the intervention than unpublished or grey literature data (Ratio of ORs 1.15, 95% CI 1.04-1.28 and 1.34, 95% CI 1.09-1.66). In the remaining research projects pooled effect estimates and/or overall findings were not significantly changed by the inclusion of unpublished and/or grey literature data. The precision of the pooled estimate was increased with narrower 95% confidence interval. Although we may anticipate that

  12. Mindfulness-based stress reduction (MBSR) as sole intervention for non-somatisation chronic non-cancer pain (CNCP): protocol for a systematic review and meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Leung, Lawrence; Han, Han; Martin, Mary; Kotecha, Jyoti

    2015-05-18

    Chronic non-cancer pain (CNCP) affects up to 50% of the world's population. It impacts negatively on quality of life; entailing high costs on our medical systems, and translates to economic burden due to work loss. Aetiology of CNCP is complex and multifactorial, embracing the somatosensory, cognitive and affective domains. Opioid analgesia and other invasive interventions are often inadequate for clinical management of CNCP. Recently, mindfulness-based stress reduction (MBSR) has become a popular therapy for various medical conditions, including CNCP. However, studies reported varying efficacies, and relevant systematic reviews have included clinical trials with inherent heterogeneity either in study conditions or types of interventions used. Our study aims to provide an updated and more critical evaluation of the efficacy of MBSR as the intervention for non-somatisation CNCP. A systematic review with meta-analysis of randomised controlled trials published in English will be performed in accordance with the Preferred Reporting Items for Systematic reviews and Meta-analyses (PRISMA) guidelines and the Cochrane Collaboration format. MEDLINE, EMBASE, PsychINFO, and the Cochrane Central Register of Controlled Trials Intervention, will be searched independently by reviewers using defined MeSH terms. Studies with full texts using MBSR as the main intervention on patients with non-somatising CNCP will be included. Outcome measures include pain scores and disability assessment scales. Continuous data will be meta-analysed using the RevMan 5 Review Manager programme. Primary analysis will adopt the random effects model in view of heterogeneity between trials. The standardised mean difference will be expressed as the effect size with 95% CIs. Forest plots, funnel plots, the I(2) statistic and the Cochrane Risks of Bias Assessment table will be included. No ethics approval is deemed necessary. Results of this study will be disseminated via peer-reviewed publications and

  13. Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

    Science.gov (United States)

    Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

    2014-07-16

    To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

  14. Randomized controlled trials of COX-2 inhibitors

    DEFF Research Database (Denmark)

    Stefansdottir, Gudrun; De Bruin, Marie L; Knol, Mirjam J

    2011-01-01

    trials after the 2004 market withdrawal of rofecoxib were excluded. RESULTS: Median defined daily dose (DDD) of celecoxib (2.00) was higher than the median DDD of rofecoxib (1.00; p ... celecoxib after the withdrawal of rofecoxib because the overall median DDD of celecoxib was substantially higher than the median DDD of rofecoxib, while non-selective NSAID DDDs were comparable....

  15. Publication status of contemporary oncology randomised controlled trials worldwide.

    Science.gov (United States)

    Chen, Yu-Pei; Liu, Xu; Lv, Jia-Wei; Li, Wen-Fei; Zhang, Yuan; Guo, Ying; Lin, Ai-Hua; Sun, Ying; Mao, Yan-Ping; Ma, Jun

    2016-10-01

    Little is known about the extent of selective publication in contemporary oncology randomised controlled trials (RCTs) worldwide. This study aimed to evaluate the rates of publication and timely publication (within 24 months) for contemporary oncology RCTs from all over the world. We also investigated the trial characteristics associated with publication and timely publication. We identified all phase III oncology RCTs registered on ClinicalTrials.gov with a primary completion date between January 2008 and December 2012. We searched PubMed and EMBASE to identify publications. The final search date was 31 December 2015. Our primary outcome measure was the time to publication from the primary completion date to the date of primary publication in a peer-reviewed journal. We identified 598 completed oncology RCTs; overall, 398 (66.6%) had been published. For published trials, the median time to publication was 25 months (interquartile range, 16-37 months). Only 192 trials (32.1%) were published within 24 months. Timely publication was independently associated with trials completed late in 2012. Trials conducted in Asia and other regions were less likely to have timely publication, but trials conducted in different locations were all equally likely to be published. Industry- and NIH-funded trials were equally likely to be published timely or at any time after trial completion. Among 391 published trials with clear primary outcomes, there was a trend for timely publication of positive trials compared with negative trials. Despite the ethical obligations and societal expectations of disclosing findings promptly, oncology RCTs performed poorly. Copyright © 2016 Elsevier Ltd. All rights reserved.

  16. Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial

    DEFF Research Database (Denmark)

    Kreiner, Frederik; Galbo, Henrik

    2010-01-01

    To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR.......To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR....

  17. Evaluation of the effect of patient education on rates of falls in older hospital patients: Description of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Hoffmann Tammy

    2009-04-01

    Full Text Available Abstract Background Accidental falls by older patients in hospital are one of the most commonly reported adverse events. Falls after discharge are also common. These falls have enormous physical, psychological and social consequences for older patients, including serious physical injury and reduced quality of life, and are also a source of substantial cost to health systems worldwide. There have been a limited number of randomised controlled trials, mainly using multifactorial interventions, aiming to prevent older people falling whilst inpatients. Trials to date have produced conflicting results and recent meta-analyses highlight that there is still insufficient evidence to clearly identify which interventions may reduce the rate of falls, and falls related injuries, in this population. Methods and design A prospective randomised controlled trial (n = 1206 is being conducted at two hospitals in Australia. Patients are eligible to be included in the trial if they are over 60 years of age and they, or their family or guardian, give written consent. Participants are randomised into three groups. The control group continues to receive usual care. Both intervention groups receive a specifically designed patient education intervention on minimising falls in addition to usual care. The education is delivered by Digital Video Disc (DVD and written workbook and aims to promote falls prevention activities by participants. One of the intervention groups also receives follow up education training visits by a health professional. Blinded assessors conduct baseline and discharge assessments and follow up participants for 6 months after discharge. The primary outcome measure is falls by participants in hospital. Secondary outcome measures include falls at home after discharge, knowledge of falls prevention strategies and motivation to engage in falls prevention activities after discharge. All analyses will be based on intention to treat principle. Discussion

  18. Incidence of schizophrenia and other psychoses in England, 1950-2009: a systematic review and meta-analyses.

    Directory of Open Access Journals (Sweden)

    James B Kirkbride

    Full Text Available We conducted a systematic review of incidence rates in England over a sixty-year period to determine the extent to which rates varied along accepted (age, sex and less-accepted epidemiological gradients (ethnicity, migration and place of birth and upbringing, time.To determine variation in incidence of several psychotic disorders as above.Published and grey literature searches (MEDLINE, PSycINFO, EMBASE, CINAHL, ASSIA, HMIC, and identification of unpublished data through bibliographic searches and author communication.Published 1950-2009; conducted wholly or partially in England; original data on incidence of non-organic adult-onset psychosis or one or more factor(s pertaining to incidence.People, 16-64 years, with first -onset psychosis, including non-affective psychoses, schizophrenia, bipolar disorder, psychotic depression and substance-induced psychosis.Title, abstract and full-text review by two independent raters to identify suitable citations. Data were extracted to a standardized extraction form. Descriptive appraisals of variation in rates, including tables and forest plots, and where suitable, random-effects meta-analyses and meta-regressions to test specific hypotheses; rate heterogeneity was assessed by the I²-statistic.83 citations met inclusion. Pooled incidence of all psychoses (N = 9 was 31.7 per 100,000 person-years (95%CI: 24.6-40.9, 23.2 (95%CI: 18.3-29.5 for non-affective psychoses (N = 8, 15.2 (95%CI: 11.9-19.5 for schizophrenia (N = 15 and 12.4 (95%CI: 9.0-17.1 for affective psychoses (N = 7. This masked rate heterogeneity (I²: 0.54-0.97, possibly explained by socio-environmental factors; our review confirmed (via meta-regression the typical age-sex interaction in psychosis risk, including secondary peak onset in women after 45 years. Rates of most disorders were elevated in several ethnic minority groups compared with the white (British population. For example, for schizophrenia: black Caribbean (pooled

  19. Incidence of schizophrenia and other psychoses in England, 1950-2009: a systematic review and meta-analyses.

    Science.gov (United States)

    Kirkbride, James B; Errazuriz, Antonia; Croudace, Tim J; Morgan, Craig; Jackson, Daniel; Boydell, Jane; Murray, Robin M; Jones, Peter B

    2012-01-01

    We conducted a systematic review of incidence rates in England over a sixty-year period to determine the extent to which rates varied along accepted (age, sex) and less-accepted epidemiological gradients (ethnicity, migration and place of birth and upbringing, time). To determine variation in incidence of several psychotic disorders as above. Published and grey literature searches (MEDLINE, PSycINFO, EMBASE, CINAHL, ASSIA, HMIC), and identification of unpublished data through bibliographic searches and author communication. Published 1950-2009; conducted wholly or partially in England; original data on incidence of non-organic adult-onset psychosis or one or more factor(s) pertaining to incidence. People, 16-64 years, with first -onset psychosis, including non-affective psychoses, schizophrenia, bipolar disorder, psychotic depression and substance-induced psychosis. Title, abstract and full-text review by two independent raters to identify suitable citations. Data were extracted to a standardized extraction form. Descriptive appraisals of variation in rates, including tables and forest plots, and where suitable, random-effects meta-analyses and meta-regressions to test specific hypotheses; rate heterogeneity was assessed by the I²-statistic. 83 citations met inclusion. Pooled incidence of all psychoses (N = 9) was 31.7 per 100,000 person-years (95%CI: 24.6-40.9), 23.2 (95%CI: 18.3-29.5) for non-affective psychoses (N = 8), 15.2 (95%CI: 11.9-19.5) for schizophrenia (N = 15) and 12.4 (95%CI: 9.0-17.1) for affective psychoses (N = 7). This masked rate heterogeneity (I²: 0.54-0.97), possibly explained by socio-environmental factors; our review confirmed (via meta-regression) the typical age-sex interaction in psychosis risk, including secondary peak onset in women after 45 years. Rates of most disorders were elevated in several ethnic minority groups compared with the white (British) population. For example, for schizophrenia: black Caribbean (pooled

  20. The Effects of Vitamin D Supplementation on Biomarkers of Inflammation and Oxidative Stress in Diabetic Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Mansournia, Mohammad Ali; Ostadmohammadi, Vahidreza; Doosti-Irani, Amin; Ghayour-Mobarhan, Majid; Ferns, Gordon; Akbari, Hossein; Ghaderi, Amir; Talari, Hamid Reza; Asemi, Zatollah

    2018-06-01

    In this systematic review and meta-analysis of randomized controlled trials (RCTs), the effects of vitamin D supplementation on biomarkers of inflammation and oxidative stress in diabetic patients are summarized. The following databases were searched up to December 2017: MEDLINE, EMBASE, Web of Science, and Cochrane Central Register of Controlled Trials. The quality of the relevant extracted data was assessed according to the Cochrane risk of bias tool. Data were pooled using the inverse variance method and expressed as mean difference with 95% Confidence Intervals (95% CI). Heterogeneity between studies was assessed by the Cochran Q statistic and I-squared tests (I 2 ). Overall, 33 studies were included in the meta-analyses. Vitamin D supplementation were found to significantly reduce serum high-sensitivity C-reactive protein (hs-CRP) (WMD 0.27; 95% CI, - 0.35, - 0.20; p<0.001) and malondialdehyde (MDA) levels (WMD - 0.43, 95% CI - 0.62, - 0.25, p<0.001) in diabetic patients. In addition, vitamin D supplementation were found to increase markers of nitric oxide (NO) release (WMD 4.33, 95% CI 0.96, 7.70), total serum antioxidant capacity (TAC) (WMD 57.34, 95% CI 33.48, 81.20, p<0.001) and total glutathione (GSH) levels (WMD 82.59, 95% CI 44.37, 120.81, p<0.001). Overall, this meta-analysis shows that in diabetic patients, taking vitamin D had significant effects on hs-CRP and MDA levels, and significantly increased NO, TAC and GSH levels. © Georg Thieme Verlag KG Stuttgart · New York.

  1. Citation networks of related trials are often disconnected: implications for bidirectional citation searches.

    Science.gov (United States)

    Robinson, Karen A; Dunn, Adam G; Tsafnat, Guy; Glasziou, Paul

    2014-07-01

    Reports of randomized controlled trials (RCTs) should set findings within the context of previous research. The resulting network of citations would also provide an alternative search method for clinicians, researchers, and systematic reviewers seeking to base decisions on all available evidence. We sought to determine the connectedness of citation networks of RCTs by examining direct (referenced trials) and indirect (through references of referenced trials, etc) citation of trials to one another. Meta-analyses were used to create citation networks of RCTs addressing the same clinical questions. The primary measure was the proportion of networks where following citation links between RCTs identifies the complete set of RCTs, forming a single connected citation group. Other measures included the number of disconnected groups (islands) within each network, the number of citations in the network relative to the maximum possible, and the maximum number of links in the path between two connected trials (a measure of indirectness of citations). We included 259 meta-analyses with a total of 2,413 and a median of seven RCTs each. For 46% (118 of 259) of networks, the RCTs formed a single connected citation group-one island. For the other 54% of networks, where at least one RCT group was not cited by others, 39% had two citation islands and 4% (10 of 257) had 10 or more islands. On average, the citation networks had 38% of the possible citations to other trials (if each trial had cited all earlier trials). The number of citation islands and the maximum number of citation links increased with increasing numbers of trials in the network. Available evidence to answer a clinical question may be identified by using network citations created with a small initial corpus of eligible trials. However, the number of islands means that citation networks cannot be relied on for evidence retrieval. Copyright © 2014 Elsevier Inc. All rights reserved.

  2. No evidence for genome-wide interactions on plasma fibrinogen by smoking, alcohol consumption and body mass index: results from meta-analyses of 80,607 subjects.

    Directory of Open Access Journals (Sweden)

    Jens Baumert

    Full Text Available Plasma fibrinogen is an acute phase protein playing an important role in the blood coagulation cascade having strong associations with smoking, alcohol consumption and body mass index (BMI. Genome-wide association studies (GWAS have identified a variety of gene regions associated with elevated plasma fibrinogen concentrations. However, little is yet known about how associations between environmental factors and fibrinogen might be modified by genetic variation. Therefore, we conducted large-scale meta-analyses of genome-wide interaction studies to identify possible interactions of genetic variants and smoking status, alcohol consumption or BMI on fibrinogen concentration. The present study included 80,607 subjects of European ancestry from 22 studies. Genome-wide interaction analyses were performed separately in each study for about 2.6 million single nucleotide polymorphisms (SNPs across the 22 autosomal chromosomes. For each SNP and risk factor, we performed a linear regression under an additive genetic model including an interaction term between SNP and risk factor. Interaction estimates were meta-analysed using a fixed-effects model. No genome-wide significant interaction with smoking status, alcohol consumption or BMI was observed in the meta-analyses. The most suggestive interaction was found for smoking and rs10519203, located in the LOC123688 region on chromosome 15, with a p value of 6.2 × 10(-8. This large genome-wide interaction study including 80,607 participants found no strong evidence of interaction between genetic variants and smoking status, alcohol consumption or BMI on fibrinogen concentrations. Further studies are needed to yield deeper insight in the interplay between environmental factors and gene variants on the regulation of fibrinogen concentrations.

  3. Alcohol Consumption and the Physical Availability of Take-Away Alcohol: Systematic Reviews and Meta-Analyses of the Days and Hours of Sale and Outlet Density.

    Science.gov (United States)

    Sherk, Adam; Stockwell, Tim; Chikritzhs, Tanya; Andréasson, Sven; Angus, Colin; Gripenberg, Johanna; Holder, Harold; Holmes, John; Mäkelä, Pia; Mills, Megan; Norström, Thor; Ramstedt, Mats; Woods, Jonathan

    2018-01-01

    Systematic reviews and meta-analyses were completed studying the effect of changes in the physical availability of take-away alcohol on per capita alcohol consumption. Previous reviews examining this topic have not focused on off-premise outlets where take-away alcohol is sold and have not completed meta-analyses. Systematic reviews were conducted separately for policies affecting the temporal availability (days and hours of sale) and spatial availability (outlet density) of take-away alcohol. Studies were included up to December 2015. Quality criteria were used to select articles that studied the effect of changes in these policies on alcohol consumption with a focus on natural experiments. Random-effects meta-analyses were applied to produce the estimated effect of an additional day of sale on total and beverage-specific consumption. Separate systematic reviews identified seven studies regarding days and hours of sale and four studies regarding density. The majority of articles included in these systematic reviews, for days/hours of sale (7/7) and outlet density (3/4), concluded that restricting the physical availability of take-away alcohol reduces per capita alcohol consumption. Meta-analyses studying the effect of adding one additional day of sale found that this was associated with per capita consumption increases of 3.4% (95% CI [2.7, 4.1]) for total alcohol, 5.3% (95% CI [3.2, 7.4]) for beer, 2.6% (95% CI [1.8, 3.5]) for wine, and 2.6% (95% CI [2.1, 3.2]) for spirits. The small number of included studies regarding hours of sale and density precluded meta-analysis. The results of this study suggest that decreasing the physical availability of take-away alcohol will decrease per capita consumption. As decreasing per capita consumption has been shown to reduce alcohol-related harm, restricting the physical availability of take-away alcohol would be expected to result in improvements to public health.

  4. Research Pearls: The Significance of Statistics and Perils of Pooling. Part 3: Pearls and Pitfalls of Meta-analyses and Systematic Reviews.

    Science.gov (United States)

    Harris, Joshua D; Brand, Jefferson C; Cote, Mark P; Dhawan, Aman

    2017-08-01

    Within the health care environment, there has been a recent and appropriate trend towards emphasizing the value of care provision. Reduced cost and higher quality improve the value of care. Quality is a challenging, heterogeneous, variably defined concept. At the core of quality is the patient's outcome, quantified by a vast assortment of subjective and objective outcome measures. There has been a recent evolution towards evidence-based medicine in health care, clearly elucidating the role of high-quality evidence across groups of patients and studies. Synthetic studies, such as systematic reviews and meta-analyses, are at the top of the evidence-based medicine hierarchy. Thus, these investigations may be the best potential source of guiding diagnostic, therapeutic, prognostic, and economic medical decision making. Systematic reviews critically appraise and synthesize the best available evidence to provide a conclusion statement (a "take-home point") in response to a specific answerable clinical question. A meta-analysis uses statistical methods to quantitatively combine data from single studies. Meta-analyses should be performed with high methodological quality homogenous studies (Level I or II) or evidence randomized studies, to minimize confounding variable bias. When it is known that the literature is inadequate or a recent systematic review has already been performed with a demonstration of insufficient data, then a new systematic review does not add anything meaningful to the literature. PROSPERO registration and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines assist authors in the design and conduct of systematic reviews and should always be used. Complete transparency of the conduct of the review permits reproducibility and improves fidelity of the conclusions. Pooling of data from overly dissimilar investigations should be avoided. This particularly applies to Level IV evidence, that is, noncomparative investigations

  5. Standards for reporting randomized controlled trials in neurosurgery.

    Science.gov (United States)

    Kiehna, Erin N; Starke, Robert M; Pouratian, Nader; Dumont, Aaron S

    2011-02-01

    The Consolidated Standards for Reporting of Trials (CONSORT) criteria were published in 1996 to standardize the reporting and improve the quality of clinical trials. Despite having been endorsed by major medical journals and shown to improve the quality of reported trials, neurosurgical journals have yet to formally adopt these reporting criteria. The purpose of this study is to evaluate the quality and reporting of randomized controlled trials (RCTs) in neurosurgery and the factors that may affect the quality of reported trials. The authors evaluated all neurosurgical RCTs published in 2006 and 2007 in the principal neurosurgical journals (Journal of Neurosurgery; Neurosurgery; Surgical Neurology; Journal of Neurology, Neurosurgery, and Psychiatry; and Acta Neurochirurgica) and in 3 leading general medical journals (Journal of the American Medical Association, Lancet, and the New England Journal of Medicine). Randomized controlled trials that addressed operative decision making or the treatment of neurosurgical patients were included in this analysis. The RCT quality was evaluated using the Jadad score and the CONSORT checklist. In 2006 and 2007, 27 RCTs relevant to intracranial neurosurgery were reported. Of these trials, only 59% had a Jadad score ≥ 3. The 3 major medical journals all endorsed the CONSORT guidelines, while none of the neurosurgical journals have adopted these guidelines. Randomized controlled trials published in the 3 major medical journals had a significantly higher mean CONSORT score (mean 41, range 39-44) compared with those published in neurosurgical journals (mean 26.4, range 17-38; p journals (mean 3.42, range 2-5) than neurosurgical journals (mean 2.45, range 1-5; p = 0.05). Despite the growing volume of RCTs in neurosurgery, the quality of reporting of these trials remains suboptimal, especially in the neurosurgical journals. Improved awareness of the CONSORT guidelines by journal editors, reviewers, and authors of these papers could

  6. From Controlled Trial to Community Adoption: The Multisite Translational Community Trial

    Science.gov (United States)

    Murimi, Mary; Gonzalez, Anjelica; Njike, Valentine; Green, Lawrence W.

    2011-01-01

    Methods for translating the findings of controlled trials, such as the Diabetes Prevention Program, into real-world community application have not been clearly defined. A standardized research methodology for making and evaluating such a transition is needed. We introduce the multisite translational community trial (mTCT) as the research analog to the multisite randomized controlled trial. The mTCT is adapted to incorporate the principles and practices of community-based participatory research and the increased relevance and generalizability gained from diverse community settings. The mTCT is a tool designed to bridge the gap between what a clinical trial demonstrates can work in principle and what is needed to make it workable and effective in real-world settings. Its utility could be put to the test, in particular with practice-based research networks such as the Prevention Research Centers. PMID:21680935

  7. Intervention Efficacy in Trials Targeting Cannabis Use Disorders in Patients with Comorbid Psychosis

    DEFF Research Database (Denmark)

    Hjorthoj, Carsten Rygaard; Baker, Amanda; Fohlmann, Allan

    2014-01-01

    Introduction: Cannabis use disorders are highly prevalent in patients with schizophrenia and other psychoses, and are probably associated with a range of poor outcomes. Several trials have been conducted on this population, the results of which have been summarized in several systematic reviews...... but never in meta-analyses specifically regarding cannabis use. Methods: PubMed, PsycINFO, EMBASE, and The Cochrane Central Register of Controlled Trials were searched using predefined search terms. We included randomized trials of all types of interventions targeting cannabis use disorders in patients...... with schizophrenia spectrum disorders. We extracted information on intervention types, efficacy, trial characteristics, and risk of bias. Results: There was no evidence of an effect on frequency of cannabis use, but intervention effects of motivational intervention with or without cognitive behavior therapy were...

  8. Antihypertensive drugs and risk of cancer: network meta-analyses and trial sequential analyses of 324,168 participants from randomised trials

    DEFF Research Database (Denmark)

    Bangalore, Sripal; Kumar, Sunil; Kjeldsen, Sverre E

    2011-01-01

    The risk of cancer from antihypertensive drugs has been much debated, with a recent analysis showing increased risk with angiotensin-receptor blockers (ARBs). We assessed the association between antihypertensive drugs and cancer risk in a comprehensive analysis of data from randomised clinical tr...

  9. The Asthma Control Questionnaire as a clinical trial endpoint

    DEFF Research Database (Denmark)

    Barnes, P J; Casale, T B; Dahl, Ronald

    2014-01-01

    these component endpoints; however, there is no consensus on the optimal instrument for use in clinical trials. The Asthma Control Questionnaire (ACQ) has been shown to be a valid, reliable instrument that allows accurate and reproducible assessment of asthma control that compares favourably with other commonly...

  10. What is the effect of health coaching on physical activity participation in people aged 60 years and over? A systematic review of randomised controlled trials.

    Science.gov (United States)

    Oliveira, Juliana S; Sherrington, Catherine; Amorim, Anita B; Dario, Amabile B; Tiedemann, Anne

    2017-10-01

    Physical inactivity is common in older age, yet increased activity benefits older people in terms of preventing chronic disease and maximising independence. Health coaching is a behaviour change intervention that has been shown to increase physical activity in clinical populations. This systematic review and meta-analysis investigated the effect of health coaching on physical activity, mobility, quality of life and mood in older people. MEDLINE, EMBASE, CENTRAL, PsycINFO, PEDro, SPORTDiscus, LILACS and CINAHL databases were used to identify randomised controlled trials which evaluated the effect of health coaching on physical activity (primary outcome) among people aged 60+. Secondary outcomes were mobility, quality of life and mood. We calculated standardised mean differences (SMDs, Hedges' g) with 95% CIs from random effects meta-analyses. 27 eligible trials were included. Health coaching had a small, statistically significant effect on physical activity (27 studies; SMD = 0.27; 95% CI 0.18 to 0.37; pcoaching on mobility (eight studies; SMD = 0.10; 95% CI -0.03 to 0.23; p=0.13), quality of life (eight studies; SMD = 0.07; 95% CI -0.06 to 0.20; pcoaching significantly increased physical activity in people aged 60+. There was no evidence of an effect of health coaching on quality of life, mobility and mood, so different approaches may be required to impact on these outcomes. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  11. Alternative intubation techniques vs Macintosh laryngoscopy in patients with cervical spine immobilization: systematic review and meta-analysis of randomized controlled trials

    Science.gov (United States)

    Suppan, L.; Tramèr, M. R.; Niquille, M.; Grosgurin, O.; Marti, C.

    2016-01-01

    Background. Immobilization of the cervical spine worsens tracheal intubation conditions. Various intubation devices have been tested in this setting. Their relative usefulness remains unclear. Methods. We searched MEDLINE, EMBASE, and the Cochrane Library for randomized controlled trials comparing any intubation device with the Macintosh laryngoscope in human subjects with cervical spine immobilization. The primary outcome was the risk of tracheal intubation failure at the first attempt. Secondary outcomes were quality of glottis visualization, time until successful intubation, and risk of oropharyngeal complications. Results. Twenty-four trials (1866 patients) met inclusion criteria. With alternative intubation devices, the risk of intubation failure was lower compared with Macintosh laryngoscopy [risk ratio (RR) 0.53; 95% confidence interval (CI) 0.35–0.80]. Meta-analyses could be performed for five intubation devices (Airtraq, Airwayscope, C-Mac, Glidescope, and McGrath). The Airtraq was associated with a statistically significant reduction of the risk of intubation failure at the first attempt (RR 0.14; 95% CI 0.06–0.33), a higher rate of Cormack–Lehane grade 1 (RR 2.98; 95% CI 1.94–4.56), a reduction of time until successful intubation (weighted mean difference −10.1 s; 95% CI −3.2 to −17.0), and a reduction of oropharyngeal complications (RR 0.24; 95% CI 0.06–0.93). Other devices were associated with improved glottis visualization but no statistically significant differences in intubation failure or time to intubation compared with conventional laryngoscopy. Conclusions. In situations where the spine is immobilized, the Airtraq device reduces the risk of intubation failure. There is a lack of evidence for the usefulness of other intubation devices. PMID:26133898

  12. Targeting intensive versus conventional glycaemic control for type 1 diabetes mellitus

    DEFF Research Database (Denmark)

    Kähler, Pernille; Grevstad, Berit; Almdal, Thomas

    2014-01-01

    OBJECTIVE: To assess the benefits and harms of targeting intensive versus conventional glycaemic control in patients with type 1 diabetes mellitus. DESIGN: A systematic review with meta-analyses and trial sequential analyses of randomised clinical trials. DATA SOURCES: The Cochrane Library, MEDLINE......, EMBASE, Science Citation Index Expanded and LILACS to January 2013. STUDY SELECTION: Randomised clinical trials that prespecified different targets of glycaemic control in participants at any age with type 1 diabetes mellitus were included. DATA EXTRACTION: Two authors independently assessed studies...... for inclusion and extracted data. RESULTS: 18 randomised clinical trials included 2254 participants with type 1 diabetes mellitus. All trials had high risk of bias. There was no statistically significant effect of targeting intensive glycaemic control on all-cause mortality (risk ratio 1.16, 95% CI 0.65 to 2...

  13. Inadequate description of educational interventions in ongoing randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Pino Cécile

    2012-05-01

    Full Text Available Abstract Background The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs of patient education. Methods On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers. Results We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%. The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47% or active treatment (47%. A minority of records (17%, 95% CI 11 to 23% reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention. Further, for most reports (59%, important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63

  14. Randomised controlled trials in educational research: Ontological ...

    African Journals Online (AJOL)

    based practice in medical and clinical settings because they are associated with a particular ontological and epistemological perspective that is situated within a positivist world view. It assumes that environments and variables can be controlled ...

  15. Heterogenic control groups in randomized, controlled, analgesic trials of total hip and knee arthroplasty.

    Science.gov (United States)

    Karlsen, Anders P; Mathiesen, Ole; Dahl, Jørgen B

    2018-03-01

    Postoperative analgesic interventions are often tested adjunct to basic non-opioid analgesics in randomized controlled trials (RCTs). Consequently, treatment in control groups, and possible assay sensitivity, differs between trials. We hypothesized that postoperative opioid requirements and pain intensities vary between different control groups in analgesic trials. Control groups from RCTs investigating analgesic interventions after total hip and knee arthroplasty were categorized based on standardized basic analgesic treatment. Morphine consumption 0 to 24 hours postoperatively, and resting pain scores at 6 and 24 hours for subgroups of basic treatments, were compared with ANOVA. In an additional analysis, we compared pain and opioid requirements in trials where a non-steroidal anti-inflammatory drug (NSAID) was administered as an intervention with trial where NSAID was administered in a control group. We included 171 RCTs employing 28 different control groups with large variability in pain scores and opioid requirements. Four types of control groups (comprising 78 trials) were eligible for subgroup comparisons. These subgroups received "opioid" alone, "NSAID + opioid", "acetaminophen + opioid", or "NSAID + acetaminophen + opioid", respectively. Morphine consumption and pain scores varied substantially between these groups, with no consistent superior efficacy in any subgroup. Additionally, trials administering NSAID as an intervention demonstrated lower pain scores and opioid requirements than trials where NSAID was administered in a control group. Analgesic treatment in RCT control groups varies considerably. Control groups receiving various combinations of opioid, NSAID and acetaminophen did not differ consistently in pain and opioid requirements. Pain and opioid requirements were lower in trials administering NSAID as an intervention compared with trials administering NSAID in a control group.

  16. Cupping therapy versus acupuncture for pain-related conditions: a systematic review of randomized controlled trials and trial sequential analysis.

    Science.gov (United States)

    Zhang, Ya-Jing; Cao, Hui-Juan; Li, Xin-Lin; Yang, Xiao-Ying; Lai, Bao-Yong; Yang, Guo-Yang; Liu, Jian-Ping

    2017-01-01

    Both cupping therapy and acupuncture have been used in China for a long time, and their target indications are pain-related conditions. There is no systematic review comparing the effectiveness of these two therapies. To compare the beneficial effectiveness and safety between cupping therapy and acupuncture for pain-related conditions to provide evidence for clinical practice. Protocol of this review was registered in PROSPERO (CRD42016050986). We conducted literature search from six electronic databases until 31st March 2017. We included randomized trials comparing cupping therapy with acupuncture on pain-related conditions. Methodological quality of the included studies was evaluated by risk of bias tool. Mean difference, risk ratio, risk difference and their 95% confidence interval were used to report the estimate effect of the pooled results through meta-analysis or the results from each individual study. Trial sequential analysis (TSA) was applied to adjust random errors and calculate the sample size. Twenty-three randomized trials with 2845 participants were included covering 12 pain-related conditions. All included studies were of poor methodological quality. Three meta-analyses were conducted, which showed similar clinical beneficial effects of cupping therapy and acupuncture for the rate of symptom improvement in cervical spondylosis (RR 1.13, 95% CI 1.01 to 1.26; n = 646), lateral femoral cutaneous neuritis (RR 1.10, 95% CI 1.00 to 1.22; n = 102) and scapulohumeral periarthritis (RR 1.31, 95% CI 1.15 to 1.51; n = 208). Results from other outcomes (such as visual analogue and numerical rating scale) in each study also showed no statistical significant difference between these two therapies for all included pain-related conditions. The results of TSA for cervical spondylosis demonstrated that the current available data have not reached a powerful conclusion. No serious adverse events related to cupping therapy or acupuncture was found in included

  17. Choosing a control intervention for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Djulbegovic Benjamin

    2003-04-01

    Full Text Available Abstract Background Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated. Discussion We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol. Summary When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.

  18. Use of commercial video games to improve postural balance in patients with multiple sclerosis: A systematic review and meta-analysis of randomised controlled clinical trials.

    Science.gov (United States)

    Parra-Moreno, M; Rodríguez-Juan, J J; Ruiz-Cárdenas, J D

    2018-03-07

    Commercial video games are considered an effective tool to improve postural balance in different populations. However, the effectiveness of these video games for patients with multiple sclerosis (MS) is unclear. To analyse existing evidence on the effects of commercial video games on postural balance in patients with MS. We conducted a systematic literature search on 11 databases (Academic-Search Complete, AMED, CENTRAL, CINAHL, WoS, IBECS, LILACS, Pubmed/Medline, Scielo, SPORTDiscus, and Science Direct) using the following terms: "multiple sclerosis", videogames, "video games", exergam*, "postural balance", posturography, "postural control", balance. Risk of bias was analysed by 2 independent reviewers. We conducted 3 fixed effect meta-analyses and calculated the difference of means (DM) and the 95% confidence interval (95% CI) for the Four Step Square Test, Timed 25-Foot Walk, and Berg Balance Scale. Five randomized controlled trials were included in the qualitative systematic review and 4 in the meta-analysis. We found no significant differences between the video game therapy group and the control group in Four Step Square Test (DM: -.74; 95% CI, -2.79-1.32; P=.48; I 2 =0%) and Timed 25-Foot Walk scores (DM: .15; 95% CI, -1.06-.76; P=.75; I 2 =0%). We did observe intergroup differences in BBS scores in favour of video game therapy (DM: 5.30; 95% CI, 3.39-7.21; P<.001; I 2 =0%), but these were not greater than the minimum detectable change reported in the literature. The effectiveness of commercial video game therapy for improving postural balance in patients with MS is limited. Copyright © 2018 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

  19. Randomised controlled trials and changing public health practice

    Directory of Open Access Journals (Sweden)

    Anne Cockcroft

    2017-05-01

    Full Text Available Abstract One reason for doing randomised controlled trials (RCTs is that experiments can be convincing. Early epidemiological experimenters, such as Jenner and the smallpox vaccine and Snow and his famous Broad Street pump handle, already knew the answer they were demonstrating; they used the experiments as knowledge translation devices to convince others. More sophisticated modern experiments include cluster randomised controlled trials (CRCTs for experiments in the public health setting. The knowledge translation value remains: RCTs and CRCTs can potentially stimulate changes of practice among stakeholders. Capitalising on the knowledge translation value of RCTs requires more than the standard reporting of trials. Those who are convinced by a trial and want to act, need to know how the trial relates to their own context, what contributed to success, and what might make it even more effective. Implementation research unpacks the back-story, examining how and why an intervention worked. The Camino Verde trial of community mobilisation for control of dengue reported a significant impact on entomological indices of the Aedes aegypti vector, and on serological dengue virus infection and self-reported dengue cases. This important study should lead to studies of similar interventions in other contexts, and ultimately to changes in dengue control practices. This supplement is the back-story of the trial, providing information to help researchers and planners to make use of the trial findings. Background articles include the full protocol, a systematic review of CRCTs of approaches for Aedes aegypti control, epidemiological and entomological findings from the baseline survey, and how baseline findings were used to set up the intervention. Secondary analyses of the entomological findings examine associations with the use of the larvicide temephos, and the impact of the intervention in different conditions of water supply and seasons. Other articles

  20. A Hierarchy of Patient-Reported Outcomes for Meta-Analysis of Knee Osteoarthritis Trials: Empirical Evidence from a Survey of High Impact Journals

    Directory of Open Access Journals (Sweden)

    Carsten Juhl

    2012-01-01

    Full Text Available Objectives. To develop a prioritised list based on responsiveness for extracting patient-reported outcomes (PROs measuring pain and disability for performing meta-analyses in knee osteoarthritis (OA. Methods. A systematic search was conducted in 20 highest impact factor general and rheumatology journals chosen a priori. Eligible studies were randomised controlled trials, using two or more PROs measuring pain and/or disability. Results. A literature search identified 402 publications and 38 trials were included, resulting in 54 randomised comparisons. Thirty-five trials had sufficient data on pain and 15 trials on disability. The WOMAC “pain” and “function” subscales were the most responsive composite scores. The following list was developed. Pain: (1 WOMAC “pain” subscale, (2 pain during activity (VAS, (3 pain during walking (VAS, (4 general knee pain (VAS, (5 pain at rest (VAS, (6 other composite pain scales, and (7 other single item measures. Disability: (1 WOMAC “function” subscale, (2 SF-36 “physical function” subscale, (3 SF-36 (Physical composite score, and (4 Other composite disability scores. Conclusions. As choosing the PRO most favourable for the intervention from individual trials can lead to biased estimates, using a prioritised list as developed in this study is recommended to reduce risk of biased selection of PROs in meta-analyses.

  1. Controlled trial of balneotherapy in treatment of low back pain.

    Science.gov (United States)

    Konrad, K; Tatrai, T; Hunka, A; Vereckei, E; Korondi, I

    1992-01-01

    Three treatments for non-specific lumbar pain--balneotherapy, underwater traction bath, and underwater massage--were assessed in a randomised prospective controlled trial in 158 outpatients. Each group was treated for four weeks and patients were reviewed at the end of this period and at 12 months after entry to the trial. The prescription of analgesics and the pain score were significantly reduced in all three treated groups, but there was no difference between the three groups. No significant change occurred in spinal motion and the straight leg raising test. After one year only the analgesic consumption was significantly lower than in the control group. PMID:1535495

  2. Risk and Protective Factors for Intimate Partner Violence Against Women: Systematic Review and Meta-analyses of Prospective-Longitudinal Studies.

    Science.gov (United States)

    Yakubovich, Alexa R; Stöckl, Heidi; Murray, Joseph; Melendez-Torres, G J; Steinert, Janina I; Glavin, Calla E Y; Humphreys, David K

    2018-07-01

    The estimated lifetime prevalence of physical or sexual intimate partner violence (IPV) is 30% among women worldwide. Understanding risk and protective factors is essential for designing effective prevention strategies. To quantify the associations between prospective-longitudinal risk and protective factors and IPV and identify evidence gaps. We conducted systematic searches in 16 databases including MEDLINE and PsycINFO from inception to June 2016. The study protocol is registered with PROSPERO (CRD42016039213). We included published and unpublished studies available in English that prospectively analyzed any risk or protective factor(s) for self-reported IPV victimization among women and controlled for at least 1 other variable. Three reviewers were involved in study screening. One reviewer extracted estimates of association and study characteristics from each study and 2 reviewers independently checked a random subset of extractions. We assessed study quality with the Cambridge Quality Checklists. When studies investigated the same risk or protective factor using similar measures, we computed pooled odds ratios (ORs) by using random-effects meta-analyses. We summarized heterogeneity with I 2 and τ 2 . We synthesized all estimates of association, including those not meta-analyzed, by using harvest plots to illustrate evidence gaps and trends toward negative or positive associations. Of 18 608 studies identified, 60 were included and 35 meta-analyzed. Most studies were based in the United States. The strongest evidence for modifiable risk factors for IPV against women were unplanned pregnancy (OR = 1.66; 95% confidence interval [CI] = 1.20, 1.31) and having parents with less than a high-school education (OR = 1.55; 95% CI = 1.10, 2.17). Being older (OR = 0.96; 95% CI = 0.93, 0.98) or married (OR = 0.93; 95% CI = 0.87, 0.99) were protective. To our knowledge, this is the first systematic, meta-analytic review of all risk and

  3. Assessing the risk of bias in randomized controlled trials in the field of dentistry indexed in the Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) database.

    Science.gov (United States)

    Ferreira, Christiane Alves; Loureiro, Carlos Alfredo Salles; Saconato, Humberto; Atallah, Alvaro Nagib

    2011-03-01

    Well-conducted randomized controlled trials (RCTs) represent the highest level of evidence when the research question relates to the effect of therapeutic or preventive interventions. However, the degree of control over bias between RCTs presents great variability between studies. For this reason, with the increasing interest in and production of systematic reviews and meta-analyses, it has been necessary to develop methodology supported by empirical evidence, so as to encourage and enhance the production of valid RCTs with low risk of bias. The aim here was to conduct a methodological analysis within the field of dentistry, regarding the risk of bias in open-access RCTs available in the Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) database. This was a methodology study conducted at Universidade Federal de São Paulo (Unifesp) that assessed the risk of bias in RCTs, using the following dimensions: allocation sequence generation, allocation concealment, blinding, and data on incomplete outcomes. Out of the 4,503 articles classified, only 10 studies (0.22%) were considered to be true RCTs and, of these, only a single study was classified as presenting low risk of bias. The items that the authors of these RCTs most frequently controlled for were blinding and data on incomplete outcomes. The effective presence of bias seriously weakened the reliability of the results from the dental studies evaluated, such that they would be of little use for clinicians and administrators as support for decision-making processes.

  4. Plastic vs. Self-Expandable Metal Stents for Palliation in Malignant Biliary Obstruction: A Series of Meta-Analyses.

    Science.gov (United States)

    Almadi, Majid A; Barkun, Alan; Martel, Myriam

    2017-02-01

    Self-expandable metal stents (SEMS) are thought to have an advantage over plastic stents in achieving biliary drainage. We performed a systematic search of MEDLINE, EMBASE, Scopus, CENTRAL, and ISI Web of knowledge databases, from January 1980 to September 2015, for randomized-controlled trials (RCTs) comparing SEMS vs. plastic stents in the palliation of malignant biliary obstruction. Primary outcomes were durations of stent patency, patient survival, and 30-day mortality. Numerous secondary outcomes were assessed, and extensive sensitivity and subgroup analyses were performed. In all, 20 RCTs totaling 1,713 patients yielded a weighted mean difference (WMD) in time to stent patency (4 studies) of 4.45 months (95% confidence interval (CI), 0.31, 8.59; GRADE=moderate) favoring SEMS. There were no differences in overall patient survival (5 studies) WMD=0.67 months (95% CI, -0.66, 1.99; GRADE=moderate), or 30-day mortality (8 studies) odds ratio (OR)=0.80 (95% CI, 0.52, 1.24; GRADE=moderate) but there was a higher symptom-free survival at 6 months (4 studies) OR=5.96 (95% CI, 1.71, 20.81; GRADE=moderate). SEMS use resulted in lower rates of late complications (11 studies) OR=0.43 (95% CI, 0.26, 0.71; GRADE=moderate), sepsis or cholangitis (14 studies) OR=0.53 (95% CI, 0.37, 0.77; GRADE=high), blocking from sludge (8 studies) OR=0.11(95% CI, 0.07, 0.17; GRADE=moderate), and mean number of re-interventions (8 studies) WMD=-0.83 interventions (95% CI, -1.64, -0.02; GRADE=moderate). There was a longer patency of SEMS for those without a prior drainage attempt (2 studies) WMD 7.70 months (95% CI, 7.14, 8.25; GRADE=high). Although a survival advantage was found when an uncovered SEMS was used (3 studies) WMD 1.31 months (95% CI, 0.30, 2.32; GRADE=high), but not partially or fully covered SEMS (2 studies) WMD -0.66 months (95% CI, -1.02, -0.30; GRADE=high) vs. plastic stents, and for SEMS in the setting of pre- or post-procedural antibiotic administration (2 studies) WMD 1

  5. External validity of randomized controlled trials of glycaemic control and vascular disease: how representative are participants?

    Science.gov (United States)

    Saunders, C; Byrne, C D; Guthrie, B; Lindsay, R S; McKnight, J A; Philip, S; Sattar, N; Walker, J J; Wild, S H

    2013-03-01

    To describe the proportion of people with Type 2 diabetes living in Scotland who meet eligibility criteria for inclusion in several large randomized controlled trials of glycaemic control to inform physicians and guideline developers about the generalizibility of trial results. A literature review was performed to identify large trials assessing the impact of glycaemic control on risk of macrovascular disease. Inclusion and exclusion criteria from each trial were applied to data on the population of people with a diagnosis of Type 2 diabetes living in Scotland in 2008 (n = 180,590) in a population-based cross-sectional study and the number and proportion of people eligible for each trial was determined. Seven trials were identified. The proportion of people with Type 2 diabetes who met the eligibility criteria for the trials ranged from 3.5 to 50.7%. Trial participants were younger at age of diagnosis of diabetes and at time of trial recruitment than in the Scottish study population. The application of upper age criteria excluded the largest proportion of patients, with up to 39% of people with Type 2 diabetes ineligible for a trial with the most stringent criteria based on age alone. We found that many of the large trials of glycaemic control among people with Type 2 diabetes have limited external validity when applied to a population-based cohort of people with Type 2 diabetes. In particular, the age distribution of trial participants often does not reflect that of people with Type 2 diabetes in a contemporary British population. © 2012 The Authors. Diabetic Medicine © 2012 Diabetes UK.

  6. Low degree of satisfactory individual pain relief in post-operative pain trials.

    Science.gov (United States)

    Geisler, A; Dahl, J B; Karlsen, A P H; Persson, E; Mathiesen, O

    2017-01-01

    The majority of clinical trials regarding post-operative pain treatment focuses on the average analgesic efficacy, rather than on efficacy in individual patients. It has been argued, that in acute pain trials, the underlying distributions are often skewed, which makes the average unfit as the only way to measure efficacy. Consequently, dichotomised, individual responder analyses using a predefined 'favourable' response, e.g. Visual Analogue Scale (VAS) pain scores ≤ 30, have recently been suggested as a more clinical relevant outcome. We re-analysed data from 16 randomised controlled trials of post-operative pain treatment and from meta-analyses of a systematic review regarding hip arthroplasty. The predefined success criterion was that at least 80% of patients in active treatment groups should obtain VAS < 30 at 6 and 24 h post-operatively. In the analysis of data from the randomised controlled trials, we found that at 6 h post-operatively, 50% (95% CI: 31-69) of patients allocated to active treatment reached the success criterion for pain at rest and 14% (95% CI: 5-34) for pain during mobilisation. At 24 h post-operatively, 60% (95% CI: 38-78) of patients allocated to active treatment reached the success criterion for pain at rest, and 15% (95% CI: 5-36) for pain during mobilisation. Similar results were found for trials from the meta-analyses. Our results indicate that for conventional, explanatory trials of post-operative pain, individual patient's achievement of a favourable response to analgesic treatment is rather low. Future pragmatic clinical trials should focus on both average pain levels and individual responder analyses in order to promote effective pain treatment at the individually patient level. © 2016 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  7. The efficacy and safety of medical leech therapy for osteoarthritis of the knee: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Wang, Haixia; Zhang, Jing; Chen, Liyan

    2018-06-01

    It is controversial on whether medical leech therapy is effective in improving pain and functional outcome in patients with knee osteoarthritis (OA). Therefore, we perform a meta-analysis from randomized controlled trials (RCTs) to evaluate the efficacy and safety of medical leech therapy in patients with knee OA. The PubMed, EMBASE, ScienceDirect, and Cochrane Library databases were systematically searched for literature up to January 2018. RCTs involving medical leech therapy in patients with knee OA were included. Two independent reviewers performed independent data abstraction. The I 2 statistic was used to assess heterogeneity. A fixed or random effects model was adopted for meta-analysis. All meta-analyses were performed by using STATA 12.0. Four RCTs with 264 patients were included in this meta-analysis. The current meta-analysis showed that there were significant differences in terms of visual analogue scale (VAS) scores and WOMAC scores at 1 week, 4weeks and 7 weeks compared with control groups. However, leech therapy was associated with a significantly higher incidence of adverse events. The overall evidence quality is moderate, which means that further research is likely to significantly change confidence in the effect estimate but may change the estimate. Medical leech therapy was associated with a significantly improved outcome in pain relief and functional recovery in patients with symptomatic knee OA. However, given the inherent limitations in the included studies, this conclusion should be interpreted cautiously. Copyright © 2018 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  8. Prevention of abdominal wound infection (PROUD trial, DRKS00000390: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Heger Ulrike

    2011-11-01

    Full Text Available Abstract Background Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating. Methods/Design The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available. Discussion The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity. Trial Registration The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390.

  9. Design, analysis and presentation of factorial randomised controlled trials

    Directory of Open Access Journals (Sweden)

    Little Paul

    2003-11-01

    Full Text Available Abstract Background The evaluation of more than one intervention in the same randomised controlled trial can be achieved using a parallel group design. However this requires increased sample size and can be inefficient, especially if there is also interest in considering combinations of the interventions. An alternative may be a factorial trial, where for two interventions participants are allocated to receive neither intervention, one or the other, or both. Factorial trials require special considerations, however, particularly at the design and analysis stages. Discussion Using a 2 × 2 factorial trial as an example, we present a number of issues that should be considered when planning a factorial trial. The main design issue is that of sample size. Factorial trials are most often powered to detect the main effects of interventions, since adequate power to detect plausible interactions requires greatly increased sample sizes. The main analytical issues relate to the investigation of main effects and the interaction between the interventions in appropriate regression models. Presentation of results should reflect the analytical strategy with an emphasis on the principal research questions. We also give an example of how baseline and follow-up data should be presented. Lastly, we discuss the implications of the design, analytical and presentational issues covered. Summary Difficulties in interpreting the results of factorial trials if an influential interaction is observed is the cost of the potential for efficient, simultaneous consideration of two or more interventions. Factorial trials can in principle be designed to have adequate power to detect realistic interactions, and in any case they are the only design that allows such effects to be investigated.

  10. The maturation of randomised controlled trials in mental health ...

    African Journals Online (AJOL)

    The aims of this paper are: (i) to give an overview of the use and maturation of randomised controlled trials (RCTs) in mental health services research, (ii) to indicate areas in which mental health may present particular challenges, and (iii) to outline necessary steps to strengthen the capacity to conduct better quality ...

  11. Randomized Controlled Trials: The Most Powerful Tool In Modern ...

    African Journals Online (AJOL)

    Randomized controlled trial (RCT) can be said to be one of the simplest but most powerful tool of research. It is the most rigorous way of determining whether a cause-effect relation exists between treatment and outcome and for assessing the cost effectiveness of a treatment. Through the randomization, bias will be avoided ...

  12. Yoga for High‑Risk Pregnancy: A Randomized Controlled Trial ...

    African Journals Online (AJOL)

    The study was a single‑blind randomized controlled clinical trial. Perceived stress scale (PSS) was measured during the 12th, 20th, and 28th weeks of pregnancy. SPSS version 16.0 (Chicago, IL, USA) was used for all data analysis. When the data were found to be normally distributed,the RMANOVA were used to assess ...

  13. Evaluating the Flipped Classroom: A Randomized Controlled Trial

    Science.gov (United States)

    Wozny, Nathan; Balser, Cary; Ives, Drew

    2018-01-01

    Despite recent interest in flipped classrooms, rigorous research evaluating their effectiveness is sparse. In this study, the authors implement a randomized controlled trial to evaluate the effect of a flipped classroom technique relative to a traditional lecture in an introductory undergraduate econometrics course. Random assignment enables the…

  14. A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

    African Journals Online (AJOL)

    A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee. ... All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy.

  15. Asthma Self-Management Model: Randomized Controlled Trial

    Science.gov (United States)

    Olivera, Carolina M. X.; Vianna, Elcio Oliveira; Bonizio, Roni C.; de Menezes, Marcelo B.; Ferraz, Erica; Cetlin, Andrea A.; Valdevite, Laura M.; Almeida, Gustavo A.; Araujo, Ana S.; Simoneti, Christian S.; de Freitas, Amanda; Lizzi, Elisangela A.; Borges, Marcos C.; de Freitas, Osvaldo

    2016-01-01

    Information for patients provided by the pharmacist is reflected in adhesion to treatment, clinical results and patient quality of life. The objective of this study was to assess an asthma self-management model for rational medicine use. This was a randomized controlled trial with 60 asthmatic patients assigned to attend five modules presented by…

  16. Benefits from antidepressants: synthesis of 6-week patient-level outcomes from double-blind placebo-controlled randomized trials of fluoxetine and venlafaxine.

    Science.gov (United States)

    Gibbons, Robert D; Hur, Kwan; Brown, C Hendricks; Davis, John M; Mann, J John

    2012-06-01

    Some meta-analyses suggest that efficacy of antidepressants for major depression is overstated and limited to severe depression. To determine the short-term efficacy of antidepressants for treating major depressive disorder in youth, adult, and geriatric populations. Reanalysis of all intent-to-treat person-level longitudinal data during the first 6 weeks of treatment of major depressive disorder from 12 adult, 4 geriatric, and 4 youth randomized controlled trials of fluoxetine hydrochloride and 21 adult trials of venlafaxine hydrochloride. All sponsor-conducted randomized controlled trials of fluoxetine and venlafaxine. Children's Depression Rating Scale-Revised scores (youth population), Hamilton Depression Rating Scale scores (adult and geriatric populations), and estimated response and remission rates at 6 weeks were analyzed for 2635 adults, 960 geriatric patients, and 708 youths receiving fluoxetine and for 2421 adults receiving immediate-release venlafaxine and 2461 adults receiving extended-release venlafaxine. Patients in all age and drug groups had significantly greater improvement relative to control patients receiving placebo. The differential rate of improvement was largest for adults receiving fluoxetine (34.6% greater than those receiving placebo). Youths had the largest treated vs control difference in response rates (24.1%) and remission rates (30.1%), with adult differences generally in the 15.6% (remission) to 21.4% (response) range. Geriatric patients had the smallest drug-placebo differences, an 18.5% greater rate of improvement, 9.9% for response and 6.5% for remission. Immediate-release venlafaxine produced larger effects than extended-release venlafaxine. Baseline severity could not be shown to affect symptom reduction. To our knowledge, this is the first research synthesis in this area to use complete longitudinal person-level data from a large set of published and unpublished studies. The results do not support previous findings that

  17. Cognitive Training for Attention-Deficit/Hyperactivity Disorder: Meta-Analysis of Clinical and Neuropsychological Outcomes From Randomized Controlled Trials

    Science.gov (United States)

    Cortese, Samuele; Ferrin, Maite; Brandeis, Daniel; Buitelaar, Jan; Daley, David; Dittmann, Ralf W.; Holtmann, Martin; Santosh, Paramala; Stevenson, Jim; Stringaris, Argyris; Zuddas, Alessandro; Sonuga-Barke, Edmund J.S.

    2015-01-01

    Objective The authors performed meta-analyses of randomized controlled trials to examine the effects of cognitive training on attention-deficit/hyperactivity disorder (ADHD) symptoms, neuropsychological deficits, and academic skills in children/adolescents with ADHD. Method The authors searched Pubmed, Ovid, Web of Science, ERIC, and CINAHAL databases through May 18, 2014. Data were aggregated using random-effects models. Studies were evaluated with the Cochrane risk of bias tool. Results Sixteen of 695 nonduplicate records were analyzed (759 children with ADHD). When all types of training were considered together, there were significant effects on total ADHD (standardized mean difference [SMD] = 0.37, 95% CI = 0.09–0.66) and inattentive symptoms (SMD = 0.47, 95% CI = 0.14–0.80) for reports by raters most proximal to the treatment setting (i.e., typically unblinded). These figures decreased substantially when the outcomes were provided by probably blinded raters (ADHD total: SMD = 0.20, 95% CI = 0.01–0.40; inattention: SMD = 0.32, 95% CI = −0.01 to 0.66). Effects on hyperactivity/impulsivity symptoms were not significant. There were significant effects on laboratory tests of working memory (verbal: SMD = 0.52, 95% CI = 0.24–0.80; visual: SMD = 0.47, 95% CI = 0.23–0.70) and parent ratings of executive function (SMD = 0.35, 95% CI = 0.08–0.61). Effects on academic performance were not statistically significant. There were no effects of working memory training, specifically on ADHD symptoms. Interventions targeting multiple neuropsychological deficits had large effects on ADHD symptoms rated by most proximal assessors (SMD = 0.79, 95% CI = 0.46–1.12). Conclusion Despite improving working memory performance, cognitive training had limited effects on ADHD symptoms according to assessments based on blinded measures. Approaches targeting multiple neuropsychological processes may optimize the transfer of effects from cognitive deficits to

  18. Ear Acupuncture for Acute Sore Throat: A Randomized Controlled Trial

    Science.gov (United States)

    2014-09-26

    SEP 2014 2. REPORT TYPE Final 3. DATES COVERED 4. TITLE AND SUBTITLE Ear acupuncture for acute sore throat. A randomized controlled trial...Auncular Acupuncture is a low risk option for acute pain control •Battlefield acupuncture (BFA) IS a specific auncular acupuncture technique •BFA IS...Strengths: Prospect1ve RCT •Weaknesses Small sample stze. no sham acupuncture performed, patients not blinded to treatment •Th1s study represents an

  19. Effectiveness of rehabilitation interventions in improving emotional and functional status in hearing or visually impaired older adults : a systematic review with meta-analyses

    NARCIS (Netherlands)

    Roets-Merken, Lieve M.; Draskovic, Irena; Zuidema, Sytse U.; van Erp, Willemijn S.; Graff, Maud J. L.; Kempen, Gertrudis I. J. M.; Vernooij-Dassen, Myrra J. F. J.

    Objective: To assess the effectiveness of non-equipment based rehabilitation interventions for older adults with an age-related hearing or visual impairment. Data sources: We searched PubMed, EMBASE, PsychInfo, CINAHL, and the Cochrane Central Register of Controlled Trials. Review methods: Two

  20. The relationship between zinc intake and serum/plasma zinc concentration in pregnant and lactating women: A systematic review with dose-response meta-analyses

    NARCIS (Netherlands)

    Hall Moran, V.; Skinner, A.L.; Warthon Medina, M.; Patel, S.; Dykes, F.; Souverein, O.W.; Dullemeijer, C.; Lowe, N.M.M.

    2012-01-01

    Recommendations for zinc intake during pregnancy and lactation vary widely across Europe. Using data on zinc intake and biomarkers of zinc status reported in randomized controlled trials (RCTs) and observational studies can provide estimates of dose–response relationships that may be used for

  1. Systematic review using meta-analyses to estimate dose-response relationships between iodine intake and biomarkers of iodine status in different population groups

    NARCIS (Netherlands)

    Ristic-Medic, D.; Dullemeijer, C.; Tepsic, J.; Petrovic-Oggiano, G.; Popovic, Z.; Arsic, A.; Glibetic, M.; Souverein, O.W.; Collings, R.; Cavelaars, A.J.E.M.; Groot, de C.P.G.M.; Veer, van 't P.; Gurinovic, M.

    2014-01-01

    The objective of this systematic review was to identify studies investigating iodine intake and biomarkers of iodine status, to assess the data of the selected studies, and to estimate dose-response relationships using meta-analysis. All randomized controlled trials, prospective cohort studies,

  2. Qigong and Fibromyalgia: Randomized Controlled Trials and Beyond

    Directory of Open Access Journals (Sweden)

    Jana Sawynok

    2014-01-01

    Full Text Available Introduction. Qigong is currently considered as meditative movement, mindful exercise, or complementary exercise and is being explored for relief of symptoms in fibromyalgia. Aim. This narrative review summarizes randomized controlled trials, as well as additional studies, of qigong published to the end of 2013 and discusses relevant methodological issues. Results. Controlled trials indicate regular qigong practice (daily, 6–8 weeks produces improvements in core domains for fibromyalgia (pain, sleep, impact, and physical and mental function that are maintained at 4–6 months compared to wait-list subjects or baselines. Comparisons with active controls show little difference, but compared to baseline there are significant and comparable effects in both groups. Open-label studies provide information that supports benefit but remain exploratory. An extension trial and case studies involving extended practice (daily, 6–12 months indicate marked benefits but are limited by the number of participants. Benefit appears to be related to amount of practice. Conclusions. There is considerable potential for qigong to be a useful complementary practice for the management of fibromyalgia. However, there are unique methodological challenges, and exploration of its clinical potential will need to focus on pragmatic issues and consider a spectrum of trial designs. Mechanistic considerations need to consider both system-wide and more specific effects.

  3. Genome-Wide Meta-Analyses of Breast, Ovarian, and Prostate Cancer Association Studies Identify Multiple New Susceptibility Loci Shared by at Least Two Cancer Types

    DEFF Research Database (Denmark)

    Kar, Siddhartha P; Beesley, Jonathan; Amin Al Olama, Ali

    2016-01-01

    UNLABELLED: Breast, ovarian, and prostate cancers are hormone-related and may have a shared genetic basis, but this has not been investigated systematically by genome-wide association (GWA) studies. Meta-analyses combining the largest GWA meta-analysis data sets for these cancers totaling 112...... (rs200182588/9q31/SMC2; rs8037137/15q26/RCCD1), and two breast and prostate cancer risk loci (rs5013329/1p34/NSUN4; rs9375701/6q23/L3MBTL3). Index variants in five additional regions previously associated with only one cancer also showed clear association with a second cancer type. Cell......-type-specific expression quantitative trait locus and enhancer-gene interaction annotations suggested target genes with potential cross-cancer roles at the new loci. Pathway analysis revealed significant enrichment of death receptor signaling genes near loci with P cancer meta-analysis. SIGNIFICANCE...

  4. Making evidence more wanted: a systematic review of facilitators to enhance the uptake of evidence from systematic reviews and meta-analyses.

    Science.gov (United States)

    Wallace, John; Byrne, Charles; Clarke, Mike

    2012-12-01

    The increased uptake of evidence from systematic reviews is advocated because of their potential to improve the quality of decision making for patient care. Systematic reviews can do this by decreasing inappropriate clinical variation and quickly expediting the application of current, effective advances to everyday practice. However, research suggests that evidence from systematic reviews has not been widely adopted by health professionals. Little is known about the facilitators to uptake of research evidence from systematic reviews and meta-analyses. To review the facilitators to the uptake by decision makers, of evidence from systematic, meta-analyses and the databases containing them. We searched 19 databases covering the full range of publication years, utilised three search engines and also personally contacted investigators. Grey literature and knowledge translation research was particularly sought. Reference lists of primary studies and related reviews were also searched. Studies were included if they reported on the views and perceptions of decision makers on the uptake of evidence from systematic reviews, meta-analyses and the databases associated with them. One investigator screened titles to identify candidate articles, and then two reviewers independently assessed the relevance of retrieved articles to exclude studies that did not meet the inclusion criteria. Quality of the included studies was also assessed. Using a pre-established taxonomy, two reviewers described the methods of included studies and extracted data that were summarised in tables and then analysed. Differences were resolved by consensus. Of articles initially identified, we selected unique published studies describing at least one facilitator to the uptake of evidence from systematic reviews. The 15 unique studies reported 10 surveys, three qualitative investigations and two mixed studies that addressed potential facilitators. Five studies were from Canada, four from the UK, three from

  5. Effects of Wearable Sensor-Based Balance and Gait Training on Balance, Gait, and Functional Performance in Healthy and Patient Populations: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Gordt, Katharina; Gerhardy, Thomas; Najafi, Bijan; Schwenk, Michael

    2018-01-01

    Wearable sensors (WS) can accurately measure body motion and provide interactive feedback for supporting motor learning. This review aims to summarize current evidence for the effectiveness of WS training for improving balance, gait and functional performance. A systematic literature search was performed in PubMed, Cochrane, Web of Science, and CINAHL. Randomized controlled trials (RCTs) using a WS exercise program were included. Study quality was examined by the PEDro scale. Meta-analyses were conducted to estimate the effects of WS balance training on the most frequently reported outcome parameters. Eight RCTs were included (Parkinson n = 2, stroke n = 1, Parkinson/stroke n = 1, peripheral neuropathy n = 2, frail older adults n = 1, healthy older adults n = 1). The sample size ranged from n = 20 to 40. Three types of training paradigms were used: (1) static steady-state balance training, (2) dynamic steady-state balance training, which includes gait training, and (3) proactive balance training. RCTs either used one type of training paradigm (type 2: n = 1, type 3: n = 3) or combined different types of training paradigms within their intervention (type 1 and 2: n = 2; all types: n = 2). The meta-analyses revealed significant overall effects of WS training on static steady-state balance outcomes including mediolateral (eyes open: Hedges' g = 0.82, CI: 0.43-1.21; eyes closed: g = 0.57, CI: 0.14-0.99) and anterior-posterior sway (eyes open: g = 0.55, CI: 0.01-1.10; eyes closed: g = 0.44, CI: 0.02-0.86). No effects on habitual gait speed were found in the meta-analysis (g = -0.19, CI: -0.68 to 0.29). Two RCTs reported significant improvements for selected gait variables including single support time, and fast gait speed. One study identified effects on proactive balance (Alternate Step Test), but no effects were found for the Timed Up and Go test and the Berg Balance Scale. Two studies reported positive results on feasibility and usability. Only one study was

  6. The differential impact of scientific quality, bibliometric factors, and social media activity on the influence of systematic reviews and meta-analyses about psoriasis.

    Science.gov (United States)

    Ruano, Juan; Aguilar-Luque, Macarena; Gómez-Garcia, Francisco; Alcalde Mellado, Patricia; Gay-Mimbrera, Jesus; Carmona-Fernandez, Pedro J; Maestre-López, Beatriz; Sanz-Cabanillas, Juan Luís; Hernández Romero, José Luís; González-Padilla, Marcelino; Vélez García-Nieto, Antonio; Isla-Tejera, Beatriz

    2018-01-01

    Researchers are increasingly using on line social networks to promote their work. Some authors have suggested that measuring social media activity can predict the impact of a primary study (i.e., whether or not an article will be highly cited). However, the influence of variables such as scientific quality, research disclosures, and journal characteristics on systematic reviews and meta-analyses has not yet been assessed. The present study aims to describe the effect of complex interactions between bibliometric factors and social media activity on the impact of systematic reviews and meta-analyses about psoriasis (PROSPERO 2016: CRD42016053181). Methodological quality was assessed using the Assessing the Methodological Quality of Systematic Reviews (AMSTAR) tool. Altmetrics, which consider Twitter, Facebook, and Google+ mention counts as well as Mendeley and SCOPUS readers, and corresponding article citation counts from Google Scholar were obtained for each article. Metadata and journal-related bibliometric indices were also obtained. One-hundred and sixty-four reviews with available altmetrics information were included in the final multifactorial analysis, which showed that social media and impact factor have less effect than Mendeley and SCOPUS readers on the number of cites that appear in Google Scholar. Although a journal's impact factor predicted the number of tweets (OR, 1.202; 95% CI, 1.087-1.049), the years of publication and the number of Mendeley readers predicted the number of citations in Google Scholar (OR, 1.033; 95% CI, 1.018-1.329). Finally, methodological quality was related neither with bibliometric influence nor social media activity for systematic reviews. In conclusion, there seems to be a lack of connectivity between scientific quality, social media activity, and article usage, thus predicting scientific success based on these variables may be inappropriate in the particular case of systematic reviews.

  7. The Influence of Study-Level Inference Models and Study Set Size on Coordinate-Based fMRI Meta-Analyses

    Directory of Open Access Journals (Sweden)

    Han Bossier

    2018-01-01

    Full Text Available Given the increasing amount of neuroimaging studies, there is a growing need to summarize published results. Coordinate-based meta-analyses use the locations of statistically significant local maxima with possibly the associated effect sizes to aggregate studies. In this paper, we investigate the influence of key characteristics of a coordinate-based meta-analysis on (1 the balance between false and true positives and (2 the activation reliability of the outcome from a coordinate-based meta-analysis. More particularly, we consider the influence of the chosen group level model at the study level [fixed effects, ordinary least squares (OLS, or mixed effects models], the type of coordinate-based meta-analysis [Activation Likelihood Estimation (ALE that only uses peak locations, fixed effects, and random effects meta-analysis that take into account both peak location and height] and the amount of studies included in the analysis (from 10 to 35. To do this, we apply a resampling scheme on a large dataset (N = 1,400 to create a test condition and compare this with an independent evaluation condition. The test condition corresponds to subsampling participants into studies and combine these using meta-analyses. The evaluation condition corresponds to a high-powered group analysis. We observe the best performance when using mixed effects models in individual studies combined with a random effects meta-analysis. Moreover the performance increases with the number of studies included in the meta-analysis. When peak height is not taken into consideration, we show that the popular ALE procedure is a good alternative in terms of the balance between type I and II errors. However, it requires more studies compared to other procedures in terms of activation reliability. Finally, we discuss the differences, interpretations, and limitations of our results.

  8. The differential impact of scientific quality, bibliometric factors, and social media activity on the influence of systematic reviews and meta-analyses about psoriasis

    Science.gov (United States)

    Gómez-Garcia, Francisco; Alcalde Mellado, Patricia; Gay-Mimbrera, Jesus; Carmona-Fernandez, Pedro J.; Maestre-López, Beatriz; Sanz-Cabanillas, Juan Luís; Hernández Romero, José Luís; González-Padilla, Marcelino; Vélez García-Nieto, Antonio; Isla-Tejera, Beatriz

    2018-01-01

    Researchers are increasingly using on line social networks to promote their work. Some authors have suggested that measuring social media activity can predict the impact of a primary study (i.e., whether or not an article will be highly cited). However, the influence of variables such as scientific quality, research disclosures, and journal characteristics on systematic reviews and meta-analyses has not yet been assessed. The present study aims to describe the effect of complex interactions between bibliometric factors and social media activity on the impact of systematic reviews and meta-analyses about psoriasis (PROSPERO 2016: CRD42016053181). Methodological quality was assessed using the Assessing the Methodological Quality of Systematic Reviews (AMSTAR) tool. Altmetrics, which consider Twitter, Facebook, and Google+ mention counts as well as Mendeley and SCOPUS readers, and corresponding article citation counts from Google Scholar were obtained for each article. Metadata and journal-related bibliometric indices were also obtained. One-hundred and sixty-four reviews with available altmetrics information were included in the final multifactorial analysis, which showed that social media and impact factor have less effect than Mendeley and SCOPUS readers on the number of cites that appear in Google Scholar. Although a journal’s impact factor predicted the number of tweets (OR, 1.202; 95% CI, 1.087–1.049), the years of publication and the number of Mendeley readers predicted the number of citations in Google Scholar (OR, 1.033; 95% CI, 1.018–1.329). Finally, methodological quality was related neither with bibliometric influence nor social media activity for systematic reviews. In conclusion, there seems to be a lack of connectivity between scientific quality, social media activity, and article usage, thus predicting scientific success based on these variables may be inappropriate in the particular case of systematic reviews. PMID:29377889

  9. Alcohol Consumption as a Risk Factor for Acute and Chronic Pancreatitis: A Systematic Review and a Series of Meta-analyses.

    Science.gov (United States)

    Samokhvalov, Andriy V; Rehm, Jürgen; Roerecke, Michael

    2015-12-01

    Pancreatitis is a highly prevalent medical condition associated with a spectrum of endocrine and exocrine pancreatic insufficiencies. While high alcohol consumption is an established risk factor for pancreatitis, its relationship with specific types of pancreatitis and a potential threshold have not been systematically examined. We conducted a systematic literature search for studies on the association between alcohol consumption and pancreatitis based on PRISMA guidelines. Non-linear and linear random-effect dose-response meta-analyses using restricted cubic spline meta-regressions and categorical meta-analyses in relation to abstainers were conducted. Seven studies with 157,026 participants and 3618 cases of pancreatitis were included into analyses. The dose-response relationship between average volume of alcohol consumption and risk of pancreatitis was monotonic with no evidence of non-linearity for chronic pancreatitis (CP) for both sexes (p = 0.091) and acute pancreatitis (AP) in men (p = 0.396); it was non-linear for AP in women (p = 0.008). Compared to abstention, there was a significant decrease in risk (RR = 0.76, 95%CI: 0.60-0.97) of AP in women below the threshold of 40 g/day. No such association was found in men (RR = 1.1, 95%CI: 0.69-1.74). The RR for CP at 100 g/day was 6.29 (95%CI: 3.04-13.02). The dose-response relationships between alcohol consumption and risk of pancreatitis were monotonic for CP and AP in men, and non-linear for AP in women. Alcohol consumption below 40 g/day was associated with reduced risk of AP in women. Alcohol consumption beyond this level was increasingly detrimental for any type of pancreatitis. The work was financially supported by a grant from the National Institute on Alcohol Abuse and Alcoholism (R21AA023521) to the last author.

  10. Genome-Wide Association Meta-Analyses to Identify Common Genetic Variants Associated with Hallux Valgus in Caucasian and African Americans

    Science.gov (United States)

    Hsu, Yi-Hsiang; Liu, Youfang; Hannan, Marian T.; Maixner, William; Smith, Shad B.; Diatchenko, Luda; Golightly, Yvonne M.; Menz, Hylton B.; Kraus, Virginia B.; Doherty, Michael; Wilson, A.G.; Jordan, Joanne M.

    2016-01-01

    Objective Hallux valgus (HV) affects ~36% of Caucasian adults. Although considered highly heritable, the underlying genetic determinants are unclear. We conducted the first genome-wide association study (GWAS) aimed to identify genetic variants associated with HV. Methods HV was assessed in 3 Caucasian cohorts (n=2,263, n=915, and n=1,231 participants, respectively). In each cohort, a GWAS was conducted using 2.5M imputed single nucleotide polymorphisms (SNPs). Mixed-effect regression with the additive genetic model adjusted for age, sex, weight and within-family correlations was used for both sex-specific and combined analyses. To combine GWAS results across cohorts, fixed-effect inverse-variance meta-analyses were used. Following meta-analyses, top-associated findings were also examined in an African American cohort (n=327). Results The proportion of HV variance explained by genome-wide genotyped SNPs was 50% in men and 48% in women. A higher proportion of genetic determinants of HV was sex-specific. The most significantly associated SNP in men was rs9675316 located on chr17q23-a24 near the AXIN2 gene (p=5.46×10−7); the most significantly associated SNP in women was rs7996797 located on chr13q14.1-q14.2 near the ESD gene (p=7.21×10−7). Genome-wide significant SNP-by-sex interaction was found for SNP rs1563374 located on chr11p15.1 near the MRGPRX3 gene (interaction p-value =4.1×10−9). The association signals diminished when combining men and women. Conclusion Findings suggest that the potential pathophysiological mechanisms of HV are complex and strongly underlined by sex-specific interactions. The identified genetic variants imply contribution of biological pathways observed in osteoarthritis as well as new pathways, influencing skeletal development and inflammation. PMID:26337638

  11. Energy consumption feedback in perspective. Integrating Australian data to meta-analyses on in-home displays

    Energy Technology Data Exchange (ETDEWEB)

    McKerracher, C. [Bloomberg New Energy Finance, City Gate House, 39-45 Finsbury Square, London, EC2A 1PQ (United Kingdom); Torriti, J. [School of Construction Management and Engineering, University of Reading, Whiteknights, PO Box 219, Reading, RG6 6AY (United Kingdom)

    2013-05-15

    Providing homeowners with real-time feedback on their electricity consumption through a dedicated display device has been shown to reduce consumption by approximately 6-10 %. However, recent advances in smart grid technology have enabled larger sample sizes and more representative sample selection and recruitment methods for display trials. By analyzing these factors using data from current studies, this paper argues that a realistic, large-scale conservation effect from feedback is in the range of 3-5 %. Subsequent analysis shows that providing real-time feedback may not be a cost effective strategy for reducing carbon emissions in Australia, but that it may enable additional benefits such as customer retention and peak-load shift.

  12. The antidepressant debate and the balanced placebo trial design: an ethical analysis.

    Science.gov (United States)

    Waring, Duff R

    2008-12-01

    There is ongoing debate about whether randomized, placebo-controlled trials under a double-blind have reliably established the pharmacological efficacy of antidepressants. Numerous meta-analyses of antidepressant efficacy trials, e.g., Kirsch et al. [Kirsch, I., Moore, T. J., Scoboria, A., & Nicholls, S. (2002). The emperor's new drugs: An analysis of antidepressant medication data submitted to the U.S. food and drug administration. Prevention and Treatment, 5, Article 23. (Retrieved July 19, 2007 from http://journals.apa.org/prevention/volume5)], have shown a modest drug-placebo difference but methodological problems with standard trial design preclude a definitive conclusion that this difference results from specific biological effects of antidepressants or the nonspecific factors that have not been adequately excluded. Standard trial design assumes the additivity thesis of pharmacological efficacy, being the assumption that the specific or "true" magnitude of the pharmacological effect is limited to the difference between the drug and placebo responses in a standard trial. If the drug effects are as small as these meta-analyses suggest, then their clinical effectiveness is questionable. If the drug effects are actually larger but masked by placebo effects, then the additivity thesis is not valid and we risk false negative results with standard trial design. Kirsch et al. propose an alternative, four arm balanced placebo trial design (BPTD) that can accurately test the additivity thesis. The BPTD uses antidepressants, active placebos and the intentional deception of research subjects. My focal question is whether the BPTD is ethically defensible. I will explore two objections that can be raised against it: 1) lying to BPTD research subjects violates their autonomy and exploits their illness and 2) the BPTD may not enable us to test the additivity thesis with accuracy, i.e., it may contribute to the masking of drug effects that it aims to avoid. I argue that these

  13. Systematic Review and Meta-Analysis of Randomized Controlled Trials Evaluating Prophylactic Intra-Operative Wound Irrigation for the Prevention of Surgical Site Infections.

    Science.gov (United States)

    de Jonge, Stijn W; Boldingh, Quirine J J; Solomkin, Joseph S; Allegranzi, Benedetta; Egger, Matthias; Dellinger, E Patchen; Boermeester, Marja A

    Surgical site infections (SSIs) are one of the most common hospital-acquired infections. To reduce SSIs, prophylactic intra-operative wound irrigation (pIOWI) has been advocated, although the results to date are equivocal. To develop recommendations for the new World Health Organization (WHO) SSI prevention guidelines, a systematic literature review and a meta-analysis were conducted on the effectiveness of pIOWI using different agents as a means of reducing SSI. The PUBMED, Embase, CENTRAL, CINAHL, and WHO databases were searched. Randomized controlled trials (RCTs) comparing either pIOWI with no pIOWI or with pIOWI using different solutions and techniques were retrieved with SSI as the primary outcome. Meta-analyses were performed, and odds ratios (OR) and the mean difference with 95% confidence intervals (CI) were extracted and pooled with a random effects model. Twenty-one studies were suitable for analysis, and a distinction was made between intra-peritoneal, mediastinal, and incisional wound irrigation. A low quality of evidence demonstrated a statistically significant benefit for incisional wound irrigation with an aqueous povidone-iodine (PVP-I) solution in clean and clean contaminated wounds (OR 0.31; 95% CI 0.13-0.73; p = 0.007); 50 fewer SSIs per 1,000 procedures (from 19 fewer to 64 fewer)). Antibiotic irrigation had no significant effect in reducing SSIs (OR 1.16; 95% CI 0.64-2.12; p = 0.63). Low-quality evidence suggests considering the use of prophylactic incisional wound irrigation to prevent SSI with an aqueous povidone-iodine solution. Antibiotic irrigation does not show a benefit and therefore is discouraged.

  14. Community-led trials: Intervention co-design in a cluster randomised controlled trial.

    Science.gov (United States)

    Andersson, Neil

    2017-05-30

    In conventional randomised controlled trials (RCTs), researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control.Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they want to do. Several discussion groups in each intervention community produced multiple plans for prevention, recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose longer term actions like garbage disposal and improving water supplies.A big part of the skill set for community-led trials is being able to stand back and simply support communities in what they want to do and how they want to do it, something that does not come naturally to many vector control programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong involvement of women in dengue control activities seems to have discouraged men in settings where activity in public spaces or outside of the home would ordinarily be considered a "male competence".Community-led trials address the tension between one-size-fits-all programme interventions and local needs. Whatever the conventional wisdom about how

  15. Community-led trials: Intervention co-design in a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Neil Andersson

    2017-05-01

    Full Text Available Abstract In conventional randomised controlled trials (RCTs, researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control. Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they want to do. Several discussion groups in each intervention community produced multiple plans for prevention, recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose longer term actions like garbage disposal and improving water supplies. A big part of the skill set for community-led trials is being able to stand back and simply support communities in what they want to do and how they want to do it, something that does not come naturally to many vector control programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong involvement of women in dengue control activities seems to have discouraged men in settings where activity in public spaces or outside of the home would ordinarily be considered a “male competence”. Community-led trials address the tension between one-size-fits-all programme interventions and local needs. Whatever the

  16. Etiologic effects and optimal intakes of foods and nutrients for risk of cardiovascular diseases and diabetes: Systematic reviews and meta-analyses from the Nutrition and Chronic Diseases Expert Group (NutriCoDE.

    Directory of Open Access Journals (Sweden)

    Renata Micha

    Full Text Available Dietary habits are major contributors to coronary heart disease, stroke, and diabetes. However, comprehensive evaluation of etiologic effects of dietary factors on cardiometabolic outcomes, their quantitative effects, and corresponding optimal intakes are not well-established.To systematically review the evidence for effects of dietary factors on cardiometabolic diseases, including comprehensively assess evidence for causality; estimate magnitudes of etiologic effects; evaluate heterogeneity and potential for bias in these etiologic effects; and determine optimal population intake levels.We utilized Bradford-Hill criteria to assess probable or convincing evidence for causal effects of multiple diet-cardiometabolic disease relationships. Etiologic effects were quantified from published or de novo meta-analyses of prospective studies or randomized clinical trials, incorporating standardized units, dose-response estimates, and heterogeneity by age and other characteristics. Potential for bias was assessed in validity analyses. Optimal intakes were determined by levels associated with lowest disease risk.We identified 10 foods and 7 nutrients with evidence for causal cardiometabolic effects, including protective effects of fruits, vegetables, beans/legumes, nuts/seeds, whole grains, fish, yogurt, fiber, seafood omega-3s, polyunsaturated fats, and potassium; and harms of unprocessed red meats, processed meats, sugar-sweetened beverages, glycemic load, trans-fats, and sodium. Proportional etiologic effects declined with age, but did not generally vary by sex. Established optimal population intakes were generally consistent with observed national intakes and major dietary guidelines. In validity analyses, the identified effects of individual dietary components were similar to quantified effects of dietary patterns on cardiovascular risk factors and hard endpoints.These novel findings provide a comprehensive summary of causal evidence, quantitative

  17. Therapeutic whole-body hypothermia reduces mortality in severe traumatic brain injury if the cooling index is sufficiently high: meta-analyses of the effect of single cooling parameters and their integrated measure.

    Science.gov (United States)

    Olah, Emoke; Poto, Laszlo; Hegyi, Peter; Szabo, Imre; Hartmann, Petra; Solymar, Margit; Petervari, Erika; Balasko, Marta; Habon, Tamas; Rumbus, Zoltan; Tenk, Judit; Rostas, Ildiko; Weinberg, Jordan; Romanovsky, Andrej A; Garami, Andras

    2018-04-21

    Therapeutic hypothermia was investigated repeatedly as a tool to improve the outcome of severe traumatic brain injury (TBI), but previous clinical trials and meta-analyses found contradictory results. We aimed to determine the effectiveness of therapeutic whole-body hypothermia on the mortality of adult patients with severe TBI by using a novel approach of meta-analysis. We searched the PubMed, EMBASE, and Cochrane Library databases from inception to February 2017. The identified human studies were evaluated regarding statistical, clinical, and methodological designs to ensure inter-study homogeneity. We extracted data on TBI severity, body temperature, mortality, and cooling parameters; then we calculated the cooling index, an integrated measure of therapeutic hypothermia. Forest plot of all identified studies showed no difference in the outcome of TBI between cooled and not cooled patients, but inter-study heterogeneity was high. On the contrary, by meta-analysis of RCTs which were homogenous with regards to statistical, clinical designs and precisely reported the cooling protocol, we showed decreased odds ratio for mortality in therapeutic hypothermia compared to no cooling. As independent factors, milder and longer cooling, and rewarming at < 0.25°C/h were associated with better outcome. Therapeutic hypothermia was beneficial only if the cooling index (measure of combination of cooling parameters) was sufficiently high. We conclude that high methodological and statistical inter-study heterogeneity could underlie the contradictory results obtained in previous studies. By analyzing methodologically homogenous studies, we show that cooling improves the outcome of severe TBI and this beneficial effect depends on certain cooling parameters and on their integrated measure, the cooling index.

  18. Moxibustion for cephalic version: a feasibility randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Bisits Andrew

    2011-09-01

    Full Text Available Abstract Background Moxibustion (a type of Chinese medicine which involves burning a herb close to the skin has been used to correct a breech presentation. Evidence of effectiveness and safety from systematic reviews is encouraging although significant heterogeneity has been found among trials. We assessed the feasibility of conducting a randomised controlled trial of moxibustion plus usual care compared with usual care to promote cephalic version in women with a breech presentation, and examined the views of women and health care providers towards implementing a trial within an Australian context. Methods The study was undertaken at a public hospital in Newcastle, New South Wales, Australia. Women at 34-36.5 weeks of gestation with a singleton breech presentation (confirmed by ultrasound, were randomised to moxibustion plus usual care or usual care alone. The intervention was administered over 10 days. Clinical outcomes included cephalic presentation at birth, the need for ECV, mode of birth; perinatal morbidity and mortality, and maternal complications. Feasibility outcomes included: recruitment rate, acceptability, compliance and a sample size for a future study. Interviews were conducted with 19 midwives and obstetricians to examine the acceptability of moxibustion, and views on the trial. Results Twenty women were randomised to the trial. Fifty one percent of women approached accepted randomisation to the trial. A trend towards an increase in cephalic version at delivery (RR 5.0; 95% CI 0.7-35.5 was found for women receiving moxibustion compared with usual care. There was also a trend towards greater success with version following ECV. Two babies were admitted to the neonatal unit from the moxibustion group. Compliance with the moxibustion protocol was acceptable with no reported side effects. Clinicians expressed the need for research to establish the safety and efficacy of moxibustion, and support for the intervention was given to

  19. Prevention and treatment of acute radiation-induced skin reactions: a systematic review and meta-analysis of randomized controlled trials

    International Nuclear Information System (INIS)

    Chan, Raymond Javan; Webster, Joan; Chung, Bryan; Marquart, Louise; Ahmed, Muhtashimuddin; Garantziotis, Stuart

    2014-01-01

    Radiation-induced skin reaction (RISR) is a common side effect that affects the majority of cancer patients receiving radiation treatment. RISR is often characterised by swelling, redness, pigmentation, fibrosis, and ulceration, pain, warmth, burning, and itching of the skin. The aim of this systematic review was to assess the effects of interventions which aim to prevent or manage RISR in people with cancer. We searched the following databases up to November 2012: Cochrane Skin Group Specialised Register, CENTRAL (2012, Issue 11), MEDLINE (from 1946), EMBASE (from 1974), PsycINFO (from 1806), CINAHL (from 1981) and LILACS (from 1982). Randomized controlled trials evaluating interventions for preventing or managing RISR in cancer patients were included. The primary outcomes were development of RISR, and levels of RISR and symptom severity. Secondary outcomes were time taken to develop erythema or dry desquamation; quality of life; time taken to heal, a number of skin reaction and symptom severity measures; cost, participant satisfaction; ease of use and adverse effects. Where appropriate, we pooled results of randomized controlled trials using mean differences (MD) or odd ratios (OR) with 95% confidence intervals (CI). Forty-seven studies were included in this review. These evaluated six types of interventions (oral systemic medications; skin care practices; steroidal topical therapies; non-steroidal topical therapies; dressings and other). Findings from two meta-analyses demonstrated significant benefits of oral Wobe-Mugos E for preventing RISR (OR 0.13 (95% CI 0.05 to 0.38)) and limiting the maximal level of RISR (MD -0.92 (95% CI -1.36 to -0.48)). Another meta-analysis reported that wearing deodorant does not influence the development of RISR (OR 0.80 (95% CI 0.47 to 1.37)). Despite the high number of trials in this area, there is limited good, comparative research that provides definitive results suggesting the effectiveness of any single intervention for

  20. Zytoprotektion mit Amifostin (Ethyol®) in der Chemotherapie: Meta-Analyse zum pharmakokinetischen Interaktionspotential mit Zytostatika.

    Science.gov (United States)

    Czejka, Martin; Schüller, Johannes; Kletzl, Heidemarie

    2017-08-25

    The cytoprotective agent amifostine (AMI) is capable to protect healthy cells (contrary to tumor cells) due to higher activity of alkaline phosphatase at the membrane site of normal cells. In seven clinical trials the influence of AMI on the pharmacokinetics of different cytostatics was investigated. Preadministration of AMI increased Cmax of doxorubicin (+ 44 %, p < 0.06), epirubicin (+ 31 %, P < 0.08), mitomycin C (+ 41 %, p < 0.01) and docetaxel (+ 31 % and + 17 %, not significant). In contrary, the peak concentration of pirarubicin , the tetrahydropyranyl-prodrug of doxorubicin was decreased (- 50 %, P < 0.03), leading to an equal higher concentrationof doxorubicin in the blood . In accordance to the peak concentrations, the AUC'ast was increased by chemoprotection: doxorubicin + 53 % (p < 0.01) and epirubicin + 23 % (not significant), docetaxel + 25 % and + 31 % (not significant). AUC'ast of mitomycin C and paclitaxel seemed to be unaffected by preadministered AMI. A particular inhibition of the protein binding by AMI has been identified as one reason for higher serum concentrations of anthracycline drugs. After cytoprotection, a possible increase of the cytostatic's Serum concentrations should be taken into account for optimal dosage schedules.

  1. A randomized, controlled trial of oral propranolol in infantile hemangioma.

    Science.gov (United States)

    Léauté-Labrèze, Christine; Hoeger, Peter; Mazereeuw-Hautier, Juliette; Guibaud, Laurent; Baselga, Eulalia; Posiunas, Gintas; Phillips, Roderic J; Caceres, Hector; Lopez Gutierrez, Juan Carlos; Ballona, Rosalia; Friedlander, Sheila Fallon; Powell, Julie; Perek, Danuta; Metz, Brandie; Barbarot, Sebastien; Maruani, Annabel; Szalai, Zsuzsanna Zsofia; Krol, Alfons; Boccara, Olivia; Foelster-Holst, Regina; Febrer Bosch, Maria Isabel; Su, John; Buckova, Hana; Torrelo, Antonio; Cambazard, Frederic; Grantzow, Rainer; Wargon, Orli; Wyrzykowski, Dariusz; Roessler, Jochen; Bernabeu-Wittel, Jose; Valencia, Adriana M; Przewratil, Przemyslaw; Glick, Sharon; Pope, Elena; Birchall, Nicholas; Benjamin, Latanya; Mancini, Anthony J; Vabres, Pierre; Souteyrand, Pierre; Frieden, Ilona J; Berul, Charles I; Mehta, Cyrus R; Prey, Sorilla; Boralevi, Franck; Morgan, Caroline C; Heritier, Stephane; Delarue, Alain; Voisard, Jean-Jacques

    2015-02-19

    Oral propranolol has been used to treat complicated infantile hemangiomas, although data from randomized, controlled trials to inform its use are limited. We performed a multicenter, randomized, double-blind, adaptive, phase 2-3 trial assessing the efficacy and safety of a pediatric-specific oral propranolol solution in infants 1 to 5 months of age with proliferating infantile hemangioma requiring systemic therapy. Infants were randomly assigned to receive placebo or one of four propranolol regimens (1 or 3 mg of propranolol base per kilogram of body weight per day for 3 or 6 months). A preplanned interim analysis was conducted to identify the regimen to study for the final efficacy analysis. The primary end point was success (complete or nearly complete resolution of the target hemangioma) or failure of trial treatment at week 24, as assessed by independent, centralized, blinded evaluations of standardized photographs. Of 460 infants who underwent randomization, 456 received treatment. On the basis of an interim analysis of the first 188 patients who completed 24 weeks of trial treatment, the regimen of 3 mg of propranolol per kilogram per day for 6 months was selected for the final efficacy analysis. The frequency of successful treatment was higher with this regimen than with placebo (60% vs. 4%, P<0.001). A total of 88% of patients who received the selected propranolol regimen showed improvement by week 5, versus 5% of patients who received placebo. A total of 10% of patients in whom treatment with propranolol was successful required systemic retreatment during follow-up. Known adverse events associated with propranolol (hypoglycemia, hypotension, bradycardia, and bronchospasm) occurred infrequently, with no significant difference in frequency between the placebo group and the groups receiving propranolol. This trial showed that propranolol was effective at a dose of 3 mg per kilogram per day for 6 months in the treatment of infantile hemangioma. (Funded by

  2. Reported challenges in nurse-led randomised controlled trials

    DEFF Research Database (Denmark)

    Wang Vedelø, Tina; Lomborg, Kirsten

    2011-01-01

    Aims: The purpose of this integrative literature review was to explore and discuss the methodological challenges nurse researchers report after conducting nurse-led randomised controlled trials in clinical hospital settings. Our research questions were (i) what are the most commonly experienced...... and the clinical nursing staff. Two lessons learned from this integrative review can be highlighted. First, we recommend researchers openly to share their experiences of barriers and challenges. They should describe factors that may have inhibited the desired outcome. Second, efforts to improve the collaboration...... between nurse researchers and clinicians, including education, training and support may increase the success rate and quality of nurse-led studies using the randomised controlled trial....

  3. Protocol for the BAG-RECALL clinical trial: a prospective, multi-center, randomized, controlled trial to determine whether a bispectral index-guided protocol is superior to an anesthesia gas-guided protocol in reducing intraoperative awareness with explicit recall in high risk surgical patients

    Directory of Open Access Journals (Sweden)

    Villafranca Alex

    2009-11-01

    . With the large patient numbers and complementary rigorous designs, it is envisaged that pre-specified meta-analyses will address some of the outstanding controversies and questions relating to processed electroencephalography monitoring. Trial registration ClinicalTrials.gov Identifier: NCT00682825

  4. Psychological rehabilitation after myocardial infarction: multicentre randomised controlled trial.

    OpenAIRE

    Jones, D. A.; West, R. R.

    1996-01-01

    OBJECTIVE: To evaluate rehabilitation after myocardial infarction. DESIGN: Randomised controlled trial of rehabilitation in unselected myocardial infarction patients in six centres, baseline data being collected on admission and by structured interview (of patients and spouses) shortly after discharge and outcome being assessed by structured interview at six months and clinical examination at 12 months. SETTING: Six district general hospitals. SUBJECTS: All 2328 eligible patients admitted ove...

  5. Neighborhood Effects in a Behavioral Randomized Controlled Trial

    OpenAIRE

    Pruitt, Sandi L.; Leonard, Tammy; Murdoch, James; Hughes, Amy; McQueen, Amy; Gupta, Samir

    2014-01-01

    Randomized controlled trials (RCTs) of interventions intended to modify health behaviors may be influenced by neighborhood effects which can impede unbiased estimation of intervention effects. Examining a RCT designed to increase colorectal cancer (CRC) screening (N=5,628), we found statistically significant neighborhood effects: average CRC test use among neighboring study participants was significantly and positively associated with individual patient’s CRC test use. This potentially import...

  6. Outcomes in registered, ongoing randomized controlled trials of patient education.

    Directory of Open Access Journals (Sweden)

    Cécile Pino

    Full Text Available BACKGROUND: With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs evaluated an educational intervention focus on patient-important outcomes (i.e., outcomes measuring patient health status and quality of life. METHODS: On May 6, 2009, we searched for all ongoing RCTs registered in the World Health Organization International Clinical Trials Registry platform. We used a standardized data extraction form to collect data and determined whether the outcomes assessed were 1 patient-important outcomes such as clinical events, functional status, pain, or quality of life or 2 surrogate outcomes, such as biological outcome, treatment adherence, or patient knowledge. PRINCIPAL FINDINGS: We selected 268 of the 642 potentially eligible studies and assessed a random sample of 150. Patient-important outcomes represented 54% (178 of 333 of all primary outcomes and 46% (286 of 623 of all secondary outcomes. Overall, 69% of trials (104 of 150 used at least one patient-important outcome as a primary outcome and 66% (99 of 150 as a secondary outcome. Finally, for 31% of trials (46 of 150, primary outcomes were only surrogate outcomes. The results varied by medical area. In neuropsychiatric disorders, patient important outcomes represented 84% (51 of 61 of primary outcomes, as compared with 54% (32 of 59 in malignant neoplasm and 18% (4 of 22 in diabetes mellitus trials. In addition, only 35% assessed the long-term impact of interventions (i.e., >6 months. CONCLUSIONS: There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs.

  7. Meta-analyses of KIF6 Trp719Arg in coronary heart disease and statin therapeutic effect.

    Directory of Open Access Journals (Sweden)

    Ping Peng

    Full Text Available The goal of our study is to assess the contribution of KIF6 Trp719Arg to both the risk of CHD and the efficacy of statin therapy in CHD patients.Meta-analysis of 8 prospective studies among 77,400 Caucasians provides evidence that 719Arg increases the risk of CHD (P<0.001, HR = 1.27, 95% CI = 1.15-1.41. However, another meta-analysis of 7 case-control studies among 65,200 individuals fails to find a significant relationship between Trp719Arg and the risk of CHD (P = 0.642, OR = 1.02, 95% CI = 0.95-1.08. This suggests that the contribution of Trp719Arg to CHD varies in different ethnic groups. Additional meta-analysis also shows that statin therapy only benefit the vascular patients carry 719Arg allele (P<0.001, relative ratio (RR = 0.60, 95% CI = 0.54-0.67. To examine the role of this genetic variant in CHD risk in Han Chinese, we have conducted a case-control study with 289 CHD cases, 193 non-CHD controls, and 329 unrelated healthy volunteers as healthy controls. On post hoc analysis, significant allele frequency difference of 719Arg is observed between female CHD cases and female total controls under the dominant model (P = 0.04, χ(2 = 4.228, df = 1, odd ratio (OR = 1.979, 95% confidence interval (CI = 1.023-3.828. Similar trends are observed for post hoc analysis between female CHD cases and female healthy controls (dominant model: P = 0.04, χ(2 = 4.231, df = 1, OR = 2.015, 95% CI = 1.024-3.964. Non-genetic CHD risk factors are not controlled in these analyses.Our meta-analysis demonstrates the role of Trp719Arg of KIF6 gene in the risk of CHD in Caucasians. The meta-analysis also suggests the role of this variant in statin therapeutic response in vascular diseases. Our case-control study suggests that Trp719Arg of KIF6 gene is associated with CHD in female Han Chinese through a post hoc analysis.

  8. The Effect of Right Ventricular Apical and Nonapical Pacing on the Short- and Long-Term Changes in Left Ventricular Ejection Fraction: A Systematic Review and Meta-Analysis of Randomized-Controlled Trials.

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    Hussain, Mohammad Akhtar; Furuya-Kanamori, Luis; Kaye, Gerald; Clark, Justin; Doi, Suhail A R

    2015-09-01

    The right ventricular apex (RVA) is the traditional lead site for chronic pacing but in some patients may cause impaired left ventricular (LV) systolic function over time. Comparisons with right ventricular nonapical (RVNA) pacing sites have generated inconsistent results and recent meta-analyses have demonstrated unclear benefit due to heterogeneity across studies. A systematic search for randomized controlled trials that compared LV ejection fraction (LVEF) outcomes between RVNA and RVA pacing was performed up to October 2014. Twenty-four studies (n = 1,628 patients) met the inclusion criteria. To avoid between study heterogeneity two homogenous groups were created; group 1 where studies reported a difference (in favor of RVNA pacing) and group 2 where studies reported no difference between pacing sites. For group 1, weighted mean difference between RVNA and RVA pacing in terms of LVEF at follow-up was 5.40% (95% confidence interval [CI]: 3.94-6.87), related in part to group one's RVA arm demonstrating a significant reduction (mean loss -3.31%; 95% CI: -6.19 to -0.43) in LVEF between study baseline and end of follow-up. Neither of these finding were seen in group 2. Weighted regression modeling demonstrated that inclusion of poor baseline LVEF (right ventricular pacing where there is inclusion of impaired baseline LVEF (<40%), RVA pacing is associated with deterioration in LV function relative to RVNA pacing. © 2015 Wiley Periodicals, Inc.

  9. UK Dermatology Clinical Trials Network’s STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum: protocol for a randomised controlled trial

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    Craig Fiona F

    2012-04-01

    Full Text Available Abstract Background Pyoderma gangrenosum (PG is a rare inflammatory skin disorder characterised by painful and rapidly progressing skin ulceration. PG can be extremely difficult to treat and patients often require systemic immunosuppression. Recurrent lesions of PG are common, but the relative rarity of this condition means that there is a lack of published evidence regarding its treatment. A systematic review published in 2005 found no randomised controlled trials (RCTs relating to the treatment of PG. Since this time, one small RCT has been published comparing infliximab to placebo, but none of the commonly used systemic treatments for PG have been formally assessed. The UK Dermatology Clinical Trials Network’s STOP GAP Trial has been designed to address this lack of trial evidence. Methods The objective is to assess whether oral ciclosporin is more effective than oral prednisolone for the treatment of PG. The trial design is a two-arm, observer-blind, parallel-group, randomised controlled trial comparing ciclosporin (4 mg/kg/day to prednisolone (0.75 mg/kg/day. A total of 140 participants are to be recruited over a period of 4 years, from up to 50 hospitals in the UK and Eire. Primary outcome of velocity of healing at 6 weeks is assessed blinded to treatment allocation (using digital images of the ulcers. Secondary outcomes include: (i time to healing; (ii global assessment of improvement; (iii PG inflammation assessment scale score; (iv self-reported pain; (v health-related quality of life; (vi time to recurrence; (vii treatment failures; (viii adverse reactions to study medications; and (ix cost effectiveness/utility. Patients with a clinical diagnosis of PG (excluding granulomatous PG; measurable ulceration (that is, not pustular PG; and patients aged over 18 years old who are able to give informed consent are included in the trial. Randomisation is by computer generated code using permuted blocks of randomly varying size

  10. Hip fracture risk in relation to vitamin D supplementation and serum 25-hydroxyvitamin D levels: a systematic review and meta-analysis of randomised controlled trials and observational studies

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    Roddam Andrew W

    2010-06-01

    Full Text Available Abstract Background Vitamin D supplementation for fracture prevention is widespread despite conflicting interpretation of relevant randomised controlled trial (RCT evidence. This study summarises quantitatively the current evidence from RCTs and observational studies regarding vitamin D, parathyroid hormone (PTH and hip fracture risk. Methods We undertook separate meta-analyses of RCTs examining vitamin D supplementation and hip fracture, and observational studies of serum vitamin D status (25-hydroxyvitamin D (25(OHD level, PTH and hip fracture. Results from RCTs were combined using the reported hazard ratios/relative risks (RR. Results from case-control studies were combined using the ratio of 25(OHD and PTH measurements of hip fracture cases compared with controls. Original published studies of vitamin D, PTH and hip fracture were identified through PubMed and Web of Science databases, searches of reference lists and forward citations of key papers. Results The seven eligible RCTs identified showed no significant difference in hip fracture risk in those randomised to cholecalciferol or ergocalciferol supplementation versus placebo/control (RR = 1.13[95%CI 0.98-1.29]; 801 cases, with no significant difference between trials of 21 (heterogeneity = 51.02, p 216 (heterogeneity = 137.9, p 29 (heterogeneity = 149.68, p Conclusions Neither higher nor lower dose vitamin D supplementation prevented hip fracture. Randomised and observational data on vitamin D and hip fracture appear to differ. The reason for this is unclear; one possible explanation is uncontrolled confounding in observational studies. Post-fracture PTH levels are unrelated to hip fracture risk.

  11. Should desperate volunteers be included in randomised controlled trials?

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    Allmark, P; Mason, S

    2006-09-01

    Randomised controlled trials (RCTs) sometimes recruit participants who are desperate to receive the experimental treatment. This paper defends the practice against three arguments that suggest it is unethical first, desperate volunteers are not in equipoise. Second clinicians, entering patients onto trials are disavowing their therapeutic obligation to deliver the best treatment; they are following trial protocols rather than delivering individualised care. Research is not treatment; its ethical justification is different. Consent is crucial. Third, desperate volunteers do not give proper consent: effectively, they are coerced. This paper responds by advocating a notion of equipoise based on expert knowledge and widely shared values. Where such collective, expert equipoise exists there is a prima facie case for an RCT. Next the paper argues that trial entry does not involve clinicians disavowing their therapeutic obligation; individualised care based on insufficient evidence is not in patients best interest. Finally, it argues that where equipoise exists it is acceptable to limit access to experimental agents; desperate volunteers are not coerced because their desperation does not translate into a right to receive what they desire.

  12. Metanálisis: Relación entre factores psicosociales en el trabajo y absentismo laboral Meta-analyses: Relation between psychosocial factors in the work and labour absenteeism

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    Josep Mª Molina Aragonés

    2010-09-01

    era relevante para ser incluidos. Control: El gráfico Forest (Fig. 2 muestra el resultado del metanálisis: el riesgo relativo de sufrir un episodio de absentismo es estadísticamente significativo, con un valor de 1,36 (CI: 1,02-1,82 (Tabla 2. Demanda: El riesgo de sufrir un episodio de absentismo no es valorable, con un valor de 1,01 (IC: 0,91-1,11. (Tabla 3. Si bien la demanda, como dimensión propia de estos factores psicosociales, no parece una variable relacionada o que influencie el absentismo laboral, el control si que se encuentra asociado a este, de manera reiterada y consistente.Introduction: In accordance with the model of demand-control, the overhead labour demand, the low control on itself and in a very special way the combination of both, it would suppose an important risk for health. The balance between demand and control depends, just as this model, on the organization of the work and not on the individual characteristics of each person, although, of course, the influence of the working psychosocial environment can be, and in fact is, moderated by the characteristics of the individual answer. Objectives: The study's objective was to analyse in a systematic way those studies that related the effects over absenteeism that the psychosocial factors have constituted in the enterprises, using as a main element of assessment, the model of demand-control of Karasek, and to make a meta-analyses to evaluated the relation between both of them. Methods: There were identified publications from the electronics data bases Medline (2004 to July 2009, Embase (2004 to March 2009, PsycInfo (2004 to July 2009 and in the Bookshop Cochrane (2004 to July 2009, without restrictions motivated by language. The keyboards used were absenteeism, sickness absence, psychosocial, occupational and combinations of them that were chosen initially by its inclusion on the meta-analyses. Additionally the appointments mentioned were reviewed in the selected originals to detect some other

  13. A Very Early Rehabilitation Trial after stroke (AVERT): a Phase III, multicentre, randomised controlled trial.

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    Langhorne, Peter; Wu, Olivia; Rodgers, Helen; Ashburn, Ann; Bernhardt, Julie

    2017-09-01

    Mobilising patients early after stroke [early mobilisation (EM)] is thought to contribute to the beneficial effects of stroke unit care but it is poorly defined and lacks direct evidence of benefit. We assessed the effectiveness of frequent higher dose very early mobilisation (VEM) after stroke. We conducted a parallel-group, single-blind, prospective randomised controlled trial with blinded end-point assessment using a web-based computer-generated stratified randomisation. The trial took place in 56 acute stroke units in five countries. We included adult patients with a first or recurrent stroke who met physiological inclusion criteria. Patients received either usual stroke unit care (UC) or UC plus VEM commencing within 24 hours of stroke. The primary outcome was good recovery [modified Rankin scale (mRS) score of 0-2] 3 months after stroke. Secondary outcomes at 3 months were the mRS, time to achieve walking 50 m, serious adverse events, quality of life (QoL) and costs at 12 months. Tertiary outcomes included a dose-response analysis. Patients, outcome assessors and investigators involved in the trial were blinded to treatment allocation. We recruited 2104 (UK, n  = 610; Australasia, n  = 1494) patients: 1054 allocated to VEM and 1050 to UC. Intervention protocol targets were achieved. Compared with UC, VEM patients mobilised 4.8 hours [95% confidence interval (CI) 4.1 to 5.7 hours; p  pattern of an improved odds of efficacy and safety outcomes in association with increased daily frequency of out-of-bed sessions but a reduced odds with an increased amount of mobilisation (minutes per day). UC clinicians started mobilisation earlier each year altering the context of the trial. Other potential confounding factors included staff patient interaction. Patients in the VEM group were mobilised earlier and with a higher dose of therapy than those in the UC group, which was already early. This VEM protocol was associated with reduced odds of favourable

  14. Heterogeneity of Clinical Trials for Antihypertensive Drugs in Japan: Exploratory Analysis of Confirmatory Phase III Trials Used for Marketing Approval.

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    Kaneko, Reina; Sano, Kota; Ono, Shunsuke

    2018-07-01

    The results of pivotal trials, which provide a rationale for marketing approval decisions for new drugs, are considered for various comparative purposes in postmarketing analyses. Using meta-regression analysis of 91 randomized controlled trials of 61 approved antihypertensive drugs in Japan, we show that mean baseline blood pressure (BP) of each arm was associated with predetermined entry criteria (EC), age, and trial start year (TSY). BP changes following treatment were associated with EC, subject characteristics (e.g., age, complications, baseline BP), study design (e.g., concomitant drug use), and TSY. Effect sizes were generally larger in trials for the first and second drugs in the same class than in trials for follow-on drugs. Results of pivotal trials may vary depending on many factors, suggesting possible challenges associated with the comparison of these results indirectly. Due to the heterogeneity in pivotal trials, caution should be exercised when comparing approved drugs and conducting meta-analyses retrospectively. © 2017, The American Society for Clinical Pharmacology and Therapeutics.

  15. Effect of low-frequency rTMS on aphasia in stroke patients: a meta-analysis of randomized controlled trials.

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    Cai-Li Ren

    Full Text Available Small clinical trials have reported that low-frequency repetitive transcranial magnetic stimulation (rTMS might improve language recovery in patients with aphasia after stroke. However, no systematic reviews or meta-analyses studies have investigated the effect of rTMS on aphasia. The objective of this study was to perform a meta-analysis of studies that explored the effects of low-frequency rTMS on aphasia in stroke patients.We searched PubMed, CENTRAL, Embase, CINAHL, ScienceDirect, and Journals@Ovid for randomized controlled trials published between January 1965 and October 2013 using the keywords "aphasia OR language disorders OR anomia OR linguistic disorders AND repetitive transcranial magnetic stimulation OR rTMS". We used fixed- and random-effects models to estimate the standardized mean difference (SMD and a 95% CI for the language outcomes.Seven eligible studies involving 160 stroke patients were identified in this meta-analysis. A significant effect size of 1.26 was found for the language outcome severity of impairment (95% CI = 0.80 to 1.71 without heterogeneity (I2 = 0%, P = 0.44. Further analyses demonstrated prominent effects for the naming subtest (SMD = 0.52, 95% CI = 0.18 to 0.87, repetition (SMD = 0.54, 95% CI = 0.16 to 0.92, writing (SMD = 0.70, 95% CI = 0.19 to 1.22, and comprehension (the Token test: SMD = 0.58, 95% CI = 0.07 to 1.09 without heterogeneity (I2 = 0%. The SMD of AAT and BDAE comprehension subtests was 0.32 (95% CI = -0.08 to 0.72 with moderate heterogeneity (I2 = 32%,P = 0.22. The effect size did not change significantly even when any one trial was eliminated. None of the patients from the 7 included articles reported adverse effects from rTMS.Low-frequency rTMS with a 90% resting motor threshold that targets the triangular part of the right inferior frontal gyrus (IFG has a positive effect on language recovery in patients with aphasia following

  16. Methodological characteristics and treatment effect sizes in oral health randomised controlled trials: Is there a relationship? Protocol for a meta-epidemiological study.

    Science.gov (United States)

    Saltaji, Humam; Armijo-Olivo, Susan; Cummings, Greta G; Amin, Maryam; Flores-Mir, Carlos

    2014-02-25

    It is fundamental that randomised controlled trials (RCTs) are properly conducted in order to reach well-supported conclusions. However, there is emerging evidence that RCTs are subject to biases which can overestimate or underestimate the true treatment effect, due to flaws in the study design characteristics of such trials. The extent to which this holds true in oral health RCTs, which have some unique design characteristics compared to RCTs in other health fields, is unclear. As such, we aim to examine the empirical evidence quantifying the extent of bias associated with methodological and non-methodological characteristics in oral health RCTs. We plan to perform a meta-epidemiological study, where a sample size of 60 meta-analyses (MAs) including approximately 600 RCTs will be selected. The MAs will be randomly obtained from the Oral Health Database of Systematic Reviews using a random number table; and will be considered for inclusion if they include a minimum of five RCTs, and examine a therapeutic intervention related to one of the recognised dental specialties. RCTs identified in selected MAs will be subsequently included if their study design includes a comparison between an intervention group and a placebo group or another intervention group. Data will be extracted from selected trials included in MAs based on a number of methodological and non-methodological characteristics. Moreover, the risk of bias will be assessed using the Cochrane Risk of Bias tool. Effect size estimates and measures of variability for the main outcome will be extracted from each RCT included in selected MAs, and a two-level analysis will be conducted using a meta-meta-analytic approach with a random effects model to allow for intra-MA and inter-MA heterogeneity. The intended audiences of the findings will include dental clinicians, oral health researchers, policymakers and graduate students. The aforementioned will be introduced to the findings through workshops, seminars, round

  17. Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Foglia, Elizabeth E; Owen, Louise S; Thio, Marta; Ratcliffe, Sarah J; Lista, Gianluca; Te Pas, Arjan; Hummler, Helmut; Nadkarni, Vinay; Ades, Anne; Posencheg, Michael; Keszler, Martin; Davis, Peter; Kirpalani, Haresh

    2015-03-15

    Extremely preterm infants require assistance recruiting the lung to establish a functional residual capacity after birth. Sustained inflation (SI) combined with positive end expiratory pressure (PEEP) may be a superior method of aerating the lung compared with intermittent positive pressure ventilation (IPPV) with PEEP in extremely preterm infants. The Sustained Aeration of Infant Lungs (SAIL) trial was designed to study this question. This multisite prospective randomized controlled unblinded trial will recruit 600 infants of 23 to 26 weeks gestational age who require respiratory support at birth. Infants in both arms will be treated with PEEP 5 to 7 cm H2O throughout the resuscitation. The study intervention consists of performing an initial SI (20 cm H20 for 15 seconds) followed by a second SI (25 cm H2O for 15 seconds), and then PEEP with or without IPPV, as needed. The control group will be treated with initial IPPV with PEEP. The primary outcome is the combined endpoint of bronchopulmonary dysplasia or death at 36 weeks post-menstrual age. www.clinicaltrials.gov , Trial identifier NCT02139800 , Registered 13 May 2014.

  18. Review of Randomized Controlled Trials of Massage in Preterm Infants

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    Anna-Kaisa Niemi

    2017-04-01

    Full Text Available Preterm birth affects about 10% of infants born in the United States. Massage therapy is being used in some neonatal intensive care units for its potential beneficial effects on preterm infants. This article reviews published randomized controlled trials on the effects of massage in preterm infants. Most studies evaluating the effect of massage in weight gain in premature infants suggest a positive effect on weight gain. Increase in vagal tone has been reported in infants who receive massage and has been suggested as a possible mechanism for improved weight gain. More studies are needed on the underlying mechanisms of the effects of massage therapy on weight gain in preterm infants. While some trials suggest improvements in developmental scores, decreased stress behavior, positive effects on immune system, improved pain tolerance and earlier discharge from the hospital, the number of