scholarly journals Planning a future randomized clinical trial based on a network of relevant past trials

2018 ◽  
Author(s):  
Georgia Salanti ◽  
Adriani Nikolakopoulou ◽  
Alex J Sutton ◽  
Stephan Reichenbach ◽  
Sven Trelle ◽  
...  
Keyword(s):  
Trial Design ◽  
Randomized Clinical Trials ◽  
Guideline Development ◽  
Meta Analysis ◽  
Indirect Evidence ◽  
Public Health Decision ◽  
Relapsing Remitting ◽  
Health Decision ◽  
Meta Analyses ◽  
Relapsing Remitting Multiple Sclerosis

ABSTRACTBackground: The important role of network meta-analysis of randomized clinical trials in health technology assessment and guideline development is increasingly recognized. This approach has the potential to obtain conclusive results earlier than with new standalone trials or conventional, pairwise meta-analyses.Methods: Network meta-analyses can also be used to plan future trials. We introduce a four-steps framework to plan a new trial that aims to identify the optimal new design that will update the existing evidence to best serve timely clinical and public health decision making. The new trial designed within this framework does not need to include all competing interventions and comparisons of interest and can contribute direct and indirect evidence to the updated network meta-analysis. We present the method by virtually planning a new trial to compare biologics in rheumatoid arthritis and a new trial to compare two drugs for relapsing-remitting multiple sclerosis.Results: A trial design based on updating the evidence from a network meta-analysis of relevant previous trials may require a considerably smaller sample size to reach the same conclusion compared with a trial designed and analyzed in isolation. Challenges in the approach include the complexity of the methodology and the need for a coherent network meta-analysis of previous trials with little heterogeneity.Conclusions: When used judiciously, conditional trial design could significantly reduce waste in clinical research.

Laser Influence on Dental Sensitivity Compared to Other Light Sources Used During In-office Dental Bleaching: Systematic Review and Meta-analysis

2020 ◽  
Vol 45 (6) ◽  
pp. 589-597
Author(s):  
BGS Casado ◽  
EP Pellizzer ◽  
JR Souto Maior ◽  
CAA Lemos ◽  
BCE Vasconcelos ◽  
...  
Keyword(s):  
Randomized Clinical Trials ◽  
Color Change ◽  
Meta Analysis ◽  
Present Review ◽  
Cochrane Library ◽  
Light Sources ◽  
Eligibility Criteria ◽  
Tooth Color ◽  
Significant Difference ◽  
Meta Analyses

Clinical Relevance The use of laser light during bleaching will not reduce the incidence or severity of sensitivity and will not increase the degree of color change compared with nonlaser light sources. SUMMARY Objective: To evaluate whether the use of laser during in-office bleaching promotes a reduction in dental sensitivity after bleaching compared with other light sources. Methods: The present review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) and is registered with PROSPERO (CDR42018096591). Searches were conducted in the PubMed/Medline, Web of Science, and Cochrane Library databases for relevant articles published up to August 2018. Only randomized clinical trials among adults that compared the use of laser during in-office whitening and other light sources were considered eligible. Results: After analysis of the texts retrieved during the database search, six articles met the eligibility criteria and were selected for the present review. For the outcome dental sensitivity, no significant difference was found favoring any type of light either for intensity (mean difference [MD]: −1.60; confidence interval [CI]: −3.42 to 0.22; p=0.09) or incidence (MD: 1.00; CI: 0.755 to 1.33; p=1.00). Regarding change in tooth color, no significant differences were found between the use of the laser and other light sources (MD: −2.22; CI: −6.36 to 1.93; p=0.29). Conclusions: Within the limitations of the present study, laser exerts no influence on tooth sensitivity compared with other light sources when used during in-office bleaching. The included studies demonstrated that laser use during in-office bleaching may have no influence on tooth color change.

scholarly journals Acupuncture for post-stroke depression: a systematic review and meta-analysis

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ran Liu ◽  
Kun Zhang ◽  
Qiu-yu Tong ◽  
Guang-wei Cui ◽  
Wen Ma ◽  
...  
Keyword(s):  
Adverse Events ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Quality Of Evidence ◽  
Post Stroke ◽  
Assessment Development ◽  
Significant Difference ◽  
Post Stroke Depression ◽  
Meta Analyses

Abstract Background Acupuncture for post-stroke depression (PSD) has been evolving, but uncertainty remains. To assess the existing evidence from randomized clinical trials (RCTs) of acupuncture for PSD, we sought to draw conclusions by synthesizing RCTs. Methods An exhaustive literature search was conducted in seven electronic databases from their inception dates to April 19, 2020, to identify systematic reviews (SRs) and meta-analyses (MAs) on this topic. The primary RCTs included in the SRs/MAs were identified. We also conducted a supplementary search for RCTs published from January 1, 2015, to May 12, 2020. Two reviewers extracted data separately and pooled data using RevMan 5.3 software. The quality of evidence was critically appraised with the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) system. Results A total of 17 RCTs involving 1402 patients were included. Meta-analysis showed that participants who received a combination of acupuncture and conventional treatments exhibited significantly lower scores on the HAM-D17, HAM-D24 and HAM-D (MD, − 5.08 [95% CI, − 6.48 to − 3.67], I2 = 0%), (MD, − 9.72 [95% CI, − 14.54 to − 4.91], I2 = 65%) and (MD, − 2.72 [95% CI, − 3.61 to − 1.82], respectively) than those who received conventional treatment. However, there was no significant difference in acupuncture versus antidepressants in terms of the 17-item, 24-item and HAM-D scales (MD, − 0.43 [95% CI, − 1.61 to 0.75], I2 = 51%), (MD, − 3.09 [95% CI, − 10.81 to 4.63], I2 = 90%) and (MD, − 1.55 [95% CI, − 4.36 to 1.26], I2 = 95%, respectively). For adverse events, acupuncture was associated with fewer adverse events than antidepressants (RR, 0.16 [95% CI, 0.07 to 0.39], I2 = 35%), but there was no significant difference in the occurrence of adverse events between the combination of acupuncture and conventional treatments versus conventional treatments (RR, 0.63 [95% CI, 0.21 to 1.83], I2 = 38%). The quality of evidence was low to very low due to the substantial heterogeneity among the included studies. Conclusions The current review indicates that acupuncture has greater effect on PSD and better safety profile than antidepressants, but high-quality evidence evaluating acupuncture for PSD is still needed.

Efficacy and tolerability of pharmacological interventions on metabolic disturbance induced by atypical antipsychotics in adults: A systematic review and network meta-analysis

2021 ◽  
pp. 026988112110353
Author(s):  
Yewei Wang ◽  
Dandan Wang ◽  
Jie Cheng ◽  
Xinyu Fang ◽  
Yan Chen ◽  
...  
Keyword(s):  
Body Weight ◽  
Atypical Antipsychotics ◽  
Randomized Clinical Trials ◽  
Weighted Mean Difference ◽  
Meta Analysis ◽  
Metabolic Disturbance ◽  
Pharmacological Interventions ◽  
Glucagon Like Peptide ◽  
Glucagon Like Peptide 1 ◽  
Meta Analyses

Background: There have been a few systematic reviews and conventional meta-analyses reporting effect of drugs on metabolic disturbance induced by atypical antipsychotics (AAPs). However, few of them provided sufficient and comprehensive comparisons between pharmacological interventions. Aims: We aimed to qualitatively compare drugs’ effect on AAPs-induced metabolic abnormalities by using network meta-analysis (NMA). Methods: We searched PubMed, EMBASE, Web of Science, Cochrane Controlled Register of Trials (CENTRAL), and PsycINFO on March 26, 2019. Of 5889 records identified, 61 randomized clinical trials including 3467 participants were included. We estimated weighted mean difference (WMD) and odds ratio (OR) using NMA. We assessed the risk of bias of individual studies with the Review Manager 5.3. Primary outcomes included change of body weight and body mass index (BMI). Secondary outcomes included change of other cardiometabolic risk factors, acceptability, and tolerability. Results: For body weight, topiramate (WMD −5.4, 95% CI −7.12 to −3.68), zonisamide (−3.44, 95% CI −6.57 to −0.36), metformin (−3.01, 95% CI −4.22 to −1.83), glucagon-like peptide-1 receptor agonists (GLP-1RAs) (−3.23, 95% CI −5.47 to −0.96), and nizatidine (−2.14, 95% CI −4.01 to −0.27) were significantly superior to placebo. Results regarding to BMI were similar to that of body weight. With respect to tolerability, only topiramate (OR 24, 95% CI 3.15 to 648) was inferior to placebo. Conclusions: Considering both efficacy and tolerability, evidence from this NMA indicates zonisamide, metformin, GLP-1RAs, and nizatidine in adults should be the first-line treatment for alleviating AAPs-induced weight gain or elevated BMI.

Treatment of Ureteral Stent-Related Symptoms

2021 ◽  
pp. 1-16
Author(s):  
Angela Pecoraro ◽  
Dario Peretti ◽  
Zhe Tian ◽  
Roberta Aimar ◽  
Gabriel Niculescu ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
A Priori ◽  
Cumulative Effect ◽  
Risk Difference ◽  
Ureteral Stent ◽  
Pde Inhibitors ◽  
Meta Analyses ◽  
Alpha Antagonist

<b><i>Background:</i></b> The aim of the study was to assess the effectiveness of the main classes of drugs used at reducing morbidity related to ureteric stents. <b><i>Summary:</i></b> After establishing a priori protocol, a systematic electronic literature search was conducted in July 2019. The randomized clinical trials (RCTs) selection proceeded in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines and was registered (PROSPERO ID 178130). The risk of bias and the quality assessment of the included RCTs were performed. Ureteral Stent Symptom Questionnaire (USSQ), International Prostate Symptom Score (IPSS), and quality of life (QoL) were pooled for meta-analysis. Mean difference and risk difference were calculated as appropriate for each outcome to determine the cumulative effect size. Fourteen RCTs were included in the analysis accounting for 2,842 patients. Alpha antagonist, antimuscarinic, and phosphodiesterase (PDE) inhibitors significatively reduced all indexes of the USSQ, the IPSS and QoL scores relative to placebo. Conversely, combination therapy (alpha antagonist plus antimuscarinic) showed in all indexes of the USSQ, IPSS, and QoL over alpha antagonist or antimuscarinic alone. On comparison with alpha blockers, PDE inhibitors were found to be equally effective for urinary symptoms, general health, and body pain parameters, but sexual health parameters improved significantly with PDE inhibitors. Finally, antimuscarinic resulted in higher decrease in all indexes of the USSQ, the IPSS, and QoL relative to alpha antagonist. <b><i>Key message:</i></b> Relative to placebo, alpha antagonist alone, antimuscarinics alone, and PDE inhibitors alone have beneficial effect in reducing stent-related symptoms. Furthermore, there are significant advantages of combination therapy compared with monotherapy. Finally, PDE inhibitors are comparable to alpha antagonist, and antimuscarinic seems to be more effective than alpha antagonist alone.

scholarly journals Effectiveness of COVID-19 Vaccines against Delta (B.1.617.2) Variant: A Systematic Review and Meta-Analysis of Clinical Studies

Vaccines ◽  
2021 ◽  
Vol 10 (1) ◽  
pp. 23
Author(s):  
Ali Pormohammad ◽  
Mohammad Zarei ◽  
Saied Ghorbani ◽  
Mehdi Mohammadi ◽  
Saeideh Aghayari Sheikh Neshin ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Severe Infection ◽  
Vaccination Rate ◽  
Decision Makers ◽  
Morbidity Rate ◽  
Short Term ◽  
Mortality And Morbidity ◽  
Public Health Decision ◽  
Health Decision

The high transmissibility, mortality, and morbidity rate of the SARS-CoV-2 Delta (B.1.617.2) variant have raised concerns regarding vaccine effectiveness (VE). To address this issue, all publications relevant to the effectiveness of vaccines against the Delta variant were searched in the Web of Science, Scopus, EMBASE, and Medline (via PubMed) databases up to 15 October 2021. A total of 15 studies (36 datasets) were included in the meta-analysis. After the first dose, the VE against the Delta variant for each vaccine was 0.567 (95% CI 0.520–0.613) for Pfizer-BioNTech, 0.72 (95% CI 0.589–0.822) for Moderna, 0.44 (95% CI 0.301–0.588) for AstraZeneca, and 0.138 (95% CI 0.076–0.237) for CoronaVac. Meta-analysis of 2,375,957 vaccinated cases showed that the Pfizer-BioNTech vaccine had the highest VE against the infection after the second dose, at 0.837 (95% CI 0.672–0.928), and third dose, at 0.972 (95% CI 0.96–0.978), as well as the highest VE for the prevention of severe infection or death, at 0.985 (95% CI 0.95–0.99), amongst all COVID-19 vaccines. The short-term effectiveness of vaccines, especially mRNA-based vaccines, for the prevention of the Delta variant infection, hospitalization, severe infection, and death is supported by this study. Limitations include a lack of long-term efficacy data, and under-reporting of COVID-19 infection cases in observational studies, which has the potential to falsely skew VE rates. Overall, this study supports the decisions by public health decision makers to promote the population vaccination rate to control the Delta variant infection and the emergence of further variants.

scholarly journals The Optimal Time of Applying Enteral Immunonutrition in Esophageal Cancer Patients Receiving Esophagectomy: A Network Meta-Analysis of Randomized Clinical Trials

2021 ◽  
Author(s):  
Xu Tian ◽  
Yan-Fei Jin ◽  
Zhao-Li Zhang ◽  
Hui Chen ◽  
Wei-Qing Chen ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Cancer Patients ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Infectious Complications ◽  
Cochrane Library ◽  
Optimal Time ◽  
Registration Number ◽  
Meta Analyses ◽  
The Impact

Abstract Background: Enteral immunonutrition (EIN) has been extensively applied in cancer patients, however its role in esophageal cancer (EC) patients receiving esophagectomy remains unclear. We performed this network meta-analysis to investigate the impact of EIN on patients undergoing surgery for EC and further determine the optimal time of applying EIN.Methods: We searched PubMed, EMBASE, Cochrane library, and China National Knowledgement Infrastructure (CNKI) to identify eligible studies. Categorical data was expressed as the odds ratio with 95% confidence interval (CI), and continuous data was expressed as mean difference (MD) with 95% CI. Pair-wise and network meta-analysis was performed to evaluate the impact of EIN on clinical outcomes using RevMan 5.3 and ADDIS V.1.16.8 softwares. The surface under the cumulative ranking curve (SUCRA) was calculated to rank all nutritional regimes.Results: Total 14 studies involving 1071 patients were included. Pair-wise meta-analysis indicated no difference between EIN regardless of the application time and standard EN (SEN), however subgroup analyses found that postoperative EIN was associated with decreased incidence of total infectious complications (OR=0.47; 95%CI=0.26 to 0.84; p=0.01) and pneumonia (OR=0.47; 95%CI=0.25 to 0.90; p=0.02) and shortened LOH (MD=-1.01; 95%CI=-1.44 to -0.57; p<0.001) compared to SEN, which were all supported by network meta-analyses. Ranking probability analysis further indicated that postoperative EIN has the highest probability of being the optimal option in terms of these three outcomes.Conclusions: Postoperative EIN should be preferentially utilized in EC patients undergoing esophagectomy because it has optimal potential of decreasing the risk of total infectious complications and pneumonia and shortening LOH.OSF registration number: 10.17605/OSF.IO/KJ9UY.

scholarly journals Vaccines to prevent COVID-19: a protocol for a living systematic review with network meta-analysis including individual patient data (The LIVING VACCINE Project)

2020 ◽  
Vol 9 (1) ◽  
Author(s):  
Steven Kwasi Korang ◽  
Sophie Juul ◽  
Emil Eik Nielsen ◽  
Joshua Feinberg ◽  
Faiza Siddiqui ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Individual Patient Data ◽  
Viral Vector ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Serious Adverse Events ◽  
Meta Analyses ◽  
Harmful Effects

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19) which has rapidly spread worldwide. Several human randomized clinical trials assessing potential vaccines are currently underway. There is an urgent need for a living systematic review that continuously assesses the beneficial and harmful effects of all available vaccines for COVID-19. Methods/design We will conduct a living systematic review based on searches of major medical databases (e.g., MEDLINE, EMBASE, CENTRAL) and clinical trial registries from their inception onwards to identify relevant randomized clinical trials. We will update the literature search once a week to continuously assess if new evidence is available. Two review authors will independently extract data and conduct risk of bias assessments. We will include randomized clinical trials comparing any vaccine aiming to prevent COVID-19 (including but not limited to messenger RNA; DNA; non-replicating viral vector; replicating viral vector; inactivated virus; protein subunit; dendritic cell; other vaccines) with any comparator (placebo; “active placebo;” no intervention; standard care; an “active” intervention; another vaccine for COVID-19) for participants in all age groups. Primary outcomes will be all-cause mortality; a diagnosis of COVID-19; and serious adverse events. Secondary outcomes will be quality of life and non-serious adverse events. The living systematic review will include aggregate data meta-analyses, trial sequential analyses, network meta-analyses, and individual patient data meta-analyses. Within-study bias will be assessed using Cochrane risk of bias tool. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) and Confidence in Network Meta-Analysis (CINeMA) approaches will be used to assess certainty of evidence. Observational studies describing harms identified during the search for trials will also be included and described and analyzed separately. Discussion COVID-19 has become a pandemic with substantial mortality. A living systematic review assessing the beneficial and harmful effects of different vaccines is urgently needed. This living systematic review will regularly inform best practice in vaccine prevention and clinical research of this highly prevalent disease. Systematic review registration PROSPERO CRD42020196492

scholarly journals Comparing the Effects of Docosahexaenoic and Eicosapentaenoic Acids on Inflammation Markers Using Pairwise and Network Meta-Analyses of Randomized Controlled Trials

2020 ◽  
Author(s):  
Cécile Vors ◽  
Janie Allaire ◽  
Sonia Blanco Mejia ◽  
Tauseef A Khan ◽  
John L Sievenpiper ◽  
...  
Keyword(s):  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Eligibility Criteria ◽  
Necrosis Factor Alpha ◽  
Assessment Development ◽  
Evaluation Approach ◽  
Tnf Α ◽  
Mean Differences ◽  
Meta Analyses

ABSTRACT Recent data from randomized clinical trials (RCTs) suggest that DHA may have stronger anti-inflammatory effects than EPA. This body of evidence has not yet been quantitatively reviewed. The aim of this study was to compare the effect of DHA and EPA on several markers of systemic inflammation by pairwise and network meta-analyses of RCTs. MEDLINE, EMBASE, and The Cochrane Library were searched through to September 2019. We included RCTs of ≥7 d on adults regardless of health status that directly compared the effects of DHA with EPA and RCTs of indirect comparisons, in which the effects of DHA or EPA were compared individually to a control fatty acid. Differences in circulating concentrations of C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α) and adiponectin were the primary outcome measures. Data were pooled by pairwise and network meta-analysis and expressed as mean differences (MDs) with 95% CIs. Heterogeneity was assessed (Cochran Q statistic) and quantified (I2 statistic) in the pairwise meta-analysis. Inconsistency and transitivity were evaluated in the network meta-analysis. The certainty of evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach. Eligibility criteria were met by 5 RCTs (N = 411) for the pairwise meta-analysis and 20 RCTs (N = 1231) for the network meta-analysis. In the pairwise meta-analysis, DHA and EPA had similar effects on plasma CRP [MDDHA versus EPA = 0.14 mg/L (95% CI: –0.57, 0.85); I2 = 61%], IL-6 [MDDHA versus EPA = 0.10 pg/mL (–0.15, 0.34); I2 = 40%], and TNF-α [MDDHA versus EPA = –0.10 pg/mL (–0.37, 0.18); I2 = 40%]. In the network meta-analysis, the effects of DHA and EPA on plasma CRP [MDDHA versus EPA = –0.33 mg/L (–0.75, 0.10)], IL-6 [MDDHA versus EPA = 0.09 pg/mL (–0.12, 0.30)], and TNF-α [MDDHA versus EPA = –0.02 pg/mL (–0.25, 0.20)] were also similar. DHA and EPA had similar effects on plasma adiponectin in the network meta-analysis. Results from pairwise and network meta-analyses suggest that supplementation with either DHA or EPA does not differentially modify systemic markers of subclinical inflammation.

scholarly journals E-Cigarette Use and Adult Cigarette Smoking Cessation: A Meta-Analysis

2020 ◽  
pp. e1-e17
Author(s):  
Richard J. Wang ◽  
Sudhamayi Bhadriraju ◽  
Stanton A. Glantz
Keyword(s):  
Public Health ◽  
Smoking Cessation ◽  
Observational Studies ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Adult Population ◽  
Consumer Products ◽  
Cigarette Use ◽  
Quit Smoking ◽  
Meta Analyses

Objectives. To determine the association between e-cigarette use and smoking cessation. Methods. We searched PubMed, Web of Science Core Collection, and EMBASE and computed the association of e-cigarette use with quitting cigarettes using random effects meta-analyses. Results. We identified 64 papers (55 observational studies and 9 randomized clinical trials [RCTs]). In observational studies of all adult smokers (odds ratio [OR] = 0.947; 95% confidence interval [CI] = 0.772, 1.160) and smokers motivated to quit smoking (OR = 0.851; 95% CI = 0.684, 1.057), e-cigarette consumer product use was not associated with quitting. Daily e-cigarette use was associated with more quitting (OR = 1.529; 95% CI = 1.158, 2.019) and less-than-daily use was associated with less quitting (OR = 0.514; 95% CI = 0.402, 0.665). The RCTs that compared quitting among smokers who were provided e-cigarettes to smokers with conventional therapy found e-cigarette use was associated with more quitting (relative risk = 1.555; 95% CI = 1.173, 2.061). Conclusions. As consumer products, in observational studies, e-cigarettes were not associated with increased smoking cessation in the adult population. In RCTs, provision of free e-cigarettes as a therapeutic intervention was associated with increased smoking cessation. Public Health Implications. E-cigarettes should not be approved as consumer products but may warrant consideration as a prescription therapy. (Am J Public Health. Published online ahead of print December 22, 2020: e1–e17. https://doi.org/10.2105/AJPH.2020.305999 )

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