Clinical Significance Versus Statistical Significance with Regards Gingival Scores in Herbal and Chlorhexidine Mouthwash Clinical Trials- A Systematic Review

ABSTRACTBloodstream infections due to vancomycin-resistant enterococci (VRE-BSI) result in substantial patient mortality and cost. Daptomycin and linezolid are commonly prescribed for VRE-BSI, but there are no clinical trials to determine optimal antibiotic selection. We conducted a systematic review for investigations that compared daptomycin and linezolid for VRE-BSI. We searched Medline from 1966 through 2012 for comparisons of linezolid and daptomycin for VRE-BSI. We included searches of EMBASE, clinicaltrials.gov, and national meetings. Data were extracted using a standardized instrument. Pooled odds ratios (OR) and 95% confidence intervals (95% CI) were calculated using a fixed-effects model. Our search yielded 4,243 publications, of which 482 contained data on VRE treatment. Most studies (452/482) did not present data on BSI or did not provide information on linezolid or daptomycin. Among the remaining 30 studies, 9 offered comparative data between the two agents. None were randomized clinical trials. There was no difference in microbiologic (n= 5 studies, 517 patients; OR, 1.0; 95% CI, 0.4 to 1.7;P= 0.95) and clinical (n= 3 studies, 357 patients; OR, 1.2; 95% CI, 0.7 to 2.0;P= 0.7) cures between the two antibiotics. There was a trend toward increased survival with linezolid compared to daptomycin treatment (n= 9 studies, 1,074 patients; OR, 1.3; 95% CI, 1.1 to 1.8;I2= 0 [whereI2is a measure of inconsistency]), but this did not reach statistical significance (P= 0.054). There are limited data to inform clinicians on optimal antibiotic selection for VRE-BSI. Available studies are limited by small sample size, lack of patient-level data, and inconsistent outcome definitions. Additional research, including randomized clinical trials, is needed before conclusions can be drawn about treatment options for VRE therapy.

Download Full-text

Bioactive Surfaces vs. Conventional Surfaces in Titanium Dental Implants: A Comparative Systematic Review

Journal of Clinical Medicine ◽

10.3390/jcm9072047 ◽

2020 ◽

Vol 9 (7) ◽

pp. 2047 ◽

Cited By ~ 2

Author(s):

Nansi López-Valverde ◽

Javier Flores-Fraile ◽

Juan Manuel Ramírez ◽

Bruno Macedo de Sousa ◽

Silvia Herrero-Hernández ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Dental Implants ◽

Animal Studies ◽

Statistical Significance ◽

Cochrane Collaboration ◽

In Vivo Experiments ◽

Bone To Implant Contact ◽

Bioactive Surfaces

Animal studies and the scarce clinical trials available that have been conducted suggest that bioactive surfaces on dental implants could improve the osseointegration of such implants. The purpose of this systematic review was to compare the effectiveness of osseointegration of titanium (Ti) dental implants using bioactive surfaces with that of Ti implants using conventional surfaces such as sandblasted large-grit acid-etched (SLA) or similar surfaces. Applying the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement, the MEDLINE, PubMed Central and Web of Science databases were searched for scientific articles in April 2020. The keywords used were “dental implants”, “bioactive surfaces”, “biofunctionalized surfaces”, and “osseointegration”, according to the question: “Do bioactive dental implant surfaces have greater osseointegration capacity compared with conventional implant surfaces?” Risk of bias was assessed using the Cochrane Collaboration tool. 128 studies were identified, of which only 30 met the inclusion criteria: 3 clinical trials and 27 animal studies. The average STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) and ARRIVE (Animal Research: Reporting of In Vivo Experiments) scores were 15.13 ± 2.08 and 17.7±1.4, respectively. Implant stability quotient (ISQ) was reported in 3 studies; removal torque test (RTT)—in 1 study; intraoral periapical X-ray and microcomputed tomography radiological evaluation (RE)—in 4 studies; shear force (SF)—in 1 study; bone-to-implant contact (BIC)—in 12 studies; and BIC and bone area (BA) jointly—in 5 studies. All animal studies reported better bone-to-implant contact surface for bioactive surfaces as compared to control implants with a statistical significance of p < 0.05. Regarding the bioactive surfaces investigated, the best results were yielded by the one where mechanical and chemical treatment methods of the Ti surfaces were combined. Hydroxyapatite (HA) and calcium–phosphate (Ca–Ph) were the most frequently used bioactive surfaces. According to the results of this systematic review, certain bioactive surfaces have a positive effect on osseointegration, although certain coating biomolecules seem to influence early peri-implant bone formation. Further and more in-depth research in this field is required to reduce the time needed for osseointegration of dental implants.

Download Full-text

A systematic review of subgroup analyses in randomised clinical trials in cardiovascular disease

Clinical Trials ◽

10.1177/1740774520984866 ◽

2021 ◽

pp. 174077452098486

Author(s):

Korbinian J Brand ◽

Alexander Hapfelmeier ◽

Bernhard Haller

Keyword(s):

Systematic Review ◽

Cardiovascular Disease ◽

Clinical Trials ◽

England Journal ◽

New England ◽

Statistical Significance ◽

Randomised Clinical Trials ◽

Primary Analysis ◽

Subgroup Analyses ◽

Trial Protocols

Background: Subgroup analyses are frequently used to assess heterogeneity of treatment effects in randomised clinical trials. Inconsistent, improper and incomplete implementation, reporting and interpretation have been identified as ongoing challenges. Further, subgroup analyses were frequently criticised because of unreliable or potentially misleading results. More recently, recommendations and guidelines have been provided to improve the reporting of data in this regard. Methods: This systematic review was based on a literature search within the digital archives of three selected medical journals, The New England Journal of Medicine, The Lancet and Circulation. We reviewed articles of randomised clinical trials in the domain of cardiovascular disease which were published in 2015 and 2016. We screened and evaluated the selected articles for the mode of implementation and reporting of subgroup analyses. Results: We were able to identify a total of 130 eligible publications of randomised clinical trials. In 89/130 (68%) articles, results of at least one subgroup analysis were presented. This was dependent on the considered journal (p < 0.001), the number of included patients (p < 0.001) and the lack of statistical significance of a trial’s primary analysis (p < 0.001). The number of reported subgroup analyses ranged from 1 to 101 (median = 13). We were able to comprehend the specification time of reported subgroup analyses for 71/89 (80%) articles, with 55/89 (62%) articles presenting exclusively pre-specified analyses. This information was not always traceable on the basis of provided trial protocols and often did not include the pre-definition of cut-off values for the categorization of subgroups. The use of interaction tests was reported in 84/89 (94%) articles, with 36/89 (40%) articles reporting heterogeneity of the treatment effect for at least one primary or secondary trial outcome. Subgroup analyses were reported more frequently for larger randomised clinical trials, and if primary analyses did not reach statistical significance. Information about the implementation of subgroup analyses was reported most consistently for articles from The New England Journal of Medicine, since it was also traceable on the basis of provided trial protocols. We were able to comprehend whether subgroup analyses were pre-specified in a majority of the reviewed publications. Even though results of multiple subgroup analyses were reported for most published trials, a corresponding adjustment for multiple testing was rarely considered. Conclusion: Compared to previous reviews in this context, we observed improvements in the reporting of subgroup analyses of cardiovascular randomised clinical trials. Nonetheless, critical shortcomings, such as inconsistent reporting of the implementation and insufficient pre-specification, persist.

Download Full-text

Second-Generation central venous catheter in the prevention of bloodstream infection: a systematic review

Revista Latino-Americana de Enfermagem ◽

10.1590/1518-8345.0756.2722 ◽

2016 ◽

Vol 24 (0) ◽

Cited By ~ 2

Author(s):

Janislei Gislei Dorociaki Stocco ◽

Hellen Hoers ◽

Franciele Soares Pott ◽

Karla Crozeta ◽

Dulce Aparecida Barbosa ◽

...

Keyword(s):

Systematic Review ◽

Sensitivity Analysis ◽

Clinical Trials ◽

Relative Risk ◽

Confidence Interval ◽

Bloodstream Infection ◽

Second Generation ◽

Statistical Significance ◽

Number Needed To Treat ◽

Central Venous

Abstract Objective: to evaluate the effectiveness and safety in the use of second-generation central venous catheters impregnated in clorhexidine and silver sulfadiazine when compared with other catheters, being them impregnated or not, in order to prevent the bloodstream infection prevention. Method: systematic review with meta-analysis. Databases searched: MEDLINE, EMBASE, CINAHL, LILACS/SciELO, Cochrane CENTRAL; search in Congress Proceedings and records from Clinical Trials. Results: 1.235 studies were identified, 97 were pre-selected and 4 were included. In catheter-related bloodstream infection, there was no statistical significance between second-generation impregnated catheter compared with the non-impregnated ones, absolute relative risk 1,5% confidence interval 95% (3%-1%), relative risk 0,68 (confidence interval 95%, 0,40-1,15) and number needed to treat 66. In the sensitivity analysis, there was less bloodstream infection in impregnated catheters (relative risk 0,50, confidence interval 95%, 0,26-0,96). Lower colonization, absolute relative risk 9,6% (confidence interval 95%, 10% to 4%), relative risk 0,51 (confidence interval 95% from 0,38-0,85) and number needed to treat 5. Conclusion: the use of second-generation catheters was effective in reducing the catheter colonization and infection when a sensitivity analysis is performed. Future clinical trials are suggested to evaluate sepsis rates, mortality and adverse effects.

Download Full-text

The Use of Titanium 3D Mini-Plates in the Surgical Treatment of Fractures of the Mandibular Condyle: A Systematic Review and Meta-Analysis of Clinical Trials

Journal of Clinical Medicine ◽

10.3390/jcm10163604 ◽

2021 ◽

Vol 10 (16) ◽

pp. 3604

Author(s):

Maciej Sikora ◽

Maciej Chęciński ◽

Zuzanna Nowak ◽

Kamila Chęcińska ◽

Tomasz Olszowski ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Bone Fractures ◽

Statistical Significance ◽

Risk Of Bias ◽

Screw Loosening ◽

Plate Shape ◽

Bone Fragments ◽

Mini Plate ◽

Osteosynthetic Material

Introduction: Fixing fractures of the base and neck of mandibular condyles is demanding due to the difficulties in surgical access and the various shapes of bone fragments. Classic fixation techniques assume the use of straight mini-plates, utilized for other craniofacial bone fractures. Three dimensional mini-plates may provide a reasonable alternative due to their ease of use and steadily improved mechanical properties. The multitude of different shapes of 3D mini-plates proves the need for their evaluation. Aim: This paper aims to summarize the clinical trials regarding the use of various types of 3D condylar mini-plates in terms of need for reoperation and the incidence of loosening and damage to the osteosynthetic material. Materials and Methods: A systematic review was conducted in accordance with PICOS criteria and PRISMA protocol. The risk of bias was assessed using ROBINS-I and RoB 2 Cochrane protocols. The obtained data series was analyzed for correlations (Pearson’s r) respecting statistical significance (Student’s t-test p > 0.05) and visualized using OriginLab. Results: 13 clinical trials with low overall risk of bias regarding 6 shapes of 3D mini-plates were included in the synthesis. The number of reoperations correlates with the number of fixations (r = 0.53; p = 0.015) and the total number of screw holes in the mini-plate (r = −0.45; p = 0.006). There is a strong correlation between the number of loosened osteosynthetic screws and the total number of fractures treated with 3D mini-plates (r = 0.79; p = 0.001 for each study and r = 0.99; p = 0.015 for each mini-plate shape). A correlation between the percentage of lost screws and the number of distal screw holes is weak regarding individual studies (r = −0.27; p = 0.000) and strong regarding individual mini-plate shape (r = −0.82; p = 0.001). Three cases of 3D mini-plate fractures are noted, which account for 0.7% of all analyzed fixation cases. Discussion: The reasons for reoperations indicated by the authors of the analyzed articles were: mispositioning of the bone fragments, lack of bone fragment union, secondary dislocation, and hematoma. The known screw loosening factors were poor bone quality, bilateral condylar fractures, difficulties in the correct positioning of the osteosynthetic material due to the limitations of the surgical approach, fracture line pattern, including the presence of intermediate fragments, and mechanical overload. Fractures of the straight mini-plates fixing the mandibular condyles amounts for up to 16% of cases in the reference articles. Conclusions: There is no convincing data that the number of reoperations depends on the type of 3D mini-plate used. The frequency of osteosynthetic screw loosening does not seem to depend on the 3D mini-plate’s shape. Clinical fractures of 3D mini-plates are extremely rare.

Download Full-text

Use of systematic reviews to justify the conduct of urology clinical trials

10.21203/rs.3.rs-33014/v1 ◽

2020 ◽

Author(s):

Samuel Shepard ◽

Audrey Wise ◽

Bradley S. Johnson ◽

Matt Vassar

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Systematic Reviews ◽

Randomized Clinical Trials ◽

Data Extraction ◽

Statistical Significance ◽

Extraction Process ◽

Current Data ◽

Research Waste ◽

Pubmed Search

Abstract Background Given the increased amount of research being funded in the field of urology, reducing the amount of research waste is vital. Systematic reviews are an essential tool in aiding in reducing waste in research; they are a comprehensive summary of the current data on a clinical question. The aim of this study is to evaluate the use of systematic reviews as justification in conducting randomized clinical trials (RCT) in high impact urology journals. Methods On December 13, 2019, one of us (BJ) conducted a PubMed search for randomized controlled trials published in the top four urology journals according to their Google Scholar h5-index. Using a masked data extraction process each RCT was searched for systematic reviews. Then each review was evaluated for if it was justification for conducting the trial based on the context the systematic review was used.Results Of the 566 articles retrieved 281 were included. Overall 60.5% (170/281) trials cited a systematic review. We found only 47.6% (134/281) studies cited a systematic review as “verbatim” justification for conducting the trial. Regression analysis yielded a finding of statistical significance in showing a correlation of studies over medical devices were more likely to cite a systematic review than other study topics ( adjusted odds ratio 2.01, 95% CI, 1.08 - 3.73) A total of 409 different systematic review citations were recorded in the 281 trials.Conclusion Less than half of clinical trials cited a systematic review as justification for conducting the trial. If clinical trials were required to support their studies with systematic reviews we believe this would greatly reduce the amount of research waste within clinical research.

Download Full-text

Abstract #273: Benefits of Extended Release Metformin: Systematic Review of the Ongoing Clinical Trials

Endocrine Practice ◽

10.1016/s1530-891x(20)44981-x ◽

2016 ◽

Vol 22 ◽

pp. 69

Author(s):

Hemant Thacker ◽

Rajeev Chawla ◽

Navneet Agrawal ◽

Rohit Kapoor ◽

Noel Somasundaram ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Extended Release

Download Full-text

L-arginine effect on inflammatory mediators: A systematic review of randomized controlled clinical trials

International Journal for Vitamin and Nutrition Research ◽

10.1024/0300-9831/a000619 ◽

2019 ◽

pp. 1-9 ◽

Cited By ~ 1

Author(s):

Seyed Reza Mirhafez ◽

Mitra Hariri

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Inflammatory Mediators ◽

Randomized Clinical Trials ◽

Randomized Controlled Clinical Trials ◽

Patients With Cancer ◽

Reactive Protein ◽

Randomized Controlled ◽

Human Adults ◽

Factor Α

Abstract. L-arginine is an important factor in several physiological and biochemical processes. Recently, scientists studied L-arginine effect on inflammatory mediators such as C-reactive protein (CRP), tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). We conducted a systematic review on randomized controlled trials assessing L-arginine effect on inflammatory mediators. We searched data bases including Google scholar, ISI web of science, SCOPUS, and PubMed/Medline up to April 2019. Randomized clinical trials assessing the effect of L-arginine on inflammatory mediators in human adults were included. Our search retrieved eleven articles with 387 participants. Five articles were on patients with cancer and 6 articles were on adults without cancer. L-arginine was applied in enteral form in 5 articles and in oral form in 6 articles. Eight articles were on both genders, two articles were on women, and one article was on men. L-arginine could not reduce inflammatory mediators among patients with and without cancer except one article which indicated that taking L-arginine for 6 months decreased IL-6 among cardiopathic nondiabetic patients. Our results indicated that L-arginine might not be able to reduce selected inflammatory mediators, but for making a firm decision more studies are needed to be conducted with longer intervention duration, separately on male and female and with different doses of L-arginine.

Download Full-text