Identification and description of controlled clinical trials published in Spanish Gynaecology and Obstetrics journals and risk of bias assessment of trials on assisted reproductive techniques

Aims: Given the variability of previously reported results, this systematic review aims to determine the clinical effectiveness of convalescent plasma employed in the treatment of hospitalized patients diagnosed with COVID-19. Methods: We conducted a systematic review of controlled clinical trials assessing treatment with convalescent plasma for hospitalized patients diagnosed with SARS-CoV-2 infection. The outcomes were mortality, clinical improvement, and ventilation requirement. Results: A total of 51 studies were retrieved from the databases. Five articles were finally included in the data extraction and qualitative and quantitative synthesis of results. The overall risk of bias in the reviewed articles was established at low-risk only in two trials. The meta-analysis suggests that there is no benefit of convalescent plasma compared with standard care or placebo in reducing the overall mortality and the ventilation requirement. However, there could be a benefit for the clinical improvement in patients treated with plasma. Conclusion: Current results led to assume that the convalescent plasma transfusion cannot reduce the mortality or ventilation requirement in hospitalized patients diagnosed with SARS-CoV-2 infection. More controlled clinical trials conducted with methodologies that ensure a low risk of bias are still needed. The reviews of this paper are available via the supplemental material section.

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Effects of Composite Attachments on Orthodontic Clear Aligners Therapy: A Systematic Review

Materials ◽

10.3390/ma15020533 ◽

2022 ◽

Vol 15 (2) ◽

pp. 533

Author(s):

Riccardo Nucera ◽

Carolina Dolci ◽

Angela Mirea Bellocchio ◽

Stefania Costa ◽

Serena Barbera ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Data Extraction ◽

Risk Of Bias ◽

Bias Assessment ◽

Bodily Movement ◽

Study Selection ◽

Medium Risk ◽

Clear Aligner ◽

Anterior Root

This systematic review aims to highlight the differences between different clear aligner therapies that differ in the presence of attachments or in attachment configuration. Eight electronic databases were searched up to March 2020. Two authors independently proceeded to study selection, data extraction, and risk of bias assessment. The analysis of the results was carried out examining six groups of movements (mesio-distal tipping/bodily movement; anterior bucco-lingual tipping/root torque; posterior bucco-lingual tipping/expansion; intrusion; extrusion; rotation). Five clinical trials were selected and all of them showed a medium risk of bias. Literature showed that attachments mostly increase the effectiveness of orthodontic treatment with clear aligners, improving anterior root torque, rotation, and mesio-distal (M-D) movement; they are also important to increase posterior anchorage. However, some articles showed contradictory or not statistically significant results. Attachments also seem to improve intrusion, but the evidence about this movement, as well as extrusion, is lacking. No studies evaluated posterior bucco-lingual tipping/expansion. Further clinical trials are strongly suggested to clarify the influence of attachments and their number, size, shape, and position on each orthodontic movement.

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Effect of Orthodontic Treatment on Tooth Autotransplantation: Systematic Review of Controlled Clinical Trials

European Journal of Dentistry ◽

10.1055/s-0040-1708329 ◽

2020 ◽

Vol 14 (03) ◽

pp. 467-482

Author(s):

Rogério Lacerda-Santos ◽

Rhaíssa Ferreira Canutto ◽

José Lucas dos Santos Araújo ◽

Fabiola Galbiatti de Carvalho ◽

Eliseu Aldrighi Münchow ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Randomized Clinical Trials ◽

Risk Of Bias ◽

Significant Heterogeneity ◽

Controlled Clinical Trials ◽

Periodontal Tissues ◽

Orthodontic Movement ◽

Anterior Teeth

AbstractThis systematic review was focused on evaluating tooth autotransplantation, considering its impacts on the teeth, bone, soft tissues, and aesthetics in orthodontic patients. A bibliographic search was conducted without limitations on year of publication or language in the databases of PubMed, Web of Science, Scopus, Medline Complete, Cochrane, Clinical Trials, and Trials Central. For triage of articles, indications, surgical planning, orthodontic movement, risk factors for treatment, and long-term follow-ups were considered. For outcomes, the results with reference to teeth, alveolar bone, periodontal tissues, and esthetic satisfaction were considered. Risk of bias was evaluated using the methodological index for nonrandomized studies-MINORS. The results showed 10 controlled clinical trials, and no randomized clinical trials were found. The selected studies included 715 patients and 934 autotransplanted teeth among which there were premolars, molars, and anterior teeth evaluated in the long term, indicating that orthodontics associated with autotransplantation indicated a result that was generally clinically acceptable. The quality of the set of evidence was considered medium due to the presence of different methodological problems, risk of bias, and significant heterogeneity in the evaluated studies. There was a sufficient body of evidence that justified autotransplantation in patients who needed orthodontic movement. In teeth, there was an increase in root resorption influenced by orthodontics, but without impacting on the general clinical result in the long term. Bone and periodontal tissue do not appear to be affected by orthodontics. The patient’s aesthetic satisfaction was not considered in the studies.

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FSH treatment of male idiopathic infertility improves pregnancy rate: a meta-analysis

Endocrine Connections ◽

10.1530/ec-15-0050 ◽

2015 ◽

Vol 4 (3) ◽

pp. R46-R58 ◽

Cited By ~ 41

Author(s):

D Santi ◽

A R M Granata ◽

M Simoni

Keyword(s):

Clinical Trials ◽

Pregnancy Rate ◽

Sperm Quality ◽

Meta Analysis ◽

Male Partner ◽

Sperm Concentration ◽

Controlled Clinical Trials ◽

Idiopathic Infertility ◽

Reproductive Techniques ◽

Infertile Couples

IntroductionThe aim of this study is to comprehensively evaluate whether FSH administration to the male partner of infertile couples improves pregnancy rate, spontaneously and/or after assisted reproductive techniques (ART).MethodsMeta-analysis of controlled clinical trials in which FSH was administered for male idiopathic infertility, compared with placebo or no treatment. Randomization was not considered as an inclusion criterion.ResultsWe found 15 controlled clinical studies (614 men treated with FSH and 661 treated with placebo or untreated). Concerning the type of FSH, eight studies used recombinant FSH, whereas seven studies used purified FSH. Nine studies evaluated spontaneous pregnancy rate, resulting in an overall odds ratio (OR) of about 4.5 (CI: 2.17–9.33). Eight studies evaluated pregnancy rate after ART, showing a significant OR of 1.60 (CI: 1.08–2.37). Sub-dividing studies according to the FSH preparations (purified/recombinant), pregnancy rate improvement remained significant for each preparation. Eleven studies considered sperm quality after FSH treatment, finding a significant improvement of sperm concentration (2.66×106/ml, CI: 0.47–4.84), but not of concentration of sperm with progressive motility (1.22×106/ml, CI: −0.07 to 2.52). Three trials evaluated testicular volume, showing a non-significant increase in men treated (1.35 ml, CI: −0.44 to 3.14).ConclusionThe results of controlled clinical trials available in the literature indicate an improvement of pregnancy rate after FSH administration to the male partner of infertile couples, both spontaneously and after ART. However, the heterogeneity of studies, the high risk of bias and the lack of precise criteria to guide FSH administration limit the strength of these results. Future studies should be designed to identify the markers of FSH response which are helpful in the decision-making process. Meanwhile, the use of FSH in the treatment of male infertility should be cautious.

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RobotReviewer: evaluation of a system for automatically assessing bias in clinical trials

Journal of the American Medical Informatics Association ◽

10.1093/jamia/ocv044 ◽

2015 ◽

Vol 23 (1) ◽

pp. 193-201 ◽

Cited By ~ 61

Author(s):

Iain J Marshall ◽

Joël Kuiper ◽

Byron C Wallace

Keyword(s):

Machine Learning ◽

Clinical Trials ◽

Systematic Reviews ◽

Risk Of Bias ◽

Reasonable Accuracy ◽

Bias Assessment ◽

Cochrane Database ◽

The Difference ◽

Using Data ◽

Unclear Risk

Abstract Objective To develop and evaluate RobotReviewer, a machine learning (ML) system that automatically assesses bias in clinical trials. From a (PDF-formatted) trial report, the system should determine risks of bias for the domains defined by the Cochrane Risk of Bias (RoB) tool, and extract supporting text for these judgments. Methods We algorithmically annotated 12,808 trial PDFs using data from the Cochrane Database of Systematic Reviews (CDSR). Trials were labeled as being at low or high/unclear risk of bias for each domain, and sentences were labeled as being informative or not. This dataset was used to train a multi-task ML model. We estimated the accuracy of ML judgments versus humans by comparing trials with two or more independent RoB assessments in the CDSR. Twenty blinded experienced reviewers rated the relevance of supporting text, comparing ML output with equivalent (human-extracted) text from the CDSR. Results By retrieving the top 3 candidate sentences per document (top3 recall), the best ML text was rated more relevant than text from the CDSR, but not significantly (60.4% ML text rated ‘highly relevant' v 56.5% of text from reviews; difference +3.9%, [−3.2% to +10.9%]). Model RoB judgments were less accurate than those from published reviews, though the difference was <10% (overall accuracy 71.0% with ML v 78.3% with CDSR). Conclusion Risk of bias assessment may be automated with reasonable accuracy. Automatically identified text supporting bias assessment is of equal quality to the manually identified text in the CDSR. This technology could substantially reduce reviewer workload and expedite evidence syntheses.

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Effectiveness of Technology-Enhanced Teaching and Assessment Methods of Undergraduate Preclinical Dental skills: A Systematic Review of Randomized Controlled Clinical Trials

10.21203/rs.3.rs-46981/v1 ◽

2020 ◽

Author(s):

Khaled Khalaf ◽

Mohamed El-Kishawi ◽

Shahd Mustafa ◽

Sausan Al Kawas

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

High Risk ◽

Dental Students ◽

Risk Of Bias ◽

Assessment Methods ◽

Inclusion Criteria ◽

Controlled Clinical Trials ◽

Randomized Controlled Clinical Trials ◽

Randomized Controlled

Abstract Background: To investigate the effectiveness of technology-enhanced teaching and assessment methods of undergraduate preclinical skills in comparison to conventional methods. Methods: A comprehensive search strategy was implemented using both manual and electronic search methods, including PubMed, Wiley, ScienceDirect, SCOPUS, and the Cochrane Central Register of Controlled Trials. The search and selection of articles that met the inclusion criteria were carried out in duplicates. A Cochrane data extraction form for RCTs was used to extract the relevant information from all included articles. Risk of bias of all included articles was assessed independently by two authors using the Cochrane risk of bias tool. Results: A total of 19 randomized controlled clinical trials met the inclusion criteria and were included in this review. The majority of the studies included in this review have a high risk of bias mainly due to incomplete data, lack of blinding of the examiners, and due to other biases, such as small sample sizes, not accounting for additional hours of training, and the lack of calibration of examiners grading the preparations. Conflicting results were reported in the included studies with regards to whether there were differences between the intervention and control groups in the outcome measure of quality of students’ performance. A meta-analysis could not be done for this study due to the heterogeneity among the included studies.Conclusions: Technology-enhanced teaching and assessment tools used in preclinical skills training of undergraduate dental students have the potential to improve students’ performance. However, due to the conflicting outcomes reported in the 19 studies included in this systematic review and their high risk of bias, better quality studies are required to find a definitive answer to the research question of this systematic review.

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Recent Research Trends in Moxibustion Treatment in Korea

Journal of Acupuncture Research ◽

10.13045/jar.2019.00227 ◽

2020 ◽

Vol 37 (1) ◽

pp. 1-12

Author(s):

Ju-Hyeon Lee ◽

Doo-ree Hwang ◽

Seung-Hyo Hong

Keyword(s):

Clinical Trials ◽

Assessment Tool ◽

Case Reports ◽

Randomized Study ◽

Risk Of Bias ◽

Control Group ◽

Bias Assessment ◽

Korean Traditional Medicine ◽

Study Type ◽

Circulatory Diseases

A total of 1,235 studies were retrieved on June 23, 2019, from 3 databases. Selected 59 studies were evaluated by year of publication, study type, subject condition/disease, acupoint, standards for reporting interventions in clinical trials of moxibustion (STRICTOM), Cochrane risk of bias (RoB), and risk of bias assessment tool for non-randomized study (RoBANS). Most studies were conducted in 2011, after which the number of studies decreased. The most common study type was 25 case reports (CR), 16 uncontrolled clinical trials (UCT), 11 randomized controlled trials (RCT), and 7 controlled clinical trials (CCT). Moxibustion treatment was mainly used for musculoskeletal and circulatory diseases/conditions. A total of 83 acupoints were used, A-shi points being the most used. As for STRICTOM, an average of 7.4 items were satisfactory for UCT and CR without a control group, and an average of 9.4 items were satisfactory for RCT and CCT. RCT was assessed using the RoB, and many items were rated as uncertain. In this study, the need for RCT of moxibustion treatment in Korea was identified. The detailed description of study methods and results will provide evidence for the efficacy of moxibustion treatment in preventive and therapeutic aspects of Korean traditional medicine.

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Dental Composite Restorations Repair: A Systematic Review and Meta-analysis

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2021/v33i59a34322 ◽

2021 ◽

pp. 707-738

Author(s):

Abdulmohsen Al Rabiah ◽

Alamri Zahrah ◽

Tuwaym Malath ◽

Al Daghri Ebtihal ◽

Al Suhaibani Daniyah ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Prospective Cohort ◽

Randomized Clinical Trials ◽

Assessment Tool ◽

Risk Of Bias ◽

Dental Composite ◽

Controlled Trials ◽

Cochrane Central Register ◽

Bias Assessment

Background: Controversy exists in the literature regarding the most optimal repair procedure for improving the adhesion between the repair resin and the existing resin composite materials. Hence the aim of the present study was to do a systematic review and to analyze the adhesion potential of resin-based composites to similar and dissimilar composites and aimed to determine the possible dominant factors affecting the bond strength results. Materials & Methods: Randomized clinical trials (RCTs) and prospective cohort design were searched through electronic databases including MEDLINE, PubMed, Web of Science, and the Cochrane Central Register of Controlled Trials for randomized clinical trials (RCTs) until July 2020 that compared different methods of composite restoration repair and a minimum mean follow-up time of 1 year. There were no restrictions on a particular treatment indication or outcome measures. Two authors independently conducted screening, risk of bias assessment, and data extraction of eligible trials in duplicate. We applied the Cochrane risk of bias assessment tool to consider the risk of bias. Results: We identified 10 articles; two of them were RCTs, and eight prospective cohort studies. There were 530 participants, with 990 teeth, dealing with resin-based composite (RBC) restorations. The intervention of defective restorations ranged from minimal intervention to total restoration replacement. The evaluation criteria were also varied with different evaluation protocols. The low number and heterogeneity of RCTs did not allow for meta-analyses. Conclusions: Although different repair protocols are mentioned in the literature according to the included studies, an appropriate and definitive conclusion can't be drawn. However, it seems repairs versus replacements should be considered as the first line of treatment when all factors lead to repair rather than replacement. Further randomized controlled trials with high methodological quality need to be conducted in order to establish evidence-based recommendations, particularly for RBC repair.

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