scholarly journals An Analysis of Fragility and Risk of Bias in Randomized Clinical Trials in Bowel Preparation Guidelines

2018 ◽  
Vol 02 (03) ◽  
Author(s):  
Chris Chapman ◽  
Benjamin Howard ◽  
Cole Wayant ◽  
Matt Vassar
Keyword(s):  
Clinical Trials ◽  
Bowel Preparation ◽  
Randomized Clinical Trials ◽  
Risk Of Bias

Dexamethasone in Patients with Spontaneous Intracerebral Hemorrhage: An Updated Meta-Analysis

2020 ◽  
Vol 49 (5) ◽  
pp. 495-502
Author(s):  
Stephanie Wintzer ◽  
Josef Georg Heckmann ◽  
Hagen B. Huttner ◽  
Stefan Schwab
Keyword(s):  
Clinical Trials ◽  
High Risk ◽  
Intracerebral Hemorrhage ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Spontaneous Intracerebral Hemorrhage ◽  
Control Groups ◽  
Language Data ◽  
Negative Effect

<b><i>Background:</i></b> Spontaneous intracerebral hemorrhage (ICH) is a frequent cerebrovascular disorder and still associated with high mortality and poor clinical outcomes. The purpose of this review was to update a 15-year-old former meta-analysis on randomized clinical trials (RCTs) addressing the question of whether ICH patients treated with dexamethasone have better outcomes than controls. <b><i>Methods:</i></b> The electronic databases PubMed, SCOPUS, and Cochrane as well as web platforms on current clinical trials were searched for the years 1970–2020 without constriction on language. Data were extracted and outcomes were pooled for conventional and cumulative meta-analysis using a commercial software program (www.Meta-Analysis.com). <b><i>Results:</i></b> Finally, 7 RCTs were identified and analyzed including 248 participants in the dexamethasone groups and 242 in the control groups. Five studies showed a high risk of bias. The overall relative risk (RR) for death was 1.32 (95% confidence interval [CI] 0.99–1.76; <i>p</i> = 0.06) and did not differ significantly between the 2 groups. After exclusion of studies with high risk of bias, the RR for death was 1.37 (95% CI 0.54–3.42; <i>p</i> = 0.51). The RR for poor outcome did not differ significantly between the 2 groups analyzed for all included studies (RR = 0.69; 95% CI 0.47–1; <i>p</i> = 0.05) and after exclusion of studies with high risk of bias (RR = 0.7; 95% CI 0.45–1.08; <i>p</i> = 0.11). The RR for complications did not differ significantly including all studies (RR = 1.29; 95% CI 0.77–2.17; <i>p</i> = 0.34) and after exclusion of studies with high risk of bias (RR = 1.27; 95% CI 0.18–8.89; <i>p</i> = 0.81). The cumulative statistics delivered no other results; however, it pointed out fewer complications over time in the dexamethasone group. <b><i>Conclusion:</i></b> Clear evidence of a beneficial or negative effect of dexamethasone is still lacking. Modern RCTs or observational studies with propensity design are necessary to evaluate the efficacy and safety of treatment with dexamethasone in patients with ICH.

scholarly journals Photobiomodulation for the Treatment of Primary Headache: Systematic Review of Randomized Clinical Trials

Life ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. 98
Author(s):  
Andréa Oliver Gomes ◽  
Ana Luiza Cabrera Martimbianco ◽  
Aldo Brugnera Junior ◽  
Anna Carolina Ratto Tempestini Horliana ◽  
Tamiris da Silva ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adjuvant Treatment ◽  
Randomized Clinical Trials ◽  
Primary Headache ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Sham Treatment ◽  
Methodological Assessment ◽  
Grade Approach

The purpose of this study was to evaluate the efficacy and safety of photobiomodulation as an adjuvant treatment for primary headache. A systematic review of randomized clinical trials was performed. For such, electronic searches were performed in the MEDLINE, Embase, Cochrane Library, LILACS, PEDro, PsycInfo, Clinicaltrials.gov., and WHO/ICTRP databases, with no restrictions imposed regarding language or year of publication. We included studies that assessed any photobiomodulation therapy as an adjuvant treatment for primary headache compared to sham treatment, no treatment, or another intervention. The methodological assessment was conducted using the Cochrane Risk of Bias tool. The certainty of the evidence was classified using the GRADE approach. Four randomized clinical trials were included. Most of the included studies had an overall high risk of bias. Compared to sham treatment, photobiomodulation had a clinically important effect on pain in individuals with primary headache. Despite the benefits reported for other outcomes, the estimates were imprecise, and the certainty of the evidence was graded as low. These findings are considered insufficient to support the use of photobiomodulation in the treatment of primary headache. Randomized clinical trials, with higher methodological quality, are needed to enhance the reliability of the estimated effects.

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

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.

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 Anti-Tumor Activity and Safety of Multikinase Inhibitors in Advanced and/or Metastatic Thyroid Cancer: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials

2019 ◽  
Vol 52 (01) ◽  
pp. 25-31 ◽  
Author(s):  
Marina Tsoli ◽  
Krystallenia I. Alexandraki ◽  
Maria-Eleni Spei ◽  
Gregory A. Kaltsas ◽  
Kosmas Daskalakis
Keyword(s):  
Clinical Trials ◽  
Thyroid Cancer ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Objective Response ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Multikinase Inhibitors ◽  
Metastatic Thyroid Cancer

AbstractMany trials have demonstrated prime antitumor activity of novel, small molecule multikinase inhibitors (MKIs) in advanced and/or metastatic thyroid cancer (TC). In this work, the PubMed, EMBASE, Cochrane Central Register of Controlled Trials, Web of Science, SCOPUS, and clinicaltrials.gov databases were searched. Quality/risk of bias were assessed using GRADE criteria. Randomized clinical trials (RCTs) comparing two or more systemic therapies in patients with advanced and/or metastatic thyroid cancer were assessed. A total of 1347 articles and 548 clinical trials in clinicaltrials.gov were screened. We included seven relevant RCTs comprising 1934 unique patients assigned to different MKIs. Two separate network meta-analyses included four RCTs in radioiodine refractory well-differentiated thyroid cancer (RR-WDTC) and three RCTs in medullary thyroid cancer (MTC), respectively; all with a low risk of bias. We identified three therapies for RR-WDTC: sorafenib [disease control rate (DCR) odds ratio (OR): 0.11 (95% CI: 0.03–0.40); progression-free survival (PFS) hazard ratio (HR): 1.99 (95% CI: 1.62–2.46)], vandetanib [DCR_OR:0.26 (95% CI: 0.06–1.24); PFS_HR: 0.99 (95% CI: 0.82–1.20)] and lenvatinib [DCR_OR: 0.26 (95% CI: 0.05–1.33); PFS_HR: 0.99 (95% CI: 0.81–1.22)]; and the following therapies for MTC: vandetanib 300 mg [objective response rate (ORR)_OR: 3.31 (95% CI: 0.68–16.22); vandetanib 150 mg ORR_OR: 0.60 (95% CI: 0.16–2.33)]; and cabozantinib [ORR_OR: 85.32 (95% CI: 5.22–1395.15)]. Serious side effect (SE) analysis per organ/system demonstrated a varying MKI SE profile across both RR-WDTC and MTC diagnoses, more commonly involving metabolic/nutritional disorders [OR: 2.07 [95% CI: 0.82–5.18)] and gastrointestinal SE [OR: 1.63 (95% CI: 1.0–2.66)]. This network meta-analysis on advanced and/or metastatic TC points towards a higher efficacy of lenvatinib in RR-WDTC. The included MKIs exhibit a varying SE profile across different organs/systems favoring a patient-tailored approach with the anticipated toxicities guiding clinicians’ decisions.

scholarly journals Effects of low-level laser therapy on the orthodontic mini-implants stability: a systematic review and meta-analysis

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ana Carolina de Figueiredo Costa ◽  
Thays Allane Cordeiro Maia ◽  
Paulo Goberlânio de Barros Silva ◽  
Lucas Guimarães Abreu ◽  
Delane Viana Gondim ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Laser Therapy ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Low Risk ◽  
Low Level Laser Therapy ◽  
Mini Implants ◽  
Level Laser

Abstract Objectives The aim of this systematic review and meta-analysis was to assess the effects of low-level laser therapy (LLLT) on the orthodontic mini-implants (OMI) stability. Materials and methods An unrestricted electronic database search in PubMed, Science Direct, Embase, Scopus, Web of Science, Cochrane Library, LILACS, Google Scholar, and ClinicalTrials.gov and a hand search were performed up to December 2020. Randomized clinical trials (RCTs) or non-randomized clinical trials (Non-RCTs) that assessed the effects of LLLT on the OMI stability were included. Data regarding the general information, LLLT characteristics, and outcomes were extracted. The authors performed risk of bias assessment with Cochrane Collaboration’s or ROBINS-I tool. Meta-analysis was also conducted. Results Five RCTs and one Non-RCT were included and 108 patients were evaluated. The LLLT characteristics presented different wavelength, power, energy density, irradiation time, and protocol duration. Five RCTs had a low risk of selection bias. Two RCTs had a low risk of performance and detection bias. All RCTs had a low risk of attrition bias, reporting bias and other bias. The Non-RCT presented a low risk of bias for all criteria, except for the bias in selection of participants. The meta-analysis revealed that LLLT significantly increased the OMI stability (p < 0.001, Cohen’s d = 0.67) and the highest clinical benefit was showed after 1 (p < 0.001, Cohen’s d = 0.75), 2 (p < 0.001, Cohen’s d = 1.21), and 3 (p < 0.001, Cohen’s d = 1.51) months of OMI placement. Conclusions LLLT shows positive effects on the OMI stability.

Compliance of Randomized Clinical Trials in Noncarious Cervical Lesions With the CONSORT Statement: A Systematic Review of Methodology

2018 ◽  
Vol 43 (3) ◽  
pp. E129-E151 ◽  
Author(s):  
A Reis ◽  
JL de Geus ◽  
L Wambier ◽  
M Schroeder ◽  
AD Loguercio
Keyword(s):  
Clinical Trials ◽  
High Risk ◽  
Randomized Clinical Trials ◽  
Cochrane Collaboration ◽  
Consort Statement ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Adhesive Systems ◽  
Cervical Lesions ◽  
Significant Difference

SUMMARY The literature was reviewed to evaluate the compliance of randomized clinical trials (RCTs) with the CONsolidated Standards of Reporting Trials (CONSORT ) and the risk of bias of these studies through the Cochrane Collaboration risk of bias tool (CCRT). RCTs were searched at Cochrane Library, PubMed, and other electronic databases to find studies about adhesive systems for cervical lesions. The compliance of the articles with CONSORT was evaluated using the following scale: 0 = no description, 1 = poor description, and 2 = adequate description. Descriptive analyses about the number of studies by journal, follow-up period, country, and quality assessments were performed with CCRT for assessing risk of bias in RCTs. One hundred thirty-eight RCTs were left for assessment. More than 30% of the studies received scores of 0 or 1. Flow chart, effect size, allocation concealment, and sample size were more critical items, with 80% receiving a score of 0. The overall CONSORT score for the included studies was 15.0 ± 4.8 points, which represents 46.9% of the maximum CONSORT score. A significant difference among countries was observed (p&lt;0.001), as well as range of year (p&lt;0.001). Only 4.3% of the studies were judged as at low risk; 36.2% were classified as having unclear risk and 59.4% as having high risk of bias. The adherence of RCTs evaluating adhesive systems to the CONSORT is low with unclear/high risk of bias.

scholarly journals Acupuncture for Managing Cancer-Related Insomnia: A Systematic Review of Randomized Clinical Trials

2016 ◽  
Vol 16 (2) ◽  
pp. 135-146 ◽  
Author(s):  
Tae-Young Choi ◽  
Jong In Kim ◽  
Hyun-Ja Lim ◽  
Myeong Soo Lee
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Sleep Quality ◽  
Randomized Clinical Trials ◽  
Data Extraction ◽  
Meta Analysis ◽  
Sham Acupuncture ◽  
Risk Of Bias ◽  
The Other ◽  
Level Of Evidence

Background. Insomnia is a prominent complaint of cancer patients that can significantly affect their quality of life and symptoms related to sleep quality. Conventional drug approaches have a low rate of success in alleviating those suffering insomnia. The aim of this systematic review was to assess the efficacy of acupuncture in the management of cancer-related insomnia. Methods. A total of 12 databases were searched from their inception through January 2016 without language restriction. Randomized controlled trials (RCTs) and quasi-RCTs were included if acupuncture was used as the sole intervention or as an adjunct to another standard treatment for any cancer-related insomnia. The data extraction and the risk of bias assessments were performed by 2 independent reviewers. Results. Of the 90 studies screened, 6 RCTs were included. The risk of bias was generally unclear or low. Three RCTs showed equivalent effects on the Pittsburgh Sleep Quality Index and 2 RCTs showed the similar effects on response rate to those of conventional drugs at the end of treatment. The other RCT showed acupuncture was better than hormone therapy in the numbers of hours slept each night and number of times woken up each night. The 3 weeks of follow-up in 2 RCTs showed superior effects of acupuncture compared with conventional drugs, and a meta-analysis showed significant effects of acupuncture. Two RCTs tested the effects of acupuncture on cancer-related insomnia compared with sham acupuncture. One RCT showed favourable effects, while the other trial failed to do so. Conclusion. There is a low level of evidence that acupuncture may be superior to sham acupuncture, drugs or hormones therapy. However, the number of studies and effect size are small for clinical significance. Further clinical trials are warranted.

scholarly journals EFFECTS OF POSTURAL EDUCATION IN ELEMENTARY SCHOOL CHILDREN: A SYSTEMATIC REVIEW

2021 ◽  
Vol 39 ◽  
Author(s):  
Paola Janeiro Valenciano ◽  
Fabíola Unbehaun Cibinello ◽  
Jessica Caroliny de Jesus Neves ◽  
Dirce Shizuko Fujisawa
Keyword(s):  
Clinical Trials ◽  
Elementary School ◽  
High Risk ◽  
School Children ◽  
Elementary School Children ◽  
Randomized Clinical Trials ◽  
Outcome Data ◽  
Risk Of Bias ◽  
Eligibility Criteria ◽  
Positive Effects

ABSTRACT Objective: To determine the effect of postural education on the learning and postural habits of elementary school children without physical intervention. Methods: We searched PubMed, Lilacs, SciELO, Cochrane, and Science Direct data bases and reference lists of studies in February 2020. The eligibility criteria were randomized clinical trials related to the effect of postural education in children aged between 6 and 12 years old. Two authors independently assessed trials for inclusion and risk of bias: randomization process, deviations from intended interventions, missing outcome data, measurement of the outcome, and selection of the reported result. Data were extracted in standardized tables including information on author, publication year, country, sample size, age, sex, intervention characteristics, outcome measurements and results. Results: We found seven clinical trials (involving 2,568 children) for the review. The studies were conducted between 2000 and 2018: four in Belgium, two in Spain, and one in Germany. All seven included trials underwent evaluation: only one had a clear process of randomization and allocation concealment. All included studies were judged as having high risk of bias in at least one domain or have concerns for multiple domains. Conclusions: The positive effects of acquired knowledge and postural habits found in the studies cannot be used to reliably support postural education in elementary school children due to a high risk of bias in the evaluated studies.

scholarly journals Limited Evidence Suggests Benefits of Single Visit Revascularization Endodontic Procedures - A Systematic Review

2019 ◽  
Vol 30 (6) ◽  
pp. 527-535 ◽  
Author(s):  
Giampiero Rossi-Fedele ◽  
Bill Kahler ◽  
Nagendrababu Venkateshbabu
Keyword(s):  
Clinical Trials ◽  
Animal Studies ◽  
Randomized Clinical Trials ◽  
Case Reports ◽  
Risk Of Bias ◽  
Permanent Teeth ◽  
Single Visit ◽  
Multiple Treatment ◽  
High Concentrations

Abstract Revascularization endodontic procedures commonly require multiple treatment sessions. However, single visit procedures may be advantageous from the clinical and patient management standpoints. The purpose of this review was to evaluate the outcomes of single-visit revascularization endodontic procedures for the management of immature permanent teeth with non-vital pulp. Two electronic databases (Scopus and PubMed) were searched, from their inception to July 2018, for studies that assessed clinical and/or radiographic and/or histologic outcomes of single-visit revascularization endodontic procedures performed in immature permanent teeth with non-vital pulp. Case reports, animal studies and clinical trials were included. The quality of case reports was appraised by Joanna Briggs Institute Critical Appraisal Checklist for Case Reports. The quality of randomized clinical trials was assessed by the revised Cochrane risk of bias tool for randomized trials. The risk of bias for animal studies was assessed using SYRCLE’s risk of bias tool. Tabulation followed by narrative synthesis was used to draw conclusions. Seven studies satisfied the selection criteria. Five were classified as case reports, one as a randomized clinical trial and one as animal study. The latter presented with a high risk of bias, whilst the remaining showed a low risk. The evidence supporting the potential use of single-visit revascularization endodontic procedures is scarce. Successful single-visit revascularization endodontic procedures commonly include the use of high concentrations of sodium hypochlorite and EDTA combined with the use of agitation systems. Further clinical trials with long term follow up are needed to confirm the results of the current review.

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