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<0.001), as well as range of year (p<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.

Behavioral therapy versus drug therapy in individuals with idiopathic overactive bladder: A systematic review and meta-analysis

2019 ◽  
Vol 25 (5) ◽  
pp. 573-585 ◽  
Author(s):  
Valentina Lucia La Rosa ◽  
Thaís Duarte de Campos da Silva ◽  
Arielle Rosa de Oliveira ◽  
Taís Marques Cerentini ◽  
Patricia Viana da Rosa ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Therapy ◽  
High Risk ◽  
Overactive Bladder ◽  
Randomized Clinical Trials ◽  
Behavioral Therapy ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Overactive Bladder Syndrome ◽  
Significant Difference

The aim of this study was to systematically review randomized clinical trials comparing the treatment of individuals with overactive bladder syndrome through the use of behavioral therapy versus drug therapy. A systematic electronic search of MEDLINE via PubMed, Embase, and Cochrane Library was performed, including studies indexed until August 2019. Five randomized clinical trials were included. The studies presented a high risk of bias. There was no significant difference between the evaluated treatments. Thus, behavioral therapy and drug therapy also promote the improvement of the symptoms of overactive bladder syndrome, and the behavioral therapy does not have significant adverse effects reported. Due to the high risk of bias in included studies, data should be interpreted with caution. Future studies with more comprehensive protocols may change the effect estimates of behavioral therapy on overactive bladder syndrome.

Clinical Performance of Filled/Nanofilled Versus Nonfilled Adhesive Systems in Noncarious Cervical Lesions: A Systematic Review and Meta-analysis

2020 ◽  
Vol 46 (1) ◽  
pp. E34-E59
Author(s):  
JL de Geus ◽  
BM Maran ◽  
KA Cabral ◽  
A Dávila-Sánchez ◽  
C Tardem ◽  
...  
Keyword(s):  
Clinical Performance ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Adhesive Systems ◽  
Cervical Lesions ◽  
Secondary Caries ◽  
Significant Difference

Clinical Relevance The use of filled adhesive systems does not influence the clinical performance of the adhesive restoration in noncarious cervical lesions. SUMMARY Objective: The aim of this meta-analysis was to investigate the clinical performance of filled vs unfilled adhesive systems when applied in noncarious cervical lesions. Methods and Materials: A systematic search was performed in PubMed, Scopus, Web of Science, LILACS, BBO, Cochrane Library, and SIGLE. Gray literature was also screened. Only randomized controlled clinical trials were included. The risk of bias of the studies was evaluated using the Cochrane Collaboration’s tool. A random-effects meta-analysis was conducted to compare the retention rate, marginal discoloration, and secondary caries of noncarious cervical lesions restored with filled adhesives vs unfilled adhesives. The quality of the body of evidence was assessed using the GRADE approach. Results: A total of 3662 studies were identified after removal of duplicates. Twenty-nine studies remained for qualitative analyses and 28 studies for the meta-analysis. Only one study was judged to have a low risk of bias, and the other 28 were considered to have unclear risk of bias. There was no statistically significant difference between filled adhesives compared with unfilled adhesives in relation to loss of retention, marginal discoloration, or secondary caries at any of the follow-up periods (12–18 months, 24–30 months, 3 years, and 5 years or longer). The quality of evidence was graded as moderate for most outcomes at the respective follow-ups, except when there was an explained heterogeneity, which occurred mainly for loss of retention at the 12-month to 3-year follow-up. The results did not depend on whether microfilled or nanofilled adhesives had been investigated. Conclusions: The addition of fillers into the composition of adhesive systems did not increase the clinical performance (retention rates, marginal discoloration, or secondary caries) of composite restorations placed in noncarious cervical lesions when compared with unfilled adhesives.

scholarly journals Benefits of Qigong as an integrative and complementary practice for health: a systematic review

2020 ◽  
Vol 28 ◽  
Author(s):  
Bruna Francielle Toneti ◽  
Rafael Fernando Mendes Barbosa ◽  
Leandro Yukio Mano ◽  
Luana Okino Sawada ◽  
Igor Goulart de Oliveira ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Cochrane Collaboration ◽  
The Elderly ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Meta Analyses

Objective: to analyze, in the literature, evidence about the benefits of the integrative and complementary practice of Qigong with regard to the health of adults and the elderly. Method: a systematic review by searching for studies in the PubMed, CINAHL, LILACS, EMBASE and Cochrane Library databases. Randomized and non-randomized clinical trials were included; in Portuguese, English and Spanish; from 2008 to 2018. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses strategy was adopted, as well as the recommendation of the Cochrane Collaboration for assessing the risk of bias in the clinical trials analyzed. Results: 28 studies were selected that indicated the benefit of the practice to the target audience, which can be used for numerous health conditions, such as: cancer; fibromyalgia; Parkinson’s disease; Chronic Obstructive Pulmonary Disease; Burnout; stress; social isolation; chronic low back pain; cervical pain; buzz; osteoarthritis; fatigue; depression; and cardiovascular diseases. However, there was a great risk of bias in terms of the blinding of the research studies. Conclusion: the practice of Qigong produces positive results on health, mainly in the medium and long term. This study contributes to the advancement in the use of integrative and complementary practices in nursing, since it brings together the scientific production in the area from the best research results available.

scholarly journals Breathing technique in pain and cognitive function: a systematic review of the literature

2020 ◽  
Vol 1 (1) ◽  
pp. 25-42
Author(s):  
Juan Pablo Alzate-Granados ◽  
Armando Solarte ◽  
Pedro Javier Lopez ◽  
Ernesto Barceló
Keyword(s):  
Cognitive Function ◽  
Randomized Clinical Trials ◽  
Cochrane Collaboration ◽  
Well Being ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Breathing Techniques ◽  
Significant Difference ◽  
Scale Difference ◽  
The Cochrane Collaboration

  Breathing techniques are key components of yoga, meditation and relaxation practices that are well known for reducing anxiety and improving overall well-being. To evaluate the efficacy of breathing techniques in pain and cognitive function. We conducted a literature review searching the main literature databases (medline, lilacs, Cochrane library) including randomized clinical trials. We assessed the risk of bias of the included studies using the methodology proposed by the Cochrane collaboration. In total, we found 16 studies that met the inclusion criteria, with an intermediate or unclear overall risk of bias. When combining the different breathing techniques vs control in the included studies, we found a statistically significant difference in terms of the visual analog scale (Difference of means, random effects; -1.21 [95% CI -1.75 to -0.68]; I2: 95%). Meditation-based breathing techniques would improve pain and cognitive function in patients with a painful entity or healthy volunteers.

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 Carbon dioxide versus air insufflation enteroscopy: a systematic review and meta-analysis based on randomized controlled trials

2018 ◽  
Vol 06 (06) ◽  
pp. E637-E645 ◽  
Author(s):  
Julio Aquino ◽  
Wanderley Bernardo ◽  
Diogo de Moura ◽  
Flávio Morita ◽  
Rodrigo Rocha ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Data Extraction ◽  
Meta Analysis ◽  
Ambient Air ◽  
Quality Analysis ◽  
Cochrane Library ◽  
Eligibility Criteria ◽  
Co2 Insufflation ◽  
Significant Difference

Abstract Objectives To compare the insufflation of CO2 and ambient air in enteroscopy. Search sources The investigators researched the electronic databases MedLine, Cochrane Library, Central, LILACS, BVS, Scopus and Cinahl. The grey search was conducted in the base of theses of the University of São Paulo, books of digestive endoscopy and references of selected articles and in previous systematic revisions. Study eligibility criteria The evaluation of eligibility was performed independently, in a non-blind manner, by two reviewers, firstly by title and abstract, followed by complete text. Disagreements between the reviewers were resolved by consensus. Data collection and analysis method Through the spreadsheet of data extraction, where one author extracted the data and a second author checked the extraction. Disagreements were resolved by debate between the two reviewers. The quality analysis of the studies was performed using the Jadad score. The software RevMan 5 version 5.3 was used for the meta-analysis. Results Four randomized clinical trials were identified, totaling 473 patients submitted to enteroscopy and comparing insufflation of CO2 and ambient air. There was no statistical difference in the intubation depth between the two groups. When CO2 insufflation was reduced, there was a significant difference in pain levels 1 hour after the procedure (95 % IC, –2.49 [–4.72, –0.26], P: 0.03, I2: 20%) and 3 hours after the procedure (95% IC, –3.05 [–5.92, –0.18], P: 0.04, I2: 0 %). There was a usage of lower propofol dosage in the CO2 insufflation group, with significant difference (95 % IC, –67.68 [–115.53, –19.84], P: 0.006, I2: 0 %). There was no significant difference between the groups in relation to the use of pethidine and to the oxygen saturation. Limitations Restricted number of randomized clinical trials and nonuniformity of data were limitations to the analysis of the outcomes. Conclusion The use of CO2 as insufflation gas in enteroscopy reduces the pain levels 1 hour and 3 hours after the procedure, in addition to the reduction of the sedation (propofol) dosage used.

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 Acupuncture Treatments for Post-stroke Depression: A Systematic Review and Network Meta-analysis

2021 ◽  
Author(s):  
Lam Wai Ching ◽  
Hui Juan Li ◽  
Jianwen Guo ◽  
Liang Yao ◽  
Janita Chau ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Rating Scale ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Depression Symptoms ◽  
Post Stroke ◽  
Significant Difference ◽  
Post Stroke Depression ◽  
The Impact

Abstract Background: Depression is one of the most common complications after stroke, with a prevalence of 30-33%. Patients with post-stroke depression (PSD) usually experience anxiety, hopelessness, and insomnia, which have a negative impact on their daily activities and post-stroke rehabilitation. In this review, we aimed to explore the impact of acupuncture in alleviating symptoms of PSD and to evaluate the difference in effectiveness between acupuncture combined with pharmacotherapies and various non-pharmacotherapies in order to provide guides and advice for clinical personnel. Methods: Six databases (Cochrane Library, PubMed, EMBASE, China National Knowledge Infrastructure, Wanfang Database, Chongqing VIP Database) and two clinical trials registration platforms were searched from inception to May 2021. Randomized clinical trials (RCTs) comparing needle-based acupuncture with pharmacotherapy, and other non-pharmacotherapy or invalid group were included. Two independent reviewers identified eligible studies. Two reviewers independently abstracted and recorded data into a pre-made form. A Bayesian network meta-analysis (NMA) was conducted to assess and compare different techniques using RStudio 3.6.0. The primary outcome was the change in scores of scales measuring depressive symptoms. The secondary outcomes were changes in serotonin levels and in quality of life. Results: Fifty-nine RCTs were included. The results of this NMA showed that compared with western medicine (WM), acupuncture alone or with repetitive transcranial magnetic stimulation (RTMS), Traditional Chinese medicine (TCM) alone or with WM, were superior for alleviating depression symptoms. Compared to Usual Care, acupuncture alone or plus other therapies could significantly decrease scores of the Hamilton Depression Rating scale. However, there was no significant difference found among acupuncture, WM, TCM with AC plus any of other treatment.Conclusions: The results of this study indicate that acupuncture alone or combined with other therapies appear to be effective in improving depression symptoms of stroke survivors. Moreover, in comparison with WM, acupuncture alone or plus RTMS, TCM, TCM with WM, or WM, were more effective in improving depression symptoms. Also, acupuncture with RTMS seems to be the most effective with the highest probability.

scholarly journals Quality assessment of studies included in Cochrane oral health systematic reviews

2020 ◽  
Author(s):  
Ahmad Sofi-Mahmudi ◽  
Pouria Iranparvar ◽  
Maryam Shakiba ◽  
Erfan Shamsoddin ◽  
Hossein Mohammad-Rahimi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Oral Health ◽  
High Risk ◽  
Systematic Reviews ◽  
Randomized Clinical Trials ◽  
Cochrane Review ◽  
Risk Of Bias ◽  
Double Blind ◽  
Cochrane Reviews ◽  
Performance Bias

AbstractObjectivesThe Risk of Bias (RoB) and other characteristics of randomized clinical trials included in Cochrane oral health systematic reviews were assessed.Study Design and SettingsAll the trials included in Cochrane oral health systematic reviews were examined. The RoB was evaluated for all the included clinical trials according to the Cochrane review standards. The Overall Risk of Bias (ORoB) was defined in this study based on the criteria for determining the overall bias in Cochrane’s RoB tool-v2. Descriptive analyses were carried out to determine the frequency of each intended variable.ResultsA total of 2565 studies were included in our analysis. The majority of the studies (n=1600) had sample sizes of 50 or higher. As for blinding, 907 studies were labelled as double-blind. Performance bias showed the highest rate of high risk (31.4%). Almost half of the studies had a high ORoB compared to 11.1% with low ORoB. The studies that used placebos had higher low ORoB (14.8% vs. 10.7%). The double-blind studies had the highest low ORoB (23.6%). The studies with a cross-over design had the highest low ORoB (28.8%).ConclusionOverall, the RoB for the studies on dentistry and oral health in Cochrane reviews was deemed high.

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