Cochrane Collaboration Risk Of Bias Tool Research Articles

Long- and short-term effectiveness of traditional Chinese exercises in improving the overall physical capacity of patients with knee osteoarthritis: A systematic review and meta-analysis.

The increasing global popularity of traditional Chinese exercise (TCE) provides substantial evidence of its significant efficacy in treating knee osteoarthritis (KOA). To assess the impact of different types of TCE and varying exercise durations on KOA patients, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) on this topic. Two investigators extensively searched four electronic databases (PubMed, Embase, Cochrane, and Web of Science) from their inception until December 16, 2023, to identify all relevant RCTs on the use of TCE for KOA treatment. The included studies were assessed for risk of bias using the Cochrane Collaboration Risk of Bias Tool (CCRBT), and data analysis was performed using Stata 15.0. A total of 20 RCTs, involving 1367 patients with KOA, met the inclusion criteria. Compared to the control group, TCE demonstrated significant improvement in three subscale scores of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Pain (SMD = -0.44; P = .0001); Stiffness (SMD = -0.35; P = .001); Physical function (SMD = -0.52; P = .0001)] and two subscale scores of the 36-item Short-Form (SF-36) [Physical score (WMD = 2.76; P = .001); Mental score (WMD = 2.49; P = .0001)] in KOA patients. Subgroup analysis showed that both long-term habitual exercise (over 12 weeks) and short-term exercise (within 12 weeks) were more effective than the control group in improving pain, joint stiffness, and physical function in KOA patients. Tai Chi, among the four TCE modalities analyzed, demonstrated improvements in all indicators. Based on the results of our meta-analysis, it can be concluded that both long-term and short-term TCE interventions are effective in alleviating the main symptoms of KOA and improving patients' physical function. However, due to limited methodological quality and inconsistent outcome measures in the included RCTs, further high-quality RCTs with larger sample sizes and longer-term interventions are necessary to validate our findings before TCE can be recommended as a treatment for KOA.

Systematic review and pooled analysis of randomized controlled trials in countries of the Gulf Cooperation Council (GCC): Methods and quality assessment.

To describe variations in characteristics of randomized controlled trials conducted in the Gulf Cooperation Council (GCC) countries, and critically appraising the quality of design, conduct and analysis of the trials. We carried out a systematically comprehensive electronic search of articles published between 1990 and 2018 and indexed in several databases: i) MEDLINE/PubMed, ii) EMBASE, iii) Cochrane Central Register of Controlled Trials (CENTRAL), iv) ClinicalTrials.gov, and v) World Health Organization International Clinical Trials Registry Platform. We summarized the overall risk of bias present in all analyzed studies using the Cochrane Collaboration risk of bias tool (CCRBT). A remarkable shift in numbers of publications from 2006 onwards was found. The largest number of publications were from Saudi Arabia and consisted of hospitals/clinics based studies. Lack of randomization was found in the majority of reports, and nearly three-fourth of the studies involved the use of intention-to-treat (ITT) principle. However, the proportion of adequately generated random sequence methods has increased yearly, and this increase accounted for a relatively large proportion over the latter half of the studied period (p<0.001), in contrast to the proportion of allocation concealment and blinding. Journal impact factor was significantly correlated with the quality of random sequence generation (r=0.145; p=0.014). The randomization methods have gained more attention over the last 3 decades. Secondly, Journal impact factor can serve as an indicator of randomization quality. To mitigate the large rate of overall high risk of bias in GCC studies, high-quality trials must be considered by ensuring adequate allocation concealment and blinding methods. PROSPERO No. ID: CRD42022310331.

Role of Antimuscarinics Combined With Alpha-blockers in the Management of Urinary Storage Symptoms in Patients With Benign Prostatic Hyperplasia: An Updated Systematic Review and Meta-analysis.

We evaluate the efficacy and safety of combining antimuscarinics with alpha-blockers to treat storage symptoms in men with benign prostatic hyperplasia. Searches were carried out on PubMed, MEDLINE, EMBASE, and Cochrane databases to identify randomized, placebo-controlled trials published before February 15, 2022, assessing the efficacy or safety of antimuscarinics in men with benign prostatic hyperplasia treated with alpha-blockers. Further meta-analyses were performed using standardized mean difference and risk ratio. A total of 12 randomized trials were included in the systematic review. The meta-analysis showed no impact of antimuscarinics on the number of urgencies per day (SMD -0.23 [95%CI: -0.64; -0.17]; P = .21). However, the use of antimuscarinics was associated with a small reduction of micturition episodes per day (SMD -0.19 [95%CI: -0.37; -0.01]; P = .045). With regard to side effects, post-void residual increased slightly in patients treated with antimuscarinics (SMD 0.26 [95%CI: 0.15; 0.37]; P < .01). In addition, there was a higher risk of acute urinary retention (RR 3.26 [95%CI: 1.35; 7.86]; P = .02), dry mouth (RR 3.43 [95%CI: 1.86; 6.32]; P < .001), and constipation (RR 2.92 [95%CI: 1.48; 5.73]; P < .001) with the use of antimuscarinics. Finally, the risk of treatment interruption due to adverse events was higher for the patients treated with antimuscarinics (RR 1.74 [95%CI: 1.27; 2.38]; P < .01). The addition of antimuscarinics to alpha-blockers was not associated with a substantial reduction in urgencies and micturition episodes in benign prostatic hyperplasia patients with storage symptoms. In addition, the toxicity profile was not in favor of antimuscarinic use in these patients.

The Effect of Probiotic and Synbiotic Consumption on the Most Prevalent Chemotherapy-related Complications: A Systematic Review of Current Literature.

To date, many investigations have employed pro-/synbiotic to examine their effects on chemotherapy-related side effects; nevertheless, their findings are inconclusive. To address this issue, we carried out a systematic review to explore the effect of pro- /synbiotic consumption on chemotherapy-related side effects, including nausea, vomiting, mucositis, diarrhea, and constipation in adults using randomized controlled trials (RCTs). The electronic databases, including PubMed, Scopus, and ISI Web of Sciences, were searched systematically from the earliest available date to March 2021 to identify eligible studies. The quality of the enrolled studies was assessed based on the Cochrane Collaboration Risk of Bias tool. A total of 10 studies involving 788 individuals were included in the current systematic review, with the sample size ranging from 25 to 200 and the mean age ranging from 51.04 to 66.91 years. The findings of this study imply that probiotic consumption may be more effective in terms of mucositis compared to other complications. Further good-quality RCTs with better methodology are required to determine whether and how pro-/synbiotics can prevent or treat chemotherapy-induced side effects. The current systematic review findings may help investigators of future studies in selecting the study population and probiotic strains.

Cardiotoxicity Associated With Chimeric Antigen Receptor (CAR)-T Cell Therapy for Hematologic Malignancies: A Systematic Review.

Chimeric Antigen Receptor (CAR)-T cell therapy has been one of the most important breakthroughs for treating hematologic malignancies. On the other hand, the therapy had many toxicities. One of the toxicities of the CAR-T therapy is cardiotoxicity. The goal of the systematic review is to elaborate on the cardiotoxicities related to CAR-T therapy for hematologic malignancies. The systematic review is following the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) 2020 guidelines. The systematic search was done using PubMed, PubMed Central (PMC), Google Scholar, Cochrane Library, ScienceDirect, and clinicaltrial.gov. The search and selection of studies were done on April 28, 2022, and May 6, 2022, respectively. The studies were selected based upon participants, intervention, and outcomes (PIO) elements and the articles that were included were, full-text articles published within the last ten years, clinical trials, meta-analyses, randomized controlled trial, review, and systematic review. The exclusion criteria were non-hematologic malignancy, non-English-language articles. The initial search had 2,159 publications. The publications were assessed with assessment tools of Scale of the Assessment of Narrative Review Articles (SANRA), Newcastle-Ottawa Scale (NCOS), and Cochrane Collaboration Risk of Bias Tool (CCRBT), which led to selection of eight publications. The systematic review concludes that cardiotoxicity happened in adults and pediatric patients receiving the CAR-T cell therapy and that those cardiac adverse events had many risk factors. Therefore, monitoring these cardiotoxicities is highly essential.

Risk of bias for randomized controlled trials in Journal of Clinical Monitoring and Computing.

Well-designed randomized controlled trials (RCTs) are considered to represent a high level of evidence and influence medical decision-making in evidence-based medicine. When biases occur in study design, processing, and reporting of RCTs, however, it is difficult to interpret results and judge the impact of interventions. Accordingly, we evaluate the quality of RCT reporting published in the Journal of Clinical Monitoring and Computing (JCMC) using three assessment tools. Reporting quality of RCTs published in the JCMC was evaluated through December 31, 2020, using Jadad and van Tulder scales and the Cochrane Collaboration's risk of bias tool (CCRBT). Stepwise regression analysis was performed to identify factors associated with reporting quality. Database searches confirmed 132 RCTs in 1,507 original articles. The numbers of RCTs meeting criteria for high reporting quality were 97 (73.5%) using the Jadad scale, 99 (75.0%) using the van Tulder scale, and 19 (14.4%) with the CCRBT. Jadad scores [median score (interquartile range) = 3.0 (2.0-5.0), coefficients (95% CI) = 0.08 (0.04, 0.11), p < 0.001], van Tulder scores [median score (interquartile range) = 7.0 (5.0-8.75), coefficients (95% CI) = 0.15 (0.11, 0.20), p < 0.001], and CCRBT assessment [coefficients (95% CI) = 0.04 (0.02, 0.06), p < 0.001] increased significantly with publication year. The median score (interquartile range) of the last 5 years were 4.0 (3.0-5.0) in Jadad scores, and 8.0 (6.0-9.0) in van Tulder scores. Only 33.3% and 37.1% of articles described detailed blinding and allocation methods, respectively. Reporting quality increased over time, with consistently high reporting quality in recently published JCMC RCTs.

Can Low-Dose of Dietary Vitamin E Supplementation Reduce Exercise-Induced Muscle Damage and Oxidative Stress? A Meta-Analysis of Randomized Controlled Trials.

Vitamin E plays an important role in attenuating muscle damage caused by oxidative stress and inflammation. Despites of beneficial effects from antioxidant supplementation, effects of antioxidants on exercise-induced muscle damage are still unclear. The aim of this meta-analysis was to investigate the effects of dietary vitamin E supplementation on exercise-induced muscle damage, oxidative stress, and inflammation in randomized controlled trials (RCTs). The literature search was conducted through PubMed, Medline, Science Direct, Scopus, SPORTDiscuss, EBSCO, Google Scholar database up to February 2022. A total of 44 RCTs were selected, quality was assessed according to the Cochrane collaboration risk of bias tool (CCRBT), and they were analyzed by Revman 5.3. Dietary vitamin E supplementation had a protective effect on muscle damage represented by creatine kinase (CK; SMD −1.00, 95% CI: −1.95, −0.06) and lactate dehydrogenase (SMD −1.80, 95% CI: −3.21, −0.39). Muscle damage was more reduced when CK was measured immediately after exercise (SMD −1.89, 95% CI: −3.39, −0.39) and subjects were athletes (SMD −5.15, 95% CI: −9.92, −0.39). Especially vitamin E supplementation lower than 500 IU had more beneficial effects on exercise-induced muscle damage as measured by CK (SMD −1.94, 95% CI: −2.99, −0.89). In conclusion, dietary vitamin E supplementation lower than 500 IU could prevent exercise-induced muscle damage and had greater impact on athletes

Treatment stability with bonded versus vacuum-formed retainers: a systematic review of randomized clinical trials.

In orthodontics, the retention phase can be considered challenging and unpredictable. Therefore, evidence obtained from different retention protocols is important to facilitate clinical decision-making. This systematic review aimed to compare the clinical effectiveness of bonded versus vacuum-formed retainers (VFRs) regarding their capacity to maintain treatment stability, periodontal effects, and failure rates. Ten databases comprising published and unpublished literature were systematically searched up to August 2021. Randomized clinical trials (RCTs) comparing both retainers were included. The risk of bias (RoB) evaluation was performed with the Cochrane Collaboration RoB Tool 2.0. All steps of the screening phase and RoB assessment were performed independently by two reviewers. The Grade of Recommendations, Assessment, Development, and Evaluation (GRADE) was used to evaluate the certainty of the evidence. Initial database search yielded 923 studies. After duplicates removal and full-text assessment, five RCTs remained. Overall, the studies presented Low RoB, except one study judged with 'Some concerns'. Based on the included studies, on a short-term (3-6 months) and long-term (4 years) basis, bonded retainers (BRs) were more effective to maintain treatment stability than VFRs in the lower arch. However, from 12 to 24 months both retainers presented the same efficacy. In the upper arch, the retainers were equally effective. BRs were associated with greater plaque and calculus accumulation than VFRs after 12 months. The retainers' failure rates were similar in the upper arch on the first year of retention; however, after 2 years VFRs showed significantly greater failure rates. Contrarily, BRs presented greater failure rates in the lower arch than VFRs. The findings of the included studies may be influenced by different factors related to the unpredictability of relapse. Most of the evidence generated in this systematic review derived from a moderate level of certainty. In the lower arch, BRs are more effective than VFRs to maintain treatment stability in the initial 6 months of retention and in the long term. In the upper arch, both retention protocols are equally effective. Regist0ration number: PROSPERO CRD42020199392. Coordination for the Improvement of Higher Educational Personnel (CAPES, Process code-001).

Antimicrobial activity of honey in periodontal disease: a systematic review

Honey has shown positive antimicrobial and anti-inflammatory actions in several dermatological studies; however, it is unclear if it could be effective in the treatment of periodontal disease. To answer the question: Does honey have antimicrobial activity against periodontopathogens? Six electronic databases were screened from initiation to 31 January 2019 for randomized clinical trials (RCTs) and controlled in vitro studies exploring the antimicrobial effect of honey against periodontopathogens. Honey's botanical origin, periopathogens that showed microbial susceptibility to honey, MICs, microbial growth conditions, control product and clinical follow-up were the main investigated outcomes. The risk of bias (RoB) of included RCTs was assessed using the Cochrane Collaboration RoB tool. The RoB of in vitro studies was evaluated based on the Sarkis-Onofre judgement model adapted to the context of honey. A total of 1448 publications were found as search results in the screened databases. Sixteen eligible papers were included based on predetermined inclusion criteria. Retained studies included 5 RCTs and 11 in vitro controlled trials. Manuka and multifloral honeys were the most studied varieties. The tested honeys showed a significant antimicrobial action, with different MICs, against eight periopathogens. Four of the five RCTs showed a high RoB, while 4 of the 11 retained in vitro studies showed a medium RoB. Honey showed a significant antimicrobial activity against all targeted periopathogens. Additional experiments are required to explore the entire antimicrobial spectrum of honey towards all pathogens involved in periodontal disease.

Reporting Quality Analysis of Randomized Controlled Trials in Journal of Neurosurgical Anesthesiology: A Methodological Assessment.

Randomized controlled trials (RCTs) are considered to provide high levels of evidence to optimize decision-making for patient care, although there can be a risk bias in their design, conduct, and analysis. Quality assessment of RCTs is necessary to assess whether they provide reliable results with little bias. We assessed the reporting quality of RCTs published in the Journal of Neurosurgical Anesthesiology (JNA) between January 1, 2000 and December 31, 2017 using the Jadad scale, van Tulder scale, and Cochrane Collaboration Risk of Bias Tool (CCRBT). We identified 130 RCTs and 570 original articles. Among the 130 RCTs, 92 (70.8%) presented an appropriate blinding method, and 70 (53.8%) described an appropriate allocation method. For the entire period, the percentages of high-quality reporting articles were 71.5%, 73.1%, and 13.8% in the Jadad scale, van Tulder scale, and CCRBT assessments, respectively. There was an improvement in the van Tulder scale over time (coefficients [95% confidence interval {CI}]=0.08 [0.01-0.15]; P=0.02). Appropriate reporting of allocation in the Jadad scale (coefficients [95% CI]=1.68 [1.28-2.07]; P<0.001) and van Tulder scale (coefficients [95% CI]=2.34 [1.97-2.70]; P<0.001), and reporting of blinding in the Jadad (coefficients [95% CI]=1.09 [0.66-1.52]; P<0.001) and van Tulder scores (coefficients [95% CI]=1.85 [1.45-2.25]; P<0.001), were associated with high-quality reporting. The ratio of high-quality reporting RCTs in JNA was consistently high compared with other journals. Thorough consideration of allocation concealment during the peer review process can further improve the reporting quality of RCTs in JNA.

Effects of physical exercises on inflammatory biomarkers and cardiopulmonary function in patients living with HIV: a systematic review with meta-analysis

BackgroundPro-inflammatory cytokines expressed in human immune deficiency virus (HIV) infection, may induce oxidative stress likely to compromise the patency of the airways or damage the lung tissues/cardiac function. However, physical (aerobic and/or resistance) exercise-induced release of heat shock protein, immune function alteration or reduced tissue hypoxia, have been highlighted as possible mechanisms by which increasing physical activity may reduce plasma pro-inflammatory cytokines in uninfected individuals and should be appraised in the literature for evidence of similar benefits in people living with HIV (PLWH). Therefore, we evaluated the effects of physical exercises on 1) inflammatory biomarkers and 2) cardiopulmonary function (VO2 Max) in PLWH.MethodA systematic review was conducted using the Cochrane Collaboration protocol. Searching databases, up to January 2018. Only randomized control trials investigating the effects of either aerobic or resistance or a combination of both exercise types with a control/other intervention(s) for a period of at least 4 weeks among adults living with HIV, were included. Two independent reviewers determined the eligibility of the studies. Data were extracted and risk of bias (ROB) was assessed with the Cochrane Collaboration ROB tool. Meta-analyses were conducted with random effect models using the Review Manager (RevMan) computer software.ResultTwenty-three studies met inclusion criteria (n = 1073 participants at study completion) comprising male and female with age range 18–65 years. Three meta-analyses across three sub-groups comparisons were performed. The result showed no significant change in biomarkers of inflammation (IL-6 and IL-1β) unlike a significant (Z = 3.80, p < 0.0001) improvement in VO2 Max. Overall, the GRADE evidence for this review was of moderate quality.ConclusionThere was evidence that engaging in either aerobic or resistance exercise, or a combination of both exercises, two to five times per week can lead to a significant improvement in cardiopulmonary function but not biomarkers of inflammation (IL-6 and IL-1β). However, this should not be interpreted as “No evidence of effect” because the individual trial studies did not attain sufficient power to detect treatment effects. The moderate grade evidence for this review suggests that further research may likely have an important impact on our confidence in the estimate of effects and may change the estimate.

Use of distraction techniques for the management of anxiety and fear in paediatric dental practice: A systematic review of randomized controlled trials

To determine whether distraction techniques (DT) reduce children's/adolescent's anxiety and fear during dental treatment. Randomized controlled trials (RCTs) in which any type of DT were used to manage dental anxiety and dental fear in children/adolescents were included. A systematic search of PubMed, Web of Science, Scopus, Cochrane Library, Lilacs, and Google Scholar was conducted. Two independent reviewers selected studies, extracted data, assessed methodological quality of studies using the Cochrane Collaboration's Risk of Bias tool (CCRBT), and approached certainty of evidence using GRADE (Grading of Recommendations, Assessment, Development and Evaluation). Data were analysed descriptively. Twenty studies covering several types of DT (audio, audiovisual, instruments camouflage, biofeedback, dental operating microscope, toys) were included. Qualitative analysis showed with very low certainty of evidence that DT effectively reduced dental anxiety and fear depending on the distraction type, instrument used to measure dental anxiety and dental fear, and dental procedure. CCRBT evaluation identified many methodological issues in included studies. There is a very low certainty of evidence that DT can be effective in managing children's/adolescents' dental fear and anxiety during dental treatment. The heterogeneity of methodologies and findings in the studies, however, suggests more robust, and well-executed RCTs are needed.

Impact of physical exercises on immune function, bone mineral density, and quality of life in people living with HIV/AIDS: a systematic review with meta-analysis

BackgroundCompromised immune function, associated with human immune deficiency virus(HIV) infection, is improved by antiretroviral therapy(ART) which also decreases bone mineral density(BMD), and possibly the quality of life(QoL). However, physical(aerobic/resistance) exercises, were reported to induce reverse effects in uninfected individuals and were appraised in the literature for evidence of similar benefits in people living with HIV/AIDS(PLWHA). The main study objective was to evaluate the impact of physical (aerobic and resistance) exercises on CD4+ count, BMD and QoL in PLWHA.MethodsA systematic review was conducted using the Cochrane Collaboration protocol. Searching databases, up to June 2017, only randomized control trials investigating the effects of either aerobic, resistance or a combination of both exercise types with a control/other intervention(s) for a period of at least 4 weeks among adults living with HIV, were included. Two independent reviewers determined the eligibility of the studies. Data were extracted and risk of bias(ROB) was assessed with the Cochrane Collaboration ROB tool. Meta-analyses were conducted using random effect models using the Review Manager(RevMan) computer software.ResultsNineteen studies met inclusion criteria(n = 491 participants at study completion) comprising male and female with age range 22–66 years. Two meta-analyses across 13 sub-group comparisons were performed. However, there were no RCTs on the impact of physical exercises on BMD in PLWHA. The result showed no significant change in CD4+ count unlike a significant effect of 5.04 point(95%CI:-8.49,-3.74,p = 0.00001) for role activity limitation due to physical health(QoL sub-domain). Overall, the GRADE evidence for this review was of moderate quality.ConclusionsThere was evidence that engaging in moderate intensity aerobic exercises (55–85% Maximum heart rate-MHR), for 30–60 min, two to five times/week for 6–24 weeks significantly improves role activity limitation due to physical health problems, otherwise physical(aerobic or/and resistance) exercises have no significant effects on CD4+ count and other domains of QoL. Also, there is lack of evidence on the impact of exercises on BMD in PLWHA due to the paucity of RCTs. The moderate grade evidence for this review suggests that further research may likely have an important impact on our confidence in the estimate of effects and may change the estimate.

The Effects of Coenzyme Q10 Supplementation on Metabolic Profiles of Patients with Chronic Kidney Disease: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

This systematic review and meta-analysis of Randomized Controlled Trials (RCTs) were conducted to determine the effects of coenzyme Q10 (CoQ10) supplementation on metabolic profiles of patients diagnosed with Chronic Kidney Disease (CKD). Two independent reviewers systematically searched online databases including PubMed, Cochrane Library, and Web of Science databases, Scopus, EMBASE until July 2018 to identify eligible clinical trials. The heterogeneity across included trials was assessed using Cochran's Q test and I-square (I2) statistic. Cochrane Collaboration risk of bias tool was applied to evaluate the quality of selected RCTs. Standardized mean difference (SMD) and 95% Confidence Interval (CI) between two groups of intervention were used to determine pooled effect sizes. Out of 721 potential papers, 7 RCTs were appropriate to be included in our meta-analysis. The pooled results revealed that CoQ10 supplementation significantly reduced total-cholesterol (SMD=-0.58; CI, -0.94, - 0.21; P=0.002; I2: 54.9), LDL-cholesterol (SMD=-0.47; 95% CI, -0.78, -0.17; P=0.003; I2:00.0), malondialdehyde (MDA) (SMD=-3.0; 95% CI, -5.10, -0.90; P=0.005; I2: 95.4) and creatinine levels (SMD=-1.65; 95% CI, - 2.75, -0.54; P=0.003; I2: 95.0) in patients diagnosed with CKD. Triglycerides, HDL-cholesterol, fasting glucose, insulin, homeostasis model assessment of insulin resistance (HOMA-IR), and C-reactive protein (CRP) concentrations did not affect following CoQ10 supplementation. Overall, the current meta-analysis demonstrated that CoQ10 supplementation significantly improved metabolic profile in patients with CKD by reducing total cholesterol, LDL-cholesterol, MDA and creatinine levels, yet it did not affect fasting glucose, insulin, HOMA-IR, and CRP concentrations.

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

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.

Quality of randomized controlled trials published in the International Urogynecology Journal 2007-2016.

Randomized controlled trials (RCTs) provide the best quality clinical evidence. The aim of this study was to assess the quality of RCTs published by the International Urogynecology Journal (IUJ) in 2007-2016. RCTs in original articles were extracted from PubMed and IUJ homepage. Change in RCT quality over time was assessed with Jadad and van Tulder scales and Cochrane Collaboration's risk of bias tool (CCRBT). Jadad scores of 3-5 or van Tulder scores of >5 indicated high-quality RCTs. The effect on RCT quality of including funding source and institutional review board (IRB) approval statements and describing the intervention was assessed. In addition, changes in RCT topics over time were assessed. Annual RCT frequencies did not change significantly (6.7-15.7%): 36.1% and 25.7% described blinding and allocation concealment, respectively. Both tended to increase between 2013and2016, particularly 2013and2014. Funding statement inclusion (39.1% overall) and intervention description (78.2% overall) tended to increase steadily. IRB statement inclusion (60.4% overall) increased significantly (p<0.01). Jadad scores and van Tulder rose significantly until 2014 (p<0.01). Frequencies of high-quality RCTs tended to rise. CCRBT indicated that RCTs with a low risk of bias tended to increase until 2014. However, from 2015, Jadad scores, van Tulder, and CCRBT the low risk tended to decreased. RCTs with funding and IRB approval statements had higher Jadad and van Tulder scores than unfunded RCTs (p<0.01 and p<0.01, respectively). Intervention description did not associate with better quality. RCT quality improved over time, but a dip in quality was observed in 2015-2016 because of decreased blinding and allocation concealment.

Randomized clinical trials of dental bleaching - Compliance with the CONSORT Statement: a systematic review.

We reviewed the literature to evaluate: a) The compliance of randomized clinical trials (RCTs) on bleaching with the CONSORT; and b) the risk of bias of these studies using the Cochrane Collaboration risk of bias tool (CCRT). We searched the Cochrane Library, PubMed and other electronic databases, to find RCTs focused on bleaching (or whitening). The articles were evaluated in compliance with CONSORT in a scale: 0 = no description, 1 = poor description and 2 = adequate description. Descriptive analyses of the number of studies by journal, follow-up period, country and quality assessments were performed with CCRT for assessing risk of bias in RCTs. 185 RCTs were included for assessment. More than 30% of the studies received score 0 or 1. Protocol, flow chart, allocation concealment and sample size were more critical items, as 80% of the studies scored 0. The overall CONSORT score for the included studies was 16.7 ± 5.4 points, which represents 52.2% of the maximum CONSORT score. A significant difference among journal, country and period of time was observed (p < 0.02). Only 7.6% of the studies were judged at "low" risk; 62.1% were classified as "unclear"; and 30.3% as "high" risk of bias. The adherence of RCTs evaluating bleaching materials and techniques to the CONSORT is still low with unclear/high risk of bias.

Effect of Tai Chi on bone mineral density in postmenopausal women: A systematic review and meta-analysis of randomized control trials

BackgroundThis meta-analysis of relative randomized control trials (RCTs) aimed to investigate whether Tai Chi exercise is able to alleviate bone mineral density (BMD) loss in postmenopausal women. MethodsElectronic databases including PubMed, Embase, Springer link, Cochrane library, Wanfang and China National Knowledge Infrastructure (CNKIi) were used to search the eligible literature up to January 28, 2016. The pooled weighted mean difference (WMD) method combined with 95% confidence interval (CI) was used as the effect size of BMD values. The quality assessment of the included articles was performed by the Cochrane Collaboration Risk of Bias Tool (CCRBT). ResultsTotal of six eligible articles with 182 participants in the Tai Chi intervention group and 168 participants in the control group were included in this study. Compared with control group, the overall analysis with the fixed-effect model showed no significant difference in BMD at the lumber spine between the intervention and control groups (WMD = 0.02, 95% CI: −0.00 to 0.05, P = 0.09). Moreover, there was no obvious difference in BMD at the femoral neck between Tai Chi interventions and controls (WMD = 0.01, 95% CI = −0.03 to 0.05, P = 0.51) via the pooled analysis with the random effects model. ConclusionTai Chi exhibits no significant role in attenuating BMD loss in postmenopausal women at the lumber spine and femoral neck.

Reporting of randomized controlled trials in andrology journals: a quality assessment.

Quality assessment of randomized controlled trials (RCTs) is important to prevent the adoption of findings of low-quality trials into clinical practice. The aim of this study was to analyze the quality of studies reporting RCTs in andrology journals (The Journal of Sexual Medicine [JSM], the Asian Journal of Andrology [AJA], the Journal of Andrology [JOA], the International Journal of Andrology [IJA]). A quality assessment was conducted on all studies identified as RCTs published in andrology journals (JSM, AJA, JOA, IJA) until 2011. The review period was divided into three terms: early, mid, and late each journal. The Jadad scale, van Tulder scale, and the Cochrane Collaboration Risk of Bias Tool (CCRBT) were employed. The RCTs were also categorized by country of origin, the inclusion of institutional review board (IRB) approval, funding, and blindness. There were1,954 original articles published in the JSM, 893 articles in the AJA, 2,527 articles in the JOA, and 2,086 articles in the IJA for the review period. There were 172 studies reporting on RCTs in the JSM, 33 RCTs in the AJA, 63 RCTs in the JOA, and 29 RCTs in the IJA. No significant increase in Jadad or van Tulder scale scores were found over time, nor were there any significant changes in the number of high-quality articles as assessed by CCRBT. However, significant differences in quality analysis were found according to blinding, funding, and IRB approval. The number of original articles and RCTs in andrology increased over time. However, the ratio of RCTs to original articles as well as RCT quality was statistically insignificant. It would be required for the researchers to focus efforts in performing high-quality studies to ensure appropriate randomization, reviews by IRB, financial support, and inclusion of allocation concealment during study performance.

Randomized Controlled Trials in the Journal of Sexual Medicine: A Quality Assessment and Relevant Clinical Impact

Quality assessment of randomized clinical trials (RCTs) is important to prevent the adoption of findings of low-quality trials into clinical practice. The aim if this study was to analyze the quality of studies reporting RCTs in the Journal of Sexual Medicine (JSM) and to find relevant clinical impact. A quality assessment was conducted in all studies identified as RCTs published in the JSM from 2004 to 2012. The review period was divided into three periods: early (2004-2006), mid (2007-2009), and late (2010-2012). The Jadad scale, van Tulder scale, and the Cochrane Collaboration Risk of Bias Tool (CCRBT) quality scoring instruments were used. The RCTs were also categorized by country of origin, topic, the inclusion of institutional review board (IRB) approval, funding, citation rate, and impact factor. A total of 2,418 original articles were published in the JSM during the review period, and 188 were reports of RCTs. There were 39 (14.89%), 70 (7.77%), and 76 (6.29%) RCTs published during the early, mid, and late terms, respectively (P < 0.001). No significant increases in Jadad or van Tulder scale scores were found over time nor were there any significant changes in the number of low-risk articles as assessed by the CCRBT. However, significant differences in quality analysis were found in funding and IRB approval. Citation rates and impact factor were not correlated with RCT quality using any of the tools. The number of original articles and RCTs published in the JSM increased over time. However, the ratio of RCTs to original articles did not increase significantly. Adequate randomization and blinding methods, IRB review, and financial support are required for the conduct of high-quality RCTs.