Risk Of Bias Scores Research Articles

Research Quality of Clinical Trials Reported for Foods with Function Claims in Japan, 2023-2024: Evaluation Based on a Revised Tool to Assess Risk of Bias in Randomized Trials.

The Foods with Function Claim was introduced in Japan in April 2015 to make more products available that are labeled with health functions. A product's functionality of function claims must be explained by the scientific evidence presented in clinical trials (CTs) or systematic reviews, but the quality of recent CTs is unclear. The purpose of this study was to evaluate the risk of bias (RoB) using "a revised tool to assess risk (RoB 2)" published in 2018 for notifications based on all recent CTs published on the Consumer Affairs Agency website. A total of 38 submitted papers based on CTs that were published on the Consumer Affairs Agency website during the period from 1 January 2023 to 30 June 2024 were eligible. The RoB 2 tool provides a framework for considering the risk of bias in the findings of any type of randomized trial. This tool with five domains was used to evaluate the quality of research methods. Eligible CTs were assessed as "low risk" (11%, n = 4), "medium risk" (13%, n = 5), and "high risk" (76%, n = 29). A number of highly biased papers were published. Bias occurred in all five domains, especially "bias in selection of the reported result (Domain 5)", which was the most serious ("high risk"; 75%). For elements correlated with RoB, there was no significant difference (p = 0.785) in the RoB 2 score between for-profit and academic research in the author's affiliated organization. There was no significant difference (p = 0.498) in the RoB score between the published year categories of 2000-2019 and 2020-2024, and no significant difference (p = 0.643) in the RoB score between English and Japanese language publications. Overall, the quality of the latest CTs submitted after 2023 was very low, occurring in all five domains, and was most serious for "bias in selection of the reported result (Domain 5)".

Long-Noncoding-RNA HOTAIR Upregulation is Associated with Poor Breast Cancer Outcome: A Systematic Review and Meta Analysis.

Breast cancer is the most frequent cancer among women worldwide with significant disproportionate mortality rates in developing countries. Although clinical management of breast cancer has been immensely improved, refinement in the prognostic and recurrent markers is still needed. Long non-coding RNAs (lncRNA) HOTAIR has recently been associated with poor outcome and is potentially used as a prognostic marker in breast cancer. We comprehensively reviewed studies evaluating lncRNA HOTAIR in association with overall and disease-free survivals in breast cancers. Systematic searches were performed in Pubmed, ProQuest, ScienceDirect, Scopus, Google Scholar, Semantic Scholar, Springer, Nature, Sage Journals, and Wiley databases using combination keywords "long non-coding RNA," "lncRNA," "HOX transcript antisense RNA," "HOTAIR," "breast can-cer," "carcinoma mammae," "prognosis," and "survival." Risk of bias score was used to assess quality of studies, I2 test was conducted to assess heterogeneity. Meta-analysis was performed to compare HOTAIR expression with breast cancer survival rates using STATA v.17 software. Of the total 1,504 screened studies, seven studies were included in the meta-analysis involving 533 patients. High expression of HOTAIR was associated with poor survival rates (pooled HR: 1.69; 95%CI: 1.11-2.59; p=0.015), shorter overall survival (OS) (pooled HR: 1.33; 95%CI: 0.78-2.26; p=0.455), poor disease-free survival (DFS) (pooled HR: 2.40; 95%CI: 1.63-3.53; p<0.001), poor distant metastatic-free survival (MFS) (HR: 1.75; 95%CI: 1.13-2.71; p=0.012). In addition, overexpression of HOTAIR was associated with positive lymph node infiltration (pooled OR: 2.38; 95%CI: 0.53-10.69; p=0.26) and ductal type cancer (pooled OR: 3.27; 95%CI: 1.15-9.30; p=0.03). Upregulation of lncRNA HOTAIR is associated with worse DFS aand MFS that can potentially be used as a prognostic marker in breast cancer patients.

The association between Aggregatibacter actinomycetemcomitans JP2 clone and periodontitis: A systematic review and meta-analysis.

To appraise the literature on the prevalence of the JP2 clone of Aggregatibacter actinomycetemcomitans (A.a.) and on its association with presence and progression of periodontitis in different populations. A systematic search of the literature was conducted in Medline, Embase and Cochrane Library for studies reporting data on detection of the JP2 clone of A.a. A total of 56 papers were included in the review, from an initial search of 685 titles. Studies were carried out in populations with a mean age of 26.34 years (range 6.24-53.85 years). Just over 16% of the overall population assessed (n=13 751) had the JP2 clone detected. Meta-analyses included 16 studies and 1775 patients, and revealed an association between detection of the JP2 clone and diagnosis of periodontitis (RR=1.86, 95% 1.43-2.42) from saliva and plaque, with high heterogeneity (I2 = 85%, p < .00001). Meta-analyses included 5 studies and 616 patients, and revealed an association between baseline detection of the JP2 clone and onset of periodontitis over 2 to 5 years (RR=4.12, 95% 2.42-7.00), with high heterogeneity (I2 = 81%, p < .0003). From the overall risk of bias score, 29 papers were judged as low risk of bias, whilst the remaining papers were judged to have an overall medium or high risk of bias. Detection of the JP2 clone of A.a. in subgingival plaque and saliva samples is associated with increased odds of diagnosis of periodontitis and may be able to predict onset of periodontitis. This systematic review provides clear evidence that in certain populations, the JP2 clone of A.a. is associated with early-onset periodontitis. Furthermore, detection of this bacterium seems to be predictive of disease onset.

The Impact of Laser Thermal Effect on Histological Evaluation of Oral Soft Tissue Biopsy: Systematic Review

The aim of the study is to review the literature to observe studies that evaluate the extent of the thermal effect of different laser wavelengths on the histological evaluation of oral soft tissue biopsies. An electronic search for published studies was performed on the PubMed and Scopus databases between July 2020 and November 2022. After the selection process, all the included studies were subjected to quality assessment and data extraction processes. A total of 28 studies met the eligibility criteria. The most studied laser was the carbon dioxide (CO2) laser, followed by the diode laser 940 nm-980 nm. Six studies were focused on each of the Erbium-doped Yttrium Aluminium Garnet (Er:YAG), Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) lasers, and diode lasers of 808 nm and 445 nm. Three studies were for the Potassium Titanyl Phosphate (KTP) laser, and four studies were for the Erbium, Chromium-doped Yttrium, Scandium, Gallium, and Garnet (Er,Cr:YSGG) laser. The quality and bias assessment revealed that almost all the animal studies were at a low risk of bias (RoB) in the considered domains of the used assessment tool except the allocation concealment domain in the selection bias and the blinding domain in the performance bias, where these domains were awarded an unclear or high score in almost all the included animal studies. For clinical studies, the range of the total RoB score in the comparative studies was 14 to 23, while in the non-comparative studies, it was 11 to 15. Almost all the studies concluded that the thermal effect of different laser wavelengths did not hinder the histological diagnosis. This literature review showed some observations. The thermal effect occurred with different wavelengths and parameters and what should be done is to minimize it by better adjusting the laser parameters. The extension of margins during the collection of laser oral biopsies and the use of laser only in non-suspicious lesions are recommended because of the difficulty of the histopathologist to assess the extension and grade of dysplasia at the surgical margins. The comparison of the thermal effect between different studies was impossible due to the presence of methodological heterogeneity.

Assessing the Effectiveness of Chin-Cup Therapy in the Treatment of Developing Class 3 Malocclusions

Background: Mandibular prognathism in Class 3 malocclusion (CLIII) is one of the most severe maxillofacial deformities. Fortunately, most of this malocclusion cases can be treated by facial growth modification, using extra and/or intra-oral appliances in growing individuals. Occipital-pull chin cup is the extra-oral orthopaedic appliance, which was mostly used for the treatment of mandibular prognathism in growing Class 3 1(Ngan, Sung, 2015). Unjustifiably, most orthodontists I know do not use chin cup therapy in the treatment of CLIII. Therefore, being new to the field of orthodontics, I needed to build a highly evidenced based knowledge on chin cup therapy’s effectiveness in the treatment of developing CLIII with prognathic mandible. Objective: Through a narrative literature review, the aim of the study was assessed following scientific methodology. Articles published from January 2010- November 2020 (commencement of the current review) were collected using keywords derived from PICO. Only highly evidence based studies (randomised and non-randomised clinical trials) with the least risk of bias scores were selected, and critically appraised using the Critical Appraisal Skill Programme (CASP). Results were used to draw the conclusion. Material and Method: The study title was broken down into its PICO (population, intervention, comparative, outcome) components and search keywords were derived. These were used to carry out a literature search through electronic search engines (Medline-PUBMED, Science Direct, ISI Web of Knowledge, Research gate, Google Scholar, Cochrane library and hand searching of references list. Collected articles were assessed for risk of bias using Downs and Black (D&amp;B) scale. Papers with score ‘good’ and above’ on the D&amp;B assessment were critically appraised. PRISMA statement reporting format and Harvard referencing system were adopted in the study. Result: Following the Downs and Black assessment only 4 studies were found at a level worthy to be critically appraised. Results of all the four articles revealed that chin cup therapy produced significant growth modification in the mandible, when applied at an early age. Moreover, chin cup was also found to increase the lower anterior facial height significantly. All the papers considered only the short-term effect of chin cup, but not the long-term effect. Treatment results stability was also not reported. Conclusion: The significant improvement in CLIII manifestation in the selected articles, make it possible to conclude that chin cup is viable for the treatment of CLIII malocclusion with mandibular prognatism. However, treatment results stability needs to be researched.

The Effects of Platelet-Rich Plasma in Conjunction with Rehabilitation for Lower Extremity Musculoskeletal Pathologies

Background: Platelet-rich plasma (PRP) has been considered for its role in facilitating the body’s own healing processes, with the potential to complement rehabilitation in the management of lower extremitymusculoskeletal pathologies.Methods: Eligible studies were randomized clinical trials and quasi-experimental trials with completed data analysis; published in English; recruited participants aged &gt;18 years; had at least two groups, with one intervention group receiving PRP injection alone or PRP injection and rehabilitation, and the comparison group receiving either rehabilitation alone or a control group receiving saline and rehabilitation; included at least one outcome measure of pain, disability, quality of life, or return to play. An electronic search was conducted using PubMed, Embase, Cochrane, Pedro, and clinicaltrials.gov. Methodological quality was assessed using the Cochrane Collaboration Risk of Bias (RoB) tool. The Grading of Recommendations Assessment, Development, and Evaluation approach was used to assess the quality of evidence. Meta-analyses were conducted across outcomes in each pathology when possible.Results: Twenty-one studies assessed Achilles rupture, Achilles tendinopathy, lateral ankle sprain, high ankle sprain, hamstring injury, knee osteoarthritis, acute muscle injury, patellar tendinopathy, and plantar fasciitis, with an average RoB score of 9.9 out of 12. Meta-analyses for Achilles rupture (n = 270) revealed a nonsignificant effect on disability in the short and long term (high level of evidence) when comparing PRP, immobilization, and exercise/physical therapy to placebo, immobilization, and exercise/physical therapy. Meta-analyses for Achilles tendinopathy revealed a nonsignificant effect on pain (n = 64) in the short term, and disability in the short (n = 138) as well as long term (n = 192) (very low to low level of evidence) when comparing PRP and exercise to placebo and exercise.Conclusions: While individual studies demonstrated significant findings across outcomes, the non-significant pooled results and inability to perform further meta-analyses made it difficult to provide definitive recommendations for the addition of PRP to exercise for lower extremity musculoskeletal pathologies. Future studies should standardized PRP exercise rehabilitation protocols with better dosage parameters, consider larger sample sizes, and have short and long term follow-up periods consistent with the Cochrane Collaboration.

Near-Infrared Spectroscopy Used to Assess Physiological Muscle Adaptations in Exercise Clinical Trials: A Systematic Review.

Simple SummaryIn recent years, physical exercise has been used as a therapeutic strategy in various clinical conditions, with pleiotropic benefits. Near-infrared spectroscopy (NIRS) has been positioned as a tool to analyze effects on muscle oxygenation, also allowing knowledge of adaptations on microvascular levels and muscle metabolism in subjects with central and peripheral vascular alterations, as well as cardiovascular, metabolic, and/or musculoskeletal diseases. This knowledge can help to guide therapeutic exercise specialists in decision making regarding the prescription and follow up of physical exercise as a therapeutic tool in the observation of acute or chronic adaptations to improve efficiency in the treatment and recovery of these patients. This review presents an overview of the effects of exercise clinical trials on muscle oxygenation in different pathologies and the technical characteristics related to the equipment used.Using muscle oxygenation to evaluate the therapeutic effects of physical exercise in pathologies through near-infrared spectroscopy (NIRS) is of great interest. The aim of this review was to highlight the use of muscle oxygenation in exercise interventions in clinical trials and to present the technological characteristics related to the equipment used in these studies. PubMed, WOS, and Scopus databases were reviewed up to December 2021. Scientific articles that evaluated muscle oxygenation after exercise interventions in the sick adult population were selected. The PEDro scale was used to analyze the risk of bias (internal validity). The results were presented grouped in tables considering the risk of bias scores, characteristics of the devices, and the effects of exercise on muscle oxygenation. All the stages were carried out using preferred reporting items for systematic reviews and meta-analyses (PRISMA). The search strategy yielded 820 clinical studies, of which 18 met the eligibility criteria. This review detailed the characteristics of 11 NIRS devices used in clinical trials that used physical exercise as an intervention. The use of this technology made it possible to observe changes in muscle oxygenation/deoxygenation parameters such as tissue saturation, oxyhemoglobin, total hemoglobin, and deoxyhemoglobin in clinical trials of patients with chronic disease. It was concluded that NIRS is a non-invasive method that can be used in clinical studies to detect the effects of physical exercise training on muscle oxygenation, hemodynamics, and metabolism. It will be necessary to unify criteria such as the measurement site, frequency, wavelength, and variables for analysis. This will make it possible to compare different models of exercise/training in terms of time, intensity, frequency, and type to obtain more precise conclusions about their benefits for patients.

Platelet-Rich Plasma and Rehabilitation for Upper Extremity Musculoskeletal Pathologies

Background: Platelet-rich plasma (PRP) is considered in clinical practice for its role in facilitating the body’s own healing processes, with the potential to complement physical therapy in managing musculoskeletal pathologies of the upper extremity. Methods: Eligible studies must be randomized with clinical/quasi-experimental trials with complete data analysis, and published in English. They have to recruit participants aged &gt;18 years; have at least two groups, with one intervention group receiving PRP injection alone or PRP injection and rehabilitation, and the comparison group receiving either rehabilitation alone or a control group receiving saline and rehabilitation; and finally include at least one outcome measure of pain, disability, or quality of life. An electronic search was conducted using PubMed, Embase, Cochrane, Pedro, and clinicaltrials.gov. Methodological quality was assessed using the Cochrane Collaboration Risk of Bias (RoB) tool. The grading of recommendations assessment, development, and evaluation approach was used to provide an overall assessment of the quality of evidence. Meta-analyses were conducted across outcomes within each pathology when possible. Results: A total of 13 studies assessing adhesive capsulitis, carpal tunnel syndrome, lateral epicondylal-gia, rotator cuff tendinopathy, subacromial impingement syndrome, and shoulder osteoarthritis were included with an average RoB score of 8.77 out of 12 across all studies. Meta-analyses for rotator cuff tendinopathy (n = 49) revealed a significant effect on pain (cm) (mean difference [MD] -2.53; 95% confidence interval [CI]: −5.02, −0.04; I2 statistic = 51%; P = 0.05), quality of life (MD 16.82; 95% CI: 0.40, 33.25; I2 = 0%; P = 0.04), and disability (standardized mean difference [SMD]: −0.64; 95% CI: −1.24, −0.04; I2 = 0%; P = 0.04) favoring PRP and physical therapy as long-term follow-up (moderate level of evidence). All other meta-analyses for adhesive capsulitis and carpal tunnel demonstrated nonsignificant effects. Conclusions: This systematic review demonstrated that PRP is a beneficial adjunct to physical therapy for reducing pain and improving disability and quality of life (moderate level of evidence) when compared to placebo plus physical therapy for the management of rotator cuff tendinopathy.

Effects of rapid maxillary expansion on head and cervical posture in growing patients: A systematic review

To identify and qualify the evidence of published studies evaluating whether rapid maxillary expansion (RME) treatment modifies the head and cervical posture in growing patients. Electronic database searches were conducted until January 2021 using PubMed/MEDLINE, Embase, Web of Science, Cochrane Library, and LILACS. Grey literature was explored using ClinicalTrials, OpenGrey and Google Scholar. Trials involving participants who underwent RME were included. Risk of Bias (RoB) assessment was conducted using the Cochrane tool for randomized trials and the Methodological Index for Non-randomized Studies (MINORS) for non-randomized trials. The certainty level of evidence was evaluated through the Grading of Recommendations, Assessment, Development and Evaluation tool (GRADE). Six clinical trials were included. The RoB scores had unclear and high risks of bias. Low certainty of evidence suggested that the effects following RME include a decrease in craniocervical angulation, as well as a very low certainty of evidence for a decrease in head elevation, an increase in cervical lordosis, and an increase in the inclination of the cervical spine. There is low and very low evidence that RME alters the head and cervical posture in growing patients. Further investigation regarding long-term effects, possible changes due to somatic growth, and clinical relevance is needed.

Physical activity following sport-related concussion in adolescents: a systematic review.

The systematic review evaluated the evidence related to how physical activity affects recovery following a sport-related concussion (SRC) in adolescents. Databases indexed were PUBMED, MEDLINE, and SPORTDiscus. Inclusion criteria included 1) original research article, 2) ≥66% have an SRC diagnosed by a clinician, 3) human research, and 4) evaluated the effect of an SRC on physical activity in adolescents only (<18 yr). Participants were seen within 1-2 wk after SRC for acute studies and 4 wk after SRC for studies focused on prolonged recoveries, which are standard timelines across the literature. Twenty-two studies met the inclusion criteria [i.e., 8 regarding physical activity (PA-daily aerobic activity including light and moderate intensities), 8 evaluating active rehabilitation/exercise programs (20 min of daily aerobic exercise below symptom threshold), 6 examining a single bout of exertion]. The methodological quality of the literature was assessed using the Downs and Black risk of bias (ROB) checklist. The ROB scores ranged from 7 to 24, with only two randomized controlled trials included. Studies demonstrated that single bouts of exertion testing were safe and feasible. Daily PA or active rehabilitation/exercise programs led to a reduction in symptoms present and a decrease in number of days to medical clearance. Following a brief period of rest (24-48 h), individuals may gradually and safely return to PA below their physical symptom exacerbation thresholds. Further research is warranted to delineate how to optimize the timing, intensity, duration, and modality of PA impacts symptom resolution and physiological recovery following different subtypes of SRC.

Systematic review of postoperative rehabilitation interventions after cranial cruciate ligament surgery in dogs.

ObjectiveTo critically evaluate the evidence for rehabilitation interventions following surgery for cranial cruciate ligament disease (CCLD) in dogs.Study designSystematic review.MethodsGoogle Scholar and Pubmed databases were searched for studies evaluating postoperative CCLD rehabilitation interventions from 1990 until March 2020 per the international Prospective Register of Systematic Reviews (PROSPERO). Each study was assigned a level of evidence score from I to IV and a risk of bias (RoB) score by 2 reviewers, and by a third reviewer, when consensus was not reached.ResultsNineteen studies met the inclusion criteria. Twelve comprised randomized, controlled trials (Level II), 6 were nonrandomized or nonblinded (Level III), and one was retrospective (Level IV). Nine studies had high RoB scores. Sixteen studies yielded positive results. Therapeutic exercise had the most studies with positive results but all had high RoB. Cold compression therapy had 3 supporting studies (2 Level II, low RoB). Extracorporeal shockwave yielded 2 positive Level II studies (low‐moderate and high‐moderate RoB) and photobiomodulation had 1 positive study (Level II, low RoB) with objective outcomes. A negative outcome was noted in 1 photobiomodulation study. There was 1 supporting study on electrical stimulation and there was none on low‐intensity pulsed ultrasound.ConclusionThis systematic review supports the use of rehabilitation interventions in recovery of postoperative CCLD in dogs; however, many studies had a high risk of bias.Clinical significanceThere is a lack of class I level evidence in veterinary rehabilitation. This study supports therapeutic exercise and cold compression therapy for postoperative CCLD rehabilitation. Existing studies on other modalities are limited and demonstrate conflicting results.

Diagnostic performance of imaging features in the HBP of gadoxetate disodium-enhanced MRI for microvascular invasion in hepatocellular carcinoma: a meta-analysis.

Microvascular invasion (MVI) is a major risk factor for early recurrence in patients with hepatocellular carcinoma (HCC). Preoperative accurate evaluation of the presence of MVI could enormously benefit its treatment and prognosis. To evaluate and compare the diagnostic performance of two imaging features (non-smooth tumor margin and peritumor hypointensity) in the hepatobiliary phase (HBP) to preoperatively diagnose the presence of MVI in HCC. Original articles were collected from Medline/PubMed, Web of Science, EMBASE, and the Cochrane Library up to 17 January 2021 linked to gadoxetate disodium-enhanced magnetic resonance imaging (MRI) on 1.5 or 3.0 T. The pooled sensitivity, specificity, and summary area under the receiver operating characteristic curve (AUC) were calculated and meta-regression analyses were performed. A total of 14 original articles involving 2193 HCCs were included. The pooled sensitivity and specificity of non-smooth tumor margin and peritumor hypointensity were 73% and 61%, and 43% and 90%, respectively, for the diagnosis of MVI in HCC. The summary AUC of non-smooth tumor margin (0.74) was comparable to that of peritumor hypointensity (0.76) (z = 0.693, P = 0.488). The meta-regression analysis identified four covariates as possible sources of heterogeneity: average size; time interval between index test and reference test; blindness to index test during reference test; and risk of bias score. This meta-analysis showed moderate and comparable accuracy for predicting MVI in HCC using either non-smooth tumor margin or peritumor hypointensity in HBP. Four discovered covariates accounted for the heterogeneity.

Improvement of kidney function in patients with chronic kidney disease and severe obesity after bariatric surgery: A systematic review and meta-analysis.

The general management for chronic kidney disease (CKD) includes treating reversible causes, including obesity, which may be both a driver and comorbidity for CKD. Bariatric surgery has been shown to reduce the likelihood of CKD progression and improve kidney function in observational studies. We performed a systematic review and meta-analysis of patients with at least stage 3 CKD and obesity receiving bariatric surgery. We searched Embase, MEDLINE, CENTRAL and identified eligible studies reporting on kidney function outcomes in included patients before and after bariatric surgery with comparison to a medical intervention control if available. Risk of bias was assessed with the Newcastle-Ottawa Risk of Bias score. Nineteen studies were included for synthesis. Bariatric surgery showed improved eGFR with a mean difference (MD) of 11.64 (95%CI: 5.84 to 17.45, I2 =66%) ml/min/1.73m2 and reduced SCr with MD of -0.24 (95%CI -0.21 to -0.39, I2 =0%) mg/dl after bariatric surgery. There was no significant difference in the relative risk (RR) of having CKD stage 3 after bariatric surgery, with a RR of -1.13 (95%CI: -0.83 to -2.07, I2 =13%), but there was reduced likelihood of having uACR >30 mg/g or above with a RR of -3.03 (95%CI: -1.44 to -6.40, I2 =91%). Bariatric surgery may be associated with improved kidney function with the reduction of BMI and may be a safe treatment option for patients with CKD. Future studies with more robust reporting are required to determine the feasibility of bariatric surgery for the treatment of CKD.

Study design and primary outcome in randomized controlled trials in periodontology. A systematic review.

The aim of this review is to assess study design and risk of bias related to primary outcome in recently published randomized controlled trials (RCTs) in periodontology. An electronic (Medline, EMBASE and Cochrane library) and a manual search were completed to detect RCTs in humans, with an outcome in the field of periodontology and published in English from January 2018 up to March 2020. Data extraction of 318 publications meeting the inclusion criteria was performed by two reviewers. Most studies adopted a parallel-group superiority design in a university setting. Overall, 54% of papers reported the primary outcome and relative sample size calculation, while only 37% also included reproducibility estimates relative to the primary outcome. Papers published in journals with higher impact factors had better compliance with primary outcome reporting and lower overall risk of bias scores. Improvements in the quality of RCTs in periodontology are still needed. The importance of defining a clinically relevant study primary outcome and building the study around it needs to be emphasized. Furthermore, RCTs in periodontology could consider, when appropriate, some of the study design options which facilitate application of the principles of personalized medicine.

Meta-analysis of randomized controlled trials on calcium supplements and dairy products for changes in body weight and obesity indices

This meta-analysis was performed to investigate whether calcium supplements and dairy products change obesity indices including fat mass. Original articles published in English between July 2009 and August 2019 were identified. Ten and 14 randomised controlled trials (RCTs) with ≥ 12 weeks interventions of calcium supplements and dairy products among overweight or obese adults aged ≥18 were critically reviewed. Mean difference (MD) or standardised mean difference (SMD) with 95% confidence interval (CI) were obtained using a random effect meta-analysis. Dairy products significantly changed fat mass (SMD, 95% CI; −0.40 [−0.77, −0.02]) and BMI (MD, 95% CI: −0.46 kg/m2 [−0.67, −0.26]), and calcium supplements also showed changes in fat mass (SMD, 95% CI; −0.15[−0.28, −0.02]). However, in the analysis of RCTs with low risk of bias scores, the significant changes remained only in the dairy-products intervention. Our findings suggest that dairy products without distinction of fat percentage may help reduce fat mass and BMI, but calcium supplements may not.

The effect of the CONSORT statement on the amount of "unclear" Risk of Bias reporting in Cochrane Systematic Reviews.

The Consolidated Standards of Reporting Trials (CONSORT) statement aims to improve clarity and consistency of transparency of reporting in Randomized Controlled Trials (RCTs). The Cochrane Risk of Bias (RoB) tool for RCTs helps authors to judge the RoB. as ''low", "high" or "unclear". In this study we aimed to assess whether the implementation and updates of the CONSORT statement influenced the trend of "unclear" RoB scores of RCTs included in Cochrane systematic reviews. All Cochrane reviews published in December to October 2016 were retrieved. The publication year of RCTS included in the reviews were sorted into time frames (≤1995, 1996-2000, 2001-2009 and ≥2010) based on the release- and updates of the CONSORT statement (1996, 2001 and 2010). The association between "unclear" RoB versus "low or high" RoB and the year of publication in different time frames were calculated using a binary logistic regression. Data was extracted from 64 Cochrane reviews, with 989 RCTS (6471 items). The logistic regression showed that the odds of RCTs published ≥2010, compared to ≤1995 were more likely not to report an "unclear" RoB for the total data (Odds Ratio (OR) 0.69 (95% Confidence interval: 0.59-0.80)), random sequence generation (OR 0.32 (0.22-0.47), allocation concealment (0.64 (0.43-0.95)) and incomplete outcome data (OR 0.60 (0.39-0.91)). A slight decrease of "unclear" RoB reporting over time was found. To improve quality of reporting authors are encouraged to adhere to reporting guidelines.

Impact of dissociation on the effectiveness of psychotherapy for post-traumatic stress disorder: meta-analysis

Many patients with post-traumatic stress disorder (PTSD) experience dissociative symptoms. The question of whether these dissociative symptoms negatively influence the effectiveness of psychotherapy for PTSD is unresolved. To determine the influence of dissociative symptoms on psychotherapy outcome in PTSD. We conducted a systematic search in Cochrane, Embase, PILOTS, PsycINFO, PubMed and Web of Science for relevant clinical trials. A random-effects meta-analysis examined the impact of dissociation on psychotherapy outcome in PTSD (pre-registered at Prospero CRD42018086575). Twenty-one trials (of which nine were randomised controlled trials) with 1714 patients were included. Pre-treatment dissociation was not related to treatment effectiveness in patients with PTSD (Pearson's correlation coefficient 0.04, 95% CI -0.04 to 0.13). Between-study heterogeneity was high but was not explained by moderators such as trauma focus of the psychotherapy or risk of bias score. There was no indication for publication bias. We found no evidence that dissociation moderates the effectiveness of psychotherapy for PTSD. The quality of some of the included studies was relatively low, emphasising the need for high-quality clinical trials in patients with PTSD. The results suggest that pre-treatment dissociation does not determine psychotherapy outcome in PTSD.

Are results from randomized trials in anesthesiology robust or fragile? An analysis using the fragility index.

In anesthesiology, the findings from randomized controlled trials often underpin guidelines influencing clinical decision-making and therefore directly affect patient care. The aim of this study is to evaluate the fragility index and fragility quotient of randomized controlled trials published in the eight highest ranked anesthesiology journals. In addition, we assess the extent to which risk of bias scores, loss to follow-up, Web of Science Citation Index, and journal impact factor influence fragility index and fragility quotient. We included randomized trials published between 2014 and 2016 from the eight highest ranking anesthesiology journals based on Clarivate Analytics' Science Citation Index and Google Scholar Metrics: Anesthesiology subcategory. We included journals that published general anesthesia topics and omitted specialty anesthesia journals. The fragility index and fragility quotient for all included trials were calculated. Risk of bias for each trial was evaluated using the Cochrane 'risk of bias' Tool 2.0. One hundred and thirty one randomized control trials were included in this analysis. The median fragility index was 3 (interquartile range 1.0-5.5) with a fragility quotient of 0.03 (interquartile range 0.01-0.08). In 11% (14/131) of trials, the number of patients lost to follow-up was greater than the corresponding fragility index. Weak correlations were found between fragility index and total sample size (r = 0.13) and between fragility index and event frequency (r = 0.19). A near-negligible correlation was found between 5-year impact factor and fragility index (r = -0.03) and, similarly, between fragility index and Science Citation Index (r = -0.05). Ten trials were at high risk of bias with the randomization process found to be the domain at the highest risk of bias. In assessing the fragility of randomized controlled trials published in the top eight anesthesiology journals, our study suggests that statistically significant results in these journals are disconcertingly fragile. The median fragility index calculated from our 131 primary studies reveals that only three nonevents must be replaced with events to negate statistical significance. Although a current scale does not exist for fragility index ranges, many trials published by the top journals in anesthesiology are based on concerning methodology and highly fragile outcomes. With small median sample sizes and few patient events characterizing a large number of these trials, many of today's current guidelines and clinical practices may be founded on research containing statistical significance but lacking clinical significance.

Contacting of authors modified crucial outcomes of systematic reviews but was poorly reported, not systematic, and produced conflicting results

ObjectivesThe objective of the study was to assess the prevalence, the reporting quality, the need, and the consequences of contacting of authors by Cochrane reviewers to obtain additional information for their reviews. Study Design and SettingCross-sectional study and survey on all new Cochrane intervention reviews published between January 1, 2016 and January 31, 2017. ResultsThe cross-sectional study found that reviewers had contacted or had tried to contact studies to obtain additional information in 73.4% (234/319) of reviews but reported poorly on the methods, outcomes, and consequences of this procedure. Most eligible studies in the reviews were poorly reported, but few reviewers 21.2% (65/306) reported that they had contacted these studies. The survey showed that risk of bias scores, Grading of Recommendations, Assessment, Development and Evaluation scores, the summary primary or secondary outcomes, and the summary effect size of the primary outcome of the review were changed as a consequence of contacting of authors. Thirty-five of one hundred and thirty (26.9%) reviews scored opposite outcomes for the same question in the cross-sectional study compared with the survey. ConclusionsOur findings on contacting of authors by Cochrane reviewers showed relevant shortcomings in the current standards and transparency of Cochrane reviews. These shortcomings can compromise the validity and reproducibility of these reviews and affect a wide audience.

Prevalence of falls and associated factors in community-dwelling older Brazilians: a systematic review and meta-analysis.

Falls determine huge epidemiological, clinical, and economic burden in the older population worldwide, presenting high odds of severe disability. The present study aimed to estimate the prevalence of falls and associated factors in older Brazilians using a systematic review with meta-analysis. Searches were performed in SciELO, PubMed, LILACS, Web of Science, Scopus and PsycINFO databases with no date or language restrictions. Studies on community-dwelling older persons aged ≥ 60 years from both sexes and with a sample size of ≥ 300 participants included. Exclusion criteria were studies conducted specifically for older adults diagnosed with chronic disabling diseases that predispose them to falls. Risk of bias of included studies was assessed using a critical appraisal tool focusing on prevalence designs. A random-effects meta-analysis was used to pool the prevalence of falls across studies. Exploratory analysis was conducted examining subgroup estimates, prevalence ratios and meta-regression. Thirty-seven studies involving 58,597 participants were included. Twelve-month prevalence of falls was 27% (95%CI: 24.3-30.0), with significantly higher estimates in female than male (PR = 1.57; 95%CI: 1.32-1.86), in age group ≥ 80 years than age group 60-69 years (PR = 1.46; 95%CI: 1.15-1.84), and in participants from the Central region than participants from the South region (PR = 1.36; 95%CI: 1.10-1.69) of Brazil. Risk of bias scores did not impact heterogeneity in the 12-month meta-analysis. These estimates strongly support evidence-based public interventions to prevent falls in older Brazilians, especially in women and the oldest-old population.