scholarly journals Randomized Controlled Trials on Complementary and Traditional Medicine in the Korean Literature

2014 ◽  
Vol 2014 ◽  
pp. 1-10 ◽  
Author(s):  
Chang-Kyu Kim ◽  
Da-Hee Kim ◽  
Myeong Soo Lee ◽  
Jong-In Kim ◽  
L. Susan Wieland ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Traditional Medicine ◽  
Systematic Reviews ◽  
Allocation Concealment ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Korean Literature ◽  
Language Bias ◽  
Randomized Controlled ◽  
Study Characteristics

Objective. This study aimed to identify all of the features of complementary and alternative (CAM) randomized controlled trials (RCTs) in the Korean literature and then introduce English-speaking researchers to the bibliometric and risk of bias characteristics of this literature.Methods. Eleven electronic databases and sixteen Korean journals were searched to August 2013 for RCTs of CAM therapies. Key study characteristics were extracted and risk of bias was assessed using the Cochrane Collaboration’s tool for assessing risk of bias.Results. Three hundred and sixty publications met our inclusion criteria. Complementary and traditional medicine RCTs in the Korean literature emerged in the mid-1990s and increased in the mid-2000s. The most common CAM interventions include acupuncture (59.4%) and herbal medicine (8.3%). The largest proportion of trials evaluated CAM for musculoskeletal conditions (20.7%). Adequate methods of randomization were reported in 41.7% of the RCTs, whereas only 8.3% reported adequate allocation concealment. A low proportion of trials reported participant blinding (34.2%) and outcome assessor blinding (22.5%).Conclusions. Korean CAM RCTs are typically omitted from systematic reviews resulting in the potential for language bias. This study will enable these trials of diverse quality to be identified and assessed for inclusion in future systematic reviews on CAM interventions.

scholarly journals Impact of risk of bias on the magnitude of treatment effects of randomized controlled trials in implant dentistry

2020 ◽  
Author(s):  
Ruolin Ding ◽  
Wenxin Lu ◽  
Jianru Yi ◽  
Liang Zhang ◽  
Zhihe Zhao
Keyword(s):  
Randomized Controlled Trials ◽  
Treatment Effects ◽  
Permutation Test ◽  
Random Sequence ◽  
Allocation Concealment ◽  
Risk Of Bias ◽  
Selective Reporting ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Implant Dentistry

Abstract Background: Risk of bias (RoB) could influence the magnitude of treatment effects of randomized controlled trials (RCTs). This study aims to investigate the potential influence of RoB on treatment effects estimates in RCTs in implant dentistry. Methods: The RCTs published in five leading oral implant journals during the recent five years were electronically searched. The RoB was assessed using the Cochrane Collaboration RoB tool. The meta-regression analysis and Monte Carlo permutation test were performed to identify the association between RoB and the magnitude of treatment effects.Results: A considerable amount of studies have high RoB in blinding of participants and personnel, and unclear RoB in allocation concealment and selective reporting. The treatment effects were exaggerated by flaws in allocation concealment for binary outcomes and by deficiencies in random sequence generation and selective reporting for continuous outcomes.Conclusion: RoB frequently exists in RCTs recently published in implant dentistry, which may lead to the exaggeration of treatment effects. Better study design, implementation, and reporting are required for clinical trials in implant dentistry to ensure more reliable evidence.

scholarly journals Are Randomized Controlled Trials on Pharmacotherapy and Psychotherapy for Positive Symptoms of Schizophrenia Comparable? A Systematic Review of Patient and Study Characteristics

2019 ◽  
Vol 46 (3) ◽  
pp. 496-504 ◽  
Author(s):  
Irene Bighelli ◽  
Claudia Leucht ◽  
Maximilian Huhn ◽  
Cornelia Reitmeir ◽  
Felicitas Schwermann ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Treatment Strategies ◽  
Patient Characteristics ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Positive Symptoms ◽  
Randomized Controlled ◽  
Study Characteristics

Abstract Background We examined patient and study characteristics of pharmacotherapy and psychotherapy trials to establish whether the effects of these 2 treatment strategies can be compared meaningfully. Methods We inspected all randomized controlled trials included in 2 recent meta-analyses on antipsychotics and psychotherapy in patients with positive symptoms of schizophrenia, searching EMBASE, MEDLINE, PsycINFO, Cochrane Library, and ClinicalTrials.gov. Differences between psychotherapy and pharmacotherapy trials were analyzed with Wilcoxon–Mann–Whitney and chi-square tests. Results Eighty studies with 18 271 participants on antipsychotic drugs and 53 studies with 4068 participants on psychotherapy were included. Psychotherapy studies included less severely ill patients (P < .0001), with a shorter duration of illness (P = .021), lasted for a longer period (P < .0001), administered the intervention as add-on to antipsychotics (P < .0001), had higher risk of bias in some domains including blinding of outcome assessment (P < .0001), and were funded publicly more frequently (P < .0001). Antipsychotic trials had larger sample sizes (P < .0001) and more study centers (P < .0001), included more males (P = .0001), inpatients (P < .0001), and slightly older patients (P = .031), more often used diagnostic operationalized criteria (P = .006), and were sponsored by pharmaceutical companies. They did not differ in conflict of interest (P = .24). Conclusions We found key differences between the 2 groups of studies that encompass higher risk of bias in psychotherapy studies and the inclusion of more severe patients in drug trials. These differences imply that study and patient characteristics should be carefully taken into account before considering a network meta-analysis. In the interest of patients, psychopharmacologists and psychotherapists should optimize their treatments rather than seeing them in competition.

scholarly journals Assessing the risk of bias in randomized controlled trials in the field of dentistry indexed in the Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) database

2011 ◽  
Vol 129 (2) ◽  
pp. 85-93 ◽  
Author(s):  
Christiane Alves Ferreira ◽  
Carlos Alfredo Salles Loureiro ◽  
Humberto Saconato ◽  
Álvaro Nagib Atallah
Keyword(s):  
Randomized Controlled Trials ◽  
Research Question ◽  
Allocation Concealment ◽  
Risk Of Bias ◽  
Low Risk ◽  
Controlled Trials ◽  
Level Of Evidence ◽  
Randomized Controlled ◽  
Decision Making Processes ◽  
Meta Analyses

CONTEXT AND OBJECTIVE: Well-conducted randomized controlled trials (RCTs) represent the highest level of evidence when the research question relates to the effect of therapeutic or preventive interventions. However, the degree of control over bias between RCTs presents great variability between studies. For this reason, with the increasing interest in and production of systematic reviews and meta-analyses, it has been necessary to develop methodology supported by empirical evidence, so as to encourage and enhance the production of valid RCTs with low risk of bias. The aim here was to conduct a methodological analysis within the field of dentistry, regarding the risk of bias in open-access RCTs available in the Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) database. DESIGN AND SETTING: This was a methodology study conducted at Universidade Federal de São Paulo (Unifesp) that assessed the risk of bias in RCTs, using the following dimensions: allocation sequence generation, allocation concealment, blinding, and data on incomplete outcomes. RESULTS: Out of the 4,503 articles classified, only 10 studies (0.22%) were considered to be true RCTs and, of these, only a single study was classified as presenting low risk of bias. The items that the authors of these RCTs most frequently controlled for were blinding and data on incomplete outcomes. CONCLUSION: The effective presence of bias seriously weakened the reliability of the results from the dental studies evaluated, such that they would be of little use for clinicians and administrators as support for decision-making processes.

scholarly journals The Risk of Bias in Iranian Randomized Controlled Trials Included in Cochrane Reviews

2020 ◽  
Author(s):  
Ali Kabir ◽  
Ahmad Sofi-Mahmudi ◽  
Arman Karimi Behnagh ◽  
Vahid Eidkhani ◽  
Hamid Reza Baradaran ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Systematic Reviews ◽  
Random Sequence ◽  
Outcome Data ◽  
Conclusive Evidence ◽  
Risk Of Bias ◽  
Controlled Clinical Trial ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Cochrane Reviews

Abstract Background: Among interventional studies, randomized controlled trials (RCTs) provide the most conclusive evidence. However, RCTs can be susceptible to the risk of bias (RoB). Systematic reviews can be performed to appraise the RoB in the included articles using evaluative tools. This study aimed to describe the main characteristics and focus on the ROB of RCTs conducted in Iran and included in Cochrane Reviews (CRs).Methods: We searched "Iran" by selecting the "Search All Text" and "Review" fields in the Cochrane Database of Systematic Reviews within Ovid. CRs that included the RCTs conducted in Iran were retrieved. A trial was selected only if it was included in CRs, described as a controlled clinical trial, involved human subjects and its RoB was assessed by CR authors. The trials were characterized by investigating the relevant articles and the table "Characteristics of included studies" in each CR. The RoB was investigated by collecting the judgments of the review authors made based on tables of RoB assessment in the CRs.Results: Out of 1166 Iranian RCTs included by 571 CRs, a low RoB was found in 44.9% for random sequence generation, 20.8% for allocation concealment, 32.3% for blinding of participants/personnel, 36.5% for blinding of outcome assessors, 56.3% for incomplete outcome data, 41.3% for selective outcome reporting and 53.8% for other sources of bias.Conclusion: The RoB in Iranian RCTs was found to be mostly high or unclear. It is therefore recommended that the methodological quality of RCTs be seriously addressed in Iran.

scholarly journals Effects of Oats (Avena sativa L.) on Inflammation: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2021 ◽  
Vol 8 ◽  
Author(s):  
Sun Jo Kim ◽  
Cheol Woon Jung ◽  
Nguyen Hoang Anh ◽  
Suk Won Kim ◽  
Seongoh Park ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Systematic Reviews ◽  
Inflammatory Markers ◽  
Meta Analysis ◽  
Random Effect Model ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Anti Inflammatory

Background: Oat and its compounds have been found to have anti-inflammatory effects. Through this systematic review and meta-analysis, we aimed to determine an evidence-based link between oat consumption and inflammatory markers.Methods: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. By the end of April 2021, we included randomized controlled trials (RCTs) that investigated the anti-inflammatory effect of oat and oat-related products through screening PubMed, Embase, Web of Science, ClinicalTrial.gov, and CENTRAL. Meta-analysis was conducted with a random-effect model on the standardized mean difference (SMD) of the change scores of inflammatory markers, including C-reactive protein (CRP), tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-8 (IL-8). Subgroup analyses were conducted to stratify confounding variables. The risk of bias was evaluated using the Cochrane risk of bias tool and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) was applied to report the quality of evidence. This study was registered in the International Prospective Register of Systematic Reviews (PROSPERO; CRD42021245844).Results: Systematic screening of five databases yielded 4,119 studies, of which 23 RCTs were finally selected. For the four systemic inflammatory markers analyzed, no significant alterations were found after oat consumption. However, oat intake was found to significantly decrease CRP levels in subjects with one or more health complications (SMD: −0.18; 95% CI: −0.36, 0.00; P = 0.05; I2 = 10%). Furthermore, IL-6 levels were significantly decreased in subjects with dyslipidemia (SMD = −0.34; 95% CI: −0.59, −0.10; P = 0.006; I2 = 0%). These beneficial effects might be attributed to the effects of avenanthramide and β-glucan.Conclusions: Overall evidence supporting the alleviation of inflammatory response by oat intake was poor, calling for future studies including a larger sample size to confirm the findings.

scholarly journals Adjuvant Transarterial Chemoembolization Following Curative-Intent Hepatectomy Versus Hepatectomy Alone for Hepatocellular Carcinoma: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Cancers ◽  
2021 ◽  
Vol 13 (12) ◽  
pp. 2984
Author(s):  
Stepan M. Esagian ◽  
Christos D. Kakos ◽  
Emmanouil Giorgakis ◽  
Lyle Burdine ◽  
J. Camilo Barreto ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Transarterial Chemoembolization ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Curative Intent ◽  
Randomized Controlled

The role of adjuvant transarterial chemoembolization (TACE) for patients with resectable hepatocellular carcinoma (HCC) undergoing hepatectomy is currently unclear. We performed a systematic review of the literature using the MEDLINE, Embase, and Cochrane Library databases. Random-effects meta-analysis was carried out to compare the overall survival (OS) and recurrence-free survival (RFS) of patients with resectable HCC undergoing hepatectomy followed by adjuvant TACE vs. hepatectomy alone in randomized controlled trials (RCTs). The risk of bias was assessed using the Risk of Bias 2.0 tool. Meta-regression analyses were performed to explore the effect of hepatitis B viral status, microvascular invasion, type of resection (anatomic vs. parenchymal-sparing), and tumor size on the outcomes. Ten eligible RCTs, reporting on 1216 patients in total, were identified. The combination of hepatectomy and adjuvant TACE was associated with superior OS (hazard ratio (HR): 0.66, 95% confidence interval (CI): 0.52 to 0.85; p < 0.001) and RFS (HR: 0.70, 95% CI: 0.56 to 0.88; p < 0.001) compared to hepatectomy alone. There were significant concerns regarding the risk of bias in most of the included studies. Overall, adjuvant TACE may be associated with an oncologic benefit in select HCC patients. However, the applicability of these findings may be limited to Eastern Asian populations, due to the geographically restricted sample. High-quality multinational RCTs, as well as predictive tools to optimize patient selection, are necessary before adjuvant TACE can be routinely implemented into standard practice. PROSPERO Registration ID: CRD42021245758.

scholarly journals Cochrane Schizophrenia Group’s Study-Based Register of Randomized Controlled Trials: Development and Content Analysis

2020 ◽  
Vol 1 (1) ◽  
Author(s):  
Farhad Shokraneh ◽  
Clive E Adams
Keyword(s):  
Content Analysis ◽  
Randomized Controlled Trials ◽  
Systematic Reviews ◽  
Research Policy ◽  
Cochrane Review ◽  
Gis Mapping ◽  
Controlled Trials ◽  
Policy And Practice ◽  
Randomized Controlled ◽  
Review Team

Abstract Background Study-based registers facilitate systematic reviews through shortening the process for review team and reducing considerable waste during the review process. Such a register also provides new insights about trends of trials in a sub-specialty. This paper reports development and content analysis of Cochrane Schizophrenia Group’s Study-Based Register. Methods The randomized controlled trials were collected through systematic searches of major information sources. Data points were extracted, curated and classified in the register. We report trends using regression analyses in Microsoft Excel and we used GIS mapping (GunnMap 2) to visualize the geographical distribution of the origin of schizophrenia trials. Results Although only 17% of trials were registered, the number of reports form registered trials is steadily increasing and registered trials produce more reports. Clinical trial registers are main source of trial reports followed by sub-specialty journals. Schizophrenia trials have been published in 23 languages from 90 countries while 105 nations do not have any reported schizophrenia trials. Only 9.7% of trials were included in at least one Cochrane review. Pharmacotherapy is the main target of trials while trials targeting psychotherapy are increasing in a continuous rate. The number of people randomized in trials is on average 114 with 60 being the most frequent sample size. Conclusions Curated datasets within the register uncover new patterns in data that have implications for research, policy, and practice for testing new interventions in trials or systematic reviews.

scholarly journals Effects of Supervised Multimodal Exercise Interventions on Cancer-Related Fatigue: Systematic Review and Meta-Analysis of Randomized Controlled Trials

2015 ◽  
Vol 2015 ◽  
pp. 1-13 ◽  
Author(s):  
José Francisco Meneses-Echávez ◽  
Emilio González-Jiménez ◽  
Robinson Ramírez-Vélez
Keyword(s):  
Systematic Review ◽  
Resistance Training ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Exercise Interventions ◽  
Training Interventions ◽  
Randomized Controlled ◽  
Cancer Related Fatigue

Objective. Cancer-related fatigue (CRF) is the most common and devastating problem in cancer patients even after successful treatment. This study aimed to determine the effects of supervised multimodal exercise interventions on cancer-related fatigue through a systematic review and meta-analysis.Design. A systematic review was conducted to determine the effectiveness of multimodal exercise interventions on CRF. Databases of PubMed, CENTRAL, EMBASE, and OVID were searched between January and March 2014 to retrieve randomized controlled trials. Risk of bias was evaluated using the PEDro scale.Results. Nine studiesn=772were included in both systematic review and meta-analysis. Multimodal interventions including aerobic exercise, resistance training, and stretching improved CRF symptoms (SMD=-0.23; 95% CI: −0.37 to −0.09;P=0.001). These effects were also significant in patients undergoing chemotherapyP<0.0001. Nonsignificant differences were found for resistance training interventionsP=0.30. Slight evidence of publication bias was observedP=0.04. The studies had a low risk of bias (PEDro scale mean score of 6.4 (standard deviation (SD) ± 1.0)).Conclusion. Supervised multimodal exercise interventions including aerobic, resistance, and stretching exercises are effective in controlling CRF. These findings suggest that these exercise protocols should be included as a crucial part of the rehabilitation programs for cancer survivors and patients during anticancer treatments.

Tools to assess the Risk of bias and Reporting Quality of Randomized Controlled Trials in Rehabilitation

2021 ◽  
Author(s):  
Susan Armijo-Olivo ◽  
Michele Patrini ◽  
Ana Izabela S de Oliveira-Souza ◽  
Liz Dennett ◽  
Chiara Arienti ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Reporting Quality ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Randomized Controlled
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