scholarly journals Bias-Variation Dilemma Challenges Clinical Trials: Inherent Limitations of Randomized Controlled Trials and Meta-Analyses Comparing Hernia Therapies

2014 ◽  
Vol 05 (13) ◽  
pp. 778-789 ◽  
Author(s):  
U. Klinge ◽  
Andreas Koch ◽  
D. Weyhe ◽  
Enrico Nicolo ◽  
R. Bendavid ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Meta Analyses

scholarly journals Follicular Fluid Meiosis-Activating Sterol in Assisted Reproductive Techniques: A Systematic Review and Meta-analysis of Randomized Controlled Trials

2020 ◽  
pp. 1-16
Author(s):  
Kien Nguyen Dang ◽  
Mohammad Rashidul Hashan ◽  
Le Huu Nhat Minh ◽  
Khalid Muhammad Khalaf ◽  
Hassan Yousif Ibrahim ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Follicular Fluid ◽  
Meta Analysis ◽  
Normal Embryo ◽  
Controlled Trials ◽  
Abnormal Embryo ◽  
Randomized Controlled ◽  
Mosaic Embryo ◽  
Meta Analyses

Background: Follicular fluid meiosis-activating sterol (FFMAS) is one of several molecular compounds that has been added into in vitro maturation (IVM) technique with contradictory results. Our study aimed to investigate the effects of FFMAS in assisted reproductive technology (ART). Methods: We searched systematically in PubMed, Web of Science, Scopus, Cochrane Registry of clinical trials, WHO registry of clinical trials, clinicaltrials.gov, Google Scholar until July 2017. Meta-analysis was used to investigate the efficacy and safety outcomes of FFMAS. Following the retrieval of potential articles, two independent reviewers screened and extracted included papers rigorously. Summary odds ratios (ORs) and 95% confidence intervals (CIs) were computed for the individual outcome when data was available. Quality of included studies was assessed using Cochrane collaboration tool. Results: A total of seven randomized controlled trials involving 1198 participants with 3105 oocytes were explored in this study. Most of the studies were at low risk of bias. Our random effects model meta-analyses in maturation and abnormal embryo rate between FFMAS-exposed oocytes compared with controls revealed no significant differences (summary OR 1.00, 95% CI 0.46–2.16, [Formula: see text] value = 0.99 and summary OR was 1.31, 95% CI 0.84–2.04, [Formula: see text] value = 0.23, respectively). Beside, our study showed a significant increase in uniformly abnormal embryo rate in FFMAS group compared with vehicle control group (summary OR 1.98, 95% CI 1.09–3.61, [Formula: see text] value = 0.03). No significances were noted on meta-analyses of normal embryo rate, uniformly abnormal embryo rate, uniformly normal embryo rate, mosaic embryo rate, abnormal blastomere rate, normal blastomere rate, aneuploidy mosaic embryo rate, and chaotic mosaic embryo rate. Conclusions: FFMAS showed no efficacy in maturation process in human oocytes and there was some evidence for detrimental effects in comparison to vehicle controls. We discouraged any further trials due to safety concern.

scholarly journals Enhancing Patient Centricity and Advancing Innovation in Clinical Research with Virtual Randomized Clinical Trials (vRCTs)

Diagnostics ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 151
Author(s):  
Raphael A. Yaakov ◽  
Özgür Güler ◽  
Tim Mayhugh ◽  
Thomas E. Serena
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Randomized Clinical Trials ◽  
Regulatory Compliance ◽  
Small Sample ◽  
Controlled Trials ◽  
Holistic View ◽  
Health Crisis ◽  
Randomized Controlled ◽  
Healthcare Needs

The current public health crisis has highlighted the need to accelerate healthcare innovation. Despite unwavering levels of cooperation among academia, industry, and policy makers, it can still take years to bring a life-saving product to market. There are some obvious limitations, including lack of blinding or masking and small sample size, which render the results less applicable to the real world. Traditional randomized controlled trials (RCTs) are lengthy, expensive, and have a low success rate. There is a growing acknowledgement that the current process no longer fully meets the growing healthcare needs. Advances in technology coupled with proliferation of telehealth modalities, sensors, wearable and connected devices have paved the way for a new paradigm. Virtual randomized controlled trials (vRCTs) have the potential to drastically shorten the clinical trial cycle while maximizing patient-centricity, compliance, and recruitment. This new approach can inform clinical trials in real time and with a holistic view of a patient’s health. This paper provides an overview of virtual clinical trials, addressing critical issues, including regulatory compliance, data security, privacy, and ownership.

scholarly journals Pre-Procedural Lumbar Neuraxial Ultrasound—A Systematic Review of Randomized Controlled Trials and Meta-Analysis

Healthcare ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. 479
Author(s):  
Tatiana Sidiropoulou ◽  
Kalliopi Christodoulaki ◽  
Charalampos Siristatidis
Keyword(s):  
Systematic Review ◽  
Lumbar Spine ◽  
Randomized Controlled Trials ◽  
Success Rate ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Technical Failure ◽  
Obese Patients ◽  
Randomized Controlled ◽  
Meta Analyses

A pre-procedural ultrasound of the lumbar spine is frequently used to facilitate neuraxial procedures. The aim of this review is to examine the evidence sustaining the utilization of pre-procedural neuraxial ultrasound compared to conventional methods. We perform a systematic review of randomized controlled trials with meta-analyses. We search the electronic databases Medline, Cochrane Central, Science Direct and Scopus up to 1 June 2019. We include trials comparing a pre-procedural lumbar spine ultrasound to a non-ultrasound-assisted method. The primary endpoints are technical failure rate, first-attempt success rate, number of needle redirections and procedure time. We retrieve 32 trials (3439 patients) comparing pre-procedural lumbar ultrasounds to palpations for neuraxial procedures in various clinical settings. Pre-procedural ultrasounds decrease the overall risk of technical failure (Risk Ratio (RR) 0.69 (99% CI, 0.43 to 1.10), p = 0.04) but not in obese and difficult spinal patients (RR 0.53, p = 0.06) and increase the first-attempt success rate (RR 1.5 (99% CI, 1.22 to 1.86), p < 0.0001, NNT = 5). In difficult spines and obese patients, the RR is 1.84 (99% CI, 1.44 to 2.3; p < 0.0001, NNT = 3). The number of needle redirections is lower with pre-procedural ultrasounds (SMD = −0.55 (99% CI, −0.81 to −0.29), p < 0.0001), as is the case in difficult spines and obese patients (SMD = −0.85 (99% CI, −1.08 to −0.61), p < 0.0001). No differences are observed in procedural times. Ιn conclusion, a pre-procedural ultrasound provides significant benefit in terms of technical failure, number of needle redirections and first attempt-success rate. Τhe effect of pre-procedural ultrasound scanning of the lumbar spine is more significant in a subgroup analysis of difficult spines and obese patients.

The effect of almond intake on lipid profile: a systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Author(s):  
Omid Asbaghi ◽  
Vihan Moodi ◽  
Amir Hadi ◽  
Elham Eslampour ◽  
Mina Shirinbakhshmasoleh ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Lipid Profile ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled

A number of clinical trials have examined the effect of almond intake on the lipid profile in recent years; however, the results remain equivocal.

scholarly journals A guide to do randomized controlled trials in the field of otolaryngology

2021 ◽  
Vol 37 (1) ◽  
Author(s):  
Sameh M. Zamzam ◽  
Mosaad Abdel-Aziz ◽  
Ahmed Atef ◽  
Usama Abdel-Naseer ◽  
Mostafa Hamoda ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Study Groups ◽  
Controlled Trials ◽  
Main Body ◽  
Main Research ◽  
Randomized Controlled ◽  
New Treatment ◽  
Meta Analyses ◽  
Based Medicine

Abstract Background Randomized controlled trials (RCTs) are prospective comparative studies in which study groups are allocated randomly to intervention or serve as controls. RCT is the mainstay to achieve evidence in the literature in clinical research. A RCT is the main research design to study the effect of an intervention and the only way to confirm the value of a new treatment. Main body RCT also gives the way to generate meta-analyses and systematic reviews giving a stronger evidence for clinical practice. Evidence-based medicine (EBM) is crucial for safe, effective, and standardized patient care. Although there is an agreement on the importance of performing RCT, it can be challenging to do it efficiently including different aspects like study design, funding, randomization, blinding, follow-up, data analysis, statistics, generalization of results, and reporting of quality of the studies. Conclusion In this article, we gave a comprehensive review for RCT in otolaryngology discussing their importance, advantages, and drawbacks, types, steps, challenges, reporting their quality and their prevalence in the literature.

Trends in randomized controlled trials in ENT: a 30-year review

1997 ◽  
Vol 111 (7) ◽  
pp. 611-613 ◽  
Author(s):  
K. W. Ah-See ◽  
N. C. Molony ◽  
A. G. D. Maran
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Randomized Controlled Trials ◽  
Gold Standard ◽  
Controlled Trials ◽  
Evidence Based ◽  
Controlled Clinical Trials ◽  
Medline Search ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled

AbstractThere is a growth in the demand for clinical practice to be evidence based. Recent years have seen a rise in the number of randomized controlled clinical trials (RCTS). Such trials while acknowledged as the gold standard for evidence can be difficult to perform in surgical specialities. We have recently identified a low proportion of RCTS in the otolaryngology literature. Our aim was to identify any trend in the number of published RCTS within the ENT literature over a 30-year period and to identify which areas of our speciality lend themselves to this form of study design. A Medline search of 10 prominent journals published between 1966 and 1995 was performed. Two hundred and ninety-six RCTS were identified. Only five were published before 1980. Two hundred (71 per cent) of RCTS were in the areas of otology and rhinology. An encouraging trend is seen in RCTS within ENT literature.

Authors' Response: NIDCAP: A Systematic Review and Meta-analyses of Randomized Controlled Trials

PEDIATRICS ◽  
2013 ◽  
Vol 132 (2) ◽  
pp. e553-e557 ◽  
Author(s):  
A. Ohlsson ◽  
S. E. Jacobs
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Meta Analyses
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