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 ◽  
...  

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.

2008 ◽  
Vol 42 (10) ◽  
pp. 1402-1409 ◽  
Author(s):  
Basil G Bereza ◽  
Márcio Machado ◽  
Thomas R Einarson

Background: Mela-analyses of randomized controlled trials (RCTs) constitute the highest level of evidence, but their usefulness depends on their quality. Objective: To assess tho reporting and scientific quality of meta-analyses of RCTs on treatments for anxiety disorders. Methods: Criteria for peer-reviewed, full-text retrieval included meta-analyses of RCTs of drugs versus active ingredient placebo, standard care, or psychotherapy. Sample populations were required to meet Diagnostic and Statistical Manual of Mental Disorders or International Classification of Diseases and Related Health Problems diagnostic criteria for anxiety disorders. Two reviewers independently searched EMBASE, EBM Reviews. Ovid MEDLINE, Ovid HealthSTAR, and International Pharmaceutical Abstracts from inception to August 2007. Search terms Included meta-analysis, randomized controlled trials, anxiety, anxiolytic, anti-depressant/antidepressant, and pharmacotherapy, without language restrictions. References and reviews were searched manually. Quality was assessed independently by 2 raters, using the Quality of Reporting of Meta-anatyses (QUOROM) and the Overview Quality Assessment Questionnaire (OQAQ). The QUOROM was used to assess the reporting quality of the study, using an 18-item checklist, and the scientific quality was assessed with the OQAQ's 10-item checklist, Kendall's - measured Interrater reliability with statistical significance at p less than or equal to 0.01. Means and standard deviations described the overall quality. A time series analysis was performed. Results: A total of 136 titles and abstracts were reviewed; 48 were retrieved, including 6 from the manual search. Thirty-two were excluded (not pooled analyses, inappropriate condition/treatment, duplications), leaving 16 studies published between 1995 and 2007. Agreement was high: t = 0.801 (p < 0.01) for QUOROM and 0.834 (p < 0.01) for OQAQ. QUOROM quality scored 61% ± 19%. Overall, the results sections of the studies scored lowest, while the introduction and discussion sections scored highest. The overall scientific qualify was 58% ± 28%. Most studies appropriately linked results to priman/ objectives but did not report how bias was avoided or how study validity was assessed. Quality Increased nonsignificantly over time. Conclusions: Reporting/scientific quality was considered less than fair-to-good. Stakeholders should strive for higher scientific quality of meta-analyses.


Conditions of the ear, nose, or throat (ENT) are common diagnoses in primary care and are a frequent indication for referral to secondary care. They have a major impact on health and health-care resources, and it is therefore important that the management of ENT conditions is based upon the best available evidence. Such evidence should come from methodologically sound research in patients representative of those seen in everyday practice. Over the past decades, general practitioners and ENT surgeons have embraced the principles of evidence-based medicine, actively contributing to randomized controlled trials in this field. Consequently, management of ENT conditions is shifting from experience-based to evidence-based. The randomized controlled trials and individual patient data meta-analyses presented in this chapter have been instrumental in the development of clinical guidelines that allow general practitioners and ENT surgeons to make evidence-based shared decisions for the management of some of the commonest ENT conditions.


Healthcare ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. 479
Author(s):  
Tatiana Sidiropoulou ◽  
Kalliopi Christodoulaki ◽  
Charalampos Siristatidis

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.


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