Assessing the Quality of Randomized Controlled Trials Published in the Journal of Korean Medical Science from 1986 to 2011

Background: Several studies have suggested that exercise capacity and quality of life are reduced in patients with pulmonary hypertension (PH), and exercise-based rehabilitation can improve exercise capacity and quality of life in patients with PH. The aim of this study is to assess the efficacy and safety of exercise-based rehabilitation in patients with PH through a meta-analysis of randomized controlled trials. Methods: We searched PubMed, Embase, Medline, and the Cochrane Central Register of Controlled Trials up to November 2018. All randomized controlled trials (RCTs) comparing exercise capacity and quality of life between patients undergoing exercise-based rehabilitation and those undergoing non-exercise training were included. Data were extracted separately and independently by two investigators, and discrepancies were arbitrated by the third investigator. We used the random-effects model to analyze the results, the GRADE to assess the risk of bias in the included studies, and I Â² statistic to estimate the degree of heterogeneity. Results: Nine RCTs are included, however, only seven RCTs were able to extract data. Including inpatients and outpatients, the total number of participants was 234, most of whom were diagnosed as pulmonary artery hypertension (PAH). The study duration ranged from 3 to15 weeks. The mean six-minute walk distance after exercise training was 51.94 metres higher than control (27.65 to 76.23 metres, n=234, 7 RCTs, low quality evidence), the mean peakÂ oxygen uptakeÂ Â was 2.96 ml/kg/minute higher (2.49 to 3.43 ml/kg/minute, n=179, 4 RCTs, low-quality evidence) than in the control groupÂ . Concluded: Our finding suggest that an exercise-based training program positively influences exercise capacity in patients with PH.

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

The Egyptian Journal of Otolaryngology ◽

10.1186/s43163-021-00142-5 ◽

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.

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Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience

Therapeutic Advances in Gastroenterology ◽

10.1177/17562848211010668 ◽

2021 ◽

Vol 14 ◽

pp. 175628482110106

Author(s):

Fabio Salvatore Macaluso ◽

Marcello Maida ◽

Mauro Grova ◽

Federica Crispino ◽

Giulia Teresi ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Randomized Controlled Trials ◽

Real World ◽

Bowel Disease ◽

Quality Data ◽

Controlled Trials ◽

Randomized Controlled ◽

Therapeutic Algorithms ◽

Inflammatory Bowel

During past years, the increasing knowledge of molecular mechanisms of inflammatory bowel disease (IBD) have led to the development of several targeted biological therapies. This great expansion of available medical options has prompted the need for comparative data between drugs. For years, given that most randomized controlled trials (RCTs) were performed only versus placebo, this demand has clashed with the absence of head-to-head trials comparing two or more treatments. The quality of evidence coming from real-world experience was low overall, so it was extremely difficult to clarify the correct positioning of the biologicals inside the therapeutic algorithms for IBD. Fortunately, times are changing: head-to-head comparative RCTs have been conducted or are ongoing, and the methodological quality of real-world studies is gradually increasing, mainly thanks to a higher rate of application of statistical methods capable of reducing the selection bias, such as the propensity score. In this evolving scenario, the increasing number of comparative RCTs is providing high-quality data for a correct drug positioning in IBD. In parallel, real-world observational studies are supporting the data coming from RCTs, and covering those comparisons not performed in the RCT setting. We believe that there is moderate evidence already available to support clinicians in the correct choice between different biologicals, and data will certainly be more robust in the near future.

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