Quality Assessment of Published Randomized, Controlled Trials in Trauma Monthly Journal

Abstract

Context: Randomized controlled trials (RCTs) have a major role in making the evidence-based decisions on healthcare. Therefore, the assessment of the quality of RCTs is important to properly apply the evidence-based healthcare. The current study aimed at assessing the quality of RCT reports published in Trauma Monthly Journal. Evidence Acquisition: The quality assessment of each report was performed using a checklist based on the CONSORT (consolidated standards of reporting trials) Statement and Jadad criteria. Results: Fifteen RCTs were published from 2011 to 2015 in Trauma Monthly journal out of which 5 (33.3%) reported the pain outcomes, 7 (46.6%) reports included surgical interventions, and 3 (33.3%) reports included patients with different types of fractures. According to the CONSORT checklist, the best report belonged to the definition of interventions for each group with sufficient details. The mean score of Jadad was 2.27 (45.4% of maximum possible total score). According to both scales, there was an increase in the periods of time in the quality of reporting. Conclusions:The results showed a moderate quality score in RCTs and a minor improvement over the years. Training courses for researchers, managing reporting standard tools presented by editors (CONSORT checklist) and employing methodologists and statistical experts can develop the quality of published RCTs.Keywords: Quality Assessment, Randomized Controlled Trial, Checklist, Trauma Context Quality Assessment of Randomized Controlled TrialsRCTs are often performed to assess the effect of new treatments and are considered evidence-based for clinical trials (1). Therefore, it is of paramount importance to design and report high-quality RCTs. Also, for proper use and exploration of the evidence-based approach, it is important and necessary to assess the quality of RCTs.The quality of a trial was explained by the validity and accuracy of analysis and design. But, the quality of reporting was explained as reporting characteristics about the analysis and design of the RCT (2).There are various approaches to assess the quality of RCTs. It is usually performed using 3 tools of the component, checklist, and scale.Also, the quality of RCTs was evaluated in the metaanalysis studies. The CONSORT (consolidated standards of reporting trials) guidelines and Jadad criteria are often used in meta-analysis studies. Recently, to integrate the results of RCTs, meta-analyses are conducted increasingly (3, 4). Therefore, there is a great interest to evaluate the quality of RCTs to include them in the meta-analyses (5-7). Therefore, since the quality of trials affect the results of meta-analyses, results may be less valuable if the quality of RCTs is not assessed (2). To achieve the valuable results of a trial, the quality of RCT is very important.It is recommended that journals implement more CONSORT guidelines (8). The works should be complete and clear before publishing.However, RCTs are increasingly published in journals (9). It is important for the promotion ...

Compliance of published randomized controlled trials on the effect of physical activity on primary dysmenorrhea with the consortium's integrated report on clinical trials statement: A critical appraisal of the literature

“…A systematic review conducted on 55 RCTs published in plastic surgery concluded that, on average, RCTs comply with just half of the CONSORT items[ 52 ] that is in line with some other studies. [ 53 ],[ 54 ],[ 55 ] But in the study of Salesi et al .,[ 56 ] only one-third of the articles achieved the maximum possible score on the scale, in which the evaluated clinical trials were all published in the Journal of Military Medicine of Baqiyatallah University, Iran; while in our study the various journals with different languages were included. Therefore, it seems that the trials published in general journals with general scope have higher report quality.…”

Bias in clinical trials into the effects of complementary and alternative medicine therapies on hemodialysis patients

“…Two earlier studies including assessed all 314 abstracts of RCTs affiliated to Tehran University of Medical Sciences ( n = 249) and Iran University of Medical Sciences ( n = 65) indexed in PubMed up to the end of 2010 and another study assessment all clinical trials that had been conducted on humans and had a control group during 1999--2015 and were published in the Journal of Military Medicine were included in the current survey also reported that some RCTs had failed to provide detailed information about their outcome variables. [3233] The main reasons behind the exclusion of some outcomes are limited permissible word count for articles and clinical and statistical insignificance of some findings. It is noteworthy that statistically significant results have higher publication chance than statistically insignificant results.…”

“…The study, Salesi et al , found that 82.85% of the trials had a sample size of less than 100. [33] One reason behind small samples in some RCTs might have been inadequate financial support. Other types of bias in RCTs were related to the provision of incomplete information about the validity and reliability of data collection tools, shortness of follow-up assessment period, no consultation with biostatisticians in all steps of RCT, and failure to register RCT in national or international registries.…”