Assessment of the Quality of Randomized Clinical Trials Published by Iranian Researchers in Persian Internal Journals in 2014

Author(s): Mohammad Rafiei, Awat Feizi, Seyyed P. Shariatpanahi, Iman Hamraz, Danial Habibi*

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs
Continued as Applied Drug Research, Clinical Trials and Regulatory Affairs

Volume 7 , Issue 1 , 2020

Graphical Abstract:


Introduction: A randomized clinical trial is known as the best and most effective way to assess the effects of interventions if it is properly planned and implemented. The purpose of this study was to evaluate the quality of clinical trials published in Persian internal journals by Iranian researchers.

Methods: In this cross-sectional study, all the clinical trials published by Iranian researchers in the Iranian Journals in 2014, were evaluated according to entry criteria and finally 587 included articles were reviewed and their quality was evaluated by using Consolidated Standards of Reporting Trials (CONSORT) checklist.

Results: The results revealed that the mean±SD adherence to the CONSORT checklist’s item in our included articles was 59.61±24.99. The lowest adherence to the items was seen for random allocation (76.1%), description of the sampling method (70.1%) and presenting RCT code registration (60.4%), respectively. The highest adherence was observed for title suitability (96%), appropriate presentation time and place of study (84.2%), a suitable expression of study participants (82.8%) and time duration of the study (82.3%).

Conclusion: The adherence to the various items of CONSORT checklist in Iranian Persian language journals was not in satisfactory status. In this regard, the CONSORT checklist needs to be carefully followed for conducting and reporting RCTs by Iranian researchers.

Keywords: Randomized clinical trial, Iranian medical journals, CONSORT, framework, investigation, persian internal journals.

Moher D, Sampson M, Campbell K, et al. Assessing the quality of reports of randomized trials in pediatric complementary and alternative medicine. BMC Pediatr 2002; 2(1): 2.
[] [PMID: 11914145]
Amanollahi A, Shokraneh F, Mohammad HH, Ebrahimi KM, Banani G. Quality assessment of randomized controlled clinical trials indexed in PubMed using CONSORT statement 2012. Healthc Inf Manage 2012; 9(3): 1.
Talachi H, Orak RJ, Ravaghi H, Amanollahi A. Assessment of the quality of methodology reporting in the randomized trials. J Heal Adm 2012; 15(48): 81-92.
Chow S-C, Liu J. Design and analysis of clinical trials: concepts and methodologies. 3rd ed. In: John Wiley & Sons 2008; p. 507.
Higgs J, Jones MA, Loftus S, Christensen N. Clinical reasoning in the health professions e-book.3rd ed In: Elsevier Health Sciences. 2008; pp. 1-485.
Akobeng AK. Principles of evidence based medicine. Arch Dis Child 2005; 90(8): 837-40.
[] [PMID: 16040884]
Young JM, Solomon MJ. How to critically appraise an article. Nat Clin Pract Gastroenterol Hepatol 2009; 6(2): 82-91.
[] [PMID: 19153565]
Turner L, Shamseer L, Altman DG, et al. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev 2012; 1(11): 1-87.
Grant S, Mayo-Wilson E, Montgomery P, et al. CONSORT-SPI 2018 explanation and elaboration: guidance for reporting social and psychological intervention trials. Trials 2018; 19(1): 406.
[] [PMID: 30060763]
Plint AC, Moher D, Morrison A, et al. Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. Med J Aust 2006; 185(5): 263-7.
[PMID: 16948622]
Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med 2010; 8(1): 18.
[] [PMID: 20334633]
Ayatollahi M, Jafari P, Ghaem H. Assessment of quality randomized controlled trials published in Iran during 2000-2002. Babol Univ Med J 2004; 7(4): 64-70.
Taghipour A, Shakeri MT, Yousefi R, Barzanouni S. assessment of randomized controlled clinical trials articles in the journal of dental school, Mashhad University of Medical Sciences: Published 2003-2015. J Mashhad Dent Sch 2017; 41(1): 11-20.
Mohammady M, Toghian CN, Abdoli S. Risk of bias in randomized controlled trials published in Iranian nursing and midwifery journals in 2010. Majallah-i Ipidimiyuluzhi-i Iran 2014; 9(3): 24-36.
Adib-Hajbaghery M, Adib ME, Eshraghi AN. Evaluating the quality of randomized trials published in Persian nursing journals with more than 10 years of publishing using the CASP checklist. Iran J Nurs 2017; 30(109): 1-9.

open access plus

Rights & PermissionsPrintExport Cite as

Article Details

Year: 2020
Published on: 03 March, 2020
Page: [65 - 70]
Pages: 6
DOI: 10.2174/2213476X06666190723115243

Article Metrics

PDF: 13
PRC: 1