Assessment of Randomized Clinical Trials articles in Medical Journal of Mashhad University of Medical Sciences based on CONSORT statement

Document Type : Research Paper

Authors

1 Professor of Biostatistics, Social Factors Affecting Health Research Center, Mashhad University of Medical Sciences, Mashhad, Iran

2 Professor of Epidemiology, School of Health, Mashhad University of Medical Sciences, Mashhad, Iran

3 Department of Biostatistics, Faculty of Health, Mashhad University of Medical Sciences, Mashhad, Iran

4 Department of Biostatistics, Faculty of Health, Mashhad University of Medical Sciences, Mashhad, Iran. Student Research Committee, Mashhad University of Medical Sciences, Mashhad, Iran

Abstract

Introduction: Clinical trial studies have a special value among a variety of studies. The results of these studies have important applications on human populations, including the study of the effects of drugs and therapies. Given the importance of such studies, it seems necessary to review the quality and evaluation of articles related to this field of research. The issue of critical appraisal has a very important place in biomedical studies; And help researchers evaluate the quality of articles. The aim of this study was to evaluate the clinical trial articles Medical Journal of Mashhad University of Medical Sciences during 1388-1398.
Method: The present study was a descriptive cross-sectional study .In this study, the study population was 173 clinical trial articles that were selected from 741 articles published in the Journal of the Faculty of Medicine of Mashhad University of Medical Sciences during 1388 to the end of 1398. These articles were reviewed using consort checklists in 25 general items by two statistical experts with an agreement of more than 0.91%. Data were analyzed by SPSS software version 23.
Findings: In evaluating the articles in this journal, a growing trend was observed in the number of clinical trial articles published in the review. According to the evaluations based on the Consort Checklist, the lowest score assigned to articles was 6 points, which was related to an article in 1394, and the highest was an article in 1397, which received a score of 27 out of 37. The average score of all articles was 13.53 with a standard deviation of 2.82. The statistical methods used and the mention of the term "clinical trial" in the title were the items that received the most and the least amount of attention in the research, respectively.
Conclusion: In general, the attention of the studied clinical trial articles to the observance of the points of the consort statement has been less than acceptable, which eliminates the shortcomings and observes more of the consort items to increase the quality of the articles in Medical Journal of Mashhad University of Medical Sciences.

Keywords


  1. Schulz KF, Chalmers I, Grimes DA, Altman DG. Assessing the quality of randomization from reports of
    controlled trials published in obstetrics and gynecology journals. Jama. 1994;272(2):125-8.
    2. Higgs J. Clinical reasoning in the health professions: Elsevier Health Sciences; 2008.
    3. Falagas ME, Grigori T, Ioannidou E. A systematic review of trends in the methodological quality of randomized
    controlled trials in various research fields. J Clin Epidemiol. 2009;62(3):227-31. e9.
    4. Amanollahi A, Shokraneh F, Mohammadhassanzadeh H, Ebrahimi KM, Banani G. [Quality assessment of
    randomized controlled clinical trials indexed in PubMed using Consort statement].Health Inf Manage. 2012;
    9(3): 415. Persian.
    5. Nouri S, Ghanei M. [Familiarity with Consolidated Standards in Reporting Trials (Consort)]. Iran J Surg. 2014;
    22(2): 88-103. Persian.
    6. Olivo SA, Macedo LG, Gadotti IC, Fuentes J, Stanton T, Magee DJ. Scales to assess the quality of randomized
    controlled trials: a systematic review. Phys Ther. 2008;88(2.75-156:)
    7. Moher D, Schulz KF, Altman DG, Group C. The CONSORT statement: revisedrecommendations for improving
    the quality of reports of parallel-group randomised trials. Elsevier;2001; 357(9263): 1191-4.
    8. CONSORT Website. http://www.consortstatement.org/ available 4-6-2016.
    9. Gohari MR, Salehi M, Vahabi N, Bazrafshan A. [Analysis of medical sciences articles structure quality during
    2002-2008]. Journal of Payavard Salamat. 2012;6(1):79-88. Persian.
    10. Talachi H, Jamshidi Orak R, Ravaghi H, Amanollahi A. [Assessment of the quality of methodology reporting in
    the randomized trials]. Journal of Health Administration. 2012;15(48):81-92. Persian.
    11. Moniri S, Jafari F. [The quality of papers of Iranian scholars in the field of medical sciences an impact survey].
    Faslnameh-Ketab. 2011;22(2):110-20. Persian.
    12. AMANOLLAHI A, SHOKRANEH F, MOHAMMADHASSANZADEH H, EBRAHIMI KALAN M, BANANI
    GJHIM. QUALITY ASSESSMENT OF RANDOMIZED CONTROLLED CLINICAL TRIALS INDEXED IN
    PUBMED USING CONSORT STATEMENT. 2012;9(3.-:)
    13. Adib-Hajbaghery M, Adib M, Eshraghi Arani N. Evaluating the Quality of Randomized Trials Published in
    Persian Nursing Journals with More than 10 Years of Publishing Using the CASP Checklist %J Iran Journal of
    Nursing. 2017;30(109):1-9.
    14. 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
    Journal of Mashhad Dental School. 2017;41(1):11-20.
    15. Estrada CA, Bloch RM, Antonacci D, Basnight LL, Patel SR, Patel SC, et al. Reporting and concordance of
    methodologic criteria between abstracts and articles in diagnostic test studies Journal of General Internal
    Medicine 2000; 1(53): 183-87.
    16. Hopewell S, Ravaud P, Baron G, Boutron I. Effect of editors’ implementation of CONSORT guidelines on the
    reporting of abstracts in high impact medical journals: interrupted time series analysis. Bmj 2012 :344 ;e4178.
    17. Clement, Zackariah & Buckley, Nick. (2011 .)Reporting of randomised controlled trials: Before and after the
    advent of the CONSORT statement. Journal of Clinical Medicine and Research. 3. 28-34 .
    18. Ayat-Elahi SMT, Jafari P, GHaem H. An evaluation of the quality of published clinical trials in Iranian medical
    journals during 2001-2004. J Babol Univ Med Sci 2005; 7(4): 64-70. [Farsi]
    19. Salesi, M., et al. (2017). "Quality Assessment of Published Randomized Controlled Trials in the Journal of
    Military Medicine during 1999-2015." Journal of Military Medicine 19(2): 106-125.
    20. Campbell MJ, Julious SA, Altman DG. Estimating sample sizes for binary, ordered categorical, and continuous
    outcomes in two group comparisons. BMJ. 1995;311(7013):1145-8.
    21. Ghimire S, Kyung E, Kang W, Kim E .Assessment of adherence to the CONSORT statement for quality of
    reports on randomized controlled trial abstracts from four high-impact general medical journals. Trials.
    2012;13:77. Published 2012 Jun 7. doi:1186/10/1745-6215-13-77.
  2. 22. Ghojazadeh M, Tavananezhad N, Karkhanee M, Naghavi Behzad M, Azami Aghdash S.[Quality of Randomized
    Clinical Trial Reports Published by Iranian Researchers in the Obstetrics and Gynecology Level 1 Journals:
    Using CONSORT]. The Iranian Journal of Obstetrics, Gynecology and Infertility. 2013;16(78):7-15. Persian
    23. Ariasepehr S, Ahmadzadeasl M. [Basic principles of research methodology in medical sciences]. Tehran:
    Nourdanesh. 2001:84-92. Persian.
    24. Hosseini S M, Ahmadinia H, Rezaeian M. Evaluation of the Quality of Writing of the Title and Abstract of
    Randomized Controlled Clinical Trial Papers Published in the Journals of the Iran,s Universities of Medical
    Sciences in 2016, Based on the CONSORT Checklist: A Descriptive Study. JRUMS. 2019; 18 (3) :267-284.
    25. Moher D, Sampson M, Campbell K, Beckner W, Lepage L, Gaboury I, et al. Assessing the quality of reports of
    randomized trials in pediatric complementary and alternative medicine. BMC Pediatrics. 2002;2.