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JNKUMS 2018, 9(3): 474-484 Back to browse issues page
Evaluating the Quality of Trial Reports in Iranian Nursing Journals
Abbas Heydari * 1, Hassan Sharifi 2
1- Professor, Department of Medical-Surgical Nursing, Evidence-Based Caring Research Center, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran
2- Instructor, Department of Medical-Surgical Nursing, Student Research Committee, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran
Abstract:   (345 Views)
Introduction: The results of randomized controlled trials (RCTs) have a significant impact on providing high-quality evidence-based nursing care. However, little is known about the quality of RCT reports in Iranian nursing journals. The aim of this study was to assess the quality of RCT reports published in nursing journal based on the CONSORT statement from 2011 to 2016.
Methods: This national cross-sectional study was conducted between May 2016 and October 2016. The study population consisted of all nursing trials indexed in domestic databases including Iranian Nursing Publications Index (nindex.ir), Magiran, Scientific Information Database (SID), as well as international databases including Pubmed and SCOPUS in a five-year period between March 2011 and March 2016. A sample of 150 papers was selected using stratified random sampling based on the inclusion criteria. The CONSORT checklist was used as the study main instrument.
Results: The overall mean quality of trials based on CONSORT was 20.20 ± 3.87 (11-30). The mean of method and randomization section was 8.85 ± 1.85 (6-3); 50% of trials had an overall score less than 20, and the methodology score of 75% of trials was less than 10.
Conclusions: Based on the evidence-based pyramid, trials play an important role in the production of specialized knowledge in the fields of nursing practice, education and community. However, these trials must be not only properly designed and implemented, but reported in the standard form. The present study determined what parts of the reports of nursing trials need a critical attention. In addition, several solutions were offered to improve the quality of these reports
Keywords: Research Report, Data Reporting, Clinical Trial, CONSORT, Nursing Research
Full-Text [PDF 813 kb]   (130 Downloads)    
Type of Study: Orginal Research | Subject: Basic Sciences
Received: 2017/12/31 | Accepted: 2017/12/31 | Published: 2017/12/31
References
1. 1. Grove SK, Burns N, Gray J. The practice of nursing research: Appraisal, Synthesis, and Generation of Evidence. 7 ed: Saunders, Elsevier Inc; 2013.
2. 2. Polit DF, Tatano Beck C. Nursing research: generating and assessing evidence for nursing practice. Ninth ed: Lippincott Williams & Wilkins; 2012.
3. 3. Stolberg HO, Norman G, Trop I. Randomized controlled trials. AJR Am J Roentgenol. 2004;183(6):1539-44. DOI: 10.2214/ajr.183.6.01831539 PMID: 15547188
4. 4. Borglin G, D AR. Bias in experimental nursing research: Strategies to improve the quality and explanatory power of nursing science. Int J Nurs Stud. 2010;47(1):123-8. DOI: 10. 1016/j.ijnurstu.2009.06.016 PMID: 19643408
5. 5. Wood L, Egger M, Gluud LL, Schulz KF, Juni P, Altman DG, et al. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ. 2008;336(7644):601-5. DOI: 10.1136/bmj.39465. 451748.AD PMID: 18316340
6. 6. Mbuagbaw L, Thabane M, Vanniyasingam T, Borg Debono V, Kosa S, Zhang S, et al. Improvement in the quality of abstracts in major clinical journals since CONSORT extension for abstracts: a systematic review. Contemp Clin Trials. 2014;38(2):245-50. DOI: 10.1016/j.cct.2014.05.012 PMID: 24861557
7. 7. Lindsay B. Randomized controlled trials of socially complex nursing interventions: creating bias and unreliability? J Adv Nurs. 2004;45(1):84-94. PMID: 14675304
8. 8. Guo JW, Sward KA, Beck SL, Staggers N. Quality of reporting randomized controlled trials in cancer nursing research. Nurs Res. 2014;63(1):26-35. DOI: 10.1097/NNR. 0000000000000007 PMID: 24335911
9. 9. Mills EJ, Ayers D, Chou R, Thorlund K. Are current standards of reporting quality for clinical trials sufficient in addressing important sources of bias? Contemp Clin Trials. 2015. DOI: 10.1016/j.cct.2015.07.019 PMID: 26232560
10. 10. McCrae N, Blackstock M, Purssell E. Eligibility criteria in systematic reviews: A methodological review. Int J Nurs Stud. 2015;52(7):1269-76. DOI: 10.1016/j.ijnurstu.2015. 02.002 PMID: 25726430
11. 11. Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55. DOI: 10. 1016/j.ijsu.2011.10.001 PMID: 22036893
12. 12. Mohammady M, Janani L. [Randomization in randomized clinical trials: From theory to practice]. Hayat. 2016;22(2):102-14.
13. 13. Group TC. The CONSORT Statement: Consolidated Standards of Reporting Trials [cited 2016 October]. 2010:[Available from: http://www.consort-statement.org/.
14. 14. Schulz KF, Altman DG, Moher D, Group C. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials. 2010;11:32. DOI: 10. 1186/1745-6215-11-32 PMID: 20334632
15. 15. Levy PS, Lemeshow S. Sampling of populations: methods and applications: John Wiley & Sons; 2013.
16. 16. Moradi M, Asadi-Samani M, Mobasheri M. [Evaluating the quality of materials and methods for writings of final proposal in clinical trial studies in Shahrekord University of Medical Sciences based on consort checklist]. J Clin Nurs Midwifery. 2013;2(4):1-7.
17. 17. Cohen JW. Statistical power analysis for the behavioral sciences. 2 ed. Hillsdale: NJ: Lawrence Erlbaum Associates; 1988.
18. 18. Peters JP, Hooft L, Grolman W, Stegeman I. Assessment of the quality of reporting of randomised controlled trials in otorhinolaryngologic literature - adherence to the CONSORT statement. PLoS One. 2015;10(3):e0122328. DOI: 10.1371/journal.pone.0122328 PMID: 25793517
19. 19. 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. DOI: 10.1186/1745-6215-13-77 PMID: 22676267
20. 20. Dwan K, Gamble C, Williamson PR, Kirkham JJ, Reporting Bias G. Systematic review of the empirical evidence of study publication bias and outcome reporting bias - an updated review. PLoS One. 2013;8(7):e66844. DOI: 10.1371/journal. pone.0066844 PMID: 23861749
21. 21. Kao LS, Tyson JE, Blakely ML, Lally KP. Clinical research methodology I: introduction to randomized trials. J Am Coll Surg. 2008;206(2):361-9. DOI: 10.1016/j.jamcollsurg. 2007.10.003 PMID: 18222393
22. 22. Stommel M, Wills CE. Clinical research: Concepts and principles for advanced practice nurses. Philadelphia: Lippincott, Williams & Wilkins; 2004.
23. 23. Boutron I, Tubach F, Giraudeau B, Ravaud P. Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials. J Clin Epidemiol. 2004;57(6):543-50. DOI: 10.1016/j.jclinepi. 2003.12.010 PMID: 15246122
24. 24. Ayatollahi M-T, Jafari P, Ghaem H. [Evaluation of the Quality of Clinical Trials Published in the Medical Sciences Journal of Iran during 1380-1382]. Babol Univ Med Sci J. 1384;4(7):64-70.
25. 25. Amanollahi A, hokraneh F, Mohammadhassanzadeh H, Ebrahimi-Kalan M, Gh. B. [Quality Assessment of Randomized Controlled Clinical Trials Indexed in PubMed Using CONSORT Statement]. Health Inf Manage. 2012;9(3):415.
26. 26. Heydari A, Rad M. [The Methodological Accuracy in Interventional Medical Education Articles Published in Approved Iranian Journals from 2005 to 2013]. Strides Dev Med Educ. 2014;10(4):459-66.
27. Grove SK, Burns N, Gray J. The practice of nursing research: Appraisal, Synthesis, and Generation of Evidence. 7 ed: Saunders, Elsevier Inc; 2013.
28. Polit DF, Tatano Beck C. Nursing research: generating and assessing evidence for nursing practice. Ninth ed: Lippincott Williams & Wilkins; 2012.
29. Stolberg HO, Norman G, Trop I. Randomized controlled trials. AJR Am J Roentgenol. 2004;183(6):1539-44. DOI: 10.2214/ajr.183.6.01831539PMID: 15547188
30. Borglin G, D AR. Bias in experimental nursing research: Strategies to improve the quality and explanatory power of nursing science. Int J Nurs Stud. 2010;47(1):123-8. DOI: 10.1016/j.ijnurstu.2009.06.016PMID: 19643408
31. Wood L, Egger M, Gluud LL, Schulz KF, Juni P, Altman DG, et al. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ. 2008;336(7644):601-5. DOI: 10.1136/bmj.39465.451748.ADPMID: 18316340
32. Mbuagbaw L, Thabane M, Vanniyasingam T, Borg Debono V, Kosa S, Zhang S, et al. Improvement in the quality of abstracts in major clinical journals since CONSORT extension for abstracts: a systematic review. Contemp Clin Trials. 2014;38(2):245-50. DOI: 10.1016/j.cct.2014.05.012PMID: 24861557
33. Lindsay B. Randomized controlled trials of socially complex nursing interventions: creating bias and unreliability? J Adv Nurs. 2004;45(1):84-94. PMID: 14675304 [DOI:10.1046/j.1365-2648.2003.02864.x]
34. Guo JW, Sward KA, Beck SL, Staggers N. Quality of reporting randomized controlled trials in cancer nursing research. Nurs Res. 2014;63(1):26-35. DOI: 10.1097/NNR.0000000000000007PMID: 24335911
35. Mills EJ, Ayers D, Chou R, Thorlund K. Are current standards of reporting quality for clinical trials sufficient in addressing important sources of bias? Contemp Clin Trials. 2015. DOI: 10.1016/j.cct.2015.07.019PMID: 26232560
36. McCrae N, Blackstock M, Purssell E. Eligibility criteria in systematic reviews: A methodological review. Int J Nurs Stud. 2015;52(7):1269-76. DOI: 10.1016/j.ijnurstu.2015.02.002PMID: 25726430
37. Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55. DOI: 10.1016/j.ijsu.2011.10.001PMID: 22036893
38. Mohammady M, Janani L. [Randomization in randomized clinical trials: From theory to practice]. Hayat. 2016;22(2):102-14.
39. Group TC. The CONSORT Statement: Consolidated Standards of Reporting Trials [cited 2016 October]. 2010:[Available from: http://www.consort-statement.org/.
40. Schulz KF, Altman DG, Moher D, Group C. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials. 2010;11:32. DOI: 10.1186/1745-6215-11-32PMID: 20334632
41. Levy PS, Lemeshow S. Sampling of populations: methods and applications: John Wiley & Sons; 2013.
42. Moradi M, Asadi-Samani M, Mobasheri M. [Evaluating the quality of materials and methods for writings of final proposal in clinical trial studies in Shahrekord University of Medical Sciences based on consort checklist]. J Clin Nurs Midwifery. 2013;2(4):1-7.
43. Cohen JW. Statistical power analysis for the behavioral sciences. 2 ed. Hillsdale: NJ: Lawrence Erlbaum Associates; 1988.
44. Peters JP, Hooft L, Grolman W, Stegeman I. Assessment of the quality of reporting of randomised controlled trials in otorhinolaryngologic literature - adherence to the CONSORT statement. PLoS One. 2015;10(3):e0122328. DOI: 10.1371/journal.pone.0122328PMID: 25793517
45. 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. DOI: 10.1186/1745-6215-13-77PMID: 22676267
46. Dwan K, Gamble C, Williamson PR, Kirkham JJ, Reporting Bias G. Systematic review of the empirical evidence of study publication bias and outcome reporting bias - an updated review. PLoS One. 2013;8(7):e66844. DOI: 10.1371/journal.pone.0066844PMID: 23861749
47. Kao LS, Tyson JE, Blakely ML, Lally KP. Clinical research methodology I: introduction to randomized trials. J Am Coll Surg. 2008;206(2):361-9. DOI: 10.1016/j.jamcollsurg.2007.10.003PMID: 18222393
48. Stommel M, Wills CE. Clinical research: Concepts and principles for advanced practice nurses. Philadelphia: Lippincott, Williams & Wilkins; 2004.
49. Boutron I, Tubach F, Giraudeau B, Ravaud P. Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials. J Clin Epidemiol. 2004;57(6):543-50. DOI: 10.1016/j.jclinepi.2003.12.010PMID: 15246122
50. Ayatollahi M-T, Jafari P, Ghaem H. [Evaluation of the Quality of Clinical Trials Published in the Medical Sciences Journal of Iran during 1380-1382]. Babol Univ Med Sci J. 1384;4(7):64-70.
51. Amanollahi A, hokraneh F, Mohammadhassanzadeh H, Ebrahimi-Kalan M, Gh. B. [Quality Assessment of Randomized Controlled Clinical Trials Indexed in PubMed Using CONSORT Statement]. Health Inf Manage. 2012;9(3):415.
52. Heydari A, Rad M. [The Methodological Accuracy in Interventional Medical Education Articles Published in Approved Iranian Journals from 2005 to 2013]. Strides Dev Med Educ. 2014;10(4):459-66.
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Heydari A, Sharifi H. Evaluating the Quality of Trial Reports in Iranian Nursing Journals. JNKUMS. 2018; 9 (3) :474-484
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Volume 9, Issue 3 (1-2018) Back to browse issues page
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