Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
권호 표지

The quality of Reports on Randomized Controlled Trials abstracts from Korean Science Citation Index journal and NEJM; Evaluation and Comparison of adherence to the CONSORT Statement

CONSORT statement를 기반으로 한 국내 Science Citation Index 저널과 NEJM의 Randomized Controlled Trial의 abstracts 질적 비교 평가 연구

  • Kyung, Eun-Jung (Department of Clinical Pharmacy, College of Pharmacy, Chungnam National University) ;
  • Kim, Hyo-Seon (College of Pharmacy, Seoul National University) ;
  • Kim, Eun-Young (Department of Clinical Pharmacy, College of Pharmacy, Chungnam National University)
  • Received : 2012.04.13
  • Accepted : 2012.06.14
  • Published : 2012.06.30
Download PDF
⟨ Previous Next ⟩

Abstract

Objective: This study evaluated and compared the adherence to the CONSORT for quality of reports on the randomized controlled trials (RCT) abstracts by four major Korean Science Citation Index (SCI) journals and The New England Journal of Medicine (NEJM). Methods: A descriptive analysis of published RCT abstracts in Korean SCI journals and NEJM from 2007/01 to 2011/06 was conducted by two reviewers, independently extracting data from a PubMed search. A modification of CONSORT for abstract was used including 16 checklist items. Reporting of checklist items for individual group was conducted to compare adherence patterns between two groups. Results: We identified the potential 57 RCT abstracts from Korean SCI and 50 from NEJM meeting our inclusion criteria; among them, three abstracts from Korean SCI and one from NEJM were excluded. Among total 16 checklist items based on CONSORT statement, Korean SCI journals and NEJM were statistically equivalent in 4 items; Korean journals were better in three items and NEJM were in nine. The methodological quality domains were inadequately reported in both journals: allocation concealment about 1.9% and 4.0%, and blinding 44.4% and 40.8%. In general, The CONSORT adherence of NEJM was better than that of Korean SCI in the method and result domain (p < 0.0001). Conclusions: The quality of NEJM reporting of RCT abstracts was better than that of Korean SCI, in general. This study on adherence of RCT reports from Korean SCI journals and NEJM abstracts to the CONSORT statement reveals that there is a need for improvement, especially Korean SCI. Further investigation on the quality of RCT reports and ways to improve reporting quality is required.

Keywords

References

  1. An Hyung Sik, The Concept and Development Plan of Evidence-based Medicine: JKMA, 2000; 43(12): 1156-64.
  2. Lee Sang Moo, Evidence-based decision-making in the health care field: J. Kor. Soc. Health-Syst. Pharm. 2008; 25(4): 270-1
  3. Kim Soo Young, Evidence Based Medicine: J. Kor. Soc. Health-Syst. Pharm. 2008; 25(4): 261-2
  4. Su Jung Kim, Jung Mi Oh, and Hyun Taek Shin, A Comparative Evaluation of Drug Information Databases in Korea. Kor. J. Clin. Pharm. 2001; 11(1): 30-1
  5. Bokyung Min, Is it too Audacious to Challenge; Roadmap for a Primetime of Clinical Pharmacy in Korea. J. Clin. Pharm. 2011; 21(2): 182-4
  6. Family medicine in Hallym University College of Medicine, The Theory and Practice of Evidence-based Medicine: Seoul Medicine Publisher, 2001: 35-45.
  7. The PLoS Medicine Editors. The Impact of Open Access upon Public Health. PLoS Med 2006; 3(5): e252. https://doi.org/10.1371/journal.pmed.0030252
  8. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D,Schulz KF, Simel D, Stroup DF. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA: the journal of the America 1996; 276(8): 637-9. https://doi.org/10.1001/jama.1996.03540080059030
  9. Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, ElbourneD, Egger M, Altman DG. CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomized trials. Journal of clinical epidemiology 2010; 63: e1-37. https://doi.org/10.1016/j.jclinepi.2010.03.004
  10. Begg C, Cho M, Eastwood S, et al., Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 1996; 276: 637-9. https://doi.org/10.1001/jama.1996.03540080059030
  11. Moher D, Schulz KF, Altman D, CONSORT Group (Consolidated Standards of Reporting Trials). The CONSORT statement: revised recommendations for improving the quality of reports of parallel- group randomized trials. JAMA 2001; 285: 1987-91, https://doi.org/10.1001/jama.285.15.1987
  12. CONSORT group. CONSORT Web site. Available from: http:// www.consort-statement.org.
  13. http://impactfactor.weebly.com/medicine.html, Date of Collection: 2011.07
  14. Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. Evidence-Based Medicine: what it is and what it isn't. BMJ 1996; 312: 71-2. https://doi.org/10.1136/bmj.312.7023.71
  15. Lionel NDW, Herxheimer. Assessing reports of therapeutic trials. Br Med J 1970; 3: 637-40. https://doi.org/10.1136/bmj.3.5723.637
  16. http://www.icmje.org/manuscript_1prepare.html
  17. Hopewell, et al., Reporting of trials presented in conference abstracts needs to be improved. Jour of Clin Epidemiol 2006; 59(7): 681-4 https://doi.org/10.1016/j.jclinepi.2005.09.016
  18. Berwanger, et al., The quality of reporting of trial abstracts is suboptimal: Survey of major general medical journals. Jourl of Clin Epidemiol 2009; 62(4): 387-92 https://doi.org/10.1016/j.jclinepi.2008.05.013
  19. NEJM [http://www.nejm.org/page/author-center/manuscriptsubmission]
  20. Zhang D, Yin P, Freemantle N, Jordan R, Zhong N, Cheng KK. An assessment of the quality of randomized controlled trials conducted in China. Trials 2008; 9:22 https://doi.org/10.1186/1745-6215-9-22
  21. Kae Uetani, Takeo Nakayama, Hiroshi Ikao, Naohiro Yonemoto. Quality of reports on randomized controlled trials conducted in Japan Evaluation of adherence to the CONSORT statement. Internal medicine 2009; 48(5): 307-13. https://doi.org/10.2169/internalmedicine.48.1358
  22. http://www.doctorsnews.co.kr/news/articleView.html?idxno= 71889
  23. Hopewell, et al., CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Medicine 2008; 5(1): e20. https://doi.org/10.1371/journal.pmed.0050020
  24. http://www.icmje.org/manuscript_1prepare.html,
  25. Berwanger O, Ribeiro RA, Finkelsztejn A, Watanabe M, Suzumura EA, Duncan BB, Devereaux PJ, Cook D. The quality of reporting of trial abstracts is suboptimal: survey of major general medical journals. Journal of clinical epidemiology 2009; 62: 387-92. https://doi.org/10.1016/j.jclinepi.2008.05.013
  26. HS Kim, EY Kim. The Quality of Reporting Randomized Controlled Trial abstracts: Survey of Korean Science Citation Index Journals and New England Journal of Medicine. J Pharm Sci 2012; 27: 62-73