Reporting Quality of Randomized Controlled Trials on Laparoscopic Surgery for Treating Colorectal Disease in Three SCI Indexed Journals_Chinese Journal of Evidence-Based Medicine

Authors：

 WANG Xiaodong ¹ , LI Mingming ² , DENG Lei ² , LI Li ¹

1. Department of Anal-colorectal Surgery, West China Hospital of Sichuan University, Chengdu 610041, China;2. Clinical Medical School of West China Hospital, Sichuan University, Chengdu 610041, China;

Corresponding author：

WANG Xiaodong, Email: lockwan@163.com

Keywords：

Laparoscopy; Colorectal neoplasms; Randomized controlled trial; Quality assessment; CONSORT Statement

DOI：

10.7507/1672-2531.20090183

Video：

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Objective 　To investigate the reporting quality of randomized controlled trials (RCT) on laparoscopic surgery for treating colorectal disease in three SCI indexed.
Methods 　We electronically retrieved the Ovid MEDLINE(R) from 1950 to present with Daily Updates for RCTs on laparoscopic surgery published in Diseases of the Colon amp; Rectum, International Journal of Colorectal Disease, or Colorectal Disease. The revised CONSORT statement and additional surgical items were adopted to assess the reporting quality. One point was assigned for each full description of an item, 0 for no description, and 0.5 for a partial description.
Results 　A total of 20 RCTs were included and 8 RCTs were excluded. Their reporting quality was low. The average scores for the following items were relatively lower, 0.150 for settings where data collected; 0.250 for sample size estimation; 0.500 for sequence generation of randomization; 0.325 for allocation concealment; 0.150 for implementation; 0.475 for measurement of outcome; 0.150 for participant flow chart; 0.450 for adverse events; 0.450 for external validity; 0.400 for financial conflicts of interest; 0.250 for perioperative pharmacological treatment; 0.075 for perioperative nonphamacological treatment; 0.000 for participation of a trial methodologist; 0.350 for surgeon’s experience (years or position). Items with the lower scores were mainly in the methods and results section and surgical items.
Conclusions 　The reporting quality of laparoscopic RCTs in these journals is low. Colorectal surgeons should rigorously evaluate reports in these journals before they apply to them in clinical practice.

Citation： WANG Xiaodong,LI Mingming,DENG Lei,LI Li. Reporting Quality of Randomized Controlled Trials on Laparoscopic Surgery for Treating Colorectal Disease in Three SCI Indexed Journals. Chinese Journal of Evidence-Based Medicine, 2009, 09(9): 1033-1036. doi: 10.7507/1672-2531.20090183 Copy

1.	郑民华. 结直肠癌外科治疗的腹腔镜应用. 消化外科, 2003, 2(6): 385-387.
2.	Schwenk W, Haase O, Neudecker J, et al. Short term benefits for laparoscopic colorectal resection. Cochrane Database Syst Rev., 2005(3): CD003145.
3.	Kuhry E, Schwenk WF, Gaupset R, et al. Long-term results of laparoscopic colorectal cancer resection. Cochrane Database Syst Rev., 2008(2): CD003432.
4.	Boutron I, Tubach F, Giraudeau B, et al. Methodological differences in clinical trials evaluating nonpharmacological and pharmacological treatments of hip and knee osteoarthritis. J Am Med Assoc, 2003, 290(8): 1062-1070.
5.	Altman DG, Schulz KF, Moher D, et al. The revised CONSORT statement for reporting randomized trials: Explanation and elaboration. Ann Intern Med, 2001, 134(8): 663-694.
6.	Shikata S, Nakayama T, Yamagishi H. Quality of surgical randomized controlled trials for acute cholecystitis: assessment based on CONSORT and additional check items. J Hepatobiliary Pancreat Surg, 2008, 15(3): 297-303.
7.	The Cochrane Collaboration Handbook. In: The Cochrane Library. Chichester , UK: John Wiley &Sons , Ltd. Cochrane. Issue 1. 2004.
8.	卫茂玲, 辜蕊, 张鸣明, 等. 11种地方性中医药期刊1995～2000年临床研究文献质量的初步分析. 中国循证医学杂志, 2004, 4(6): 410-413.
9.	Kabbinavar FF, Hurwitz HI, Yi J, et al. Addition of Bevacizumab to Fluorouracil-Based First-Line Treatment of Metastatic Colorectal Cancer: Pooled Analysis of Cohorts of Older Patients From Two Randomized Clinical Trials. J Clin Oncol, 2009, 27(2): 199-205.
10.	Wright FC, Gagliardi AR, Law CHL, et al. A randomized controlled trial to improve lymph node assessment in stage II colon cancer. Arch Surg, 2008, 143(11): 1050-5; discussion 1055.
11.	Schwenk W, Haase O, Gunther N, et al. Methodological quality of randomised controlled trials comparing short-term results of laparoscopic and conventional colorectal resection. Int J Colorectal Dis, 2007, 22(11): 1369-1376.
12.	Jacquier I, Boutron I, Moher D, et al. The reporting of randomized clinical trials using a surgical intervention is in need of immediate improvement: a systematic review. Ann Surg, 2006, 244(5): 677-683.
13.	Balasubramanian SP, Wiener M, Alshameeri Z, et al. Standards of reporting of randomized controlled trials in general surgery - Can we do better? Ann Surg, 2006, 244(5): 663-667.
14.	Farrokhyar F, Chu R, Whitlock R, et al. A systematic review of the quality of publications reporting coronary artery bypass grafting trials. Can J Surg, 2007, 50(4): 266-277.
15.	Testori A, Bartolomei M, Grana C, et al. Sentinel node localization in primary melanoma: learning curve and results. Melanoma Res, 1999, 9(6): 587-93.
16.	McCulloch P, Taylor I, Sasako M, et al. Randomised trials in surgery: problems and possible solutions. BMJ, 2002, 324(7351): 1448-1451.
17.	McLeod R. Randomized, controlled trials: is there a role for them in surgery? Ann Surg, 2006, 244(5): 684-685.
18.	Gattellari M, Ward JESolomon MJ. Randomized, controlled trials in surgery: perceived barriers and attitudes of Australian colorectal surgeons. Dis Colon Rectum, 2001, 44(10): 1413-1420.
19.	Boutron I, Moher D, Altman DG, et al. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: Explanation and elaboration. Ann Intern Med, 2008, 148(4): 295-309.

1. 郑民华. 结直肠癌外科治疗的腹腔镜应用. 消化外科, 2003, 2(6): 385-387.
2. Schwenk W, Haase O, Neudecker J, et al. Short term benefits for laparoscopic colorectal resection. Cochrane Database Syst Rev., 2005(3): CD003145.
3. Kuhry E, Schwenk WF, Gaupset R, et al. Long-term results of laparoscopic colorectal cancer resection. Cochrane Database Syst Rev., 2008(2): CD003432.
4. Boutron I, Tubach F, Giraudeau B, et al. Methodological differences in clinical trials evaluating nonpharmacological and pharmacological treatments of hip and knee osteoarthritis. J Am Med Assoc, 2003, 290(8): 1062-1070.
5. Altman DG, Schulz KF, Moher D, et al. The revised CONSORT statement for reporting randomized trials: Explanation and elaboration. Ann Intern Med, 2001, 134(8): 663-694.
6. Shikata S, Nakayama T, Yamagishi H. Quality of surgical randomized controlled trials for acute cholecystitis: assessment based on CONSORT and additional check items. J Hepatobiliary Pancreat Surg, 2008, 15(3): 297-303.
7. The Cochrane Collaboration Handbook. In: The Cochrane Library. Chichester , UK: John Wiley &Sons , Ltd. Cochrane. Issue 1. 2004.
8. 卫茂玲, 辜蕊, 张鸣明, 等. 11种地方性中医药期刊1995～2000年临床研究文献质量的初步分析. 中国循证医学杂志, 2004, 4(6): 410-413.
9. Kabbinavar FF, Hurwitz HI, Yi J, et al. Addition of Bevacizumab to Fluorouracil-Based First-Line Treatment of Metastatic Colorectal Cancer: Pooled Analysis of Cohorts of Older Patients From Two Randomized Clinical Trials. J Clin Oncol, 2009, 27(2): 199-205.
10. Wright FC, Gagliardi AR, Law CHL, et al. A randomized controlled trial to improve lymph node assessment in stage II colon cancer. Arch Surg, 2008, 143(11): 1050-5; discussion 1055.
11. Schwenk W, Haase O, Gunther N, et al. Methodological quality of randomised controlled trials comparing short-term results of laparoscopic and conventional colorectal resection. Int J Colorectal Dis, 2007, 22(11): 1369-1376.
12. Jacquier I, Boutron I, Moher D, et al. The reporting of randomized clinical trials using a surgical intervention is in need of immediate improvement: a systematic review. Ann Surg, 2006, 244(5): 677-683.
13. Balasubramanian SP, Wiener M, Alshameeri Z, et al. Standards of reporting of randomized controlled trials in general surgery - Can we do better? Ann Surg, 2006, 244(5): 663-667.
14. Farrokhyar F, Chu R, Whitlock R, et al. A systematic review of the quality of publications reporting coronary artery bypass grafting trials. Can J Surg, 2007, 50(4): 266-277.
15. Testori A, Bartolomei M, Grana C, et al. Sentinel node localization in primary melanoma: learning curve and results. Melanoma Res, 1999, 9(6): 587-93.
16. McCulloch P, Taylor I, Sasako M, et al. Randomised trials in surgery: problems and possible solutions. BMJ, 2002, 324(7351): 1448-1451.
17. McLeod R. Randomized, controlled trials: is there a role for them in surgery? Ann Surg, 2006, 244(5): 684-685.
18. Gattellari M, Ward JESolomon MJ. Randomized, controlled trials in surgery: perceived barriers and attitudes of Australian colorectal surgeons. Dis Colon Rectum, 2001, 44(10): 1413-1420.
19. Boutron I, Moher D, Altman DG, et al. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: Explanation and elaboration. Ann Intern Med, 2008, 148(4): 295-309.

Chinese Journal of Evidence-Based Medicine

Reporting Quality of Randomized Controlled Trials on Laparoscopic Surgery for Treating Colorectal Disease in Three SCI Indexed Journals

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