三种SCI收录的结直肠疾病专业杂志腹腔镜结直肠手术随机对照试验报告质量评价_《中国循证医学杂志》

作者：

 汪晓东 ¹ , 李旻珉 ² , 邓磊 ² , 李立 ¹

1. 四川大学华西医院肛肠外科（成都 610041）；2. 四川大学华西临床医学院（成都 610041）;

关键词：

腹腔镜结直肠肿瘤随机对照试验文献质量评价 CONSORT 声明

DOI：

10.7507/1672-2531.20090183

视频：

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摘要 全文 图表 视频 参考文献 施引文献 补充材料

目的　调查三种SCI 收录的结直肠病专业杂志中腹腔镜随机对照试验（RCT）的报告质量。
方法　电子检索MEDLINE(R) 1950 to Present with Daily Update 数据库中Diseases of the Colon amp; Rectum，International Journal ofColorectal Disease 和 Colorectal Disease 三种杂志刊载的腹腔镜结直肠手术的RCT，采用CONSORT 声明修订版和根据外科临床情况制定的条目进行报告质量评价。若文章完全符合该条目，得1 分；若完全没有提及该项条目，得0 分；若有提及但阐述不全面的，得0.5 分。
结果　共检出28 篇文献，8 篇不符合纳入标准。RCT 报告整体质量不高。其中以下条目平均分较低：资料收集的地点与背景0.150；确定样本量0.250；产生随机分配序列的方法0.500；分配隐藏0.325；执行情况0.150；提高测量质量的方法0.475；受试者每阶段的流程0.150；各干预组中所有重要不良事件或副作用0.450；外部真实性0.450；资助0.400；术前药物处理0.250；术前非药物处理0.075；方法学家参与0.000；术者年资0.350。得分较低的条目集中于方法、结果和外科特色条目。
结论　三种SCI 收录的结直肠病杂志腹腔镜RCT报告的方法学质量均不高，结直肠外科医师在采用RCT 结论时需进行严格评价。

引用本文： 汪晓东,李旻珉,邓磊,李立. 三种SCI收录的结直肠疾病专业杂志腹腔镜结直肠手术随机对照试验报告质量评价. 中国循证医学杂志, 2009, 09(9): 1033-1036. doi: 10.7507/1672-2531.20090183 复制

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.

《中国循证医学杂志》

三种SCI收录的结直肠疾病专业杂志腹腔镜结直肠手术随机对照试验报告质量评价

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《中国循证医学杂志》

三种SCI收录的结直肠疾病专业杂志腹腔镜结直肠手术随机对照试验报告质量评价

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