三種SCI收錄的結直腸疾病專業雜志腹腔鏡結直腸手術隨機對照試驗報告質量評價_《中國循證醫學雜志》

作者：

 汪曉東 ¹ , 李旻珉 ² , 鄧磊 ² , 李立 ¹

1. 四川大學華西醫院肛腸外科（成都 610041）；2. 四川大學華西臨床醫學院（成都 610041）;

關鍵詞：

腹腔鏡結直腸腫瘤隨機對照試驗文獻質量評價 CONSORT 聲明

DOI：

10.7507/1672-2531.20090183

視頻：

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目的　調查三種SCI 收錄的結直腸病專業雜志中腹腔鏡隨機對照試驗（RCT）的報告質量。
方法　電子檢索MEDLINE(R) 1950 to Present with Daily Update 數據庫中Diseases of the Colon amp; Rectum，International Journal ofColorectal Disease 和 Colorectal Disease 三種雜志刊載的腹腔鏡結直腸手術的RCT，采用CONSORT 聲明修訂版和根據外科臨床情況制定的條目進行報告質量評價。若文章完全符合該條目，得1 分；若完全沒有提及該項條目，得0 分；若有提及但闡述不全面的，得0.5 分。
結果　共檢出28 篇文獻，8 篇不符合納入標準。RCT 報告整體質量不高。其中以下條目平均分較低：資料收集的地點與背景0.150；確定樣本量0.250；產生隨機分配序列的方法0.500；分配隱藏0.325；執行情況0.150；提高測量質量的方法0.475；受試者每階段的流程0.150；各干預組中所有重要不良事件或副作用0.450；外部真實性0.450；資助0.400；術前藥物處理0.250；術前非藥物處理0.075；方法學家參與0.000；術者年資0.350。得分較低的條目集中于方法、結果和外科特色條目。
結論　三種SCI 收錄的結直腸病雜志腹腔鏡RCT報告的方法學質量均不高，結直腸外科醫師在采用RCT 結論時需進行嚴格評價。

引用本文： 汪曉東,李旻珉,鄧磊,李立. 三種SCI收錄的結直腸疾病專業雜志腹腔鏡結直腸手術隨機對照試驗報告質量評價. 中國循證醫學雜志, 2009, 09(9): 1033-1036. doi: 10.7507/1672-2531.20090183 復制

1.	鄭民華. 結直腸癌外科治療的腹腔鏡應用. 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.
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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.
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8.	衛茂玲, 辜蕊, 張鳴明, 等. 11種地方性中醫藥期刊1995～2000年臨床研究文獻質量的初步分析. 中國循證醫學雜志, 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. 鄭民華. 結直腸癌外科治療的腹腔鏡應用. 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. 衛茂玲, 辜蕊, 張鳴明, 等. 11種地方性中醫藥期刊1995～2000年臨床研究文獻質量的初步分析. 中國循證醫學雜志, 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.

《中國循證醫學雜志》

三種SCI收錄的結直腸疾病專業雜志腹腔鏡結直腸手術隨機對照試驗報告質量評價

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《中國循證醫學雜志》

三種SCI收錄的結直腸疾病專業雜志腹腔鏡結直腸手術隨機對照試驗報告質量評價

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