引用本文: 張錦倩 譯,林東濤 張鳴明 李幼平 審校. 不良反應(yīng)CONSORT聲明擴(kuò)展版中文譯文的評論. 中國循證醫(yī)學(xué)雜志, 2005, 05(10): 729-732. doi: 復(fù)制

1. Ioannidis JP,Evans SJ,Gotzsche PC,O’Neill RT,Altman DG,Schulz K,Moher D;CONSORT Group.Better reporting of harms in randomized trials:an extension of the CONSORT statement[J].Ann Intern Med,2004;141(10):781-788.
2. Altman DG,Schulz KF,Moher D,Egger M,Davidoff F,Elbourne D,Gotzsche PC,Lang T;CONSORT GROUP (Consolidated Standards of Reporting Trials).The revised CONSORT statement for reporting randomized trials:explanation and elaboration[J].Ann Intern Med,2001;134(8):663-694.
3. Schulz KF,Chalmers I,Hayes RJ,Altman DG.Empirical evidence of bias.Dimensions of methodological quality associated with estimates of treatment effects in controlled trials[J].JAMA,1995;273(5):408-412.
4. Balk EM,Bonis PA,Moskowitz H,Schmid CH,Ioannidis JP,Wang C,Lau J.Correlation of quality measures with estimates of treatment effect in meta-analyses of randomized controlled trials[J].JAMA,2002;287(22):2973-2982.
5. Bausell RB,Lee WL,Soeken KL,Li YF,Berman BM.Larger effect sizes were associated with higher quality ratings in complementary and alternative medicine randomized controlled trials[J].J Clin Epidemiol,2004;57(5):438-446.
6. Soares HP,Daniels S,Kumar A,Clarke M,Scott C,Swann S,Djulbegovic B;Radiation Therapy Oncology Group.Bad reporting does not mean bad methods for randomised trials:observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group[J].BMJ,2004;328(7430):22-24.
7. Pildal J,Chan AW,Hrobjartsson A,Forfang E,Altman DG,Gotzsche PC.Comparison of descriptions of allocation concealment in trial protocols and the published reports:cohort study[J].BMJ,2005;330(7499):1049.
8. Grimes DA,Hubacher D,Nanda K,Schulz KF,Moher D,Altman DG.The Good Clinical Practice guideline:a bronze standard for clinical research[J].Lancet,2005;366(9480):172-174.
9. Ioannidis JP,Contopoulos-Ioannidis DG.Reporting of safety data from randomised trials[J].Lancet,1998;352(9142):1752-1753.
10. Ioannidis JP,Lau J.Completeness of safety reporting in randomized trials:an evaluation of 7 medical areas[J].JAMA,2001;285(4):437-443.
11. Loke YK,Derry S.Reporting of adverse drug reactions in randomised controlled trials- a systematic survey[J].BMC Clin Pharmacol,2001;1(1):3.
12. Bryant J,Loveman E,Cave C,Chase D,Milne R.Endocrinology trial design:adverse event reporting in randomised controlled trials of recombinant human GH in GH-deficient adults[J].J Endocrinol,2002;175(2):545-552.
13. Price D,Jefferson T,Demicheli V.Methodological issues arising from systematic reviews of the evidence of safety of vaccines[J].Vaccine,2004;22(15-16):2080-2084.
14. Ioannidis JP,Lau J.Improving safety reporting from randomised trials[J].Drug Saf,2002;25(2):77-84.
15. Papanikolaou PN,Churchill R,Wahlbeck K,Ioannidis JP.Safety reporting in randomized trials of mental health interventions[J].Am J Psychiatry,2004;161(9):1692-1697.
16. Ethgen M,Boutron I,Baron G,Giraudeau B,Sibilia J,Ravaud P.Reporting of harm in randomized,controlled trials of nonpharmacologic treatment for rheumatic disease[J].Ann Intern Med,2005;143(1):20-25.
17. Hayashi K,Walker AM.Japanese and American reports of randomized trials:differences in the reporting of adverse effects[J].Control Clin Trials,1996;17(2):99-110.
18. Lao L.Recommendations for enhancing the quality of traditional Chinese medicine clinical research reporting[article in Chinese][J].Zhong Xi Yi Jie He Xue Bao,2004;2(6):402-406.
19. Liang C,Chen N.Analysis of randomized controlled trials on otolaryngological diseases in China[article in Chinese][J].Zhonghua Er Bi Yan Hou Ke Za Zhi,2002;37(1):60-63.
20. Patsopoulos NA,Analatos AA,Ioannidis JP.Relative citation impact of various study designs in the health sciences[J].JAMA,2005;293(19):2362-2366.
21. Papanikolaou PN,Ioannidis JP.Availability of large-scale evidence on specific harms from systematic reviews of randomized trials[J].Am J Med,2004;117(8):582-589.
22. Chou R,Helfand M.Challenges in systematic reviews that assess treatment harms[J].Ann Intern Med,2005;142(12 Pt 2):1090-1099.
23. McIntosh HM,Woolacott NF,Bagnall AM.Assessing harmful effects in systematic reviews[J].BMC Med Res Methodol,2004;4(1):19.
24. Ioannidis JP,Chew P,Lau J.Standardized retrieval of side effects data for meta-analysis of safety outcomes.A feasibility study in acute sinusitis[J].J Clin Epidemiol,2002;55(6):619-626.
25. McPherson K,Hemminki E.Synthesising licensing data to assess drug safety[J].BMJ,2004;328(7438):518-520.
26. Vandenbroucke JP.Benefits and harms of drug treatments[J].BMJ,2004;329(7456):2-3.
27. Chan AW,Altman DG.Epidemiology and reporting of randomised trials published in PubMed journals[J].Lancet,2005;365(9465):1159-1162.
28. Chan AW,Hrobjartsson A,Haahr MT,Gotzsche PC,Altman DG.Empirical evidence for selective reporting of outcomes in randomized trials:comparison of protocols to published articles[J].JAMA,2004;291(20):2457-2465.
  1. 1. Ioannidis JP,Evans SJ,Gotzsche PC,O’Neill RT,Altman DG,Schulz K,Moher D;CONSORT Group.Better reporting of harms in randomized trials:an extension of the CONSORT statement[J].Ann Intern Med,2004;141(10):781-788.
  2. 2. Altman DG,Schulz KF,Moher D,Egger M,Davidoff F,Elbourne D,Gotzsche PC,Lang T;CONSORT GROUP (Consolidated Standards of Reporting Trials).The revised CONSORT statement for reporting randomized trials:explanation and elaboration[J].Ann Intern Med,2001;134(8):663-694.
  3. 3. Schulz KF,Chalmers I,Hayes RJ,Altman DG.Empirical evidence of bias.Dimensions of methodological quality associated with estimates of treatment effects in controlled trials[J].JAMA,1995;273(5):408-412.
  4. 4. Balk EM,Bonis PA,Moskowitz H,Schmid CH,Ioannidis JP,Wang C,Lau J.Correlation of quality measures with estimates of treatment effect in meta-analyses of randomized controlled trials[J].JAMA,2002;287(22):2973-2982.
  5. 5. Bausell RB,Lee WL,Soeken KL,Li YF,Berman BM.Larger effect sizes were associated with higher quality ratings in complementary and alternative medicine randomized controlled trials[J].J Clin Epidemiol,2004;57(5):438-446.
  6. 6. Soares HP,Daniels S,Kumar A,Clarke M,Scott C,Swann S,Djulbegovic B;Radiation Therapy Oncology Group.Bad reporting does not mean bad methods for randomised trials:observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group[J].BMJ,2004;328(7430):22-24.
  7. 7. Pildal J,Chan AW,Hrobjartsson A,Forfang E,Altman DG,Gotzsche PC.Comparison of descriptions of allocation concealment in trial protocols and the published reports:cohort study[J].BMJ,2005;330(7499):1049.
  8. 8. Grimes DA,Hubacher D,Nanda K,Schulz KF,Moher D,Altman DG.The Good Clinical Practice guideline:a bronze standard for clinical research[J].Lancet,2005;366(9480):172-174.
  9. 9. Ioannidis JP,Contopoulos-Ioannidis DG.Reporting of safety data from randomised trials[J].Lancet,1998;352(9142):1752-1753.
  10. 10. Ioannidis JP,Lau J.Completeness of safety reporting in randomized trials:an evaluation of 7 medical areas[J].JAMA,2001;285(4):437-443.
  11. 11. Loke YK,Derry S.Reporting of adverse drug reactions in randomised controlled trials- a systematic survey[J].BMC Clin Pharmacol,2001;1(1):3.
  12. 12. Bryant J,Loveman E,Cave C,Chase D,Milne R.Endocrinology trial design:adverse event reporting in randomised controlled trials of recombinant human GH in GH-deficient adults[J].J Endocrinol,2002;175(2):545-552.
  13. 13. Price D,Jefferson T,Demicheli V.Methodological issues arising from systematic reviews of the evidence of safety of vaccines[J].Vaccine,2004;22(15-16):2080-2084.
  14. 14. Ioannidis JP,Lau J.Improving safety reporting from randomised trials[J].Drug Saf,2002;25(2):77-84.
  15. 15. Papanikolaou PN,Churchill R,Wahlbeck K,Ioannidis JP.Safety reporting in randomized trials of mental health interventions[J].Am J Psychiatry,2004;161(9):1692-1697.
  16. 16. Ethgen M,Boutron I,Baron G,Giraudeau B,Sibilia J,Ravaud P.Reporting of harm in randomized,controlled trials of nonpharmacologic treatment for rheumatic disease[J].Ann Intern Med,2005;143(1):20-25.
  17. 17. Hayashi K,Walker AM.Japanese and American reports of randomized trials:differences in the reporting of adverse effects[J].Control Clin Trials,1996;17(2):99-110.
  18. 18. Lao L.Recommendations for enhancing the quality of traditional Chinese medicine clinical research reporting[article in Chinese][J].Zhong Xi Yi Jie He Xue Bao,2004;2(6):402-406.
  19. 19. Liang C,Chen N.Analysis of randomized controlled trials on otolaryngological diseases in China[article in Chinese][J].Zhonghua Er Bi Yan Hou Ke Za Zhi,2002;37(1):60-63.
  20. 20. Patsopoulos NA,Analatos AA,Ioannidis JP.Relative citation impact of various study designs in the health sciences[J].JAMA,2005;293(19):2362-2366.
  21. 21. Papanikolaou PN,Ioannidis JP.Availability of large-scale evidence on specific harms from systematic reviews of randomized trials[J].Am J Med,2004;117(8):582-589.
  22. 22. Chou R,Helfand M.Challenges in systematic reviews that assess treatment harms[J].Ann Intern Med,2005;142(12 Pt 2):1090-1099.
  23. 23. McIntosh HM,Woolacott NF,Bagnall AM.Assessing harmful effects in systematic reviews[J].BMC Med Res Methodol,2004;4(1):19.
  24. 24. Ioannidis JP,Chew P,Lau J.Standardized retrieval of side effects data for meta-analysis of safety outcomes.A feasibility study in acute sinusitis[J].J Clin Epidemiol,2002;55(6):619-626.
  25. 25. McPherson K,Hemminki E.Synthesising licensing data to assess drug safety[J].BMJ,2004;328(7438):518-520.
  26. 26. Vandenbroucke JP.Benefits and harms of drug treatments[J].BMJ,2004;329(7456):2-3.
  27. 27. Chan AW,Altman DG.Epidemiology and reporting of randomised trials published in PubMed journals[J].Lancet,2005;365(9465):1159-1162.
  28. 28. Chan AW,Hrobjartsson A,Haahr MT,Gotzsche PC,Altman DG.Empirical evidence for selective reporting of outcomes in randomized trials:comparison of protocols to published articles[J].JAMA,2004;291(20):2457-2465.