Interpreting and reporting clinical trials with results of borderline significance

被引:72
作者
Hackshaw, Allan [1 ]
Kirkwood, Amy [1 ]
机构
[1] UCL, Canc Res UK & UCL Canc Trials Ctr, London W1T 4TJ, England
来源
BMJ-BRITISH MEDICAL JOURNAL | 2011年 / 343卷
关键词
PHASE-III; RANDOMIZED-TRIAL; INTERVENTION; CANCER; CHEMOTHERAPY; THERAPY; ABSENCE;
D O I
10.1136/bmj.d3340
中图分类号
R5 [内科学];
学科分类号
100201 [内科学];
摘要
The quality of randomised clinical trials and how they are reported have improved over time, with clearer guidelines on conduct and statistical analysis.(1) Clinical trials often take several years, but interpreting the results at the end is arguably the most important activity because it influences whether a new intervention is recommended or not. Although researchers have become more familiar with medical statistics, the interpretation and reporting of results of borderline significance remains a problem. We examine the problem and recommend some solutions.
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页数:5
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共 30 条
[1]
Adjuvant chemotherapy and timing of tamoxifen in postmenopausal patients with endocrine-responsive, node-positive breast cancer: a phase 3, open-label, randomised controlled trial [J].
Albain, Kathy S. ;
Barlow, William E. ;
Ravdin, Peter M. ;
Farrar, William B. ;
Burton, Gary V. ;
Ketchel, Steven J. ;
Cobau, Charles D. ;
Levine, Ellis G. ;
Ingle, James N. ;
Pritchard, Kathleen I. ;
Lichter, Allen S. ;
Schneider, Daniel J. ;
Abeloff, Martin D. ;
Henderson, I. Craig ;
Muss, Hyman B. ;
Green, Stephanie J. ;
Lew, Danika ;
Livingston, Robert B. ;
Martino, Silvana ;
Osborne, C. Kent .
LANCET, 2009, 374 (9707) :2055-2063
[2]
Absence of evidence is not evidence of absence - We need to report uncertain results and do it clearly [J].
Alderson, P .
BMJ-BRITISH MEDICAL JOURNAL, 2004, 328 (7438) :476-477
[3]
STATISTICS NOTES - ABSENCE OF EVIDENCE IS NOT EVIDENCE OF ABSENCE [J].
ALTMAN, DG ;
BLAND, JM .
BRITISH MEDICAL JOURNAL, 1995, 311 (7003) :485-485
[4]
Moderate Hypothermia to Treat Perinatal Asphyxial Encephalopathy. [J].
Azzopardi, Denis V. ;
Strohm, Brenda ;
Edwards, A. David ;
Dyet, Leigh ;
Halliday, Henry L. ;
Juszczak, Edmund ;
Kapellou, Olga ;
Levene, Malcolm ;
Marlow, Neil ;
Porter, Emma ;
Thoresen, Marianne ;
Whitelaw, Andrew ;
Brocklehurst, Peter .
NEW ENGLAND JOURNAL OF MEDICINE, 2009, 361 (14) :1349-1358
[5]
Effects of a Palliative Care Intervention on Clinical Outcomes in Patients With Advanced Cancer The Project ENABLE II Randomized Controlled Trial [J].
Bakitas, Marie ;
Lyons, Kathleen Doyle ;
Hegel, Mark T. ;
Balan, Stefan ;
Brokaw, Frances C. ;
Seville, Janette ;
Hull, Jay G. ;
Li, Zhongze ;
Tosteson, Tor D. ;
Byock, Ira R. ;
Ahles, Tim A. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2009, 302 (07) :741-749
[6]
Intravenous Platelet Blockade with Cangrelor during PCI. [J].
Bhatt, Deepak L. ;
Lincoff, A. Michael ;
Gibson, C. Michael ;
Stone, Gregg W. ;
McNulty, Steven ;
Montalescot, Gilles ;
Kleiman, Neal S. ;
Goodman, Shaun G. ;
White, Harvey D. ;
Mahaffey, Kenneth W. ;
Pollack, Charles V., Jr. ;
Manoukian, Steven V. ;
Widimsky, Petr ;
Chew, Derek P. ;
Cura, Fernando ;
Manukov, Ivan ;
Tousek, Frantisek ;
Jafar, M. Zubair ;
Arneja, Jaspal ;
Skerjanec, Simona ;
Harrington, Robert A. .
NEW ENGLAND JOURNAL OF MEDICINE, 2009, 361 (24) :2330-2341
[7]
Phase III Randomized Comparison of Gemcitabine Versus Gemcitabine Plus Capecitabine in Patients With Advanced Pancreatic Cancer [J].
Cunningham, David ;
Chau, Ian ;
Stocken, Deborah D. ;
Valle, Juan W. ;
Smith, David ;
Steward, William ;
Harper, Peter G. ;
Dunn, Janet ;
Tudur-Smith, Catrin ;
West, Julia ;
Falk, Stephen ;
Crellin, Adrian ;
Adab, Fawzi ;
Thompson, Joyce ;
Leonard, Pauline ;
Ostrowski, Joe ;
Eatock, Martin ;
Scheithauer, Werner ;
Herrmann, Richard ;
Neoptolemos, John P. .
JOURNAL OF CLINICAL ONCOLOGY, 2009, 27 (33) :5513-5518
[8]
Glucose Control and Vascular Complications in Veterans with Type 2 Diabetes [J].
Duckworth, William ;
Abraira, Carlos ;
Moritz, Thomas ;
Reda, Domenic ;
Emanuele, Nicholas ;
Reaven, Peter D. ;
Zieve, Franklin J. ;
Marks, Jennifer ;
Davis, Stephen N. ;
Hayward, Rodney ;
Warren, Stuart R. ;
Goldman, Steven ;
McCarren, Madeline ;
Vitek, Mary Ellen ;
Henderson, William G. ;
Huang, Grant D. .
NEW ENGLAND JOURNAL OF MEDICINE, 2009, 360 (02) :129-U62
[9]
Phase III Study of Immediate Compared With Delayed Docetaxel After Front-Line Therapy With Gemcitabine Plus Carboplatin in Advanced Non-Small-Cell Lung Cancer [J].
Fidias, Panos M. ;
Dakhil, Shaker R. ;
Lyss, Alan P. ;
Loesch, David M. ;
Waterhouse, David M. ;
Bromund, Jane L. ;
Chen, Ruqin ;
Hristova-Kazmierski, Maria ;
Treat, Joseph ;
Obasaju, Coleman K. ;
Marciniak, Martin ;
Gill, John ;
Schiller, Joan H. .
JOURNAL OF CLINICAL ONCOLOGY, 2009, 27 (04) :591-598
[10]
Pre-referral rectal artesunate to prevent death and disability in severe malaria: a placebo-controlled trial [J].
Gomes, M. F. ;
Faiz, M. A. ;
Gyapong, J. O. ;
Warsame, M. ;
Agbenyega, T. ;
Babiker, A. ;
Baiden, F. ;
Yunus, E. B. ;
Binka, F. ;
Clerk, C. ;
Folb, P. ;
Hassan, R. ;
Hossain, M. A. ;
Kimbute, O. ;
Kitua, A. ;
Krishna, S. ;
Makasi, C. ;
Mensah, N. ;
Mrango, Z. ;
Olliaro, P. ;
Peto, R. ;
Peto, T. J. ;
Rahman, M. R. ;
Ribeiro, I. ;
Samad, R. ;
White, N. J. .
LANCET, 2009, 373 (9663) :557-566