Increasing value and reducing waste in research design, conduct, and analysis

被引:1036
作者
Ioannidis, John P. A. [1 ,3 ,6 ,7 ]
Greenland, Sander [8 ,9 ]
Hlatky, Mark A. [2 ,4 ]
Khoury, Muin J. [10 ,11 ]
Macleod, Malcolm R. [12 ]
Moher, David [13 ,14 ]
Schulz, Kenneth F. [15 ,16 ]
Tibshirani, Robert [5 ,6 ]
机构
[1] Stanford Univ, Stanford Prevent Res Ctr, Stanford, CA 94305 USA
[2] Stanford Univ, Sch Med, Dept Med, Div Cardiovasc Med, Stanford, CA 94305 USA
[3] Stanford Univ, Sch Med, Div Epidemiol, Stanford, CA 94305 USA
[4] Stanford Univ, Div Hlth Serv Res, Stanford, CA 94305 USA
[5] Stanford Univ, Dept Hlth Res & Policy, Stanford, CA 94305 USA
[6] Stanford Univ, Dept Stat, Sch Humanities & Sci, Stanford, CA 94305 USA
[7] Stanford Univ, Meta Res Innovat Ctr Stanford METRICS, Stanford, CA 94305 USA
[8] Univ Calif Los Angeles, Sch Publ Hlth, Dept Epidemiol, Los Angeles, CA 90024 USA
[9] Univ Calif Los Angeles, Sch Publ Hlth, Dept Stat, Los Angeles, CA 90024 USA
[10] Ctr Dis Control & Prevent, Off Publ Hlth Genom, Atlanta, GA USA
[11] NCI, Epidemiol & Genom Res Program, Rockville, MD USA
[12] Univ Edinburgh, Sch Med, Dept Clin Neurosci, Edinburgh, Midlothian, Scotland
[13] Univ Ottawa, Ottawa Hosp Res Inst, Clin Epidemiol Program, Ottawa, ON, Canada
[14] Univ Ottawa, Fac Med, Dept Epidemiol & Community Med, Ottawa, ON, Canada
[15] FHI 360, Durham, NC USA
[16] Univ N Carolina, Sch Med, Dept Obstet & Gynecol, Chapel Hill, NC USA
基金
英国国家替代、减少和改良动物研究中心;
关键词
CONFLICTS-OF-INTEREST; PATIENT-IMPORTANT OUTCOMES; REPRODUCIBLE RESEARCH; CLINICAL-TRIALS; SYSTEMATIC REVIEWS; REPORTING GUIDELINES; VALIDATION PRACTICES; CUMULATIVE EVIDENCE; SAMPLE-SIZE; QUALITY;
D O I
10.1016/S0140-6736(13)62227-8
中图分类号
R5 [内科学];
学科分类号
100201 [内科学];
摘要
Correctable weaknesses in the design, conduct, and analysis of biomedical and public health research studies can produce misleading results and waste valuable resources. Small effects can be difficult to distinguish from bias introduced by study design and analyses. An absence of detailed written protocols and poor documentation of research is common. Information obtained might not be useful or important, and statistical precision or power is often too low or used in a misleading way. Insufficient consideration might be given to both previous and continuing studies. Arbitrary choice of analyses and an overemphasis on random extremes might affect the reported findings. Several problems relate to the research workforce, including failure to involve experienced statisticians and methodologists, failure to train clinical researchers and laboratory scientists in research methods and design, and the involvement of stakeholders with conflicts of interest. Inadequate emphasis is placed on recording of research decisions and on reproducibility of research. Finally, reward systems incentivise quantity more than quality, and novelty more than reliability. We propose potential solutions for these problems, including improvements in protocols and documentation, consideration of evidence from studies in progress, standardisation of research efforts, optimisation and training of an experienced and non-conflicted scientific workforce, and reconsideration of scientific reward systems.
引用
收藏
页码:166 / 175
页数:10
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