Should preregistration of epidemiologic study protocols become compulsory? Reflections and a counterproposal

Epidemiology

Volumn 23, Issue 2, 2012, Pages 184-188

  Lash, Timothy L ^a,b   Vandenbroucke, Jan P ^c,d  

^a AARHUS UNIVERSITY HOSPITAL   (Denmark)

^b WAKE FOREST SCHOOL OF MEDICINE   (United States)

^c ROYAL NETHERLANDS ACADEMY OF ARTS AND SCIENCES   (Netherlands)

^d LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL PROTOCOL; CLINICAL TRIAL (TOPIC); EPIDEMIOLOGY; HUMAN; INFORMATION PROCESSING; MEDICAL RESEARCH; NOTE; OBSERVATIONAL STUDY; PATIENT SELECTION; PRIORITY JOURNAL; PROGRAM DEVELOPMENT; RANDOMIZED CONTROLLED TRIAL (TOPIC); STUDY PREREGISTRATION;

EPIDEMIOLOGIC METHODS; EPIDEMIOLOGIC STUDIES; HUMANS; MANDATORY PROGRAMS; MODELS, THEORETICAL; REGISTRIES;

EID: 84856839260     PISSN: 10443983     EISSN: 15315487     Source Type: Journal    
DOI: 10.1097/EDE.0b013e318245c05b     Document Type: Note

References (35)

1. Bracken MB. Pre-registration of epidemiology protocols: A commentary in support. Epidemiology. 2011;22:135-137.
2. European Center for Ecotoxicology and Toxicology of Chemicals. Workshop: Enhancement of the Scientific Process and Transparency of Observational Epidemiology Studies. Workshop Report No. 18. Available at http://www.ecetoc. org/workshops.
3. Rushton L. Should protocols for observational research be registered? Occup Environ Med. 2011;68:84-86.
4. Editorial. Should protocols for observational research be registered? Lancet. 2010;375:348.
5. Sørensen HT, Rothman KJ. The prognosis for research. Br J Med. 2010;340.
6. Vandenbroucke JP. Registering observational research: Second thoughts. Lancet. 2010;375:982-983.
7. Samet JM. To register or not register. Epidemiology. 2010;21:610-611.
8. Takkouche B, Norman G. Meta-Analysis protocol registration: Sed quis custodiet ipsos custodies-But who will guard the guardians? Epidemiology. 2010;21:614-615.
9. Lash TL. Pre-registration of study protocols is unlikely to improve the yield from our science, but other strategies might. Epidemiology. 2010; 21:612-613.
10. Poole C. A vision of accessible epidemiology. Epidemiology. 2010;21: 616-618.
11. Vandenbroucke JP. Pre-registration of epidemiologic studies: An illfounded mix of ideas. Epidemiology. 2010;21:619-620.
12. Pearce N. Registration of protocols for observational research is unnecessary and would do more harm than good. Occup Environ Med. 2011;68:86-88.
13. Williams RJ, Tse T, Harlan WR, Zarin DA. Registration of observational studies: Is it time? CMAJ. 2010;182:1638-1642.
14. The Editors. The registration of observational studies-when metaphors go bad. Epidemiology. 2010;21:607-609.
15. De Angelis C, Drazen JM, Frizelle FA, et al. Clinical trial registration: A statement from the International Committee of Medical Journal Editors. N Engl J Med. 2004;351:1250-1251. (Pubitemid 39296312)
16. Krleza-Jeriae K, Chan AW, Dickersin K, Sim I, Grimshaw J, Gluud C. Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1). BMJ. 2005;330:956-958. (Pubitemid 40592318)
17. Loder E, Groves T, MacAuley D. Registration of observational studies, The next step towards research transparency. BMJ. 2010;340:375-376.
18. Cole P. The hypothesis generating machine. Epidemiology. 1993;4:271-273. (Pubitemid 23159539)
19. Michels KB, Rosner BA. Data trawling: To fish or not to fish. Lancet. 1996;348:1152-1153. (Pubitemid 26358619)
20. Savitz DA. Commentary: Prior specification of hypotheses: Cause or just correlate of informative studies. Int J Epidemiol. 2001;30:957-958. (Pubitemid 33049021)
21. Rothman KJ. No adjustments are needed for multiple comparisons. Epidemiology. 1990;1:43-46. (Pubitemid 20255621)
22. Greenland S, Robins JM. Empirical-Bayes adjustments for multiple comparisons are sometimes useful. Epidemiology. 1991;2:244-251.
23. Lipton P. Testing hypotheses: Prediction and prejudice. Science. 2005; 307:219-221. (Pubitemid 40116228)
24. Katzav JK. Should we assess climate model predictions in light of severe tests? Eos, Transactions, American Geophysical Union. 2011;92:195.
25. Parascandola M. Epistemic risk: Empirical science and the fear of being wrong. Law Probab Risk. 2010;9:201-214.
26. Brush SG. Accommodation or prediction? Science. 2005;308:1409-1412.
27. Medawar 4PB. "Is the scientific paper a fraud?" In: Medawar PB, The Threat and the Glory: Reflections on Science and Scientists. Oxford: Oxford University Press; 1991:228-233.
28. Popper KR. Objective Knowledge. An evolutionary approach. Revised edition. Oxford: Oxford University Press; 1979;259.
29. Sankaranarayanan R, Wahrendorf J, D 233 maret E, eds. Directory of On-Going Research in Cancer Epidemiology 1996. IARC Scientific Publication No. 137. Lyon: International Agency for Research on Cancer; 1996.
30. Taubes G. Epidemiology faces its limits. Science. 1995;269:164-169.
31. Ioannidis JP. Why most published research findings are false. PLoS Med. 2005;8:e214.
32. Boffetta P, McLaughlin JK, La Vecchia C, Tarone RE, Lipworth L, Blot WJ. False-positive results in cancer epidemiology: A plea for epistemological modesty. J Natl Cancer Inst. 2008;100:988-995. (Pubitemid 352019795)
33. Wynder EL. Invited commentary: Response to science article, "Epidemiology faces its limits." Am J Epidemiol. 1996;143:747-749.
34. Goodman S, Greenland S. Why most published research findings are false: Problems in the analysis. PLoS Med. 2007;4:e168.
35. Blair A, Saracci R, Vineis P, et al. Epidemiology, public health, and the rhetoric of false positives. Environ Health Perspect. 2009;117:1809-1813.