Grading Evidence with a Focus on Etiology, Surrogates, and Clinical Devices

Statistical and Methodological Aspects of Oral Health Research

Volumn , Issue , 2009, Pages 13-25

  Hujoel, Philippe ^a  

^a UNIVERSITY OF WASHINGTON   (United States)

Author keywords

Biological justification of surrogate endpoints; Dental clinical decisions and poor quality evidence; Epidemiological baton of discovery fluoride use in dentistry; Evidence pyramid; Expert opinion, biological plausibility, bench research, animal studies, and case series; Inverted evidence pyramid potential to arcane causal thinking; Missing epidemiological baton on causality; Relying on low level evidence serious adverse public health consequences; Surrogate endpoints and validity; Unnatural inflammation free condition 'Aarhus superhealthy gingiva'

Indexed keywords

EID: 84876325788     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470744116.ch2     Document Type: Chapter

References (58)

1. AMP News Service (2008) Nobel Award in Medicine Holds Strong Message for Animal Activists. URL: http://www.amprogress.org/site/apps/nl/content2.asp?c=jrLUK0PDLoF& b=1311499&ct=4512083.
2. Anonymous (1989) Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. The Cardiac Arrhythmia Suppression Trial (CAST) Investigators. N Engl J Med 321(6), 406-12.
3. Bergstrom J (2004) Tobacco smoking and chronic destructive periodontal disease. Odontology 92(1), 1-8.
4. Brenner D & Georgsson M (2005) Mass screening with CT colonography: should the radiation exposure be of concern?. Gastroenterology 129(1), 328-37.
5. Burzykowski T, Molenberghs G & Buyse M 2005 The Evaluation of Surrogate Endpoints. Statistics for Biology and Health. New York: Springer.
6. Centers for Disease Control and Prevention (2000) Achievements in public health, 1900-1999: fluoridation of drinking water to prevent dental caries. JAMA 283(10), 1283-6.
7. Chakravarty A (2005) Regulatory Aspects in Using Surrogate Markers in Clinical Trials. New York: Springer.
8. Cox R, Muirhead C & Stather, J. W. et al. (1995) Risk of Radiation-Induced Cancer at Low Doses and Low Dose Rates for Radiation Protection Purposes. Documents of the NRPB Vol. 6, No. 1.
9. Dahlen G, Luan W & Baelum, V. et al. (1995) Periodontopathogens in elderly Chinese with different periodontal disease experience. J Clin Periodontol 22(3), 188-200.
10. Ekman L, Hansson E & Havu, N. et al. (1985) Toxicological studies on omeprazole. Scand J Gastroenterol Suppl 108, 53-69.
11. Fleming T (2005) Surrogate endpoints and FDA's accelerated approval process. Health Aff (Millwood) 24(1), 67-78.
12. Fleming T & DeMets D (1996) Surrogate end points in clinical trials: are we being misled?. Ann Intern Med 125(7), 605-13.
13. Guyatt G (1992) Evidence-based medicine. A new approach to teaching the practice of medicine. JAMA 268(17), 2420-5.
14. Haber J, Wattles J & Crowley, M. et al. (1993) Evidence for cigarette smoking as a major risk factor for periodontitis. J Periodontol 64(1), 16-23.
15. Haffajee A & Socransky S (1994) Microbial etiological agents of destructive periodontal diseases. Periodontol 2000 5, 78-111.
16. Hayashi M & Yeung C (2003) Ceramic inlays for restoring posterior teeth. Cochrane Database Syst Rev 2003(1) CD003450.3.
17. Heinonen O, Huttunen J and Albanes, D. et al. (1994) The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. the Alpha-Tocopherol, Beta Carotene Cancer Prevention Study Group. N Engl J Med 330(15), 1029-35.
18. Helmuth L (2003) In sickness or in health?. Science 302(5646), 808-10.
19. Holt S, Ebersole J & Felton, J. et al. (1988) Implantation of bacteroides gingivalis in nonhuman primates initiates progression of periodontitis. Science 239(4835), 55-7.
20. Houck V, Reader A & Beck, M. et al. (2000) Effect of trephination on postoperative pain and swelling in symptomatic necrotic teeth. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 90(4), 507-13.
21. Hujoel P (2004) Endpoints in periodontal trials: the need for an evidence-based research approach. Periodontol 2000 36, 196-204.
22. Ingle J & Bakland L (2002) Endodontics (5th edition). Hamilton, Ont. London: B C Decker.
23. Ingle J & Beveridge E (1976) Endodontics (2nd edition). Philadelphia: Lea & Febiger.
24. International Agency for Research on Cancer (2004) IARC Classifies Formaldehyde as Carcinogenic to Humans. URL: http://www.iarc.fr/ENG/PressReleases/archives/pr153a.html (Accessed 19 August 2007).
25. Kaiser J (2006) Cancer research. After regime change at the National Cancer Institute. Science 312(5772), 357-9.
26. Lesaffre E, Garcia-Zattera M & Redmond, C. et al. (2007) Reported methodological quality of split-mouth studies. J Clin Periodontol 34(9), 756-61.
27. Levy D & Brink S (2005) A Change of Heart: How the Framingham Heart Study Helped Unravel the Mysteries of Cardiovascular Disease (1st edition). New York: Knopf.
28. Löe H (1997) Closing remarks: trials and tribulations. Annals of Periodontology 2(1), 359-63.
29. Löe H, Theilade E & Jensen S (1965) Experimental gingivitis in man. J Periodontol 36, 177-87.
30. Lopez R, Scheutz F, Errboe M & Baelum V 2007 Selection bias in case-control studies on periodontitis. A systematic review. European Journal of Oral Sciences 115, 339-43.
31. Machtei E, Hausmann E & Dunford, R. et al. (1999) Longitudinal study of predictive factors for periodontal disease and tooth loss. J Clin Periodontol 26(6), 374-380.
32. Mendenhall S (1995) Tmj implants: lessons for all of us. Orthopedic Network News 6(2), 1-6.
33. Moriconi E, Popowich L & Guernsey L 1986 Alloplastic reconstruction of the temporomandibular joint. Dent Clin North Am 30(2), 307-25.
34. Myers D, Shoaf H & Dirksen, T. R. et al. (1978) Distribution of 14C-formaldehyde after pulpotomy with formocresol. J Am Dent Assoc 96(5), 805-13.
35. Nally J (1969) Uranium content of some dental porcelains and beta activity. Helv Odont Acta 13, 32-5.
36. National Council on Radiation Protection and Measurements (2001) Evaluation of the Linear-Nonthreshold Dose-Response Model for Ionizing Radiation. Bethesda, Md.: National Council on Radiation Protection and Measurements.
37. National Research Council (2006) Health Risks from Exposure to Low Levels of Ionizing Radiation: BEIR VII Phase 2 . The National Academies Press.
38. Nelson H, Humphrey L & Nygren, P. et al. (2002) Postmenopausal hormone replacement therapy: scientific review. JAMA 288(7), 872-81.
39. Nist E, Reader A & Beck M (2001) Effect of trephination on postoperative pain and swelling in symptomatic necrotic teeth. J Endod 27(6), 415-20.
40. Offenbacher S (1996) Periodontal diseases: pathogenesis. Ann Periodontol 1(1), 821-78.
41. Otterson E & Arra M (1974) Potential hazards of asbestos in periodontal packs. J Wis Dent Assoc 50(11), 435-438.
42. Pitts N (2005) Indiana Conference ICDAS Workshop Group Report. Caries Proceedings of the 7th Indiana Conference, Indianapolis, Indiana, by George K. Stookey and Indiana University School of Dentistry. ISBN 0965514951/9780965514958/0-9655149-5-1, Publisher Indiana University School of Dentistry.
43. Pitts N & Stamm J (2004) International consensus workshop on caries clinical trials (icw-cct)-final consensus statements: agreeing where the evidence leads. J Dent Res 83(Spec Iss C), C125-8.
44. Psaty B, Weiss N & Furberg, C. D. et al. (1999) Surrogate end points, health outcomes, and the drug-approval process for the treatment of risk factors for cardiovascular disease. JAMA 282(8), 786-90.
45. Rees J (2002) Complex disease and the new clinical sciences. Science 296(5568), 698-700.
46. Sivin I (1993) Another look at the Dalkon Shield: meta-analysis underscores its problems. Contraception 48(1), 1-12.
47. Smith G & Pell J (2003) Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials. BMJ 327(7429), 1459-61.
48. Tanner A, Maiden M & Macuch, P. J. et al. (1998) Microbiota of health, gingivitis, and initial periodontitis. J Clin Periodontol 25(2), 85-98.
49. Temple R (1995) A regulatory authority's opinion about surrogate endpoints, in Clinical Measurement in Drug Evaluation (eds W. S. Nimmo and G. T. Tucker). New York: Wiley.
50. Theilade E (1987) This week's citation classic. Current Contents 1987(5), 16.
51. Thompson D (1976) Uranium in Dental Porcelain. U.S. Dept. of Health, Education, and Welfare, HEW Publication (FDA) 76-8061.
52. Thomson W, Broadbent J & Welch, D. et al. (2007) Cigarette smoking and periodontal disease among 32-year-olds: a prospective study of a representative birth cohort. J Clin Periodontol 34, 828-34.
53. Timmerman M, Van der Weijden G & Abbas, F. et al. (2000) Untreated periodontal disease in Indonesian adolescents. Longitudinal clinical data and prospective clinical and microbiological risk assessment. J Clin Periodontol 27(12), 932-42.
54. Tomar S & Asma S 2000 Smoking-attributable periodontitis in the united states: findings from nhanes iii. national health and nutrition examination survey. J Periodontol 71(5), 743-51.
55. United Nations 2000 Sources and Effects of Ionizing Radiation. United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) 2000 Report to the General Assembly.
56. Valentin J (2005) Low-dose extrapolation of radiation-related cancer risk. Ann ICRP 35(4), 1-140.
57. Van Damme L, Ramjee G and Alary, M. et al. (2002) Effectiveness of col-1492, a nonoxynol-9 vaginal gel, on hiv-1 transmission in female sex workers: a randomised controlled trial. The Lancet 360(9338), 971-7.
58. Williams R (1990) Periodontal disease. N Engl J Med 322(6), 373-82.