Guidelines to Evaluate Human Observational Studies for Quantitative Risk Assessment

Overview

Journal Environ Health Perspect

Date 2008 Dec 17

PMID 19079723

Citations 15

Authors

Jelle Vlaanderen

Roel Vermeulen

Dick Heederik

Hans Kromhout

Affiliations

Soon will be listed here.

Abstract

Background: Careful evaluation of the quality of human observational studies (HOS) is required to assess the suitability of HOS for quantitative risk assessment (QRA). In particular, the quality of quantitative exposure assessment is a crucial aspect of HOS to be considered for QRA.

Objective: We aimed to develop guidelines for the evaluation of HOS for QRA and to apply these guidelines to case-control and cohort studies on the relation between exposure to benzene and acute myeloid leukemia (AML).

Methods: We developed a three-tiered framework specific for the evaluation of HOS for QRA and used it to evaluate HOS on the relation between exposure to benzene and AML.

Results: The developed framework consists of 20 evaluation criteria. A specific focus of the framework was on the quality of exposure assessment applied in HOS. Seven HOS on the relation of benzene and AML were eligible for evaluation. Of these studies, five were suitable for QRA and were ranked based on the quality of the study design, conduct, and reporting on the study.

Conclusion: The developed guidelines facilitate a structured evaluation that is transparent in its application and harmonizes the evaluation of HOS for QRA. With the application of the guidelines, it was possible to identify studies suitable for QRA of benzene and AML and rank these studies based on their quality. Application of the guidelines in QRA will be a valuable addition to the assessment of the weight of evidence of HOS for QRA.

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References

Kromhout H, Loomis D, Kleckner R . Uncertainty in the relation between exposure to magnetic fields and brain cancer due to assessment and assignment of exposure and analytical methods in dose-response modeling. Ann N Y Acad Sci. 2000; 895:141-55. DOI: 10.1111/j.1749-6632.1999.tb08082.x. View

Vacek P . Assessing the effect of intensity when exposure varies over time. Stat Med. 1997; 16(5):505-13. DOI: 10.1002/(sici)1097-0258(19970315)16:5<505::aid-sim424>3.0.co;2-z. View

STEVENS S . On the theory of scales of measurement. Science. 2010; 103(2684):677-80. View

Rinsky R . Benzene and leukemia: an epidemiologic risk assessment. Environ Health Perspect. 1989; 82:189-91. PMC: 1568103. DOI: 10.1289/ehp.8982189. View

Lewis S, Bell G, Cordingley N, Pearlman E, Rushton L . Retrospective estimation of exposure to benzene in a leukaemia case-control study of petroleum marketing and distribution workers in the United Kingdom. Occup Environ Med. 1997; 54(3):167-75. PMC: 1128679. DOI: 10.1136/oem.54.3.167. View

Seixas N, Robins T, Becker M . A novel approach to the characterization of cumulative exposure for the study of chronic occupational disease. Am J Epidemiol. 1993; 137(4):463-71. DOI: 10.1093/oxfordjournals.aje.a116695. View

Ireland B, Collins J, Buckley C, Riordan S . Cancer mortality among workers with benzene exposure. Epidemiology. 1997; 8(3):318-20. DOI: 10.1097/00001648-199705000-00016. View

Shore R, Iyer V, ALTSHULER B, Pasternack B . Use of human data in quantitative risk assessment of carcinogens: impact on epidemiologic practice and the regulatory process. Regul Toxicol Pharmacol. 1992; 15(2 Pt 1):180-221. DOI: 10.1016/0273-2300(92)90049-f. View

Wong O . An industry wide mortality study of chemical workers occupationally exposed to benzene. II. Dose response analyses. Br J Ind Med. 1987; 44(6):382-95. PMC: 1007839. DOI: 10.1136/oem.44.6.382. View

10.

Ott M, Townsend J, Fishbeck W, Langner R . Mortality among individuals occupationally exposed to benzene. Arch Environ Health. 1978; 33(1):3-10. DOI: 10.1080/00039896.1978.10667299. View

11.

Loomis D, Kromhout H . Exposure variability: concepts and applications in occupational epidemiology. Am J Ind Med. 2003; 45(1):113-22. DOI: 10.1002/ajim.10324. View

12.

Heederik D, Miller B . Weak associations in occupational epidemiology: adjustment for exposure estimation error. Int J Epidemiol. 1988; 17(4):970-4. DOI: 10.1093/ije/17.4.970. View

13.

Hayes R, Yin S, Dosemeci M, Li G, Wacholder S, Travis L . Benzene and the dose-related incidence of hematologic neoplasms in China. Chinese Academy of Preventive Medicine--National Cancer Institute Benzene Study Group. J Natl Cancer Inst. 1997; 89(14):1065-71. DOI: 10.1093/jnci/89.14.1065. View

14.

Wong O . Risk of acute myeloid leukaemia and multiple myeloma in workers exposed to benzene. Occup Environ Med. 1995; 52(6):380-4. PMC: 1128241. DOI: 10.1136/oem.52.6.380. View

15.

Xue X, Kim M, Shore R . Estimation of health risks associated with occupational radiation exposure: addressing measurement error and minimum detectable exposure level. Health Phys. 2006; 91(6):582-91. DOI: 10.1097/01.HP.0000225466.45659.08. View

16.

Vandenbroucke J, von Elm E, Altman D, Gotzsche P, Mulrow C, Pocock S . Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. Epidemiology. 2007; 18(6):805-35. DOI: 10.1097/EDE.0b013e3181577511. View

17.

Zartarian V, Ott W, Duan N . A quantitative definition of exposure and related concepts. J Expo Anal Environ Epidemiol. 1997; 7(4):411-37. View

18.

Tielemans E, Marquart H, de Cock J, Groenewold M, Van Hemmen J . A proposal for evaluation of exposure data. Ann Occup Hyg. 2002; 46(3):287-97. DOI: 10.1093/annhyg/mef047. View

19.

Weed D . Weight of evidence: a review of concept and methods. Risk Anal. 2006; 25(6):1545-57. DOI: 10.1111/j.1539-6924.2005.00699.x. View

20.

Glass D, Gray C, Jolley D, Gibbons C, Sim M . Health Watch exposure estimates: do they underestimate benzene exposure?. Chem Biol Interact. 2005; 153-154:23-32. DOI: 10.1016/j.cbi.2005.03.006. View