BACKGROUND Misclassification of smoking habits leads to underestimation of true relationships between diseases and active smoking, and overestimation of true relationships with passive smoking. Information on misclassification rates can be obtained from studies using cotinine as a marker.AIM To estimate overall misclassification rates based on a review and meta-analysis of the available evidence, and to investigate how misclassification rates depend on other factors.METHODS We searched for studies using cotinine as a marker which involved at least 200 participants and which provided information on high cotinine levels in selfreported non-, never, or ex-smokers or on low levels in self-reported smokers. We estimated overall misclassification rates weighted on sample size and investigated heterogeneity by various study characteristics. Misclassification rates were calculated for two cotinine cut points to distinguish smokers and nonsmokers, the higher cut point intended to distinguish regular smoking.RESULTS After avoiding double counting, 226 reports provided 294 results from 205 studies. A total of 115 results were from North America, 128 from Europe, 25 from Asia and 26 from other countries. A study on 6.2 million life insurance applicants was considered separately. Based on the lower cut point, true current smokers represented 4.96%(95% CI 4.32-5.60%) of reported non-smokers, 3.00%(2.45-3.54%) of reported never smokers, and 10.92%(9.23-12.61%) of reported exsmokers. As percentages of true current smokers, non-, never and ex-smokers formed, respectively, 14.50%(12.36-16.65%), 5.70%(3.20-8.20%), and 8.93%(6.57-11.29%). Reported current smokers represented 3.65%(2.84-4.45%) of true non-smokers. There was considerable heterogeneity between misclassification rates.Rates of claiming never smoking were very high in Asian women smokers, the individual studies reporting rates of 12.5%, 22.4%, 33.3%, 54.2% and 66.3%. False claims of quitting were relatively high in pregnant women, in diseased individuals who may recently have been advised to quit, and in studies considering cigarette smoking rather than any smoking. False claims of smoking were higher in younger populations. Misclassification rates were higher in more recently published studies. There was no clear evidence that rates varied by the body fluid used for the cotinine analysis, the assay method used, or whether the respondent was aware their statements would be validated by cotinine-though here many studies did not provide relevant information. There was only limited evidence that rates were lower in studies classified as being of good quality,based on the extent to which other sources of nicotine were accounted for.CONCLUSION It is important for epidemiologists to consider the possibility of bias due to misclassification of smoking habits, especially in circumstances where rates are likely to be high. The evidence of higher rates in more recent studies suggests that the extent of misclassification bias in studies relating passive smoking to smoking-related disease may have been underestimated.
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