Page 62 - Spring2012
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2002. 29-31                                   Oxford Journal, “A simple rule of thumb
                                        In the 2002 CEBP study, Horn-Ross, Hog-   is to use conditional logistic regression if
                                    gatt and Lee attempted to determine how soy   matching has been done, and unconditional
                                    phytoestrogen intake relates to thyroid cancer   if no matching has been done. A second
                                    once other factors such as age, race and other   rule of thumb is, when in doubt always use
                                    known risk factors were taken into account. In   conditional because it always gives unbiased
                                    the results section they reported, “In general, a   results.” 35
                                    reduction in thyroid cancer risk of 35 percent
                                    to 55 percent was associated with increased   •   Because the study used unconditional lo-
                                    consumption of non-fermented traditional and   gistic regression, the researchers did not
                                    nontraditional soy-based foods and sprouts.” 32   include the matching information in the
                                                                                          36
                                        An astonishing 35 to 55 percent reduction in   analysis.  This is most interesting in the
                                    risk with clear cause and effect certainly seems   light of research from the University Gradu-
                                    to support the idea of consuming soy—includ-  ate School of Public Health in Kyoto, Japan,
                                    ing modern industrial soy products—for thyroid   which examined 507 studies from 1991-2000
                                                                                                                   37
                                    cancer prevention. But what seems to be too   that used case control matched data sets.  Of
                                    good to be true is often just that. A long, hard   these studies, conditional logistic regression
                                    look at the study—and not just at the headlines   was used in 90.5 percent, and unconditional
                                    publicized by the soy industry—reveals serious   logistic regression in only 9.5 percent of
                                    flaws in design, methods, and analysis, including:   them. Yet Horn-Ross and colleagues chose
                                                                                  to use the unconditional method.


                                    •   This paper describes an observational, case-  •   Unconditional logistic regression analy-
                                        control, matched study. As J.M. Utts and   sis seriously overestimates the odds ratio
                                        R. Heckard write in their textbook, Mind   when there are matching data—as was the
                                        on Statistics, “The most common mistake   case with Horn-Ross and colleagues—and
                                        made in reporting research studies is to im-  great caution should be taken in interpret-
                                                                                               38
                                        ply that a cause and effect relationship can   ing the results.  In Statistical Methods in
                                        be concluded from an observational study.   Cancer Research, a classic text in disease
                                        With an observational study, it is difficult,   epidemiology, Breslow and Day state: “The
                                        perhaps impossible, to separate the effects   unconditional analysis of matched pair data
                                        of confounding variables from the effects of   results in an estimate of the odds ratio which
                                        the main explanatory variables of interest.” 33  is the square of the correct, conditional one:
                                                                                  a relative risk of 2 will tend to be estimated
                                    •   The study was not a randomized, controlled   as 4 by this approach…” (italic emphasis
                                        trial, which is the gold standard for testing   from Breslow and Day). 39
                 What seems             an intervention. Cases were not randomized   •    The spotlighted phytoestrogens yet included
                     to be too          to treatment groups but drawn from a cancer   a large number of potentially interrelated
                                        registry, which was a sample of convenience.
                   good to be           As Utts and Heckard put it, “If the sample   variables that could interact with one an-
                  true is often         does not represent a larger population for   other. In a high quality study, the researchers
                                                                                  should have addressed the possibility of col-
                   just that. A         the question of interest, and randomization   linearity and taken care to rule it out. Col-
                                        to treatments was not used, no inferences
              long, hard look           can be drawn.” 34                         linearity is a bias in statistical procedure due
                  at the study      •    The data were analyzed using unconditional   to the correlation of multiple independent
               reveals serious          logistic regression. When the sample comes   variables that influence a single dependent
                                                                                  variable. Collinearity can lead to unstable
              flaws in design,          from matched pairs—as was the case in     and untrustworthy results. 40
                methods and             this study—conditional logistic regression   •    All the subjects came from the San Fran-
                                        is the appropriate test, not unconditional
                       analysis.        logistic regression. As summed up in the   cisco Bay Area and many were of Asian

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