Spin used frequently in breast cancer trial reports

Spin and bias are prevalent in papers reporting clinical trial outcomes for breast cancer treatments, new research shows (Annals of Oncology, online 9 January 2013).

Clinicians should apply a critical eye to trial reports and be wary of the possibility of biased reporting, the authors warn.

They assessed 164 phase III randomised controlled trials of systemic, radiation or surgical therapy for women with metastatic breast cancer for signs of biased reporting strategies (see Panel). Around a third of these trials (32.9 per cent) showed bias in their reporting of efficacy, with non-primary endpoints used in order to report the findings as positive.

The incidence of bias rose to 59 per cent when only studies that had a non-significant primary endpoint (PE) were considered. "Spin was used frequently to influence, positively, the interpretation of negative trials by emphasising the apparent benefit of a secondary endpoint," the authors say.

Studies with a non-significant PE were also more likely (odds ratio 5.15, 95 per cent confidence interval 1.86?14.26; P=0.001) to exclude the PE from the concluding statement of the study?s abstract ? which is often the only bit of a publication that busy clinicians have time to read, the authors say.

Toxicity findings were reported in a biased way in 67.1 per cent of the papers. Studies in which the PE reached significance were twice as likely to have biased toxicity reporting than studies that failed to reach significance (OR 2.00, CI 1.02?3.94; P=0.044). "A possible explanation for this finding may be that investigators and/or sponsors . . . focus on efficacy as the basis of registration and downplay toxicity to make the results more attractive," the authors say.

Industry funding was not associated with biased reporting of toxicity or of efficacy.

The authors note that 83.5 per cent of the studies used disease-free survival or progression-free survival as the PE. Neither of these endpoints has been shown, in this patient cohort, to be an adequate surrogate for overall survival ? the gold-standard for the assessment of benefit.

Definition of bias and spin Bias in the reporting of trial findings includes selective reporting of favourable results and suppression of unfavourable data from publication, the study authors say. Spin, a type of bias, is defined as use of reporting strategies to highlight that the experimental treatment is beneficial, despite a statistically non-significant difference in the primary endpoint (PE), or to distract the reader from statistically non-significant results. In this study, bias was defined as inappropriate reporting of the PE and toxicity, particularly in the abstract. For example, the use of a secondary endpoint to imply benefit of the experimental arm or failure to mention in the abstract grade 3 and 4 toxicities, or statistically significant difference in toxicity. Spin was defined as the use of words in the concluding statement of the abstract to suggest that a trial with a negative PE was positive based on some apparent benefits shown in one or more secondary endpoints. Predictors of bias were explored, including the source of funding.

Source: http://feeds.pjonline.com/~r/pjonline/news/~3/_LfsP6lv7T0/spin_used_frequently_in_breast_cancer_trial_reports

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