The relevance of good research reporting

Abstract

When reported in non-academic publications, research findings can differ substantially from those presented in peer-reviewed journals. This difference is attributable to peer review, which helps to ensure that reporting of research in journals is accurate and balanced, with acknowledgment of limitations. Without peer review, reporting can be easily biased and therefore misleading. Bias and misinformation commonly arise because investigators tend to focus on positive results and are reluctant to emphasise negative findings. Misleading or inaccurate reporting of scientific information can create unrealistic expectations, and can put patients at risk of unnecessary harm. Such reporting can also lead to waste of research resources. The EQUATOR Network has guidelines for transparent and accurate reporting—eg, CONSORT, an itemised checklist of the information that should be included in reports of randomised controlled trials—that help readers by providing easily understandable information that they can assess for themselves. Most academic journals endorse and encourage investigators to apply these guidelines and thereby help to improve the quality and transparency of research reports. No guidelines exist for the transparent and accurate reporting of scientific information in non-academic outlets, and perhaps they would be perceived as censorship. However, misleading information seems to be rampant in non-academic publications. Hence, readers should be critical about research reported without peer review. Although there are countless examples of misreporting, a recent example was the media's dissemination of the findings from a phase 3 trial of an anti-tau drug presented at the 2016 Alzheimer's Association International Conference (AAIC; Toronto, ON, Canada). On July 27, researchers debated the results from the first phase 3 trial of leuco-methylthioninium-bis(hydromethanesulfonate) (LMTM), a tau-aggregation inhibitor. According to the press release by the AAIC before the debate, 891 participants (mean age 70·6 years) with mild to moderate Alzheimer's disease were randomly allocated in a 3:3:4 ratio to receive oral LMTM at 150 mg/day or 250 mg/day, or control (containing 8 mg/day of LMTM to maintain masking) in a 15 month double-blind trial in 16 countries in Asia, Europe, North America, and Russia. 85% of the participants were taking approved treatments for Alzheimer's disease. Before the debate, TauRx, the manufacturer of LMTM, reported in its press release that although the trial “failed to meet its co-primary endpoints [change from baseline on the Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog) and Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)], clinically meaningful and statistically significant reductions in the rate of disease progression were observed across three key measures [ADAS-Cog, ADCS-ADL, and level of brain atrophy] in patients who were treated with LMTM as their only Alzheimer's disease medication”. Media reports about the findings from this trial varied from sensationalism to criticism depending on whether they were based on the press releases by the AAIC and TauRx or the AAIC presentation that followed later in the day. For example, the New Scientist reported in an article with the title “Alzheimer's drug that failed trial may still slow disease” that “While the drug did not prove successful for treating people who are already taking other Alzheimer's medication, it did seem to have an effect on a smaller number of people who took only LMTX [15% of patients]”. By contrast, Alzforum reported after the AAIC debate that a prespecified subgroup analysis was presented “that held no statistical credence yet purported to show a strong benefit on cognition and brain atrophy”. Also, according to Alzforum, this analysis “lacked any statistical basis” because it “compared people on LMTM therapy alone with the placebo group for the whole trial, which includes people taking standard AD [Alzheimer's disease] drugs” and because the alpha of 0·05 was spent on the primary analysis. Although guidelines could improve media reporting, realistically they would not be feasible or enforceable. Inappropriate media reports compound the problem of biased reporting, which leads to unrealistic expectations. Research reporting in the media is crucial for the dissemination of knowledge, and should be encouraged and lauded, when done responsibly.