Randomized clinical trials (RCTs) are considered to be the preferred criterion standard in research for assessing the effectiveness of clinical interventions. Yet, a level that lofty has not always prevailed in experimental work. At the turn of the 20th century, a physician from Haverhill, Massachusetts by the name of Duncan MacDougall conducted an experiment that involved weighing six terminally ill patients immediately before and after being pronounced dead. Upon recording a reduction in a single patient’s weight of 21 grams, he believed the loss represented that individual’s departed soul, while excluding data from the other patients. His findings were reported in both a 1907 issue of the Journal of the American Society for Psychical Research and the periodical American Medicine. A reference to the study also was mentioned in the New York Times.

Progress has been made since then as evidenced by the fact that a lot more rigor characterizes clinical investigations conducted today. Nonetheless, as noted in an article that appeared in the May 2019 issue of the journal JAMA Network Open, scientific lapses committed by MacDougall, such as excluding potentially eligible patients, using unreliable measures, and selectively reporting results that are favorable to the investigator’s hypothesis remain distressingly common. A possible explanation is that confirmation bias may lead to accepting data that support a researcher’s preconceptions and to rejecting data that do not.

Another manuscript in the same issue of that journal entails a systematic review of the level and prevalence of spin in published cardiovascular randomized clinical trial reports with statistically nonsignificant primary outcomes. Spin in this instance is defined as the use of specific reporting strategies, from whatever motive, to highlight that the experimental treatment is beneficial, despite a statistically nonsignificant difference for the primary outcome (i.e., inappropriate use of causal language), or to distract the reader from statistically nonsignificant results (i.e., to focus on a statistically significant secondary result). The authors of the review found that RCTs with statistically nonsignificant primary outcomes were published in high-impact cardiovascular journals and that considerable manipulation of language occurred in both the abstracts and full texts of the reports. Their observations have significant implications for the integrity of clinical science, the translation of clinical evidence at the bedside, peer review, and the rate of medical progress. Indeed, manipulation of language to distort findings also may contribute to further public distrust in science.

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RANDOMIZED CLINICAL TRIALS AND THE WEIGHT OF A SOUL

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