Bias was reduced through the removal of subjective elements from the outcome definition, Kahan et al, 2016

Bias was reduced in an open-label trial through the removal of subjective elements from the outcome definition

Objective: To determine whether modifying an outcome definition to remove subjective elements reduced bias in a trial that could not use blinded outcome assessment.

Study design and setting: Reanalysis of an open-label trial comparing a restrictive vs. liberal transfusion strategy for gastrointestinal bleeding. The usual definition of the primary outcome, further bleeding, allows subjective clinical symptoms to be used alone for diagnosis, whereas the definition used in the trial required more objective confirmation by endoscopy. We compared treatment effect estimates for these two definitions.

Results: Fewer subjective symptom-identified events were confirmed using more objective methods in the restrictive arm (18%) than in the liberal arm (56%), indicating differential assessment between arms. An analysis using all events (both subjective and more objective) led to an odds ratio of 0.83 (95% confidence interval [CI]: 0.50-1.37). When only events confirmed using more objective methods were included, the odds ratio was 0.50 (95% CI: 0.32-0.78). The ratio of the odds ratios was 1.66, indicating that including unconfirmed events in the definition biased the treatment effect upward by 66%.

Conclusion: Modifying the outcome definition to exclude subjective elements substantially reduced bias. This may be a useful strategy for reducing bias in trials that cannot blind outcome assessment.

https://www.jclinepi.com/article/S0895-4356(16)30141-X/fulltext

Free access: https://discovery.ucl.ac.uk/id/epri...tive elements from the outcome definition.pdf

 

In other words: putting the scale out of reach of hands make them less likely to tip the scale whenever convenient.

It's wild that this will either be ignored, or be very controversial. Because removing the ability of researchers to influence outcomes of their experiments would mean the end of psychosomatic medicine and psychosociomumbujumbo, but unfortunately there are very heavy hands tipping the scale in favor of myths over reliable science that doesn't confirm 90% of their assumptions.

It's hands-tipping-the-scale all the way up.