Why Publish Study Protocols?

In this issue, PTJ publishes “Build Better Bones With Exercise: Protocol for a Feasibility Study of a Multicenter Randomized Controlled Trial of 12 Months of Home Exercise in Women With a Vertebral Fracture.”1 This is not the first protocol paper published in PTJ, but it is the debut of protocols as an official manuscript category in PTJ. Clinical trials that adhere to the highest standards of internal and external validity are imperative to best inform optimal decision making for patients. It's therefore necessary to rule out as many sources of bias and confounders as possible. Factors such as randomization and blinding are integral to minimizing bias in clinical trials, but even the most well-designed studies could be at risk for not getting published if the results are negative or inconsistent with the investigators' prevailing hypotheses. Once a study protocol is available to the public, however, there is a reasonable expectation to eventually find the results in the literature, which adds an element of accountability for authors to report their results in a timely manner. Reporting of study protocols in advance allows the scientific community to evaluate whether the eventual analysis and results are consistent with the investigators' original intent. For example, in the cases of studies supported by grant funding, there is a legitimate concern that a sponsor's interests could interfere with a timely, accurate, and transparent publication of the findings.2,3