Clinical trials are, for many good reasons, focused on a single endpoint, and usually on an endpoint that can be objectively determined. But it is also critical to ask the patient whether the treatment worked for her.
A case in point is a recent review of six randomized clinical trials that considered whether being screened for prostate cancer reduced overall and cancer-specific mortality in men. Mia Djubegovic and her colleagues analyzed data on over 350,000 men who participated in experiments where they either were or were not screened. Their stark conclusions:
In this systematic review and meta-analysis of prostate cancer screening we failed to find a significant impact of prostate cancer screening on overall mortality or death from prostate cancer.
This is very disappointing, given that prostate cancer is the second leading cause of cancer deaths among US men. I concluded that I would not get screened.
What really surprised me, though, was this:
All trials had one or more substantial methodological limitations. None provided data on the effects of screening on participants’ quality of life. Little information was provided about potential harms associated with screening. (emphasis added)
This is extraordinary. A positive screening result often leads to prostate cancer surgery, and even with the vaunted robotic surgical technologies, the outcomes often include incontinence and loss of sexual function. I don't know, maybe I'm crazy, but I imagine that that would lower my quality of life. So I would really like to know how being screened, and everything that followed after, changed how patients felt about their lives. These trials cost many millions of dollars. Absurdly, the researchers either did not ask patients about their quality of life, or they have not bothered to report it.