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Sept 29, 2009 (Ft. Lauderdale, Florida)

One of the most significant barriers to being able to conclude that one type of treatment mode is better or worse than another type of treatment mode is the inherent inaccuracies in the way success or failure of the treatment is measured. In many, if not all cases, the success or failure “rate” is based upon either or both some “subjective” and some “objective” measurements.

The “subjective” measurement usually means some type of feedback from the patients themselves on their personal assessment as to how well the treatment worked, while the “objective” measurement could entail counting the number of outcomes that end in death or serious complications. It is, of course, no secret that subjective patient assessments are just that, with very little ability to quantify such things as “do you feel better?” versus “do you feel MUCH better?” versus “do you feel CURED?”. However, even objective measurements can have a wide range of subjective outcomes as adverse events associated with any particular treatment (one of the most often used objective measurements of any trial) can have a wide range of severity, with little means of QUANTIFYING such adverse events (for instance, was the heart attack caused by the drug very mild or very severe, etc.).

This problem is no more evident than in measuring the “outcomes” of severe urinary incontinence (UI) treatments, as the one of the primary subjective measurements is simply asking the patient at what level of satisfaction the patient is at after treatment, and further used as an objective measure, how many pads per day the patient uses after treatment (i.e.; some patients may use a pad after a minor accident, while others may not change pads until the pad is full, etc.). Measuring the true outcomes of competing medical treatments are subject to a significant amount of subjectivity. Additionally, it has been proffered by a number of major medical journal articles that many of the conclusions reported in clinical trials, related to trial outcomes, have been overly “optimistic”. This is why one sees trial outcomes that report widely disparate efficacy “rates” (that can literally range from 1% to 100%) for the exact same treatment mode. Some of the disparate efficacy rates can also be associated with the disparate skill levels of the physicians doing the procedure. Anyone reviewing efficacy rates resulting from any clinical trial for any medical procedure should automatically take into account all of the subjective (opinion) measurements used to reach the conclusions.