TY - JOUR T1 - Quality improvement research: are randomised trials necessary? JF - Quality and Safety in Health Care JO - Qual Saf Health Care SP - 77 LP - 80 DO - 10.1136/qshc.2006.021584 VL - 16 IS - 1 AU - D Neuhauser AU - M Diaz Y1 - 2007/02/01 UR - http://qualitysafety.bmj.com/content/16/1/77.abstract N2 - Have you ever heard the criticism that a quality improvement project was not scientific because it was not carried out as a randomised controlled trial (RCT)? These critics have got it wrong and here is why. This answer requires a review of the scientific method. (There are lots of good references to the scientific method. See http://www.wikipedia.org on “the scientific method”.) At its core, science is based on generalisable theory. This theory leads to hypotheses which can be tested experimentally over and over again. If the test fails, the theory must be rejected or modified. Replication, not peer review, is the standard of scientific evidence. Look at the pen in your hand. There is scientific theory called gravity from which you can hypothesise that if you let go of your pen it will fall to your desk top. Drop your pen and you have tested this hypothesis and supported the theory of gravity. If instead, your pen flies into the air you may have thrown it, be on a space ship or in Harry Potter’s magic arts class. The first two possibilities are well defined and predictable by the full mathematical theory of gravity. The third possibility puts us in the realm of imagination which we can enjoy, but not replicate in reality. In a way, Harry Potter’s Hogwarts School is like pure mathematics. Both are built on assumptions that lead logically to imaginary behaviour or theory which are beyond our real world of experimentation. Scientific theory simplifies reality, tells us what is important, and allows us to generalise to other circumstances. It does not matter for the simple theory of gravity whether your pen is blue or black or even if it is a pencil or a penny. Theory defines what is not relevant, and what is relevant (height … ER -