Quality assessment in clinical trials: considerations for outcomes research in interventional pain medicine.

The assessment of quality in clinical trials involves multiple considerations. While compliance with both Good Clinical Practice and International Conference on Harmonisation guidelines is required, variations in many other factors contribute to the overall quality of the report. Principal among these factors is the development of a testable study question. Study questions that are feasible, interesting, novel, ethical, and relevant are desirable. The methodology used to answer the question should be described in sufficient detail and documented to provide for reproducibility and transparency. This is essential for both interpretation of the results and for assessing the applicability of the results to clinical practice. While randomized controlled trials (RCT) are currently the penultimate methodological standard for quality in research study design, they typically do not mimic clinical practice, which can present limitations to their value. This is particularly relevant with respect to interventional therapies, where RCT designs can be associated with scientific and ethical challenges. Well-designed observational studies may overcome some of these drawbacks, but often require very large study populations. Technological advances in communication may permit the pooling of data and the emergence of new standards for interventional pain research.