CLSI GP45-A:2004

This guideline describes the essential issues in planning outcomes research, including resources needed, formulating a research question, validity and sources of error, feasibility, and ethical issues; addresses the design and implementation of a patient outcomes research plan, including study design, study subjects, measurements, interventions, and analysis; summarizes recommendations for reporting patient outcomes research; and includes definitions, references, and resources for those interested in planning, conducting, and using patient outcomes research.