Methodological aspects of outcomes research

A critical evaluation of existing scientific evidence of treatment efficacy can be an important part of communicating risk and benefits of treatment options to patients during the course of clinical practice. A checklist of key methodological issues to examine when reading a research study is presented and discussed. Steps in reading a paper include: identifying the research question; identifying the manner in which subjects get enrolled in the study; identifying the treatments and outcomes used; identifying the study design and the comparisons being made; evaluating the study methods for the possibility of bias and uncontrolled confounding; assessing whether the statistical analysis used is appropriate for the study design; assessing whether the study has sufficient statistical power to demonstrate hypotheses being tested. Finally, procedures for grading and evaluating evidence, as used by systematic review groups and international best evidence synthesis consensus groups is briefly described.