Was A Data Analysis Plan, Including Study Hypotheses, Developed A Priori?
Because of the retrospective nature and relatively easy access of claims data, the opportunities for unsystematic data exploration are significant. Accordingly, it is particularly important that evidence of a well-developed a priori data analysis plan be noted for hypothesis-testing studies. For research funded by government or other non-profit agencies, the proposal has typically undergone a rigorous peer-review process prior to funding. When other or no funding is extant, it may be unclear whether the analysis plan was developed a priori unless the authors explicitly make this statement. Hypothesis-generating studies allow for more latitude on this issue. Design Selection: Has The Investigator Provided A Rationale For The Particular Research Design? Many designs are available to the investigator, each with particular strengths and weaknesses depending on setting, research question, and data. The investigator should provide a clear rational for the selection of the design given the sa
