How to Create an Orthopaedic Arthroplasty Database Project: A Step-by-Step Guide Part II: Study Execution.

In recent years, the use of national databases in orthopaedic surgery research has grown substantially with database studies comprising an estimated ∼10% of all published lower extremity arthroplasty research. The aim of this review is to serve as a guide on how to: (1) design; (2) execute; and (3) publish an orthopaedic database arthroplasty project. In part II, we discuss how to collect data, propose a novel checklist/standards for presenting orthopaedic database information (SOPOD), discuss methods for appropriate data interpretation/analysis, and summarize how to convert findings to a manuscript (providing a previously published example study). Data collection can be divided into two stages: baseline patient demographics and primary/secondary outcomes of interest. Our proposed SOPOD is more orthopaedic-centered and builds upon previous standards for observational studies from the EQUATOR network. There are a host of statistical methods available to analyze data to compare baseline demographics, primary/secondary outcomes, and reduce type 1 errors seen in large datasets. When drafting a manuscript, it is important to consider and discuss the limitations of database studies, including their retrospective nature, issues with coding/billing, differences in statistical versus clinical significance (or relevance), lack of surgery details (approach, laterality, and implants), and limited sampling or follow-up. We hope this paper will serve as a starting point for those interested in conducting lower extremity arthroplasty database studies.