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SUMMARY Real-world data (RWD) play an increasingly important role in orthopaedics as demonstrated by the rapidly growing number of publications using registry, administrative, and other databases. Each type of RWD source has its strengths and weaknesses, as does each specific database. Linkages between real-world data sets provide even greater utility and value for research than single data sources. The unique qualities of an RWD data source and all data linkages should be considered before use. Close attention to data quality and use of appropriate analysis methods can help alleviate concerns about validity of orthopaedic studies using RWD. This article describes the main types of RWD used in orthopaedics and provides brief descriptions and a sample listing of publications from selected, key data sources.

SUMMARY The insights that real-world data (RWD) can provide, beyond what can be learned within the traditional clinical trial setting, have gained enormous traction in recent years. RWD, which are increasingly available and accessible, can further our understanding of disease, disease progression, and safety and effectiveness of treatments with the speed and accuracy required by the health care environment and patients today. Over the decades since RWD were first recognized, innovation has evolved to take real-world research beyond finding ways to identify, store, and analyze large volumes of data. The research community has developed strong methods to address challenges of using RWD and as a result has increased the acceptance of RWD in research, practice, and policy. Historic concerns about RWD relate to data quality, privacy, and transparency; however, new tools, methods, and approaches mitigate these challenges and expand the utility of RWD to new applications. Specific guidelines for RWD use have been developed and published by numerous groups, including regulatory authorities. These and other efforts have shown that the more RWD are used and understood and the more the tools for handling it are refined, the more useful it will be.

Feasibility assessment is an important step before initiating any research study, including pragmatic clinical trials. Choosing the correct data source safeguards against substantial difficulties later in the design and implementation process. Based on availability and adequacy of systems already collecting data, it may be viable to embed a pragmatic randomized clinical trial within an already existing data source. Electronic health records (EHR) and administrative insurance (“claims”) data may provide opportunities for embedded pragmatic trials. The feasibility of using EHR, claims, or other ongoing data collection for analysis in a pragmatic trial depends on the specific research question and the availability, quality and relevance of the collected data needed to address that question. This chapter describes considerations for determining whether existing real-world data (RWD) sources can be used for specific pragmatic trials and highlights a structured approach for assessing the feasibility of these data in pragmatic clinical trial research.

The insights that real-world data (RWD) can provide, beyond what can be learned within the traditional clinical trial setting, have gained enormous traction in recent years. RWD, which are increasingly available and accessible, can further our understanding of disease, disease progression, and safety and effectiveness of treatments with the speed and accuracy required by the health care environment and patients today. Over the decades since RWD were first recognized, innovation has evolved to take real-world research beyond finding ways to identify, store, and analyze large volumes of data. The research community has developed strong methods to address challenges of using RWD and as a result has increased the acceptance of RWD in research, practice, and policy. Historic concerns about RWD relate to data quality, privacy, and transparency; however, new tools, methods, and approaches mitigate these challenges and expand the utility of RWD to new applications. Specific guidelines for RWD use have been developed and published by numerous groups, including regulatory authorities. These and other efforts have shown that the more RWD are used and understood and the more the tools for handling it are refined, the more useful it will be.

Real-world data (RWD) play an increasingly important role in orthopaedics as demonstrated by the rapidly growing number of publications using registry, administrative, and other databases. Each type of RWD source has its strengths and weaknesses, as does each specific database. Linkages between real-world data sets provide even greater utility and value for research than single data sources. The unique qualities of an RWD data source and all data linkages should be considered before use. Close attention to data quality and use of appropriate analysis methods can help alleviate concerns about validity of orthopaedic studies using RWD. This article describes the main types of RWD used in orthopaedics and provides brief descriptions and a sample listing of publications from selected, key data sources.

Compared to non-Hispanic women, Hispanic women have disproportional mortality rates due to breast cancer. Mammographic screening detects breast cancer in its early stages and reduces mortality. We examined data obtained from the 2002 Behavioral Risk Factor Surveillance System questionnare using logistic regression analyses to study the relationships between demographic and healthcare factors and mammography use among Hispanic and non-Hispanic White women 40 years and older. Overall, the odds of ever having had a mammogram were similar among Hispanic and non-Hispanic White women (odds ratio = 1.2; 95% confidence interval = 0.9, 1.6), when adjusted for age, employment status, and other demographic variables. Having a personal physician and the type of healthcare facility typically used were associated with mammography use, regardless of Hispanic ethnicity. Although associations between mammography use and demographic factors were similar between ethnic groups, larger proportions of Hispanics had demographic characteristics that were negatively associated with mammography use. Establishing policies and mechanisms to provide all women with regular access to a personal physician or healthcare professional for their preventive and nonemergency healthcare needs may improve mammography use among both Hispanic and non-Hispanic White women. Similarly, reaching out to women who are uninsured and who use facilities other than physicians' offices for their healthcare needs may increase the use of mammography among both ethnic groups.