Table 1.
Characteristics | Observational data | Clinical trial | |
RWD-EHR | Prospective longitudinal cohort study or registry | ||
Definition | Data from EHR relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources | Non-interventional clinical study, prospectively collecting data on a group of patients with a particular disease or symptom | Patients assigned to one or more interventions to evaluate its impact on healthcare outcomes, for example, randomised controlled trial |
Patient population | Broad, encompassing medical system or population area | Restricted by study participation | Restricted eligibility criteria, often excluding elderly and people with comorbidities |
Data types | High dimensional | High no, limited by research design and variables for collection decided a priori | Variables/outcomes for collection decided a priori |
Data collected as part of patient care from both patients and physicians | Structured data collection and questionnaires | ||
Data presence | Sparce, noisy | Structured, same data collected on all participants | Highly structured and often with detailed clinical data |
Missingness not at random | Fairly complete | Low missingness | |
Scale | Large, thousands to millions | Modest, hundreds to thousands | Small, tens to thousands |
Generalisability | Strong local structure can restrict generalisability Incorporating real-life noise into the analyses improves applicability to real life settings |
Easily replicable in similar designed cohorts Generalisability restricted by patient selection and data not always directly implementable to real life settings. |
The more restrained the patient selection the less generalisable |
EHR, electronic health record; RWD, real-world data.