Research Pipeline
Below is an example pipeline or process for conducting research with Health Data such as EHR data. The list is by no means exhaustive. However, it is a good place to start. A page could be written on each of the steps in the pipeline - and most likely will be in future releases of CODIAC for Health.
Conduct a literature review.
Explicitly describe the research question.
Form an interdisciplinary team that can guide and perform each step of the study.
Fully specify the research protocol in advance of executing the study.
Apply for IRB approval of the study.
Apply for an Institutional Reliance Agreement, if necessary.
Execute a Data (Transfer and) Use Agreement (DUA, DTUA), as required
Comply with any application and approval procedures set forth by the data provider.
Request access to / Set up computing infrastructure, as necessary.
Assess the suitability (strengths and weaknesses) of the dataset(s) to be used in the study.
Assess the quality of the dataset(s).
Define the study cohort (and matching cases, if applicable).
Create standard code sets for each clinical concept in the cohort definition and every independent and dependent variable.
Compose a computable data request / data extraction specification.
Clean and stage extracted data for analysis; handle missing values according to protocol.
Characterize the study cohort (and matching cases, if applicable).
Adjust for any bias or confounders in the data.
Analyze the data according to protocol.
Produce research products.
Comply with any review procedures required by the data provider.
Publish your work!
Resources
Articles
Shang N, Weng C, Hripcsak G. A conceptual framework for evaluating data suitability for observational studies. J Am Med Inform Assoc. 2018 Mar 1;25(3):248-258. doi: 10.1093/jamia/ocx095. PMID: 29024976; PMCID: PMC7378879.
Books
Secondary Analysis of Electronic Health Records [Internet]. Cham (CH): Springer; 2016. Available from: https://www.ncbi.nlm.nih.gov/books/NBK543630/ doi: 10.1007/978-3-319-43742-2
O’Neil ST, Beasley W, Loomba J, Patrick S, Wilkins KJ, Crowley KM., Anzalone, AJ (Eds.) (2023). The Researcher’s Guide to N3C: A National Resource for Analyzing Real-World Health Data. DOI: 10.5281/zenodo.7749367
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