Guide
How to run a retrospective chart review.
Clinical Extract turns the data-pull step of a retrospective chart review into one export: paste the patient list, confirm the graded matches, and start the review from a CSV and its data dictionary. This guide covers the study from the IRB application to the review.
1 The study
What a retrospective chart review is, and what the IRB asks.
A retrospective chart review answers a defined question from records that already exist: a cohort, a set of variables, an outcome. The IRB asks who the patients are, which variables you will collect, where each one comes from and how identifiers are handled. Answer those four questions before you open a chart: they set up the data dictionary, the patient list or criteria, and the honest broker's release. If your site routes research data requests through your informatics team, the same four answers start that request.
2 The variables
Define the variables before the review starts.
Write every variable with its definition and its source before the review starts: the diagnosis code set, the lab and its LOINC code, the medication class, the date rule. Split the list in two. The coded variables (diagnoses, dates, results, medications, procedures, staging) come out of the EHR as columns. The judgment variables (a reading of a note, an ambiguous stage, a cause) are the medical chart review itself, and they get an abstraction rule and a second reader. The first list becomes data-dictionary.json; the second is the abstraction form.
3 The patient list
Grade the patient list you already have.
Most chart reviews start from a list: MRNs from a pathology log, names and dates of birth from a clinic schedule, a CSV from a prior study. Roster pull matches every row against the EHR, an exact MRN first, then the FHIR Patient/$match operation on name, date of birth and sex, then a demographic search, and grades it certain, probable, possible, multiple or none. You confirm the matches, and the confirmed rows become the cohort the export runs on. A study that starts from criteria instead of a list builds the cohort the same way and reads the count first.
Figure 1 as a table
| Grade | How the row matched | Rows | Next |
|---|---|---|---|
| certain | exact MRN, or Patient/$match match-grade certain | 198 | joins the cohort when you confirm |
| probable | demographic search, one candidate | 20 | joins the cohort when you confirm |
| possible | Patient/$match match-grade possible | 8 | joins the cohort when you confirm |
| multiple | demographic search, two or more candidates | 9 | held for your review |
| none | no candidate found | 5 | held for your review |
| All rows | pasted roster | 240 | 226 confirmed, 14 held |
4 The export
One export fills every coded variable.
The export runs for the cohort and the resource types the variable list names, through the certified bulk FHIR API, in your environment. What comes back is study.csv, one row per patient and one column per coded variable, and data-dictionary.json. For every coded variable the reviewers work in the CSV, and each cell can be traced to the FHIR element it came from.
5 The review
Manual review covers only the judgment variables.
The judgment variables are the review: two readers, an abstraction rule per variable, an agreement check on a sample. With the coded fields filled, the readers open a chart only for the questions that take a reading of the notes. Abstraction starting from the coded record shows the split for each field and what it does to the minutes per case.
6 Questions
Questions about chart reviews
Does a retrospective chart review need IRB approval?
A review of identified records for research needs IRB review; many qualify for expedited review and a waiver of consent when the records exist already and the risk is confidentiality alone. Your IRB decides. The variable list and the cohort definition are what the application quotes, and both come out of this workflow as a data dictionary and a count.
What is a medical chart review?
Reading patient records to answer a defined question: for a study, a quality measure, a registry or a payer audit. A retrospective chart review is the research form of it, run on records that exist already. A record’s coded fields are exported, and its narrative is read.
What is the difference between a prospective and a retrospective chart review?
A prospective review defines the variables and collects them as care happens. A retrospective review defines them now and collects them from records already written. The second one is where a study-scoped export does the most work, because the coded data is already there.
What level of evidence is a retrospective chart review?
Observational. It describes and compares what happened in the records; it does not randomize. A clean variable list, a defined cohort and a data dictionary that states each column’s source are what make its findings reproducible.
How many charts can we pull?
A pasted list runs up to 500 rows a run through roster pull, and a cohort of any size runs as a Group export. The chart review then starts from one study.csv.
Next
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