Data from a medical document

A discharge summary, a test report or a conclusion as a PDF or a photo: values for the form's fields, each checked by the investigator.

A discharge summary, a test or procedure report or a specialist’s conclusion need not be copied into a form by hand. Upload the PDF or take a photo of the page, and YouEDC Capture proposes values for the fields of the form: blood pressure and pulse, the dates of the stay, the diagnosis and its ICD-10 code, comorbidities, recommendations. You compare each value with the document and confirm it. Nothing goes into the form without your confirmation, and the history of each value says the machine proposed it from that document and the investigator checked it.

Checking the document: the field of the form on the left, the words of the document the value comes from, then the value for the form and who proposed it. “АД 128/74” gives two fields at once.

How to fill in a form from a document

1. Open the patient’s form (for example “Vital signs” or “Primary diagnosis”) and click Fill in from a medical document. The button is shown to those who enter data when the form has fields that medical documents usually contain.
2. Choose the kind of document (discharge summary, report, conclusion, outpatient record) and upload a PDF with text, as the hospital’s system or the patient’s personal account gives it. Take a photo of a paper document instead (see below).
3. Click Read the document. The check of the document opens. Each field shows the words of the document its value comes from. Compare the value and tick Compared with the document, correct it or empty it. Fields marked “Not in the document” do not go into the form.
4. Tick that this is your patient’s document and you compared every value with it, and click Confirm and fill in the form. Remove another patient’s document with Drop the document.
5. The values go into the form, with a blue notice on top naming the document (MD-1, MD-2…). Look the form over and save it as usual: the form’s checks and queries work as with typing.

Upload: on the right, who reads the document on this server and which fields of the form can be filled in.

After confirming: the values in the form; the notice reminds you to save the form.

How to fill in a form from a photo of the page

1. On the same page, choose the picture in Or a photo of the page. On a phone the camera opens.
2. Take one page, flat, in good light. Drag the four corners of the frame onto the part of the page with the data, and leave the header with the patient’s name outside if you can.
3. Click Read the document. If the picture is too small or blurred, the page says so: take it again, closer and straighter.
4. In the check, each field shows the piece of the photo its value comes from. On a photo every value needs a tick, even when it looks right.

Checking a photo: each field with its piece of the picture. The letter I of the ICD-10 code was read as the digit 1, and YouEDC put the letter back with a note: check such a value with special care.

Who reads the document

• The rules always work. They find values written after their names and know how doctors write: “АД 142/88 мм рт. ст.” gives systolic and diastolic pressure, “вес” fits the field “Body weight”, the dates of the stay come from “was treated from … to …”, the ICD-10 code from the brackets after the diagnosis. “Diabetes: no” gives “no”, not “yes”.
• The local model works only when the administrator has connected a language model on the installation’s own server or in its private network. It reads free text and adds what the rules missed. The model must quote the words of the document it took the value from. If those words are not in the document, the value is not proposed. The model takes a few minutes to read: the page waits for it, or click Don’t wait: check what the rules found.
• The column Proposed by shows where the value comes from: the rules, the local model, or both reading the same. The notes next to it say what to check: a value outside the usual range, the other reader proposing something else, several codes in the document.

On youedc.com the local model will be switched on after the move to the production server: it needs a server with enough memory and processor. Until then the rules read the documents, and the upload page shows it.

A model on an outside service cannot be connected: YouEDC accepts only an address on its own server or in the private network. Medical data does not go to any outside service.

Medical documents of the study

The menu item Medical documents lists all documents read in the study (each person sees only their sites): number, patient, visit and form, who read it, how many values were to check, how many were confirmed and changed, and the status. It also shows whether a local model works on the server. The table of changes by site helps notice a site that never corrects anything: it may be confirming without looking, and its documents are worth a look at SDV.

Medical documents of the study: who reads them on this server, changes by site and the documents themselves.

Patient data and audit

• Personal data is hidden first. Lines with the name, address, phone, insurance, SNILS and passport numbers are hidden before anything reads the text: neither the rules nor the model see them. Sex and year of birth in the document are only compared with the patient card.
• The PDF is not stored. What remains is its SHA-256 fingerprint, the proposals and what you confirmed. Of a photo, the straightened piece is kept with the personal data lines painted over: it stays with the document as the source of the values.
• Audit. Reading a document is written to the audit trail. The history of each saved value says “proposed by the machine (rules, or rules and local model) from document MD-n; checked and confirmed by the investigator”. If you corrected the value, it says “typed by the investigator while checking document MD-n”. Every call to the model is logged with the model’s name, the fingerprint of its file and the fingerprint of the text; the text itself is not kept (ALCOA+, 21 CFR Part 11).

Try it in the demo. In the demo project the upload page has the buttons Demo summary (PDF) and Demo photo of it: YouEDC writes a discharge summary of the invented “Демо-клиника” for this patient and the fields of this form, in the words doctors use.