Studies let your clinic run research alongside normal care. You set a study up once — who and what it applies to, its participant target, and its approved consent document — and it then becomes available to select on the consent form whenever a matching patient is consented.
ℹ️ Note: Setting up a study is a clinic‑level configuration task, usually done by a practice administrator. You only need to do it once per study; after that, clinicians simply tick the study during consent.
Before you start
You'll need the study's approved Participant Information and Consent Form (PICF) ready to upload, and you should know which surgeons and procedures the study applies to.
Open the Studies page
In the left‑hand menu, select Studies. The page opens under the Research Configuration heading, where you can "Configure study eligibility, participant targets, and approved PICF documents for this clinic."
Create a new study
In the left panel, select + New Study. The configuration form opens on the right.
💡 Tip: To change an existing study instead, use Filter by surgeon and the Select study dropdown to find it, then edit its details.
Name the study
Enter a Study title — for example, "Knee recovery outcomes study". The Identifier is generated automatically from the title.
⚠️ Important: The identifier is fixed after creation and generated from the title, so choose the title carefully before you save.
Set the study status
Use the Enabled toggle in the top‑right of the form to control whether the study is live:
- Enabled — the study can be selected during consent for matching patients.
- Disabled — the study is paused but kept, so you can re‑enable it later without losing its configuration.
Choose who and what the study applies to
Assigned surgeons — tick All surgeons, or select specific surgeons. Selecting All surgeons also includes any surgeons you add to the clinic later.
Procedures — tick All procedures, or choose the specific procedures that can participate in the study.
Consent Forms — tick All consent forms, or select the relevant hospitals that can participate in the procedure.
Add cohorts (labels)
Use labels to set up the study's cohorts or arms, for example a treatment group and a control group, or "Implant A" and "Implant B". They are not free-text tags. These become the options a clinician chooses from when they consent a patient to the study, and you can use them to download results for one cohort at a time.
Set a participant target
Enter the target participant number — the number of participants you're aiming to enrol. This lets the clinic track recruitment against the target.
Upload the PICF
Upload the study's approved Participant Information and Consent Form (PICF). This is the document shown to patients as a link during consent, so make sure it's the current, approved version.
Save
Save the study. Once it's saved and Enabled, it will appear as an option during consent for any patient whose surgeon and procedure match the study's eligibility.
ℹ️ Note: OrthoMate syncs configuration changes automatically — you don't need to notify clinicians when a new study goes live. The study simply becomes selectable on matching consent forms.
Download study results
To export the results for a study, select it with Select study. In the Study results section:
- Choose a Study cohort, or leave it as All cohorts.
- Click Download results CSV.
The CSV includes completed PROM scores and question responses for participants who currently consent to the study. Participant codes replace names and contact details.