In general, it is best to use REDCap as your primary tracking mechanism. However, if desired, you may use a spreadsheet to track screened patients – for example, if your site has multiple recruiters and physicians and would like to use a shared spreadsheet to avoid duplicate screening log entries. Please make sure any additional [...]
See below for example circumstances in which each designation should be used. Records initially saved as UNVERIFIED or INCOMPLETE should eventually be updated as appropriate and saved as COMPLETE. Incomplete/Unverified records that are more than 30 days past the original appointment date should be reviewed and closed out as appropriate on a monthly basis. COMPLETE [...]
What if a patient is already being/ has been successfully treated for a rotator cuff tear and does not need new or further treatment?
If this is the case, the patient is not suitable for randomization and should not be assessed for eligibility for the study. The doctor should simply check the box at the top of the Clinic Screening Form indicating this is the case and stop filling out the form. In the Screening Log, under Pre-MRI Eligibility, [...]
How should I complete the screening log if the physician misplaced the Clinic Screening Form for a patient who was not eligible?
As long as the physician communicates to you why a patient was excluded, you can fill out the screening log entry without the physical CSF. The physician could let you know this retroactively via email (as long as no protected health information is included) or in person. The most important part is recording why a [...]
CSFs for patients who are found ELIGIBLE for the trial should be completed and returned to the RA immediately so that the patient can be approached for study enrollment in clinic. However, for patients who are not eligible for the study, completed CSFs do not necessarily need to be returned to you on the same [...]
Complete the admin & demographic sections (A & B) of the screening log while pre-screening before the patient’s appointment. Fill in the rest of the log once the recruiting physician has completed the Clinic Screening Form and/or the patient has provided consent. If there is a pending MRI, you will not be able to complete [...]
Do I still complete the screening log for a patient whose medical record definitely shows they are not eligible?
Yes, you would still enter those patients in the screening log. You would indicate why they are ineligible (e.g., surgery on the affected side or unable to give consent, etc.) and then save the entry as COMPLETE. The only difference is you would not create a CSF for the doctor to fill out for these [...]
In general, a CSF should be created for ALL patients who go into the screening log. In some cases, it may be possible to determine definitively from a review of the patient’s medical record that they do not meet eligibility criteria. “Black and white” examples of this would be a patient who has already had [...]
How do I avoid creating a duplicate screening record for someone who is returning to clinic or coming in for a rescheduled appointment?
Prior to creating each new screening record, do a quick search in the REDCap Screening Log for the patient’s initials. If an entry with those same initials is found, review the record to see if it is the same person. (TIP: Use the appointment date in the screening record to cross reference with your electronic [...]
What if a pre-screened patient cancels their appointment or is not screened in clinic for some reason?
In the Pre-MRI Eligibility section (C1.) of the screening log, select “Patient Not Assessed.” Then select the reason the patient was not assessed and save the record as COMPLETE. It is not necessary to track these patients, even if they are expected to reschedule or be seen in clinic again. Following the process described in [...]