No. There is no minimum amount of time for patients to have been experiencing symptoms in order to be eligible for participation in the study.
No. Patients may only be enrolled in the trial for one shoulder. If a patient has MRI-confirmed tears of ≤ 4cm in both shoulders at the time of enrollment, they should be enrolled for the shoulder with the larger tear (unless MD advises otherwise). Treatment for the enrolled shoulder would be randomly assigned. The patient [...]
It depends on what kind of study the patient is already participating in. If it is not related to their shoulder or does not interfere with their shoulder treatment, then the answer is likely yes. (Use your best judgment.) If you are unsure or have questions on this front, contact ARC coordinating center personnel for [...]
Yes. Previous physical therapy for their shoulder does not prevent a patient from participating in the trial (if they have not previously followed the ARC physical therapy protocol). However, they would still have a 50-50 chance of being randomized to either treatment. So long as the patient is ok with receiving more physical therapy (without [...]
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 [...]
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, [...]
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 [...]