The Physical Exam Form (CRF-02) has two parts: Part A – Range of Motion Measurements (completed by the physician or designee), and Part B – Strength Measurements (completed by research personnel). The physician (or designee) can complete Part A in one of three ways: on paper, electronically in clinic, or as a REDCap email survey [...]
Can anyone besides the recruiting MD complete part A of the Physical Exam Form? (range of motion measurements)
Yes, an individual such as a Physician’s Assistant (PA) or Medical Assistant (MA) designated and trained by the physician may perform the range of motion measurements. However, these individuals must complete the necessary research training and be added to the study roster before performing any research activities. Please notify the study coordinator immediately if your [...]
Call the coordinating center immediately for assistance. If the problem is local to your site, coordinating center staff may be able to randomize the patient for you. Otherwise, you would need to either wait until the system is working again to randomize the patient & inform them by phone or withdraw the patient from the [...]
What if a patient with a pending MRI who was provisionally enrolled in the study turns out to not be eligible?
The patient should be informed of this when they receive their MRI results (either in person or via phone). The Patient Study Info Overview in REDCap should be updated to reflect that the patient was “not randomized” and the patient should be withdrawn from the study. This would then be counted as a screen fail.
How and when do I randomize an eligible patient who is not coming back to clinic for their MRI results?
You should track when the patient’s MRI is scheduled and confer with the physician to determine if the patient meets the remaining MRI & post-MRI criteria and finish filling out the CSF accordingly. If the patient meets all eligibility criteria, then they should be randomized when they are called with their MRI results. The RA [...]
No. Under certain circumstances (see D1 above) the patient may provide consent and be provisionally enrolled in the study prior to receiving their MRI results, but they should not be randomized until the tear has been confirmed on an MRI.
No, enrollment & randomization will be based on the treating MD’s read of the MRI. The study radiologist will later review the MRI to verify the presence of a tear and its size. If the size is different than that indicated by the MD, but still within the range of eligibility for the trial, the [...]
A patient should only be randomized if ALL of the following conditions obtain: (1) the patient meets all eligibility requirements, (2) the tear size, as seen on MRI, is greater than 0 and less than or equal to 4cm (as determined by the treating physician), (3) the patient has provided informed consent and confirmed willingness [...]
It is the job of the study recruiter to make sure each patient (a) meets eligibility criteria, and (b) fully understands and freely consents to the terms of participation in the study. Beyond that it is up to the patient to decide whether or not to participate in the study. You should not try to [...]
What if a patient is interested in the study but indicates a strong preference for or against one of the two treatments on the baseline questionnaire?
The last section of the Baseline Questionnaire that asks about treatment preference should ALWAYS be reviewed prior to randomizing a patient. If the patient indicates a strong preference for one treatment over the other, or there is a significant difference in how successful the patient believes each of the two treatments will be, take a [...]