These are areas for you record any relevant information not already captured in the form that would be helpful for coordinating center staff or someone looking at the record later on to know (e.g., if the patient cancelled their original appointment and has rescheduled for another date, or the patient is leaving on vacation and [...]
Sections with GREEN headers are for site RAs to complete. Do not complete sections with GOLD or BLUE headers.
The RA should complete the following REDCap instruments during screening/enrollment: Screening Log Informed Consent Eligibility Patient Study Info Overview Randomization Module (once patient is ready to be randomized), and Source Documents (upload scanned copies of paper documents) Physical Exam Form Part B (if RA is using the electronic version) Research staff at Vanderbilt will complete [...]
No. Coordinating Center staff will be responsible for following up with patients to get contact information for their treating physical therapist and will send out Physical Therapy Report Forms via email (using a REDCap survey) to treating physical therapists at the appropriate time points.
There are 3 ways to complete the Surgery Report Form: On Paper – The site RA provides the MD a paper copy on the day of surgery that the MD completes and returns within 1 week. The site RA then uploads the completed form to REDCap. Electronically in clinic – The site RA pulls up [...]
The physician should receive the form either on the day of the surgery or the day after by one of the methods described below (see F3).
The Surgery Report Form should be completed within one week of the surgery date.
Yes. Appropriate follow-up care and treatment should be provided based on each individual patient’s needs and the determination of their treating physician. Ideally, patients randomized to non-operative treatment should wait 6 months before pursuing surgery, if possible, in order for the treatment to be fully effective. However, if, prior to the 6-month mark, the physician [...]
Yes. The patient is free to switch treatments at any time. However, ideally, patients are asked to stick with their assigned treatment for at least 6 months. If there are a significant number of patients who “cross over” within the first 6 months – operative patients who do not have surgery or nonoperative patients who [...]
The patient would remain in the study and continue to be followed. Depending on the particular circumstances and their treatment assignment, the patient may become a “crossover” and/or may generate a protocol deviation (if treatment is not started with 2 months of randomization).