Encourage them to do their home exercises as instructed, emphasizing the role doing so plays in both the length and success of their recovery, as you would for any patient. However, patient compliance with the home exercise program is distinct from physical therapist compliance with the treatment protocol. When completing the Physical Therapist Report Form(s) [...]
How should I indicate in the Physical Therapist Report that modifications to the treatment protocol were made?
Even if you made some modifications to the treatment protocol, you should still answer YES on the PT Report form that the prescribed PT Protocol was followed. Further on in the report you should indicate which sets of exercises, if any, weren’t performed and why. However, if you did not follow the treatment protocol at [...]
What if a patient I am treating crosses over to the other treatment arm (e.g. operative patient does not have surgery or non-operative patient ends up having surgery)?
You will be referred to the site lead physical therapist for a call to discuss the treatment protocol changes. If needed, you can access the appropriate non-op or post-op PT treatment protocol on the study website: shoulderstudy.org/studies/arc-trial/physical-therapists. After the patient finishes physical therapy, you will receive an additional retrospective PT report form, which you will [...]
What if my post-operative patient has had a surgical procedure other than (or in addition to) a rotator cuff repair? What protocol should I follow?
If a post-operative patient has had alternate or additional surgical procedures, you may modify the treatment protocol as appropriate based on the procedures they received. For example, if an operative patient had a debridement only, you should follow the post-operative treatment protocol but may advance the patient through each phase as tolerated (as opposed to [...]
No, we will continue to follow you as planned even if you switch treatment groups or do not pursue treatment at all.
Protocol deviations and violations should be reported as soon as possible to the Trial Coordinator, who will document the occurrence and report it to the IRB as appropriate. Local IRB reporting requirement may also apply.
A protocol violation is an accidental or unintentional change to the IRB-approved protocol procedures without prior sponsor and IRB approval. Violations, as opposed to simply deviations, generally affect the subject’s rights, safety, welfare, and/or the integrity of the resultant data. Examples of protocol violations include (not an exhaustive list): Informed consent obtained after the initiation [...]
A protocol deviation is an incident involving noncompliance with the protocol, but one that typically does not have a significant effect on the subject’s rights, safety, welfare, and/or the integrity of the resultant data. Deviations may result from the action of the participant, investigator, or staff. Examples of protocol deviations include (not an exhaustive list): [...]
It is important that serious adverse events (SAEs), adverse events (AEs), or other unanticipated problems be reported immediately to both the Trial PI (Nitin Jain) & Trial Coordinator (Helen Koudelková). Information about Serious Adverse Events (SAEs) and Adverse Events (AEs) will be systematically collected via patient questionnaires. However, should study personnel become aware of such [...]
If you become aware that a study participant is deceased, notify the Trial Coordinator at Vanderbilt right away so that the patient can be appropriately withdrawn from the study and the death can be evaluated as a potential SAE (see J1 below).