A patient can take as much time as they need to consider and/or discuss with other family members before deciding to participate. If they need more time, give them a Patient Study Fact Sheet to take home, as well as your business card with your contact information. Ask the patient to contact you if they [...]
Yes, but ONLY IF: (1) the patient meets ALL other pre-MRI eligibility requirements, (2) an MRI has been ordered, and (3) the patient will not return to clinic to receive their MRI results (due to provider standard practice); OR the patient will receive a research MRI. (NOTE: A patient must be consented prior to receiving [...]
If this is the patient’s only hesitation about participating in the study, remind them that they are permitted to withdraw from the study at any point in time. The data for the first 12 months (i.e., the primary study) is the most important, so we would like for them to participate for at least that [...]
The ARC Recruitment & Consent videos can be found in the Research Personnel section of the www.shoulderstudy.org website. Both that section of the website and the videos themselves are password protected. The password to access the Research Personnel section is: arcshoulder123 (all lowercase). The password for the videos is: ARCtrial (ARC in caps, trial lowercase)
For this study, a patient must be able to voluntarily provide informed consent for him/herself. A guardian or family member cannot give consent on behalf of a patient. If a patient has a legal guardian or a conservator for medical decisions, they should be excluded from the study. In some cases, a physician or family [...]
The patient must be able to complete the study questionnaires in English because the standardized questionnaires are only validated in English. If the patient requires a translator, they should be excluded from the study. Otherwise, you should assess the patient’s language comprehension skills as you speak with them. If you believe the patient can communicate [...]
No, the study will only pay for a research MRI – for patients who meet the criteria above in "Which patients may be offered an initial research MRI."
At enrollment, research MRIs are intended solely/specifically for the purpose of determining if a patient is eligible for the trial. They may be offered at the discretion of the treating physician, as appropriate. Research MRIs (if available at a recruiting site) should only be offered to patients who: (1) meet all pre-MRI eligibility criteria, (2) [...]
There is no pre-determined time point at which MRIs are “too old.” This will be a clinical determination made by the treating physician. The key question is whether, in the physician’s judgment, the MRI in question accurately represents the patient’s current symptoms. If so, then that MRI may be used to determine eligibility for the [...]
No, this is a pragmatic trial. So, the standard clinical MRI a patient would normally receive, as read by their treating physician, is sufficient to determine if the patient meets the MRI & post-MRI eligibility criteria for the study.