The Agency for Healthcare Research and Quality (AHRQ) published a notice in the Federal Register on April 11 announcing that it is seeking submissions of published and unpublished scientific information to inform its review of the evidence for lower-limb prostheses, which is currently being conducted by AHRQ’s Evidence-based Practice Centers (EPC) Program. The submission deadline is May 11.
According to the notice, the EPC Program would find the following information on lower-limb prostheses helpful. The contents of submissions will be made available to the public upon request.
- A list of completed studies that your organization has sponsored for this indication. In the list, please indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number.
- For completed studies that do not have results on ClinicalTrials.gov, please provide a summary, including the following elements: study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety results.
- A list of ongoing studies that your organization has sponsored for this indication. In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes.
- Description of whether the above studies constitute all Phase II and above clinical trials sponsored by your organization for this indication and an index outlining the relevant information in each submitted file.
Submissions may be sent via email to [email protected]. Print submissions may be mailed to Portland VA Research Foundation, Scientific Resource Center, Attn: Scientific Information Packet Coordinator, P.O. Box 69539, Portland, OR 97239. The shipping address for FedEx, UPS, etc. is Portland VA Research Foundation, Scientific Resource Center, Attn: Scientific Information Packet Coordinator, 3710 SW U.S. Veterans Hospital Road, Mail Code: R&D 71, Portland, OR 97239.
For more information, contact Ryan McKenna at 503.220.8262 ext. 51723, or send an email to [email protected]. To access the notice, click here.
