[Federal Register Volume 78, Number 166 (Tuesday, August 27, 2013)]
[Notices]
[Pages 52929-52930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20849]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Scientific Information Request on Imaging Tests for the Diagnosis 
and Staging of Pancreatic Adenocarcinoma

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for scientific information submissions.

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public on imaging 
tests for the diagnosis and staging of pancreatic adenocarcinoma. 
Scientific information is being solicited to inform our review of 
Imaging Tests for the Diagnosis and Staging of Pancreatic 
Adenocarcinoma, which is currently being conducted by the Evidence-
based Practice Centers for the AHRQ Effective Health Care Program. 
Access to published and unpublished pertinent scientific information on 
imaging tests for the diagnosis and staging of pancreatic 
adenocarcinoma will improve the quality of this review. AHRQ is 
conducting this comparative effectiveness review pursuant to Section 
1013 of the Medicare Prescription Drug, Improvement, and Modernization 
Act of 2003, Public Law 108-173, and Section 902(a) of the Public 
Health Service Act, 42 U.S.C. 299a(a).

DATES: Submission Deadline on or before September 26, 2013.

ADDRESSES: Online submissions: http://effectivehealthcare.AHRQ.gov/index.cfm/submit-scientific-information-packets/. Please select the 
study for which you are submitting information from the list to upload 
your documents.
    Email submissions: src.org">SIPS@epc-src.org.
    Print submissions:

Mailing Address: Portland VA Research Foundation, Scientific Resource 
Center, ATTN: Scientific Information Packet Coordinator, P.O. Box 
69539, Portland, OR 97239.
Shipping Address (FedEx, UPS, etc.): 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 FURTHER INFORMATION CONTACT: Robin Paynter, Research Librarian, 
Telephone: 503-220-8262 ext. 58652 or Email: src.org">SIPS@epc-src.org.

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Effective Health Care (EHC) Program 
Evidence-based Practice Centers to complete a review of the evidence 
for Imaging Tests for the Diagnosis and Staging of Pancreatic 
Adenocarcinoma.
    The EHC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on Imaging Tests for the Diagnosis and Staging of 
Pancreatic Adenocarcinoma, including those that describe adverse 
events. The entire research protocol, including the key questions, is 
also available online at:

[[Page 52930]]

http://www.effectivehealthcare.AHRQ.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=1620.
    This notice is to notify the public that the EHC program would find 
the following information on imaging tests for the diagnosis and 
staging of pancreatic adenocarcinoma helpful:
    [ssquf] A list of completed studies your company has sponsored for 
this indication. In the list, indicate whether results are available on 
ClinicalTrials.gov along with the ClinicalTrials.gov trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, 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.
    [ssquf] A list of ongoing studies your company 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.
    [ssquf] Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your company for this 
indication and an index outlining the relevant information in each 
submitted file.
    Your contribution is very beneficial to the Program. The contents 
of all submissions will be made available to the public upon request. 
Materials submitted must be publicly available or can be made public. 
Materials that are considered confidential; marketing materials; study 
types not included in the review; or information on indications not 
included in the review cannot be used by the Effective Health Care 
Program. This is a voluntary request for information, and all costs for 
complying with this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EHC program Web 
site and available for public comment for a period of 4 weeks. If you 
would like to be notified when the draft is posted, please sign up for 
the email list at: http://effectivehealthcare.AHRQ.gov/index.cfm/join-the-email-list1/.
    The systematic review will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions. The entire research 
protocol, is also available online at: http://www.effectivehealthcare.AHRQ.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=1620.

The Key Questions

Question 1

    What is the comparative effectiveness of imaging techniques (e.g., 
MDCT angiography  3D reconstruction, other MDCT, EUS-FNA, 
PET-CT, MRI) for diagnosis of pancreatic adenocarcinoma in adults with 
suspicious symptoms?
    a. What is the accuracy of each imaging technique for diagnosis and 
assessment of resectability?
    b. What is the comparative accuracy of the different imaging 
techniques for diagnosis and assessment of resectability?
    c. What is the comparative diagnostic accuracy of using a single 
imaging technique versus using multiple imaging techniques?
    d. How is test experience (e.g., operative experience, assessor 
experience, center's annual volume) related to comparative diagnostic 
accuracy of the different imaging strategies?
    e. How are patient factors and tumor characteristics related to the 
comparative diagnostic accuracy of the different imaging strategies?
    f. What is the comparative clinical management after the different 
imaging strategies when used for diagnosis?
    What is the comparative impact of the different imaging strategies 
on long-term survival and quality of life when used for diagnosis?

Question 2

    What is the comparative effectiveness of imaging techniques (e.g., 
MDCT angiography  3D reconstruction, other MDCT, EUS-FNA, 
PET-CT, MRI) for staging of pancreatic adenocarcinoma among adults with 
a diagnosis of pancreatic adenocarcinoma?
    a. What is the staging accuracy of each imaging technique (for 
tumor size, lymph node status, vessel involvement, metastases, stage 
[I-IV], and resectability)?
    b. What is the comparative staging accuracy among the different 
imaging techniques?
    c. What is the comparative staging accuracy of using a single 
imaging technique versus using multiple imaging techniques?
    d. How is test experience (e.g., operative experience, assessor 
experience, center's annual volume) related to comparative staging 
accuracy of the different imaging strategies?
    e. How are patient factors and tumor characteristics related to the 
comparative staging accuracy of the different imaging strategies?
    f. What is the comparative clinical management of the different 
imaging strategies when used for staging?
    What is the comparative impact of the different imaging strategies 
on long-term survival and quality of life when used for staging?

Question 3

    What are the rates of harms of imaging techniques (e.g., MDCT 
angiography  3D reconstruction, other MDCT, EUS-FNA, PET-
CT, MRI) when used to diagnose and/or stage pancreatic adenocarcinoma?
    a. How are patient factors related to the harms of different 
imaging techniques?
    What are patient perspectives on the tolerance of different imaging 
techniques and the balance of benefits and harms of different imaging 
techniques?

Question 4

    What is the comparative screening accuracy of imaging techniques 
(e.g., MDCT angiography  3D reconstruction, other MDCT, 
EUS-FNA, PET-CT, MRI) in high-risk asymptomatic adults (i.e., those at 
genetic or familial risk of pancreatic adenocarcinoma)?

    Dated: August 19, 2013.
Carolyn M. Clancy,
AHRQ, Director.
[FR Doc. 2013-20849 Filed 8-26-13; 8:45 am]
BILLING CODE 4160-90-P