[Federal Register Volume 78, Number 124 (Thursday, June 27, 2013)]
[Notices]
[Pages 38716-38717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-15288]



[[Page 38716]]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Scientific Information Request on Imaging Tests for the Staging 
of Colorectal Cancer

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

ACTION: Request for Scientific Information Submissions.

-----------------------------------------------------------------------

SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions on imaging tests for the 
staging of colorectal cancer (e.g., Chest x-ray, computed tomography, 
multidetector computed tomography (MD-CT), CT colonography, magnetic 
resonance imaging (MRI), transabdominal ultrasound (TUS), endoscopic 
ultrasound (EUS), transrectal ultrasound (TRUS), positron emission 
tomography (PET), positron emission tomography combined with computed 
tomography (PET/CT fusion), or positron emission tomography combined 
with magnetic resonance imaging (PET/MRI fusion)) from medical device 
manufacturers. Scientific information is being solicited to inform our 
Comparative Effectiveness Review of Imaging Tests for the Staging of 
Colorectal Cancer, which is currently being conducted by one of the 
Evidence-based Practice Centers for the AHRQ Effective Health Care 
Program. Access to published and unpublished pertinent scientific 
information on these devices will improve the quality of this 
comparative effectiveness review. AHRQ is requesting this scientific 
information and 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 July 29, 2013.

ADDRESSES:
    Online submissions: http://effectivehealthcare.AHRQ.gov/index.cfm/submitscientific-information-packets/. Please select the study for 
which you are submitting information from the list to upload your 
documents.
    Email submissions: [email protected].
    Print submissions:
    Mailing Address:

Portland VA Research Foundation, Scientific Resource Center, ATTN: 
Scientific Information Packet Coordinator, PO 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: [email protected].

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned one of the Effective Health Care (EHC) Program 
Evidence-based Practice Centers to complete a comparative effectiveness 
review of the evidence for Imaging Tests for the Staging of Colorectal 
Cancer.
    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 systematically requesting 
information (e.g., details of studies conducted) from medical device 
industry stakeholders through public information requests, including 
via the Federal Register and direct postal and/or online solicitations. 
We are looking for studies that report on Imaging Tests for the Staging 
of Colorectal Cancer, including those that describe adverse events, as 
specified in the key questions detailed below. The entire research 
protocol, including the key questions, is also available online at: 
http://www.effectivehealthcare.AHRQ.gov/search-for-GUIDES-reviews-and-reports/?PAGEACTION=displayproduct&productID=1510.
    This notice is a request for information about the following:
     A list of all completed studies your company has sponsored 
for this indication, and if the results are available on 
ClinicalTrials.gov along with the CT.gov trial number.
     For completed studies that do not have results on CT.gov, 
a summary that includes 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, and 
effectiveness/efficacy and safety results.
     In addition, ongoing studies your company has sponsored 
for this indication. In the list, please provide the CT.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.
    Your contribution is very beneficial to this program. The contents 
of all submissions will be available to the public upon request. 
Materials submitted must be publicly available or materials that can be 
made public. Materials that are considered confidential; marketing 
materials; pharmacoeconomic, pharnnacokinetic or pharmacodynamic 
studies; 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/.

Key Question 1

    What is the comparative effectiveness of imaging techniques for 
pretreatment staging of patients with primary and recurrent colorectal 
cancer?
    a. What is the test performance of the imaging techniques used 
(singly, in combination, or in a specific sequence) to stage colorectal 
cancer when compared with a reference standard?
    b. What is the impact of alternative imaging techniques on 
intermediate outcomes, including stage reclassification and changes in 
therapeutic management?
    c. What is the impact of alternative imaging techniques on clinical 
outcomes?
    d. What are the adverse effects or harms associated with using 
imaging techniques, including harms of test-directed management?
    e. How is the comparative effectiveness of imaging techniques 
modified by the following factors:
    i. Patient-level characteristics (e.g., age, sex, body mass index)
    ii. Disease characteristics (e.g., tumor grade)
    iii. Imaging technique or protocol characteristics (e.g., use of 
different tracers or contrast agents, radiation dose of the imaging 
modality, slice thickness, timing of contrast)

[[Page 38717]]

Key Question 2

    What is the comparative effectiveness of imaging techniques for 
restaging patients with primary and recurrent colorectal cancer after 
initial treatment?
    a. What is the test performance of the imaging techniques used 
(singly, in combination, or in a specific sequence) to restage 
colorectal cancer when compared with a reference standard?
    b. What is the impact of alternative imaging techniques on 
intermediate outcomes, including stage reclassification and changes in 
therapeutic management?
    c. What is the impact of alternative imaging techniques on clinical 
outcomes?
    d. What are the adverse effects or harms associated with using 
imaging techniques, including harms of test-directed management?
    e. How is the comparative effectiveness of imaging techniques 
modified by the following factors:
    i. Patient-level characteristics (e.g., age, sex, body mass index)
    ii. Disease characteristics (e.g., tumor grade)
    iii. Imaging technique or protocol characteristics (e.g., use of 
different tracers or contrast agents, radiation dose of the imaging 
modality, slice thickness, timing of contrast)

PICOTS Criteria (Population, Intervention, Comparator, Outcomes, 
Timing, Setting)

Populations

     Adult patients with an established diagnosis of primary 
colorectal cancer
     Adult patients with an established diagnosis of recurrent 
colorectal cancer

Interventions

    Noninvasive imaging using the following tests (alone or in 
combination) to assess the stage of colorectal cancer:
     CT
     PET/CT
     MRI
     Endoscopic ultrasound
    Combinations of particular interest include endoscopic ultrasound 
to evaluate the T stage combined with PET/CT or CT to evaluate the N 
and M stages.

Reference Standards To Assess Test Performance

     Histopathological examination of tissue
     Intraoperative findings
     Clinical followup
    Histopathology of surgically resected specimens is the reference 
standard for pretherapy staging. In patients undergoing surgery, the 
nodal (N) stage and spread of the tumor to nearby regional structures 
and other organs is assessed intraoperatively, either by palpation or 
ultrasound. However, in patients with metastatic disease who undergo 
palliative care, a combination of initial biopsy results and clinical 
followup serves as the reference standard.
    Clinicians use the results from the imaging modality or modalities 
to arrive at a stage determination that is compared against the stage 
established by the reference standard. These comparisons tell us how 
many people were correctly classified in the various stages of the 
disease and allow us to calculate the test performance metrics of 
sensitivity, specificity, and accuracy. The selection of the reference 
standard is important in evaluating the true performance of an imaging 
modality for staging.

Comparators

     Any direct comparisons of the imaging tests of interest
     Any direct comparisons of variations of any of the imaging 
tests of interest (e.g., diffusion-weighted MRI vs. T2-weighted MRI)
    Comparators thought to be of particular clinical interest are 
listed below:
     For colon cancer: a contrast-enhanced CT of the chest, 
abdomen, and pelvis versus whole-body PET/CT versus a contrast-enhanced 
MRI of the chest, abdomen, and pelvis
     For rectal cancer: a contrast-enhanced CT of the abdomen 
and pelvis versus an MRI of the abdomen and pelvis
     For rectal cancer: endoscopic ultrasound versus MRI
     For suspected liver metastasis: CT scan versus MRI or PET/
CT of the abdomen
     For suspected widespread metastasis, CT of the chest, 
abdomen, and pelvis versus whole-body PET/CT or contrast-enhanced MRI 
of the chest, abdomen, and pelvis
    We note that this list is based on a preliminary literature search 
and discussions with a limited number of clinicians and the Technical 
Expert Panel (TEP). Thus, we do not anticipate that the listed items 
cover all of the comparisons of interest. We expect that additional 
comparisons will be identified during the literature review.

Outcomes

 Test performance outcomes
     Test performance (e.g., sensitivity, specificity, 
understaging, and overstaging) against a reference standard test 
(pathological examination, intraoperative findings, clinical followup)
 Intermediate outcomes
     Stage reclassification
     Changes in therapeutic management
 Clinical outcomes
     Overall mortality
     Colorectal cancer-specific mortality
     Quality of life and anxiety
     Need for additional staging tests, including invasive 
procedures
     Need for additional treatment, including surgery, 
radiotherapy, or chemotherapy
     Resource utilization related to testing and treatment 
(when reported in the included studies)
 Adverse effects and harms
     Harms of testing per se (e.g., radiation exposure)
     Harms from test-directed treatments (e.g., overtreatment, 
undertreatment)

Timing

     Primary staging
     Interim restaging
     Duration of followup will vary by outcome (e.g., from no 
followup for test performance measurements to many years for mortality)

Setting

     Any setting will be considered

    Dated: June 13, 2013.
Carolyn M. Clancy,
AHRQ, Director.
[FR Doc. 2013-15288 Filed 6-26-13; 8:45 am]
BILLING CODE 4160-90-P