[Federal Register Volume 80, Number 13 (Wednesday, January 21, 2015)]
[Notices]
[Pages 2939-2941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-00762]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Scientific Information Request on Imaging for Pretreatment 
Staging of Small Cell Lung Cancer

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. Scientific 
information is being solicited to inform our review of Imaging for 
Pretreatment Staging of Small Cell Lung Cancer, which is currently 
being conducted by the AHRQ's Evidence-based Practice Centers (EPC) 
Programs. Access to published and unpublished pertinent scientific 
information will improve the quality of this review. AHRQ is conducting 
this systematic review pursuant to Section 902(a) of the Public Health 
Service Act, 42 U.S.C. 299a(a).

DATES: Submission Deadline on or before February 20, 2015.

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: <a href="/cdn-cgi/l/email-protection#a9fae0f9fae9ccd9ca8495c889c1dbcccf94" http: src.org">src.org</a>">SIPS@epc-src.org</a>.

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: Ryan McKenna, Telephone: 503-220-8262 
ext. 58653 or Email: <a href="/cdn-cgi/l/email-protection#ecbfa5bcbfac899c8fc1d08dcc849e898ad1" http: src.org">src.org</a>">SIPS@epc-src.org</a>.

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Programs to complete a review of the evidence for Imaging for 
Pretreatment Staging of Small Cell Lung Cancer.

[[Page 2940]]

    The EPC 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 for Pretreatment Staging of Small Cell Lung 
Cancer, including those that describe adverse events. The entire 
research protocol, including the key questions, is also available 
online at: http://effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=2020.
    This notice is to notify the public that the EPC Program would find 
the following information on Imaging for Pretreatment Staging of Small 
Cell Lung Cancer helpful:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    Your contribution will be very beneficial to the EPC 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 EPC 
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 EPC 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 available online at: http://effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=2020.

The Key Questions

Question 1

    What are the test concordance and comparative accuracy of imaging 
tests (MDCT, PET/CT, MRI, PET/MRI, EBUS, EUS, bone scintigraphy) for 
the pretreatment staging of small cell lung cancer?
<bullet> Test concordance
<bullet> Sensitivity
<bullet> Specificity
<bullet> Positive Predictive Value
<bullet> Negative Predictive Value
<bullet> Positive Likelihood Ratio
<bullet> Negative Likelihood Ratio

Question 2

    When used for the pretreatment staging of small cell lung cancer, 
what is the comparative effectiveness of imaging tests (MDCT, PET/CT, 
MRI, PET/MRI, EBUS, EUS, bone scintigraphy) on later outcomes?
<bullet> Choice of treatment (e.g., surgery, chemotherapy, radiation)
<bullet> Timeliness of treatment
<bullet> Tumor response
<bullet> Harms due to overtreatment or undertreatment
<bullet> Survival
<bullet> Quality of life

Question 3

    To what extent are the following factors associated with the 
comparative accuracy or effectiveness of imaging tests (MDCT, PET/CT, 
MRI, PET/MRI, EBUS, EUS, bone scintigraphy) when used for the 
pretreatment staging of small cell lung cancer?
<bullet> comorbidities
<bullet> body habitus
<bullet> tumor characteristics
PICOTS (Population, Intervention, Comparator, Timing, Setting) 
Population(s)
Adults with diagnosed SCLC or combined SCLC

Interventions

<bullet> Any of the following imaging tests when used for pretreatment 
staging:
    [cir] MDCT
    [cir] PET/CT
    [cir] MRI
    [cir] PET/MRI
    [cir] EBUS
    [cir] EUS
    [cir] Bone scintigraphy

Comparators

<bullet> Single test (one of the above) vs. single test (another one of 
the above)
<bullet> Single test (one of the above) vs. single test (a specific 
variant of the same modality)
<bullet> Single test (one of the above) vs. multiple tests (more than 
one of the above)
<bullet> Multiple test (more than one of the above) vs. other multiple 
tests (more than one of the above)
<bullet> Test comparisons for patients with comorbid illnesses vs. 
those without (KQ3)
<bullet> Test comparisons at different levels of body habitus (KQ3)
<bullet> Test comparisons for different tumor characteristics (KQ3)

Outcomes

<bullet> Intermediate outcomes
    [cir] Test concordance (the percentage of patients for whom two 
imaging tests give the same result or different results)
    [cir] Sensitivity (KQ1 and KQ3) (separately for different potions 
of the anatomy such as mediastinal lymph nodes, brain, etc.)
    [cir] Specificity (KQ1 and KQ3) (separately for different potions 
of the anatomy such as mediastinal lymph nodes, brain, etc.)
    [cir] Timeliness of treatment (KQ2 and KQ3)
    [cir] Choice of treatment (KQ2 and KQ3)
    [cir] Tumor response (KQ2 and KQ3)
<bullet> Patient-centered outcomes
    [cir] Survival (KQ2 and KQ3)
    [cir] Quality of life (KQ2 and KQ3)
    [cir] Harms due to overtreatment or undertreatment (KQ2 and KQ3)

Timing

<bullet> For test concordance: no minimum follow-up
<bullet> For accuracy: no minimum follow-up
<bullet> For timeliness of treatment, timing is the outcome itself
<bullet> For choice of treatment, no minimum follow-up

[[Page 2941]]

<bullet> For tumor response, no minimum follow-up
<bullet> For harms due to overtreatment or undertreatment, no minimum 
follow-up
<bullet> For survival and quality of life, at least six months minimum 
follow-up

Setting

    Any setting.

    Dated: December 29, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2015-00762 Filed 1-20-15; 8:45 am]
BILLING CODE 4160-90-M


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