[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 Access to published and unpublished pertinent scientific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: src.org">SIPS@epc-src.org.
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: src.org">SIPS@epc-src.org.
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:
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.
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?
Test concordance
Sensitivity
Specificity
Positive Predictive Value
Negative Predictive Value
Positive Likelihood Ratio
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?
Choice of treatment (e.g., surgery, chemotherapy, radiation)
Timeliness of treatment
Tumor response
Harms due to overtreatment or undertreatment
Survival
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?
comorbidities
body habitus
tumor characteristics
PICOTS (Population, Intervention, Comparator, Timing, Setting)
Population(s)
Adults with diagnosed SCLC or combined SCLC
Interventions
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
Single test (one of the above) vs. single test (another one of
the above)
Single test (one of the above) vs. single test (a specific
variant of the same modality)
Single test (one of the above) vs. multiple tests (more than
one of the above)
Multiple test (more than one of the above) vs. other multiple
tests (more than one of the above)
Test comparisons for patients with comorbid illnesses vs.
those without (KQ3)
Test comparisons at different levels of body habitus (KQ3)
Test comparisons for different tumor characteristics (KQ3)
Outcomes
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)
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
For test concordance: no minimum follow-up
For accuracy: no minimum follow-up
For timeliness of treatment, timing is the outcome itself
For choice of treatment, no minimum follow-up
[[Page 2941]]
For tumor response, no minimum follow-up
For harms due to overtreatment or undertreatment, no minimum
follow-up
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