Scientific Information Request on Imaging for Pretreatment Staging of Small Cell Lung Cancer, 2939-2941 [2015-00762]
Download as PDF
Federal Register / Vol. 80, No. 13 / Wednesday, January 21, 2015 / Notices
asabaliauskas on DSK5VPTVN1PROD with NOTICES
article published in 2013 in Medical
Care Research and Review is available at
https://www.ncbi.nlm.nih.gov/pmc/
articles/PMC3959996/. Given the
importance of care coordination for
stakeholders and patients, AHRQ
proposes to add a composite measure to
the CG–CAHPS core survey. Since two
of the items are already part of the core
survey, this new composite requires the
addition of only one item to the core
survey.
The new three-item care coordination
composite would consist of ‘‘Follow up
on test results’’ (from the CG–CAHPS
core survey), ‘‘Knows important
information about medical history’’
(from the CG–CAHPS core survey), and
‘‘Provider talked about all prescription
medicines being taken’’ (from the PCMH
Item Set).
With these changes, including the
addition of the care coordination
measure, the final core CG–CAHPS
Survey will be reduced from 34 items to
31 items.
Patient-Centered Medical Home
(PCMH) Item Set
The PCMH Item Set is a collection of
supplemental items that ask about
experiences with the domains of a
medical home. The combination of the
core CG–CAHPS Survey with the PCMH
Item Set constitutes the CAHPS PCMH
Survey. The PCMH Survey has been
used by the National Committee for
Quality Assurance (NCQA) as part of its
PCMH Recognition Program (see below,
Related Efforts). AHRQ proposes the
following changes to the PCMH Item
Set.
Shared decision making: AHRQ
proposes moving three items to the
general set of supplemental items.
Rationale: The items require large
sample sizes to achieve acceptable unitlevel reliability.
Self-management support: AHRQ
proposes retaining two items. Rationale:
While reliability estimates were mixed
for different data sets, stakeholders have
deemed these items critical to PCMH
Item Set.
Attention to mental or emotional
health: AHRQ proposes retaining one
item ‘‘Things that cause worry or stress’’
and moving the other two items—
‘‘Depression screening’’ and ‘‘Personal
or family problems’’—to the general set
of supplemental items. Rationale: AHRQ
agrees with NCQA’s view that three
items are not necessary to capture
comprehensiveness. The retained item
is most correlated with the overall
composite.
Information on getting care on
evenings, weekends, and holidays:
AHRQ proposes retaining this item,
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which is also regarded by NCQA’s
stakeholders as critical for inclusion for
PCMH Item Set.
Getting care on evenings, weekends,
and holidays: AHRQ proposes moving
this item to the general set of
supplemental items. Rationale: The
number of responses in most practicebased surveys is insufficient to achieve
reliability.
Days wait for urgent care: AHRQ
proposes moving this item to the general
set of supplemental items. Rationale:
AHRQ supports NCQA’s proposal
regarding this item.
Reminders between visits: AHRQ
proposes moving this item to the general
set of supplemental items. Rationale:
AHRQ supports NCQA’s proposal
regarding this item.
Care coordination items: The PCMH
Item Set includes two items related to
care coordination. These items did not
combine to form a composite measure.
As noted above, AHRQ proposes
moving the item ‘‘Provider talked about
all the prescription medicines being
taken’’ into the core survey for the new
measure of care coordination. AHRQ
also proposes changing the current,
‘‘Yes-No response’’, scale for this item to
a, ‘‘Never/Sometimes/Usually/Always’’
frequency response, scale. The second
item, ‘‘Provider informed and up-to-date
on care from specialists’’ would remain
in the PCMH Item Set.
Related Efforts
AHRQ has been working closely with
the CMS, our Federal partner in the
CAHPS Consortium, throughout this
process to achieve alignment with the
CAHPS Survey for ACOs and the
CAHPS for PQRS Survey. For specific
questions about these surveys, contact
the ACO CAHPS team at acocahps@
hcqis.org or 1–855–472–4746 or the
PQRS CAHPS team at pqrscahps@
hcqis.org.
As noted, NCQA currently uses the
CAHPS PCMH Survey as part of its
PCMH Recognition Program. NCQA has
issued a separate proposal for changes
to the survey that may be used for the
PCMH program in the future. For
specific questions about the use of the
PCMH Survey by NCQA, contact their
customer support at (888) 275–7585 or
customersupport@ncqa.org.
Dated: January 13, 2015.
Richard Kronick,
AHRQ Director.
[FR Doc. 2015–00767 Filed 1–20–15; 8:45 am]
BILLING CODE 4160–90–M
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2939
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 for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for scientific
information submissions.
AGENCY:
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: https://
effectivehealthcare.AHRQ.gov/
index.cfm/submit-scientificinformation-packets/. Please select the
study for which you are submitting
information from the list to upload your
documents.
Email submissions: SIPS@epc-src.org.
SUMMARY:
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: SIPS@epcsrc.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.
E:\FR\FM\21JAN1.SGM
21JAN1
asabaliauskas on DSK5VPTVN1PROD with NOTICES
2940
Federal Register / Vol. 80, No. 13 / Wednesday, January 21, 2015 / Notices
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: https://
effectivehealthcare.ahrq.gov/search-forguides-reviews-and-reports/
?pageaction=displayproduct&product
ID=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
VerDate Sep<11>2014
17:50 Jan 20, 2015
Jkt 235001
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:
https://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:
https://effectivehealthcare.ahrq.gov/
search-for-guides-reviews-and-reports/
?pageaction=displayproduct&product
ID=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
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
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:
Æ MDCT
Æ PET/CT
Æ MRI
Æ PET/MRI
Æ EBUS
Æ EUS
Æ 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
Æ Test concordance (the percentage of
patients for whom two imaging tests
give the same result or different
results)
Æ Sensitivity (KQ1 and KQ3)
(separately for different potions of
the anatomy such as mediastinal
lymph nodes, brain, etc.)
Æ Specificity (KQ1 and KQ3)
(separately for different potions of
the anatomy such as mediastinal
lymph nodes, brain, etc.)
Æ Timeliness of treatment (KQ2 and
KQ3)
Æ Choice of treatment (KQ2 and KQ3)
Æ Tumor response (KQ2 and KQ3)
• Patient-centered outcomes
Æ Survival (KQ2 and KQ3)
Æ Quality of life (KQ2 and KQ3)
Æ 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
E:\FR\FM\21JAN1.SGM
21JAN1
Federal Register / Vol. 80, No. 13 / Wednesday, January 21, 2015 / Notices
• For tumor response, no minimum
follow-up
• For harms due to overtreatment or
undertreatment, no minimum followup
• For survival and quality of life, at
least six months minimum follow-up
Hospital Road, Mail Code: R&D 71,
Portland, OR 97239.
FOR FURTHER INFORMATION CONTACT:
Ryan McKenna, Telephone: 503–220–
8262 ext. 58653 or Email: SIPS@epcsrc.org.
Setting
The Agency for Healthcare Research
and Quality has commissioned the
Evidence-based Practice Centers (EPC)
Programs to complete a review of the
evidence for Treatments for Fecal
Incontinence.
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 Treatments for Fecal
Incontinence, including those that
describe adverse events. The entire
research protocol, including the key
questions, is also available online at:
https://effectivehealthcare.AHRQ.gov/
search-for-guides-reviews-and-reports/
?pageaction=display
product&productID=2013.
This notice is to notify the public that
the EPC Program would find the
following information on Treatments for
Fecal Incontinence (FI) 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
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Scientific Information Request on
Treatments for Fecal Incontinence
Agency for Healthcare Research
and Quality (AHRQ), HHS
ACTION: Request for scientific
information submissions.
AGENCY:
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
Treatments for Fecal Incontinence,
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: https://
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: 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
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:50 Jan 20, 2015
Jkt 235001
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
2941
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:
https://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:
https://effectivehealthcare.AHRQ.gov/
search-for-quides-reviews-and-reports/
?pageaction=displayproduct&product
ID=2013.
The Key Questions
Key Question 1
What is the comparative effectiveness
of treatments to improve quality of life
and continence and lessen the severity
of FI in affected adults?
Key Question 2
What adverse effects are associated
with specific treatments for adults with
FI?
PICOTS
The PICOTS Framework (Population,
Intervention, Comparator, Outcomes,
Timing, Setting) will be identified for
each key question.
Population
We will include adults with FI and
classify them within the etiologic
categories listed below, and by adult age
groups (geriatric versus other).
Whenever possible, we will examine
treatment effects within etiologic
subgroups of adults, since affected
individuals are highly heterogeneous
and not all treatments are feasible for
specific subgroups. Patients with FI due
to spinal cord injury will be separately
evaluated. Adults with fistulas will be
excluded. The possible associations of
E:\FR\FM\21JAN1.SGM
21JAN1
Agencies
[Federal Register Volume 80, Number 13 (Wednesday, January 21, 2015)]
[Notices]
[Pages 2939-2941]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00762]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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: https://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: https://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: https://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