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 http://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, VerDate Sep<11>2014 17:50 Jan 20, 2015 Jkt 235001 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 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 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: http:// 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: http:// 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: 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&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: http://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: 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: 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: 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-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: 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