Federal Register / Vol. 80, No. 13 / Wednesday, January 21, 2015 / Notices 2939 

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, 

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 

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-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. 

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. 


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 

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 

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 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 13 / Wednesday, January 21, 2015 / Notices 2941 

• 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 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Treatments for Fecal Incontinence 

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 

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 

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 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 

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 


asabaliauskas on DSK5VPTVN1PROD with NOTICES