Scientific Information Request on Treatments for Fecal Incontinence, 2941-2943 [2015-00764]

Download as PDF 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and secondary outcomes, baseline characteristics, number of patients screened/eligible/ enrolled/lost to follow-up/withdrawn/ analyzed, effectiveness/efficacy, and safety results.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 2942 Federal Register / Vol. 80, No. 13 / Wednesday, January 21, 2015 / Notices treatments and etiologic subgroups are shown in Appendix A of the research protocol. Potential Subgroups Include: • Structural (damage or variants) Æ Anal sphincter • Injury (often due to episiotomy): from muscle damage and/or nerve damage • Damage from surgery (for hemorrhoids or cancer [after anal, rectal or colon resection]) or underlying systemic condition (such as scleroderma) Æ Pelvic floor • Weakening (atrophy), prolapse (pelvic organs, rectal), or stretching (chronic constipation) Æ Rectal • Post-radiation (mainly for prostate and rectal cancer) • Rectal filling and storage problems • Hemorrhoids • Rectocele Æ Congenital malformations (anorectal, anal sphincter) • Alterations in gastrointestinal motility or fecal texture (due to conditions or ingestibles) Æ Crohn’s disease, ulcerative colitis, irritable bowel syndrome Æ Medications Æ Autoimmune disorders (such as systemic lupus erythematosus) • Neurogenic etiologies Æ Nerve injury to pelvic floor Æ Spinal cord injury, spina bifida Æ Traumatic brain injury Æ Stroke Æ Neurodegenerative diseases (such as multiple sclerosis, multiple system atrophy, Shy-Drager syndrome, etc.) • Multiple Æ Any combination of above etiologies • Unknown Æ FI etiology(ies) unknown or not reported asabaliauskas on DSK5VPTVN1PROD with NOTICES Interventions We will include FDA-approved treatments for FI and FDA-approved medications used off-label (not specifically approved for the treatment of FI) and available for use in the United States. Interventions that do not require FDA approval and are used in the United States will be included. Since a number of treatments that are not FDAapproved are commonly used in Europe, the following additional specifications will apply: • If the device is FDA approved for an indication and is used off label for FI, we will include the studies (e.g., rectal irrigation). • If a device is FDA approved under VerDate Sep<11>2014 18:58 Jan 20, 2015 Jkt 235001 a certain brand name for FI (e.g., anal plugs), and there are studies that compare it to other brands approved only in Europe, we will include those studies. Colostomy, treatments for diarrhea (not FI), and laxatives used to treat stool impaction will be excluded. • Nonsurgical Æ Functional enhancement therapies (muscle training/biofeedback/ electrostimulation): • Pelvic floor muscle training exercises (PFMT) • PFMT with biofeedback (using electrical or ultrasound sensors) EMG • PFMT with biofeedback, plus electrostimulation Æ Dietary modifications: Fiber, probiotic supplements, other Æ Medications: such as • Antidiarrheal or constipating drugs (such as loperamide hydrochloride [e.g., Imodium®], diphenoxylate plus atropine [e.g., Lomoti1®], codeine) • Sphincter function enhancers (topical phenylepinephrine gel, sodium valproate) • Other bowel-affecting drugs: Anticholinergics (hyoscyamine sulfate), tricyclic agents (amitriptyline, imipramine) Æ Behavior modification Æ Stool consistency management Æ Devices: anal plugs Æ Rectal irrigation Æ Injections of local biocompatible tissue-bulking agent (into the anal canal walls) • Dextranomer in stabilized sodium hyaluronate (Solesta®) • Surgical Æ Implanted neurostimulation (sacral nerve stimulators) Æ Radiofrequency anal sphincter remodeling (SECCA)—(may be inoffice procedure) Æ Anal sphincter repair (sphincteroplasty or muscle transposition) Æ Sphincter replacement (artificial anal sphincter) Æ Surgical correction of condition that led to FI (such as rectal prolapse, hemorrhoids, or rectocele) • Combined treatments: any combination Comparators All other treatment options, alone or in combination. Where available, trials with placebo or sham controls will be included. Outcomes The review will focus on patientimportant outcomes as listed below. PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 Intermediate outcomes, such as physiologic measures of sphincter function (electromyography (EMG) recruitment, direct EMG [pudendal nerve terminal motor latency test], anorectal manometry, defecography, etc.), will not be examined due to the lack of correlation with patientimportant outcomes. Key Question 1 (Final health outcomes) • Quality of Life (multiple scales, such as the Fecal Incontinence Quality of Life [FIQL],25 Gastrointestinal Quality of Life Index, or the Medical Outcomes Survey 36-item health survey (SF–36), others) • Reduced frequency of incontinence episodes (bowel diaries, episode counts, etc.) • Reduced severity of incontinence (volume and type of leakage; the use of coping behaviors): multiple scales such as the Fecal Incontinence Severity Index [FISI], Jorge/Wexner (Cleveland Clinic) Incontinence Score, Vaizey/St. Mark’s Hospital incontinence score, Pescatori, Miller Incontinence Score, and others. • Urgency • Emotional and psychological outcomes (fear, shame, embarrassment, depression, humiliation, anger, etc.): FIQL subscales, Euro-QoL 5D (anxiety/ depression subscale) • Change (reduction) in coping behaviors relative to FI management • Social activity • Sexual function Key Question 2 (Adverse effects of specific treatments) • • • • • • • • • • • • Pain: abdominal, other Worsening of FI (frequency, severity) Constipation and/or diarrhea Other gastrointestinal symptoms (such as cramping, bloating, etc.) Difficulty evacuating bowels Headache Nausea Change in appetite Local dermatitis Surgical complications (infection, revision surgery, etc.) Negative emotional/psychological effects (depression, anger, etc.) Other adverse effect(s) related to treatment (skin breakdown, urinary tract infection, etc.) Timing Duration of follow up: Since FI is a chronic condition, studies with at least 3 months of follow up after treatment initiation are the main focus of the review. However, since some interventions may have only short follow up (such as medications or E:\FR\FM\21JAN1.SGM 21JAN1 2943 Federal Register / Vol. 80, No. 13 / Wednesday, January 21, 2015 / Notices dietary interventions), we will include all studies that otherwise meet the selection criteria to allow us to make overarching comments about the status of the FI treatment-outcomes literature in the final report. Setting Any setting (community dwelling, long-term care, other). Dated: December 30, 2014. Richard Kronick, AHRQ Director. [FR Doc. 2015–00764 Filed 1–20–15; 8:45 am] BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects Title: Performance Measures for Community-Centered Healthy Marriage, Pathways to Responsible Fatherhood and Community-Centered Responsible Fatherhood Ex-Prisoner Reentry grant programs. OMB No.: 0970–0365—Reinstatement with changes of a previously approved collection. Description: The Office of Family Assistance (OFA), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), intends to request approval from the Office of Management and Budget (OMB) to renew OMB Form 0970–0365 for the collection of performance measures from grantees for the Community-Centered Healthy Marriage, Pathways to Responsible Fatherhood and Community-Centered Responsible Fatherhood Ex-Prisoner Reentry discretionary grant programs. The performance measure data obtained from the grantees will be used by OFA to report on the overall performance of these grant programs. Data will be collected from all 60 Community-Centered Healthy Marriage, 54 Pathways to Responsible Fatherhood and 5 Community-Centered Responsible Fatherhood Ex-Prisoner Reentry grantees in the OFA programs. Grantees will report on program and participant outcomes in such areas as participants’ improvement in knowledge skills, attitudes, and behaviors related to healthy marriage and responsible fatherhood. Grantees will be asked to input data for selected outcomes for activities funded under the grants. Grantees will extract data from program records and will report the data twice yearly through an on-line data collection tool. Training and assistance will be provided to grantees to support this data collection process. Respondents: Office of Family Assistance Funded CommunityCentered Healthy Marriage, Pathways to Responsible Fatherhood and Community-Centered Responsible Fatherhood Ex-Prisoner Reentry Grantees. ANNUAL BURDEN ESTIMATES Number of responses per respondent Number of respondents Instrument Average burden hours per response Total annual burden hours 110 2 0.8 176 9 2 0.8 14 Estimated Total Annual Burden Hours ..................................................... asabaliauskas on DSK5VPTVN1PROD with NOTICES Performance measure reporting form (for private sector affected public) ...... Performance measure reporting form (for State, local, and tribal government affected public) ............................................................................................. ........................ ........................ ........................ 190 In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email address: infocollection@ acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the VerDate Sep<11>2014 19:33 Jan 20, 2015 Jkt 235001 proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products Food and Drug Administration, ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of SUMMARY: BILLING CODE 4184–01–P Fmt 4703 [Docket No. FDA–2008–N–0500] HHS. [FR Doc. 2015–00809 Filed 1–20–15; 8:45 am] Frm 00032 Food and Drug Administration AGENCY: Robert Sargis, Reports Clearance Officer. PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES Sfmt 4703 E:\FR\FM\21JAN1.SGM 21JAN1

Agencies

[Federal Register Volume 80, Number 13 (Wednesday, January 21, 2015)]
[Notices]
[Pages 2941-2943]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00764]


-----------------------------------------------------------------------

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: 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 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=displayproduct&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&productID=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

[[Page 2942]]

treatments and etiologic subgroups are shown in Appendix A of the 
research protocol.

Potential Subgroups Include:

 Structural (damage or variants)
    [cir] Anal sphincter
     Injury (often due to episiotomy): from muscle damage and/
or nerve damage
     Damage from surgery (for hemorrhoids or cancer [after 
anal, rectal or colon resection]) or underlying systemic condition 
(such as scleroderma)
    [cir] Pelvic floor
     Weakening (atrophy), prolapse (pelvic organs, rectal), or 
stretching (chronic constipation)
    [cir] Rectal
     Post-radiation (mainly for prostate and rectal cancer)
     Rectal filling and storage problems
     Hemorrhoids
     Rectocele
    [cir] Congenital malformations (anorectal, anal sphincter)
 Alterations in gastrointestinal motility or fecal texture (due 
to conditions or ingestibles)
    [cir] Crohn's disease, ulcerative colitis, irritable bowel syndrome
    [cir] Medications
    [cir] Autoimmune disorders (such as systemic lupus erythematosus)
 Neurogenic etiologies
    [cir] Nerve injury to pelvic floor
    [cir] Spinal cord injury, spina bifida
    [cir] Traumatic brain injury
    [cir] Stroke
    [cir] Neurodegenerative diseases (such as multiple sclerosis, 
multiple system atrophy, Shy-Drager syndrome, etc.)
 Multiple
    [cir] Any combination of above etiologies
 Unknown
    [cir] FI etiology(ies) unknown or not reported

Interventions

    We will include FDA-approved treatments for FI and FDA-approved 
medications used off-label (not specifically approved for the treatment 
of FI) and available for use in the United States. Interventions that 
do not require FDA approval and are used in the United States will be 
included. Since a number of treatments that are not FDA-approved are 
commonly used in Europe, the following additional specifications will 
apply:
     If the device is FDA approved for an indication and is 
used off label for FI, we will include the studies (e.g., rectal 
irrigation).
     If a device is FDA approved under a certain brand name for 
FI (e.g., anal plugs), and there are studies that compare it to other 
brands approved only in Europe, we will include those studies.
    Colostomy, treatments for diarrhea (not FI), and laxatives used to 
treat stool impaction will be excluded.

     Nonsurgical
    [cir] Functional enhancement therapies (muscle training/
biofeedback/electrostimulation):
     Pelvic floor muscle training exercises (PFMT)
     PFMT with biofeedback (using electrical or ultrasound 
sensors) EMG
     PFMT with biofeedback, plus electrostimulation
    [cir] Dietary modifications: Fiber, probiotic supplements, other
    [cir] Medications: such as
     Antidiarrheal or constipating drugs (such as loperamide 
hydrochloride [e.g., Imodium[supreg]], diphenoxylate plus atropine 
[e.g., Lomoti1[supreg]], codeine)
     Sphincter function enhancers (topical phenylepinephrine 
gel, sodium valproate)
     Other bowel-affecting drugs: Anticholinergics (hyoscyamine 
sulfate), tricyclic agents (amitriptyline, imipramine)
    [cir] Behavior modification
    [cir] Stool consistency management
    [cir] Devices: anal plugs
    [cir] Rectal irrigation
    [cir] Injections of local biocompatible tissue-bulking agent (into 
the anal canal walls)
     Dextranomer in stabilized sodium hyaluronate 
(Solesta[supreg])
 Surgical
    [cir] Implanted neurostimulation (sacral nerve stimulators)
    [cir] Radiofrequency anal sphincter remodeling (SECCA)--(may be in-
office procedure)
    [cir] Anal sphincter repair (sphincteroplasty or muscle 
transposition)
    [cir] Sphincter replacement (artificial anal sphincter)
    [cir] Surgical correction of condition that led to FI (such as 
rectal prolapse, hemorrhoids, or rectocele)
 Combined treatments: any combination

Comparators

    All other treatment options, alone or in combination. Where 
available, trials with placebo or sham controls will be included.

Outcomes

    The review will focus on patient-important outcomes as listed 
below. Intermediate outcomes, such as physiologic measures of sphincter 
function (electromyography (EMG) recruitment, direct EMG [pudendal 
nerve terminal motor latency test], anorectal manometry, defecography, 
etc.), will not be examined due to the lack of correlation with 
patient-important outcomes.

Key Question 1 (Final health outcomes)

 Quality of Life (multiple scales, such as the Fecal 
Incontinence Quality of Life [FIQL],25 Gastrointestinal Quality of Life 
Index, or the Medical Outcomes Survey 36-item health survey (SF-36), 
others)
 Reduced frequency of incontinence episodes (bowel diaries, 
episode counts, etc.)
 Reduced severity of incontinence (volume and type of leakage; 
the use of coping behaviors): multiple scales such as the Fecal 
Incontinence Severity Index [FISI], Jorge/Wexner (Cleveland Clinic) 
Incontinence Score, Vaizey/St. Mark's Hospital incontinence score, 
Pescatori, Miller Incontinence Score, and others.
 Urgency
 Emotional and psychological outcomes (fear, shame, 
embarrassment, depression, humiliation, anger, etc.): FIQL subscales, 
Euro-QoL 5D (anxiety/depression subscale)
 Change (reduction) in coping behaviors relative to FI 
management
 Social activity
 Sexual function

Key Question 2 (Adverse effects of specific treatments)

 Pain: abdominal, other
 Worsening of FI (frequency, severity)
 Constipation and/or diarrhea
 Other gastrointestinal symptoms (such as cramping, bloating, 
etc.)
 Difficulty evacuating bowels
 Headache
 Nausea
 Change in appetite
 Local dermatitis
 Surgical complications (infection, revision surgery, etc.)
 Negative emotional/psychological effects (depression, anger, 
etc.)
 Other adverse effect(s) related to treatment (skin breakdown, 
urinary tract infection, etc.)

Timing

    Duration of follow up: Since FI is a chronic condition, studies 
with at least 3 months of follow up after treatment initiation are the 
main focus of the review. However, since some interventions may have 
only short follow up (such as medications or

[[Page 2943]]

dietary interventions), we will include all studies that otherwise meet 
the selection criteria to allow us to make overarching comments about 
the status of the FI treatment-outcomes literature in the final report.

Setting

    Any setting (community dwelling, long-term care, other).

    Dated: December 30, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2015-00764 Filed 1-20-15; 8:45 am]
BILLING CODE 4160-90-M