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


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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.

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review of 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unpublished pertinent scientific information will improve the quality 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: <a href="/cdn-cgi/l/email-protection#dc8f958c8f9cb9acbff1e0bdfcb4aeb9bae1" http: src.org">src.org</a>">SIPS@epc-src.org</a>.
    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: <a href="/cdn-cgi/l/email-protection#eebda7bebdae8b9e8dc3d28fce869c8b88d3" http: src.org">src.org</a>">SIPS@epc-src.org</a>.

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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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:

<bullet> Structural (damage or variants)
    [cir] Anal sphincter
    <bullet> Injury (often due to episiotomy): from muscle damage and/
or nerve damage
    <bullet> Damage from surgery (for hemorrhoids or cancer [after 
anal, rectal or colon resection]) or underlying systemic condition 
(such as scleroderma)
    [cir] Pelvic floor
    <bullet> Weakening (atrophy), prolapse (pelvic organs, rectal), or 
stretching (chronic constipation)
    [cir] Rectal
    <bullet> Post-radiation (mainly for prostate and rectal cancer)
    <bullet> Rectal filling and storage problems
    <bullet> Hemorrhoids
    <bullet> Rectocele
    [cir] Congenital malformations (anorectal, anal sphincter)
<bullet> 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)
<bullet> 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.)
<bullet> Multiple
    [cir] Any combination of above etiologies
<bullet> 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:
    <bullet> 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).
    <bullet> 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.

    <bullet> Nonsurgical
    [cir] Functional enhancement therapies (muscle training/
biofeedback/electrostimulation):
    <bullet> Pelvic floor muscle training exercises (PFMT)
    <bullet> PFMT with biofeedback (using electrical or ultrasound 
sensors) EMG
    <bullet> PFMT with biofeedback, plus electrostimulation
    [cir] Dietary modifications: Fiber, probiotic supplements, other
    [cir] Medications: such as
    <bullet> Antidiarrheal or constipating drugs (such as loperamide 
hydrochloride [e.g., Imodium[supreg]], diphenoxylate plus atropine 
[e.g., Lomoti1[supreg]], codeine)
    <bullet> Sphincter function enhancers (topical phenylepinephrine 
gel, sodium valproate)
    <bullet> 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)
    <bullet> Dextranomer in stabilized sodium hyaluronate 
(Solesta[supreg])
<bullet> 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)
<bullet> 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)

<bullet> 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)
<bullet> Reduced frequency of incontinence episodes (bowel diaries, 
episode counts, etc.)
<bullet> 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.
<bullet> Urgency
<bullet> Emotional and psychological outcomes (fear, shame, 
embarrassment, depression, humiliation, anger, etc.): FIQL subscales, 
Euro-QoL 5D (anxiety/depression subscale)
<bullet> Change (reduction) in coping behaviors relative to FI 
management
<bullet> Social activity
<bullet> Sexual function

Key Question 2 (Adverse effects of specific treatments)

<bullet> Pain: abdominal, other
<bullet> Worsening of FI (frequency, severity)
<bullet> Constipation and/or diarrhea
<bullet> Other gastrointestinal symptoms (such as cramping, bloating, 
etc.)
<bullet> Difficulty evacuating bowels
<bullet> Headache
<bullet> Nausea
<bullet> Change in appetite
<bullet> Local dermatitis
<bullet> Surgical complications (infection, revision surgery, etc.)
<bullet> Negative emotional/psychological effects (depression, anger, 
etc.)
<bullet> 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


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