[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unpublished pertinent scientific information will improve the quality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: 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
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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