Notice2023-04800
Supplemental Evidence and Data Request on Genitourinary Syndrome of Menopause
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 9, 2023
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
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 on Genitourinary Syndrome of Menopause, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Full Text
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<title>Federal Register, Volume 88 Issue 46 (Thursday, March 9, 2023)</title>
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[Federal Register Volume 88, Number 46 (Thursday, March 9, 2023)]
[Notices]
[Pages 14616-14618]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-04800]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Genitourinary Syndrome
of Menopause
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data 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 on Genitourinary
Syndrome of Menopause, which is currently being conducted by the AHRQ's
Evidence-based Practice Centers (EPC) Program. Access to published and
unpublished pertinent scientific information will improve the quality
of this review.
DATES: Submission Deadline on or before April 10, 2023.
ADDRESSES:
Email submissions: <a href="/cdn-cgi/l/email-protection#ef8a9f8caf8e879d9ec187879cc1888099"><span class="__cf_email__" data-cfemail="2d485d4e6d4c455f5c0345455e034a425b">[email protected]</span></a>.
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement, Agency
for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857
Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice
Improvement, Agency for Healthcare Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD
20857
FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496
or Email: <a href="/cdn-cgi/l/email-protection#3a5f4a597a5b52484b14525249145d554c"><span class="__cf_email__" data-cfemail="0d687d6e4d6c657f7c2365657e236a627b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for Genitourinary Syndrome
of Menopause. AHRQ is conducting this systematic review pursuant to
Section 902 of the Public Health Service Act, 42 U.S.C. 299a.
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 Genitourinary Syndrome of Menopause, including those
that describe adverse events. The entire research protocol is available
online at: <a href="https://effectivehealthcare.ahrq.gov/products/genitourinary-syndrome/protocol">https://effectivehealthcare.ahrq.gov/products/genitourinary-syndrome/protocol</a>.
This is to notify the public that the EPC Program would find the
following information on Genitourinary Syndrome of Menopause helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this indication. In the list, please indicate whether
results are available on <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> along with the
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> trial number.
[ssquf] For completed studies that do not have results on
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>, 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.
[[Page 14617]]
[ssquf] A list of ongoing studies that your organization has
sponsored for this indication. In the list, please provide the
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> 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.
[ssquf] 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 is very beneficial to the Program. Materials
submitted must be publicly available or able to 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
website 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: <a href="https://www.effectivehealthcare.ahrq.gov/email-updates">https://www.effectivehealthcare.ahrq.gov/email-updates</a>.
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.
Key Questions (KQ)
KQ 1: What is the effectiveness and harms of screening strategies
to identify GSM in postmenopausal women? Does screening impact patient
reported symptoms or improve quality of life?
KQ 2: What is the effectiveness and comparative effectiveness of
hormonal, non-hormonal, and energy-based interventions when used alone
or in combination for treatment of GSM symptoms? Which treatments show
improvement for which symptoms?
KQ 3: What are the harms (and comparative harms) of hormonal, non-
hormonal, and energy-based interventions for GSM symptoms?
KQ 4: What is the appropriate follow-up interval to assess
improvement, sustained improvement, or regression of symptoms of GSM in
women treated with hormonal, non-hormonal, and energy-based
interventions?
KQ 5: What is the effectiveness, comparative effectiveness, and
harms of endometrial surveillance among women who have a uterus and are
using hormonal therapy for GSM?
Population, Intervention, Comparator, Outcome, Timing, Setting/Study Design (PICOTS)
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Inclusion Exclusion
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Population:
KQ1:......................... Postmenopausal women..............................
KQ2-4:....................... Postmenopausal women, premenopausal women in Individuals with
hypoestrogenic state, or gender diverse genitourinary symptoms
individuals on hormonal therapy, with one or more for reasons other than
symptom of GSM. GSM.
KQ5:......................... Patients with a uterus using hormonal therapy Patients using hormonal
primarily for GSM symptoms. therapy for reasons
other than GSM.
Interventions:
KQ1:......................... Screening evaluations and/or questionnaires....... Physical exam.
KQ2-4:....................... Hormonal Interventions: Systemic estrogen for GSM, Menopausal hormone
vaginal estrogen therapy, including vaginal therapy only for reasons
cream, tablets, inserts or ring, selective other than GSM.
estrogen receptor modulator (SERM), intravaginal Laser therapy for
dehydroepiandrosterone (DHEA), vaginal anatomic areas other
testosterone, compounded and bioidentical than the vagina.
hormonal therapies; phytoestrogens. Pelvic floor physical
Energy-based interventions: CO2 laser, Erbium: therapy for urinary
YAG, radio-frequency laser. incontinence.
Non-hormonal interventions: Over-the-counter non-
hormone vaginal lubricants and moisturizers,
hyaluronic acid, herbal therapies/supplemental
alternatives, vitamin D, vitamin E, probiotics,
oxytocin vaginal gel, pelvic floor physical
therapy to treat vaginal or sexual symptoms of
GSM.
For KQ4. Assess different durations of follow-up..
KQ5:......................... Endometrial surveillance with ultrasound or biopsy
Comparison:
KQ1:......................... Usual care........................................
KQ2-4:....................... Effectiveness: Placebo, inactive control, sham.
Comparative Effectiveness: Another hormonal, non-
hormonal, or energy-based intervention..
For KQ4. Assess different durations of follow up..
KQ5:......................... Usual care, or different type or level of
surveillance.
Outcomes:
KQ1:......................... Diagnosis of GSM, potential harms: misdiagnosis as
another condition with similar presentation such
as inflammatory dermatologic conditions,
malignancy, infections, or presence of symptoms
prior to menopause. Progressing to unnecessary
diagnostics for the index patient such as vaginal
or endometrial biopsy.
KQ 1, 2&4........................ Change in symptoms:............................... Serum hormone
Genitourinary symptoms: urinary frequency, urinary concentration, Stress
urgency, nocturia, dysuria, recurrent urinary incontinence.
tract infections.
Other urinary symptoms (outcomes evaluated for
interventions other than PFMT): urinary urge
incontinence, overactive bladder.
Genital signs and symptoms: urethral caruncle,
urethral prolapse, vaginal atrophy or atrophic
vaginitis, vaginal dryness, vaginal/vulvar
irritation, vaginal soreness, vaginal
lubrication, vaginal pain.
Sexual symptoms: dyspareunia, orgasmic
dysfunction, low libido, decreased arousal,
sexual desire, sexual function, bleeding
associated with sexual activity.
[[Page 14618]]
Psychological symptoms: depression, anxiety,
quality of life, partner satisfaction.
KQ3&5:....................... Safety outcomes: breast cancer, breast cancer
recurrence or progression, breast tenderness,
cardiovascular risk, endometrial cancer (KQ5),
post-menopausal bleeding (KQ5), endometrial
hyperplasia (KQ5), endometrial thickness (KQ5).
Adverse events: worsening or onset of urinary,
genital, or sexual symptoms: vaginal burning,
vaginal bleeding, vaginal discharge, vaginal
scarring, vaginal stenosis; pelvic pain;
dyspareunia; urethral strictures; meatal
stricture/stenosis..
Systemic adverse events: chronic pain, stroke; VTE
(DVT or PE); death; hot flashes; headache; breast
pain; cramps; bloating; nausea; vomiting.
Timing:
All KQ....................... Intervention: any.
Outcomes: any.....................................
Setting:
All KQ....................... Any...............................................
Study design:
KQ1.......................... RCTs and prospective observational studies with
concurrent comparison group and analytic
techniques to control for sample selection bias;
systematic reviews of these study designs that
assessed ROB of included studies using validated
tools.
KQ2.......................... RCTs or systematic review of RCTs that assessed
ROB of included studies using validated tools.
KQ3.......................... RCTs and prospective observational studies with
concurrent comparison group and analytic
techniques to control for sample selection bias;
systematic reviews of these study designs that
assessed ROB of included studies using validated
tools.
KQ4.......................... RCTs or systematic review of RCTs that assessed
ROB of included studies using validated tools.
KQ5.......................... RCTs and prospective observational studies with
concurrent comparison group and analytic
techniques to control for sample selection bias;
systematic reviews of these study designs that
assessed ROB of included studies using validated
tools.
Language......................... English only (due to resource limitations)........
Geographic Location.............. Any...............................................
Study size....................... N = 20 or more participants analyzed per study arm
for RCTs.
Publication date................. Any...............................................
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Abbreviations: CO2 = carbon dioxide; DHEA = dehydroepiandrosterone; DVT = deep venous thromboembolism; GSM =
Genitourinary Syndrome of Menopause; KQ = key question; PE = pulmonary embolism; PFMT = pelvic floor muscle
training; RCT = randomized controlled trial; SERM = selective estrogen receptor modulator; VTE = venous
thromboembolism.
Dated: March 3, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023-04800 Filed 3-8-23; 8:45 am]
BILLING CODE 4160-90-P
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