[Federal Register Volume 88, Number 46 (Thursday, March 9, 2023)]
[Notices]
[Pages 14616-14618]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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unpublished pertinent scientific information will improve the quality 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: [email protected].
    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: [email protected].

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: https://effectivehealthcare.ahrq.gov/products/genitourinary-syndrome/protocol.
    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 ClinicalTrials.gov along with the 
ClinicalTrials.gov trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, 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 
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.
    [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: https://www.effectivehealthcare.ahrq.gov/email-updates.
    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
----------------------------------------------------------------------------------------------------------------
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