[Federal Register Volume 86, Number 194 (Tuesday, October 12, 2021)]
[Notices]
[Pages 56708-56711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22074]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Telehealth for Women

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 Telehealth for 
Women, 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 Access to published and unpublished 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 November 12, 2021.

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 Telehealth for Women. 
AHRQ is conducting this technical brief 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 Telehealth for Women, including those that describe 
adverse

[[Page 56709]]

events. The entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/telehealth-women/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Telehealth for Women 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.
    [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 (KQs)

    KQ 1: For conditions related to women's reproductive health 
(including family planning, contraception, and sexually transmitted 
infection counseling):
    (a) What is the evidence of effectiveness of telehealth as a 
strategy for delivery of health care services for reproductive health?
    (b) What are patient preferences and patient choice in the context 
of telehealth utilization?
    (c) What is the effectiveness of patient engagement strategies for 
telehealth?
    (d) What is the impact of COVID-19 on the effectiveness of 
telehealth and patient engagement?
    (e) What are the barriers to and facilitators of telehealth for 
women's reproductive health in low-resources settings and populations?
    (f) What are the harms of telehealth for women's reproductive 
health?
    KQ 2: For interpersonal violence (including intimate partner 
violence and domestic violence):
    (a) What is the evidence of effectiveness of telehealth as a 
strategy for screening and interventions for interpersonal violence?
    (b) What are patient preferences and patient choice in the context 
of telehealth utilization?
    (c) What is the effectiveness of patient engagement strategies for 
telehealth?
    (d) What is the impact of COVID-19 on the effectiveness of 
telehealth and patient engagement?
    (e) What are the barriers to and facilitators of telehealth for 
screening and interventions for interpersonal violence in low-resources 
settings and populations?
    (f) What are the harms of telehealth for screening and 
interventions for interpersonal violence?
    Contextual Question: What guidelines, recommendations or best 
practices have been developed for the design and use of telehealth and 
virtual health technologies for women for any clinical conditions, 
including on patient preferences, patient choice, patient engagement, 
and implementation in low-resource settings?

PICOTS (Population, Intervention, Comparator, Outcome, Timing, Setting)

    Tables 1 and 2 shows full eligibility criteria to identify studies 
that address the KQs.

                       Table 1--PICOTS and Corresponding Inclusion and Exclusion Criteria
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                                                            Include                             Exclude
----------------------------------------------------------------------------------------------------------------
Population..............................  Adolescent and adult women (age 13 years     Men.
                                           and older), including those who are         Children under
                                           pregnant, eligible for screening,           13.
                                           counseling, or treatment for:
                                          KQ 1: Reproductive health services:
                                           (Family planning, contraception, STI
                                           counseling)..
                                          KQ 2: Interpersonal violence..............
Interventions...........................  KQ1: Reproductive health services:           KQ1: Non-FDA-
                                           Family planning (preconception      approved contraceptive
                                           counseling and care)..                      devices, medications, and
                                           Contraception (screening,           other methods that are
                                           counseling, provision, and follow-up        not currently in clinical
                                           care)..                                     use in the U.S. as of
                                           STI counseling...................   2021.
                                          KQ2: Interpersonal violence (intimate        Telehealth
                                           partner violence, domestic violence)..      clinician-to-clinician
                                          KQ 1a, 1b, 1e, 1f, 2a, 2b, 2e, and 2f:       consults.
                                           Telehealth and virtual health, defined      Interventions
                                           as:.                                        without bidirectional
                                           Any two-way telehealth strategy     communication between the
                                           intended to supplement or replace           patient and the health
                                           traditional in-person care (e.g., virtual   care team (e.g., one way
                                           visits, remote monitoring, mobile           email or text messages).
                                           applications, at-home use of medical        Peer-led
                                           devices, use of a facilitator; use of       interventions
                                           patient-portal or electronic medical
                                           record)..
                                           Must include direct contact
                                           between a clinician or other provider and
                                           a patient or group of patients..
                                           Telehealth can be synchronous or
                                           asynchronous..
                                           Interventions may be comprised of
                                           a single telehealth strategy or may be
                                           delivered as telehealth packages,
                                           comprised of multiple telehealth
                                           strategies..

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                                          KQ 1c, 1d, 2c, and 2d: Patient engagement    (no clinician involve-
                                           strategies using telehealth and virtual     ment).
                                           health.                                     Maternity Care.
Comparators.............................   For effectiveness and harms (KQ    No comparison for
                                           1a, 1c, 1d, 1f, 2a, 2c, 2d, 2f): Usual or   effectiveness and harms.
                                           in-person care or traditional care models
                                           (care provided without telehealth);
                                           telehealth + in-person care vs. in-person
                                           care alone (augmentation).
                                           For barriers, facilitators,
                                           preferences (KQ 1b, 1e, 2b, 2e): Studies
                                           with or without comparison groups (i.e.,
                                           patients' perceptions are based on
                                           comparisons of their own previous
                                           experiences).
                                           KQ 1d and 2d: During COVID-19:
                                           Clinical services before and after COVID-
                                           19 pandemic.
Outcomes................................  See Table 2.                                 Outcomes not
                                                                                       relevant to the KQs.
                                                                                       Cost analyses.
                                                                                       Patient knowledge/
                                                                                       education.
Clinical Setting........................   Home, outpatient, primary care,    Studies of health care
                                           or primary care-referable.                  services delivered
                                           Contact can be simultaneous         outside of health care
                                           (synchronous) or communicating across       settings (e.g., social
                                           time (asynchronous)..                       services, churches,
                                           Individuals providing care          schools, prisons).
                                           include a broad range of health care
                                           workers (physicians, nurses, pharmacists,
                                           counselors, etc.)..
                                           No geographic restriction: Can be
                                           urban, suburban, or rural..
Country Setting.........................  Research conducted in the U.S. or in        Countries with
                                           populations similar to U.S. populations,    significantly different
                                           with services and interventions             health care systems and
                                           applicable to U.S. practice (i.e.,          fewer resources (e.g.,
                                           countries with a United Nations HDI of      low-income countries);
                                           ``very high'').                             not rated `very high' on
                                                                                       the 2018 HDI.
Study types and designs.................   RCTs.                              Case reports, case series.
                                           A best evidence approach will be
                                           used for considering inclusion of
                                           observational studies (non-RCT with some
                                           type of comparison):
                                          [cir] Comparative studies including trial
                                           and observational studies, including
                                           prospective and retrospective cohort
                                           studies and before-after studies (i.e.,
                                           natural experiments).
                                          [cir] Qualitative studies that evaluate
                                           preferences, barriers/facilitators.
                                          [cir] Studies that specifically note that
                                           they were conducted during the COVID-19
                                           pandemic (e.g., either specify they are
                                           assessing effects of COVID-19, or compare
                                           practices before and after March 2020)
                                           will be included. Studies with data that
                                           overlap this period will be considered
                                           only if results are stratified by pre-
                                           post pandemic.
Language................................  English language.                           Non-English.
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Abbreviations: COVID-19 = novel coronavirus; FDA = U.S. Food and Drug Administration; HDI = human development
  index rating; KQ = key question; RCT = randomized controlled trial; STI = sexually transmitted infection; U.S.
  = United States.


                       Table 2--Table of Outcomes
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             Category                         Included outcomes
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All conditions/services...........  KQ 1a and 2a:
                                     Clinical effectiveness,
                                     patient health outcomes (see
                                     specific outcomes).
                                     Quality of life, function.
                                    KQ 1b, 1c, 1d, 2b, 2c, and 2d:
                                     Measures or descriptions of patient
                                     satisfaction, patient engagement
                                     and activation, patient choice.
                                    KQ 1e and 2e: Measures or
                                     descriptions of barriers and
                                     facilitators in low-resource
                                     settings.
                                     Patient-reported outcomes:
                                     Patient empowerment, engagement,
                                     and satisfaction.
                                     Measures of health care
                                     access, equity, and utilization.
                                       [cir] Rates of screening and
                                        followup; adherence; no-shows.
                                       [cir] Utilization of services.
                                     KQ 1f and 2f: Harms (e.g.,
                                     missed diagnosis, incorrect
                                     diagnosis, overdiagnosis, delay in
                                     treatment, increase in redundant
                                     testing or in low-value care,
                                     mental health outcomes, stress,
                                     anxiety, loss to followup).
Family planning...................   Desired pregnancy; unwanted/
                                     unintended pregnancy.
                                     Interpregnancy interval.
                                     Resource utilization.
Contraception.....................   Reduced unintended or
                                     unwanted pregnancy and births.
                                     Increased contraceptive use/
                                     uptake.
                                     Change in contraceptive
                                     method.
                                     Reproductive health
                                     outcomes.
                                     Harms associated with
                                     contraceptive care (e.g.,
                                     complications of contraceptive
                                     methods; delayed method start;
                                     unable to start method of choice;
                                     reproductive coercion).
STI counseling....................   Health outcomes:

[[Page 56711]]

 
                                       [cir] STI incidence (based on
                                        testing/biologic confirmation).
                                       [cir] STI complications.
                                     Behavioral outcomes:
                                       [cir] Changes in STI risk
                                        behaviors (e.g., multiple sexual
                                        partners, concurrent sexual
                                        partners, sexual partners with
                                        high STI risk, unprotected
                                        sexual intercourse or contact,
                                        sex while intoxicated with
                                        alcohol or other substances, sex
                                        in exchange for money or drugs).
                                       [cir] Changes in protective
                                        behaviors (e.g., sexual
                                        abstinence; mutual monogamy;
                                        delayed initiation of
                                        intercourse or age of sexual
                                        debut; use of condoms, other
                                        barrier methods, or chemical
                                        barriers; or other changes in
                                        sexual behavior).
                                     STI harms:
                                       [cir] Health care avoidance.
                                       [cir] Psychological harms (e.g.,
                                        anxiety, shame, guilt, stigma).
IPV...............................   Health outcomes:
                                       [cir] Reduced exposure to IPV as
                                        measured by a validated
                                        instrument (e.g., Community
                                        Composite Scale), self-report
                                        frequency of abuse (e.g., number
                                        of physical/sexual assaults), or
                                        discontinuation of an unsafe
                                        relationship.
                                       [cir] Physical morbidity caused
                                        by IPV, including acute physical
                                        trauma (e.g., fractures,
                                        dislocations).
                                       [cir] Mental health morbidity
                                        caused by IPV, including acute
                                        mental morbidity (e.g., stress,
                                        nightmares) and chronic mental
                                        health conditions (e.g.,
                                        posttraumatic stress disorder,
                                        anxiety, depression).
                                       [cir] Sexual trauma, unintended
                                        pregnancy, pregnancy loss, and
                                        sexually transmitted infections.
                                       [cir] Health care utilization
                                        attributed to physical or mental
                                        effects of IPV (e.g., rates of
                                        emergency room visits).
                                       [cir] Social isolation.
                                     Harms:
                                       [cir] Increased abuse or other
                                        forms of retaliation; and other
                                        reported harms of screening or
                                        identification.
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Abbreviations: IPV = interpersonal violence; KQ = key question; STI =
  sexually transmitted infections.


Marquita Cullom,
Associate Director.
[FR Doc. 2021-22074 Filed 10-8-21; 8:45 am]
BILLING CODE 4160-90-P