Notice2021-22074
Supplemental Evidence and Data Request on Telehealth for Women
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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
October 12, 2021
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 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.
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<title>Federal Register, Volume 86 Issue 194 (Tuesday, October 12, 2021)</title>
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[Federal Register Volume 86, Number 194 (Tuesday, October 12, 2021)]
[Notices]
[Pages 56708-56711]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 Access to published and unpublished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: <a href="/cdn-cgi/l/email-protection#b0d5c0d3f0d1d8c2c19ed8d8c39ed7dfc6"><span class="__cf_email__" data-cfemail="4421342704252c36356a2c2c376a232b32">[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#b7d2c7d4f7d6dfc5c699dfdfc499d0d8c1"><span class="__cf_email__" data-cfemail="690c190a2908011b184701011a470e061f">[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 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: <a href="https://effectivehealthcare.ahrq.gov/products/telehealth-women/protocol">https://effectivehealthcare.ahrq.gov/products/telehealth-women/protocol</a>.
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 <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.
[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 (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
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Population.............................. Adolescent and adult women (age 13 years <bullet> Men.
and older), including those who are <bullet> 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: <bullet> KQ1: Non-FDA-
<bullet> Family planning (preconception approved contraceptive
counseling and care).. devices, medications, and
<bullet> Contraception (screening, other methods that are
counseling, provision, and follow-up not currently in clinical
care).. use in the U.S. as of
<bullet> STI counseling................... 2021.
KQ2: Interpersonal violence (intimate <bullet> Telehealth
partner violence, domestic violence).. clinician-to-clinician
KQ 1a, 1b, 1e, 1f, 2a, 2b, 2e, and 2f: consults.
Telehealth and virtual health, defined <bullet> Interventions
as:. without bidirectional
<bullet> 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 <bullet> Peer-led
devices, use of a facilitator; use of interventions
patient-portal or electronic medical
record)..
<bullet> Must include direct contact
between a clinician or other provider and
a patient or group of patients..
<bullet> Telehealth can be synchronous or
asynchronous..
<bullet> Interventions may be comprised of
a single telehealth strategy or may be
delivered as telehealth packages,
comprised of multiple telehealth
strategies..
[[Page 56710]]
KQ 1c, 1d, 2c, and 2d: Patient engagement (no clinician involve-
strategies using telehealth and virtual ment).
health. <bullet> Maternity Care.
Comparators............................. <bullet> 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).
<bullet> 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).
<bullet> KQ 1d and 2d: During COVID-19:
Clinical services before and after COVID-
19 pandemic.
Outcomes................................ See Table 2. <bullet> Outcomes not
relevant to the KQs.
<bullet> Cost analyses.
<bullet> Patient knowledge/
education.
Clinical Setting........................ <bullet> Home, outpatient, primary care, Studies of health care
or primary care-referable. services delivered
<bullet> Contact can be simultaneous outside of health care
(synchronous) or communicating across settings (e.g., social
time (asynchronous).. services, churches,
<bullet> Individuals providing care schools, prisons).
include a broad range of health care
workers (physicians, nurses, pharmacists,
counselors, etc.)..
<bullet> 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................. <bullet> RCTs. Case reports, case series.
<bullet> 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
------------------------------------------------------------------------
Category Included outcomes
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All conditions/services........... KQ 1a and 2a:
<bullet> Clinical effectiveness,
patient health outcomes (see
specific outcomes).
<bullet> 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.
<bullet> Patient-reported outcomes:
Patient empowerment, engagement,
and satisfaction.
<bullet> Measures of health care
access, equity, and utilization.
[cir] Rates of screening and
followup; adherence; no-shows.
[cir] Utilization of services.
<bullet> 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................... <bullet> Desired pregnancy; unwanted/
unintended pregnancy.
<bullet> Interpregnancy interval.
<bullet> Resource utilization.
Contraception..................... <bullet> Reduced unintended or
unwanted pregnancy and births.
<bullet> Increased contraceptive use/
uptake.
<bullet> Change in contraceptive
method.
<bullet> Reproductive health
outcomes.
<bullet> Harms associated with
contraceptive care (e.g.,
complications of contraceptive
methods; delayed method start;
unable to start method of choice;
reproductive coercion).
STI counseling.................... <bullet> Health outcomes:
[[Page 56711]]
[cir] STI incidence (based on
testing/biologic confirmation).
[cir] STI complications.
<bullet> 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).
<bullet> STI harms:
[cir] Health care avoidance.
[cir] Psychological harms (e.g.,
anxiety, shame, guilt, stigma).
IPV............................... <bullet> 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.
<bullet> Harms:
[cir] Increased abuse or other
forms of retaliation; and other
reported harms of screening or
identification.
------------------------------------------------------------------------
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
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