[Federal Register Volume 85, Number 136 (Wednesday, July 15, 2020)]
[Notices]
[Pages 42855-42857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15190]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Disparities and
Barriers for Pediatric Cancer Survivorship Care
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submissions.
-----------------------------------------------------------------------
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 Disparities and
Barriers for Pediatric Cancer Survivorship Care, 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 Access to published and unpublished pertinent scientific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 30 days after the date of
publication of this Notice.
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 Disparities and
Barriers for Pediatric Cancer Survivorship Care. AHRQ is conducting
this systematic review pursuant to Section 903 of the Public Health
Service Act, 42 U.S.C. 299a-1.
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 Disparities and Barriers for Pediatric Cancer
Survivorship Care, including those that describe adverse events. The
entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/pediatric-cancer-survivorship/protocol.
This is to notify the public that the EPC Program would find the
following information on Disparities and Barriers for Pediatric Cancer
Survivorship Care 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://
[[Page 42856]]
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.
Guiding Questions (GQs)
The brief will be facilitated by guiding questions, documenting
research and Key Informant input.
GQ1. What are the disparities in survivorship care for pediatric
cancer survivors?
GQ2. What are the barriers to survivorship care for pediatric
cancer survivors who experience disparities?
GQ3. What are proposed strategies for addressing those barriers?
GQ4. What published and unpublished studies have assessed these
strategies?
GQ5. What are future directions for research in addressing barriers
to survivorship care for pediatric cancer survivors?
----------------------------------------------------------------------------------------------------------------
PICOTSS (populations, interventions,
comparators, outcomes, timing, Inclusion Exclusion
settings, study designs) PICOTSS
----------------------------------------------------------------------------------------------------------------
Population........................... All GQs: All GQs:
Childhood cancer survivors Studies that
(CCS) of all ages. We will accept the predominantly include
authors' definition of CCS. Mixed other populations than
samples will be included where studies CCS, that include
include at least 50% CCS or report a patients diagnosed
subgroup analysis. In studies not self- predominantly after the
identifying as CCS research, we will age of 20, that had other
apply the following criteria: conditions than cancer,
Diagnosed before age 21, received or that are currently
primary acute treatment for cancer, undergoing treatment for
currently in remission, eligible to cancer.
receive survivorship care services,
care plans, and/or models of follow-up
care.
Independent variables and GQ1: All GQs:
interventions.
Survivorship care. We will Studies without
include studies addressing healthcare reference to survivorship
approaches aimed at the health and care and studies not
wellbeing of cancer survivors. addressing care
disparities, barriers to
care, or strategies
outside of healthcare.
GQ2:
Barriers and facilitators of
survivorship care for CCS.
GQ3, GQ4, GQ5:
Strategies to address barriers
to survivorship care and to reduce
care disparities. We will include care
initiatives, structured care programs,
care plan, care models, and healthcare
interventions aiming to address
barriers or disparities. Strategies
may target CCS (e.g., providing
patient information), healthcare
providers (e.g., initiating training),
or healthcare systems (e.g.,
implementing health information
technologies such as telemedicine).
Comparators.......................... GQ1, GQ2: All GQs:
We will accept the authors' Studies not
choice of a participant characteristic addressing patient
comparator. Studies may compare characteristics or
subgroups to the general population of intervention
CCS or compare multiple participant characteristics.
subgroups defined by participant
characteristics (e.g., race/ethnicity,
socioeconomic status, gender, rural
residence, educational attainment or
patient or their parents, other
disparate population).
GQ3:
Strategies do not need to
document alternative care models in
detail as long as the difference of
the proposed survivorship care
strategy to usual care is described.
GQ4, GQ5:
Studies comparing participant
subgroups as defined in GQ1 and GQ2
and studies comparing to other care
strategies (no intervention, waitlist,
usual care, other active strategies
aiming to address barriers or
disparities).
Outcomes............................. GQ1, GQ2: All GQs:
Disparities and barriers Studies that do
(causes of disparity) in: not relate to disparities
[cir] Any patient outcomes related to or barriers to
utilization of survivorship care survivorship care for
services, care plans, or models of care. pediatric survivors.
[cir] Intermediate health outcomes
and adverse events (short-term).
[cir] Mortality (long-term, not
related to cancer).
[cir] Late effects and morbidity
(including psychosocial).
[cir] Quality of life and wellbeing
and satisfaction with care.
[cir] Cost and resource utilization.
[[Page 42857]]
GQ3:
Strategies will be documented
regardless of any information on
outcome effects, but strategies need
to aim to prevent, reduce, or mitigate
disparities and barriers to
survivorship care.
GQ4:
Changes (reduction) in
disparities between comparison groups
for outcomes listed in GQ1 and GQ2.
GQ5:
Ongoing and upcoming studies
need to indicate that the study will
report on outcomes eligible for GQ1,
GQ2, or GQ4.
Timing............................... All GQs: All GQs:
No timing restriction apply. No exclusions
Studies may address CCS who recently apply.
or long in the past experienced
pediatric cancer and are now in
remission.
Setting(s)........................... All GQs: All GQs:
All care settings applicable Studies in
to US settings will be eligible, resource-limited settings
including primary, secondary, and such as developing
tertiary care; inpatient and countries will be
outpatient care; pediatric and adult reviewed for
care context. comparability with US
settings.
Study design and other limiters...... All GQs: All GQs:
English-language publications. Evaluations
GQ1, GQ2, GQ4, GQ5: reported only in
Primary studies reporting abbreviated format (e.g.,
empirical data (including both in a conference abstract)
quantitative and qualitative data). with the exception of
GQ1, GQ2: trial records.
Studies may either report on Studies exclusively
distinct subgroups, e.g., dividing the reported in non-English
sample by geographic characteristic and publications.
reporting data separately for rural and Systematic reviews
for urban participants or studies may will be retained for
report associations with participant reference mining but are not
characteristics, e.g., reporting eligible for inclusion.
correlations with a factor of interest
such as gender differences.
GQ3:
Strategies have to have been
empirically tested in a research study
reporting on the outcomes of interest
or have been suggested by an
authoritative source such as a
clinical practice guideline or
relevant professional organization.
GQ 4:
Studies with concurrent (e.g.,
randomized controlled trial) or
historic comparator (e.g.,
organizational pre-post studies).
Studies with results published in
clinicaltrials.gov will be included
regardless of whether a journal
publication is available.
GQ5:
Ongoing and upcoming studies
have to have a published protocol or
are registered in a research registry.
----------------------------------------------------------------------------------------------------------------
Dated: July 9, 2020.
Virginia Mackay-Smith,
Associate Director.
[FR Doc. 2020-15190 Filed 7-14-20; 8:45 am]
BILLING CODE 4160-90-P