Supplemental Evidence and Data Request on Breast Reconstruction After Mastectomy, 39904-39909 [2020-14237]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Breast Reconstruction
After Mastectomy
Agency for Healthcare Research
and Quality (AHRQ), Health and Human
Services (HHS).
ACTION: Request for supplemental
evidence and data submissions.
AGENCY:
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
Breast Reconstruction after Mastectomy,
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published and unpublished pertinent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: epc@
ahrq.hhs.gov.
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.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Jenae Benns, Telephone: 301–427–1496
or Email: epc@ahrq.hhs.gov.
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 Breast Reconstruction after
Mastectomy. AHRQ is conducting this
systematic review pursuant to Section
902(a) of the Public Health Service Act,
42 U.S.C. 299a(a).
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
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from the public (e.g., details of studies
conducted). We are looking for studies
that report on Breast Reconstruction
after Mastectomy, including those that
describe adverse events. The entire
research protocol is available online at:
https://effectivehealthcare.ahrq.gov/
products/breast-reconstructionmastectomy/protocol.
This is to notify the public that the
EPC Program would find the following
information on Breast Reconstruction
after Mastectomy helpful:
D 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.
D 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.
D 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.
D 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 four 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.
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Federal Register / Vol. 85, No. 128 / Thursday, July 2, 2020 / Notices
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: For adult women who are
undergoing (or have undergone)
mastectomy for breast cancer, what are
the comparative benefits and harms of
implant-based (IBR) versus autologous
(AR) breast reconstruction?
KQ 2: For adult women undergoing
IBR or AR after mastectomy for breast
cancer that requires either
chemotherapy or radiation therapy,
what is the optimal time for IBR or AR
with respect to
(a) chemotherapy or
(b) radiation therapy?
KQ 3: For adult women undergoing
IBR after mastectomy for breast cancer,
what are the comparative benefits and
harms of different types of implants
(e.g., silicone, saline)?
KQ 4: For adult women undergoing
IBR after mastectomy for breast cancer,
what are the comparative benefits and
harms of different anatomic planes of
implant placement (prepectoral, partial
submuscular, and total submuscular)?
KQ 5: For adult women undergoing
IBR after mastectomy for breast cancer,
what are the comparative benefits and
harms of IBR with versus without the
use of a human acellular dermal matrix
(ADM) in the reconstruction procedure?
KQ 6: For adult women undergoing
AR after mastectomy for breast cancer,
what are the comparative benefits and
harms of different flap types for AR?
khammond on DSKJM1Z7X2PROD with NOTICES
Contextual Questions
Contextual Question 1:
What patient preferences and values
inform decisionmaking about breast
reconstruction after mastectomy for
breast cancer? This includes the initial
choice to undergo reconstruction, as
well as the type and timing of surgery.
Contextual Question 2:
What strategies or tools (including
shared decisionmaking) are available to
help women make informed choices
about breast reconstruction after
mastectomy for breast cancer?
Study Eligibility Criteria
The specific eligibility criteria
provided below have been refined based
on discussions with a panel of Key
Informants (KIs) and a Technical Expert
Panel (TEP).
Key Question 1 (IBR Versus AR)
Population
• Adult (≥18 years old) women who are
undergoing (or have undergone)
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mastectomy for any type of breast
cancer (or carcinoma in situ) and
have decided to undergo breast
reconstruction
• Either therapeutic or prophylactic
mastectomy
• Exclude: Studies where ≥10% of
women underwent breast
reconstruction (combined across
reasons):
Æ For solely cosmetic purposes (i.e.,
augmentation)
Æ for revision reconstruction (i.e.,
after a previous reconstruction for
breast cancer)
Interventions
• IBR
Æ Either single- or multi-stage
Æ Any type of implant material, either
smooth or textured, silicone or
saline
Æ Any anatomic plane of implant
placement
Æ With or without use of human
ADM
Æ With or without mastectomy and
reconstruction of the contralateral
breast (i.e., unilateral or bilateral)
Æ With or without symmetry
procedure (e.g., mastopexy) in the
contralateral breast
Comparators
• AR using any flap (either free flap or
pedicled), for example:
Æ Deep inferior epigastric perforator
(DIEP)
Æ Latissimus dorsi (LD)
Æ Transverse rectus abdominis
myocutaneous (TRAM)
Æ Superficial inferior epigastric artery
perforator (SIEA)
Æ Gluteal artery perforator (GAP)
Æ Transverse musculocutaneous
gracilis (TMG)
Æ Transverse upper gracilis (TUG)
Æ Profundal artery perforator (PAP)
• Combination of IBR and AR
• Exclude: Non-autologous flap
transplants (i.e., cadaveric or
xenotransplant)
• Exclude: Exclusive lipofilling/
autologous fat reconstruction
Outcomes
• Quality of life
• Physical well-being (e.g., pain,
discomfort)
• Psychosocial well-being (e.g., selfesteem, emotionality, normality)
• Sexual well-being
• Patient satisfaction with aesthetics
(i.e., satisfaction with breast)
• Patient satisfaction with outcome
(e.g., satisfaction with care)
• Planned staged surgeries for
reconstruction
• Recurrence of breast cancer
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• Harms
Æ Mortality
Æ Unplanned repeat hospitalization
Æ Duration of unplanned repeat
hospitalization
Æ Unplanned repeat surgeries—for
revision of reconstruction (e.g., for
asymmetry)
Æ Unplanned repeat surgeries—for
complications (e.g., for infection,
bleeding)*
Æ Pain, including chronic pain
Æ Analgesic (e.g., opioid) use
Æ Necrosis, such as of the nipple or
of the flap
Æ Animation deformity
Æ Complications that lead to delays in
other cancer-related treatments
(e.g., chemotherapy, radiation
therapy)
Æ Thromboembolic events
Æ Infection
Æ Wound dehiscence
Æ Delayed healing
Æ Seroma
Æ Chronic conditions (e.g.,
rheumatologic diseases)
Æ Touch sensitivity
Æ Scarring
Potential Effect Modifiers
• Age
• Stage of breast cancer
• First occurrence versus recurrent
breast cancer
• Immediate versus delayed
reconstruction
• Single-stage (direct to reconstruction)
versus multi-stage (with tissue
expander) reconstruction
• Unilateral versus bilateral
reconstruction
• Radiation therapy versus no radiation
therapy
• Chemotherapy versus no
chemotherapy
Timing
• Any
Setting
• Any, including single- and
multicenter
Design
• Randomized controlled trials (RCTs),
N≥10 per group
• Nonrandomized comparative studies
(NRCSs), N≥30 per group
• Case-control studies, N≥100 per group
• Single group studies, N≥500
• Studies may be prospective or
retrospective
• Exclude: case reports and series of
individually-reported case reports
Key Question 2 (Optimal Time For IBR
or AR)
Population(s)
• Adult (≥18 years old) women who are
undergoing IBR or AR after a
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Federal Register / Vol. 85, No. 128 / Thursday, July 2, 2020 / Notices
mastectomy for breast cancer (or
carcinoma in situ) that requires
either chemotherapy or radiation
therapy
• Either therapeutic or prophylactic
mastectomy
• Exclude: Studies where ≥10% of
women underwent breast
reconstruction (combined across
reasons):
Æ For solely cosmetic purposes (i.e.,
augmentation)
Æ for solely prophylactic purposes
(i.e., without diagnosed breast
cancer)
Æ for revision reconstruction (i.e.,
after a previous reconstruction for
breast cancer)
Interventions
(a) IBR or AR before chemotherapy
(b) IBR or AR before radiation therapy
Æ Either single- or multistage
Æ With or without mastectomy and
reconstruction of the contralateral
breast (i.e., unilateral or bilateral)
Æ With or without symmetry
procedure (e.g., mastopexy) in the
contralateral breast
Æ With or without use of human
ADM
Æ For IBR—Any type of implant
material, either smooth or textured
Æ For IBR—Any anatomic plane of
implant placement
Æ For AR—Any flap type
Comparators
(a) IBR or AR after chemotherapy
(b) IBR or AR after radiation therapy
khammond on DSKJM1Z7X2PROD with NOTICES
Outcomes
• Quality of life
• Physical well-being (e.g., pain,
discomfort)
• Psychosocial well-being (e.g., selfesteem, emotionality, normality)
• Sexual well-being
• Patient satisfaction with aesthetics
(i.e., satisfaction with breast)
• Patient satisfaction with outcome
(e.g., satisfaction with care)
• Planned staged surgeries for
reconstruction
• Recurrence of breast cancer
• Harms
Æ Mortality
Æ Unplanned repeat hospitalization
Æ Duration of unplanned repeat
hospitalization
Æ Unplanned repeat surgeries—for
revision of reconstruction (e.g., for
asymmetry)
Æ Unplanned repeat surgeries—for
complications (e.g., for infection,
bleeding)*
Æ Pain, including chronic pain
Æ Analgesic (e.g., opioid) use
Æ Necrosis, such as of the nipple or
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of the flap
Æ Animation deformity
Æ Complications that cause delays in
other cancer-related treatments
(e.g., chemotherapy, radiation
therapy)
Æ Thromboembolic events
Æ Infection
Æ Wound dehiscence
Æ Delayed healing
Æ Seroma
Æ Chronic conditions (e.g.,
rheumatologic diseases)
Æ Touch sensitivity
Æ Scarring
Potential Effect Modifiers:
• Age
• Stage of breast cancer
• First occurrence versus recurrent
breast cancer
• Type of chemotherapy (for KQ 2a) or
radiation therapy (for KQ 2b)
• Immediate versus delayed
reconstruction
• Single-stage (direct to reconstruction)
versus multi-stage (with tissue
expander) reconstruction
• Unilateral versus bilateral
reconstruction
Timing
• Any
Setting
• Any, including single- and
multicenter
Design
• RCTs, N≥10 per group
• NRCSs, N≥30 per group
• Case-control studies, N≥100 per group
• Single group studies, N≥500
• Studies may be prospective or
retrospective
• Exclude: case reports and series of
individually-reported case reports
Key Question 3 (Type of Implant
Material)
Population(s)
• Adult (≥18 years old) women who are
undergoing (or have undergone)
mastectomy for any type of breast
cancer (or carcinoma in situ) and
have decided to undergo IBR
• Either therapeutic or prophylactic
mastectomy
• Exclude: Studies where ≥10% of
women underwent breast
reconstruction (combined across
reasons):
Æ For solely cosmetic purposes (i.e.,
augmentation)
Æ for revision reconstruction (i.e.,
after a previous reconstruction for
breast cancer)
Interventions
• IBR using one type of implant
material
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Sfmt 4703
Æ
Æ
Æ
Æ
Æ
Æ
Saline
Silicone
Other materials
Either smooth or textured
Either single- or multistage
Any anatomic plane of implant
placement
Æ
With or without use of human ADM
Æ With or without mastectomy and
reconstruction of the contralateral
breast (i.e., unilateral or bilateral)
Æ With or without symmetry
procedure (e.g., mastopexy) in the
contralateral breast
Comparators
• IBR using another type of implant
material
Outcomes
• Quality of life
• Physical well-being (e.g., pain,
discomfort)
• Psychosocial well-being (e.g., selfesteem, emotionality, normality)
• Sexual well-being
• Patient satisfaction with aesthetics
(i.e., satisfaction with breast)
• Patient satisfaction with outcome
(e.g., satisfaction with care)
• Planned staged surgeries for
reconstruction
• Recurrence of breast cancer
• Harms
Æ Mortality
Æ Unplanned repeat hospitalization
Æ Duration of unplanned repeat
hospitalization
Æ Unplanned repeat surgeries—for
revision of reconstruction (e.g., for
asymmetry)
Æ Unplanned repeat surgeries—for
complications (e.g., for infection,
bleeding) *
Æ Pain, including chronic pain
Æ Analgesic (e.g., opioid) use
Æ Necrosis, such as of the nipple
Æ Animation deformity
Æ Implant-related infections
Æ Implant rupture, including
asymptomatic rupture
Æ Implant deflation
Æ Implant malposition
Æ Need for explant surgery
Æ Capsular contracture
Æ New neoplasms (e.g., BIA–ALCL)
Æ Complications that cause delays in
other cancer-related treatments
(e.g., chemotherapy, radiation
therapy)
Æ Thromboembolic events
Æ Wound dehiscence
Æ Delayed healing
Æ Seroma
Æ Chronic conditions (e.g.,
rheumatologic diseases)
Æ Touch sensitivity
Æ Scarring
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Federal Register / Vol. 85, No. 128 / Thursday, July 2, 2020 / Notices
Æ Red breast syndrome
reconstruction of the contralateral
breast (i.e., unilateral or bilateral)
Æ With or without symmetry
procedure (e.g., mastopexy) in the
contralateral breast
Potential Effect Modifiers
• Age
• Stage of breast cancer
• First occurrence versus recurrent
breast cancer
• Immediate versus delayed
reconstruction
• Single-stage (direct to reconstruction)
versus multistage (with tissue
expander) reconstruction
• Unilateral versus bilateral
reconstruction
• Surface of implant (smooth versus
textured)
• Shape of implant (round versus
anatomic/teardrop)
• Size of implant (volume)
Timing
• Any
Setting
• Any, including single- and
multicenter
Design
•
•
•
•
•
RCTs, N≥10 per group
NRCSs, N≥30 per group
Case-control studies, N≥100 per group
Single group studies, N≥500
Studies may be prospective or
retrospective
• Exclude: case reports and series of
individually-reported case reports
Key Question 4 (Anatomic Plane of
Implant Placement)
Population(s)
• Adult (≥18 years old) women who are
undergoing (or have undergone)
mastectomy for any type of breast
cancer (or carcinoma in situ) and
have decided to undergo IBR
• Either therapeutic or prophylactic
mastectomy
• Exclude: Studies where ≥10% of
women underwent breast
reconstruction (combined across
reasons):
Æ for solely cosmetic purposes (i.e.,
augmentation)
Æ for revision reconstruction (i.e.,
after a previous reconstruction for
breast cancer)
khammond on DSKJM1Z7X2PROD with NOTICES
Interventions
• IBR with implant placement in one
anatomic plane
Æ Prepectoral placement
Æ Partial submuscular placement
Æ Total submuscular placement
Æ Either single- or multi-stage
Æ Any type of implant material, either
smooth or textured
Æ With or without use of human
ADM
Æ With or without mastectomy and
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Comparators
• IBR with implant placement in a
different anatomic plane
Outcomes
• Single-stage (direct to reconstruction)
versus multistage (with tissue
expander) reconstruction
• Unilateral versus bilateral
reconstruction
• Surface of implant (smooth versus
textured)
• Shape of implant (round versus
anatomic/teardrop)
• Size of implant (volume)
• Quality of life
• Physical well-being (e.g., pain,
discomfort)
• Psychosocial well-being (e.g., selfesteem, emotionality, normality)
• Sexual well-being
• Patient satisfaction with aesthetics
(i.e., satisfaction with breast)
• Patient satisfaction with outcome
(e.g., satisfaction with care)
• Planned staged surgeries for
reconstruction
• Recurrence of breast cancer
• Harms
Æ Mortality
Æ Unplanned repeat hospitalization
Æ Duration of unplanned repeat
hospitalization
Æ Unplanned repeat surgeries—for
revision of reconstruction (e.g., for
asymmetry)
Æ Unplanned repeat surgeries—for
complications (e.g., for infection,
bleeding)*
Æ Pain, including chronic pain
Æ Analgesic (e.g., opioid) use
Æ Necrosis, such as of the nipple
Æ Animation deformity
Æ Implant-related infections
Æ Implant rupture, including
asymptomatic rupture
Æ Implant deflation
Æ Implant malposition
Æ Need for explant surgery
Æ Capsular contracture
Æ New neoplasms (e.g., BIA–ALCL)
Æ Complications that cause delays in
other cancer-related treatments
(e.g., chemotherapy, radiation
therapy)
Æ Thromboembolic events*
Æ Infection
Æ Wound dehiscence
Æ Delayed healing
Æ Seroma
Æ Chronic conditions (e.g.,
rheumatologic diseases)
Æ Touch sensitivity
Æ Scarring
Æ Red breast syndrome
Timing
Potential Effect Modifiers:
• IBR without use of human or
nonhuman ADM
• Age
• Stage of breast cancer
• First occurrence versus recurrent
breast cancer
• Immediate versus delayed
reconstruction
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39907
• Any
Setting
• Any, including single- and
multicenter
Design
•
•
•
•
•
RCTs, N≥10 per group
NRCSs, N≥30 per group
Case-control studies, N≥100 per group
Single group studies, N≥500
Studies may be prospective or
retrospective
• Exclude: case reports and series of
individually-reported case reports
Key Question 5 (Use of Human ADM)
Population(s)
• Adult (≥18 years old) women who are
undergoing (or have undergone
mastectomy) for any type of breast
cancer (or carcinoma in situ) and
have decided to undergo IBR
• Either therapeutic or prophylactic
mastectomy
• Exclude: Studies where ≥10% of
women underwent breast
reconstruction (combined across
reasons):
Æ for solely cosmetic purposes (i.e.,
augmentation)
Æ for revision reconstruction (i.e.,
after a previous reconstruction for
breast cancer)
Interventions
• IBR with use of human ADM
Æ Either single- or multistage
Æ Any anatomic plane of implant
placement
Æ Any type of implant material, either
smooth or textured
Æ With or without mastectomy and
reconstruction of the contralateral
breast (i.e., unilateral or bilateral)
Æ With or without symmetry
procedure (e.g., mastopexy) in the
contralateral breast
Comparators
Outcomes
• Quality of life
• Physical well-being (e.g., pain,
discomfort)
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Federal Register / Vol. 85, No. 128 / Thursday, July 2, 2020 / Notices
• Psychosocial well-being (e.g., selfesteem, emotionality, normality)
• Sexual well-being
• Patient satisfaction with aesthetics
(i.e., satisfaction with breast)
• Patient satisfaction with outcome
(e.g., satisfaction with care)
• Planned staged surgeries for
reconstruction
• Recurrence of breast cancer
• Harms
Æ Mortality
Æ Unplanned repeat hospitalization
Æ Duration of unplanned repeat
hospitalization
Æ Unplanned repeat surgeries—for
revision of reconstruction (e.g., for
asymmetry)
Æ Unplanned repeat surgeries—for
complications (e.g., for infection,
bleeding)
Æ Pain, including chronic pain
Æ Analgesic (e.g., opioid) use
Æ Necrosis, such as of the nipple
Æ Animation deformity
Æ Implant-related infections
Æ Implant rupture, including
asymptomatic rupture
Æ Implant deflation
Æ Implant malposition
Æ Need for explant surgery
Æ Capsular contracture
Æ New neoplasms (e.g., BIA–ALCL)
Æ Complications that cause delays in
other cancer-related treatments
(e.g., chemotherapy, radiation
therapy)
Æ Thromboembolic events
Æ Infection
Æ Wound dehiscence
Æ Delayed healing
Æ Seroma
Æ Chronic conditions (e.g.,
rheumatologic diseases)
Æ Touch sensitivity
Æ Scarring
Æ Red breast syndrome
khammond on DSKJM1Z7X2PROD with NOTICES
Potential Effect Modifiers
• Age
• Stage of breast cancer
• First occurrence versus recurrent
breast cancer
• Immediate versus delayed
reconstruction
• Single-stage (direct to reconstruction)
versus multi-stage (with tissue
expander) reconstruction
• Unilateral versus bilateral
reconstruction
• Anatomic plane of implant placement
(prepectoral versus partial
submuscular versus total
submusclar)
• Surface of implant (smooth versus
textured)
• Shape of implant (round versus
anatomic/teardrop)
• Size of implant (volume)
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• Brand of human ADM (e.g.,
Alloderm®, FlexHD®, BellaDerm®,
AlloMax®, Cortiva®, DermACELL®)
Timing
• Any
Setting
• Any, including single- and
multicenter
•
•
•
•
•
RCTs, N≥10 per group
NRCSs, N≥30 per group
Case-control studies, N≥100 per group
Single group studies, N≥500
Studies may be prospective or
retrospective
• Exclude: case reports and series of
individually-reported case reports
Key Question 6 (Different Flap Types
For AR)
Population(s)
• Adult (≥18 years old) women who are
undergoing (or have undergone
mastectomy) for any type of breast
cancer (or carcinoma in situ) and
have decided to undergo AR
• Either therapeutic or prophylactic
mastectomy
• Exclude: Studies where ≥10% of
women underwent breast
reconstruction (combined across
reasons):
Æ for solely cosmetic purposes (i.e.,
augmentation)
Æ for revision reconstruction (i.e.,
after a previous reconstruction for
breast cancer)
Interventions
• AR using one flap (either free flap or
pedicled), for example:
Æ Deep inferior epigastric perforator
(DIEP)
Æ Latissimus dorsi (LD)
Æ Transverse rectus abdominis
myocutaneous (TRAM)
Æ Superficial inferior epigastric artery
perforator (SIEA)
Æ Gluteal artery perforator (GAP)
Æ Transverse musculocutaneous
gracilis (TMG)
Æ Transverse upper gracilis (TUG)
Æ Profundal artery perforator (PAP)
Æ With or without mastectomy and
reconstruction of the contralateral
breast (i.e., unilateral or bilateral)
Æ With or without symmetry
procedure (e.g., mastopexy) in the
contralateral breast
Æ Exclude: Non-autologous flap
transplants (i.e., cadaveric or
xenotransplant)
Æ Exclude: Exclusive lipofilling/
autologous fat reconstruction
Frm 00040
Fmt 4703
Sfmt 4703
• AR using a different flap (either free
flap or pedicled)
• Combination of IBR and AR
• Exclude: Non-autologous flap
transplants (i.e., cadaveric or
xenotransplant)
• Exclude: Exclusive lipofilling/
autologous fat reconstruction
Outcomes
Design
PO 00000
Comparators
• Quality of life
• Physical well-being (e.g., pain,
discomfort)
• Psychosocial well-being (e.g., selfesteem, emotionality, normality)
• Sexual well-being
• Patient satisfaction with aesthetics
(i.e., satisfaction with breast)
• Patient satisfaction with outcome
(e.g., satisfaction with care)
• Planned staged surgeries for
reconstruction
• Duration of initial hospitalization
• Recurrence of breast cancer
• Harms
Æ Mortality
Æ Unplanned repeat hospitalization
Æ Duration of unplanned repeat
hospitalization
Æ Unplanned repeat surgeries—for
revision of reconstruction (e.g., for
asymmetry)
Æ Unplanned repeat surgeries—for
complications (e.g., for infection,
bleeding)
Æ Pain, including chronic pain
Æ Analgesic (e.g., opioid) use
Æ Necrosis, such as of the nipple or
of the flap
Æ Harms to area of flap harvest (e.g.,
hernia, bulge formation)
Æ Complications that lead to delays in
other cancer-related treatments
(e.g., chemotherapy, radiation
therapy)
Æ Thromboembolic events
Æ Infection
Æ Wound dehiscence
Æ Delayed healing
Æ Seroma
Æ Touch sensitivity
Æ Scarring
Potential Effect Modifiers
• Age
• Stage of breast cancer
• First occurrence versus recurrent
breast cancer
• Immediate versus delayed
reconstruction
• Single-stage (direct to reconstruction)
versus multi-stage (with tissue
expander) reconstruction
• Unilateral versus bilateral
reconstruction
Timing
• Any
E:\FR\FM\02JYN1.SGM
02JYN1
Federal Register / Vol. 85, No. 128 / Thursday, July 2, 2020 / Notices
Setting
• Any, including single- and
multicenter
Design
•
•
•
•
•
RCTs, N≥10 per group
NRCSs, N≥30 per group
Case-control studies, N≥100 per group
Single group studies, N≥500
Studies may be prospective or
retrospective
• Exclude: case reports and series of
individually-reported case reports
Dated: June 26, 2020.
Virginia Mackay-Smith,
Associate Director.
[FR Doc. 2020–14237 Filed 7–1–20; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–20–20EC]
khammond on DSKJM1Z7X2PROD with NOTICES
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled Enterprise
Laboratory Information Management
System (ELIMS) to the Office of
Management and Budget (OMB) for
review and approval. CDC previously
published a ‘‘Proposed Data Collection
Submitted for Public Comment and
Recommendations’’ notice on December
23, 2019 to obtain comments from the
public and affected agencies. CDC
received one comment related to the
previous notice. This notice serves to
allow an additional 30 days for public
and affected agency comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
VerDate Sep<11>2014
21:18 Jul 01, 2020
Jkt 250001
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) Minimize the burden of the
collection of information on those who
are to respond, including, through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. Direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
Proposed Project
Enterprise Laboratory Information
Management System (ELIMS) Existing
Collection in Use Without an OMB
Control Number—National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The collection of specimen
information designated for testing by the
CDC occurs on a regular and recurring
basis (multiple times per day) using an
electronic PDF file called the CDC
Specimen Submission 50.34 Form or an
electronic XSLX file called the Global
File Accessioning Template. Hospitals,
doctor’s offices, medical clinics,
commercial testing labs, universities,
state public health laboratories, U.S.
federal institutions and foreign
institutions use the CDC Specimen
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
39909
Submission Form 50.34 when
submitting a single specimen to CDC
Infectious Diseases laboratories for
testing. The CDC Specimen Submission
50.34 Form consists of over 200 data
entry fields (of which five are
mandatory fields that must be
completed by the submitter) that
captures information about the
specimen being sent to the CDC for
testing. The type of data captured on the
50.34 Form identifies the origin of the
specimen (human, animal, food,
environmental, medical device or
biologic), CDC test order name/code,
specimen information, patient
information (as applicable), animal
information (as applicable) information
about the submitting organization
requesting the testing, patient history (as
applicable), owner information and
animal history (as applicable) and
epidemiological information. The
collection of this type of data is
pertinent in ensuring a specimen’s
testing results are linked to the correct
patient and the final test reports are
delivered to the appropriate submitting
organization to aid in making proper
health-related decisions related to the
patient. Furthermore, the data provided
on this form may be used by the CDC
to identify sources of potential
outbreaks and other public-health
related events. When the form is filled
out, a user in the submitting
organization prints a hard copy of it that
will be included in the specimen’s
shipping package sent to the CDC. The
printed form has barcodes on it that
allow the CDC testing laboratory to scan
its data directly into ELIMS where the
specimen’s testing lifecycle is tracked
and managed.
Likewise, the Global File
Accessioning Template records the
same data as the 50.34 Form but
provides the capability to submit
information for a batch of specimens
(typically 50–1,000 specimens per
batch) to a specific CDC laboratory for
testing. The CDC testing laboratory
electronically uploads the Global File
Accessioning Template into ELIMS
where the batch of specimens are then
logged and are ready to be tracked
through their respective testing and
reporting workflow. There is no cost to
respondents other than their time. The
total burden hours are 2,131 hours.
E:\FR\FM\02JYN1.SGM
02JYN1
]]>Agencies
[Federal Register Volume 85, Number 128 (Thursday, July 2, 2020)]
[Notices]
[Pages 39904-39909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14237]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Breast Reconstruction
After Mastectomy
AGENCY: Agency for Healthcare Research and Quality (AHRQ), Health and
Human Services (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 Breast
Reconstruction after Mastectomy, 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 Breast Reconstruction
after Mastectomy. AHRQ is conducting this systematic review pursuant to
Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).
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 Breast Reconstruction after Mastectomy, including those
that describe adverse events. The entire research protocol is available
online at: https://effectivehealthcare.ahrq.gov/products/breast-reconstruction-mastectomy/protocol.
This is to notify the public that the EPC Program would find the
following information on Breast Reconstruction after Mastectomy
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 four 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.
[[Page 39905]]
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: For adult women who are undergoing (or have undergone)
mastectomy for breast cancer, what are the comparative benefits and
harms of implant-based (IBR) versus autologous (AR) breast
reconstruction?
KQ 2: For adult women undergoing IBR or AR after mastectomy for
breast cancer that requires either chemotherapy or radiation therapy,
what is the optimal time for IBR or AR with respect to
(a) chemotherapy or
(b) radiation therapy?
KQ 3: For adult women undergoing IBR after mastectomy for breast
cancer, what are the comparative benefits and harms of different types
of implants (e.g., silicone, saline)?
KQ 4: For adult women undergoing IBR after mastectomy for breast
cancer, what are the comparative benefits and harms of different
anatomic planes of implant placement (prepectoral, partial submuscular,
and total submuscular)?
KQ 5: For adult women undergoing IBR after mastectomy for breast
cancer, what are the comparative benefits and harms of IBR with versus
without the use of a human acellular dermal matrix (ADM) in the
reconstruction procedure?
KQ 6: For adult women undergoing AR after mastectomy for breast
cancer, what are the comparative benefits and harms of different flap
types for AR?
Contextual Questions
Contextual Question 1:
What patient preferences and values inform decisionmaking about
breast reconstruction after mastectomy for breast cancer? This includes
the initial choice to undergo reconstruction, as well as the type and
timing of surgery.
Contextual Question 2:
What strategies or tools (including shared decisionmaking) are
available to help women make informed choices about breast
reconstruction after mastectomy for breast cancer?
Study Eligibility Criteria
The specific eligibility criteria provided below have been refined
based on discussions with a panel of Key Informants (KIs) and a
Technical Expert Panel (TEP).
Key Question 1 (IBR Versus AR)
Population
Adult (>=18 years old) women who are undergoing (or have
undergone) mastectomy for any type of breast cancer (or carcinoma in
situ) and have decided to undergo breast reconstruction
Either therapeutic or prophylactic mastectomy
Exclude: Studies where >=10% of women underwent breast
reconstruction (combined across reasons):
[cir] For solely cosmetic purposes (i.e., augmentation)
[cir] for revision reconstruction (i.e., after a previous
reconstruction for breast cancer)
Interventions
IBR
[cir] Either single- or multi-stage
[cir] Any type of implant material, either smooth or textured,
silicone or saline
[cir] Any anatomic plane of implant placement
[cir] With or without use of human ADM
[cir] With or without mastectomy and reconstruction of the
contralateral breast (i.e., unilateral or bilateral)
[cir] With or without symmetry procedure (e.g., mastopexy) in the
contralateral breast
Comparators
AR using any flap (either free flap or pedicled), for example:
[cir] Deep inferior epigastric perforator (DIEP)
[cir] Latissimus dorsi (LD)
[cir] Transverse rectus abdominis myocutaneous (TRAM)
[cir] Superficial inferior epigastric artery perforator (SIEA)
[cir] Gluteal artery perforator (GAP)
[cir] Transverse musculocutaneous gracilis (TMG)
[cir] Transverse upper gracilis (TUG)
[cir] Profundal artery perforator (PAP)
Combination of IBR and AR
Exclude: Non-autologous flap transplants (i.e., cadaveric or
xenotransplant)
Exclude: Exclusive lipofilling/autologous fat reconstruction
Outcomes
Quality of life
Physical well-being (e.g., pain, discomfort)
Psychosocial well-being (e.g., self-esteem, emotionality,
normality)
Sexual well-being
Patient satisfaction with aesthetics (i.e., satisfaction with
breast)
Patient satisfaction with outcome (e.g., satisfaction with
care)
Planned staged surgeries for reconstruction
Recurrence of breast cancer
Harms
[cir] Mortality
[cir] Unplanned repeat hospitalization
[cir] Duration of unplanned repeat hospitalization
[cir] Unplanned repeat surgeries--for revision of reconstruction
(e.g., for asymmetry)
[cir] Unplanned repeat surgeries--for complications (e.g., for
infection, bleeding)*
[cir] Pain, including chronic pain
[cir] Analgesic (e.g., opioid) use
[cir] Necrosis, such as of the nipple or of the flap
[cir] Animation deformity
[cir] Complications that lead to delays in other cancer-related
treatments (e.g., chemotherapy, radiation therapy)
[cir] Thromboembolic events
[cir] Infection
[cir] Wound dehiscence
[cir] Delayed healing
[cir] Seroma
[cir] Chronic conditions (e.g., rheumatologic diseases)
[cir] Touch sensitivity
[cir] Scarring
Potential Effect Modifiers
Age
Stage of breast cancer
First occurrence versus recurrent breast cancer
Immediate versus delayed reconstruction
Single-stage (direct to reconstruction) versus multi-stage
(with tissue expander) reconstruction
Unilateral versus bilateral reconstruction
Radiation therapy versus no radiation therapy
Chemotherapy versus no chemotherapy
Timing
Any
Setting
Any, including single- and multicenter
Design
Randomized controlled trials (RCTs), N>=10 per group
Nonrandomized comparative studies (NRCSs), N>=30 per group
Case-control studies, N>=100 per group
Single group studies, N>=500
Studies may be prospective or retrospective
Exclude: case reports and series of individually-reported case
reports
Key Question 2 (Optimal Time For IBR or AR)
Population(s)
Adult (>=18 years old) women who are undergoing IBR or AR
after a
[[Page 39906]]
mastectomy for breast cancer (or carcinoma in situ) that requires
either chemotherapy or radiation therapy
Either therapeutic or prophylactic mastectomy
Exclude: Studies where >=10% of women underwent breast
reconstruction (combined across reasons):
[cir] For solely cosmetic purposes (i.e., augmentation)
[cir] for solely prophylactic purposes (i.e., without diagnosed
breast cancer)
[cir] for revision reconstruction (i.e., after a previous
reconstruction for breast cancer)
Interventions
(a) IBR or AR before chemotherapy
(b) IBR or AR before radiation therapy
[cir] Either single- or multistage
[cir] With or without mastectomy and reconstruction of the
contralateral breast (i.e., unilateral or bilateral)
[cir] With or without symmetry procedure (e.g., mastopexy) in the
contralateral breast
[cir] With or without use of human ADM
[cir] For IBR--Any type of implant material, either smooth or
textured
[cir] For IBR--Any anatomic plane of implant placement
[cir] For AR--Any flap type
Comparators
(a) IBR or AR after chemotherapy
(b) IBR or AR after radiation therapy
Outcomes
Quality of life
Physical well-being (e.g., pain, discomfort)
Psychosocial well-being (e.g., self-esteem, emotionality,
normality)
Sexual well-being
Patient satisfaction with aesthetics (i.e., satisfaction with
breast)
Patient satisfaction with outcome (e.g., satisfaction with
care)
Planned staged surgeries for reconstruction
Recurrence of breast cancer
Harms
[cir] Mortality
[cir] Unplanned repeat hospitalization
[cir] Duration of unplanned repeat hospitalization
[cir] Unplanned repeat surgeries--for revision of reconstruction
(e.g., for asymmetry)
[cir] Unplanned repeat surgeries--for complications (e.g., for
infection, bleeding)*
[cir] Pain, including chronic pain
[cir] Analgesic (e.g., opioid) use
[cir] Necrosis, such as of the nipple or of the flap
[cir] Animation deformity
[cir] Complications that cause delays in other cancer-related
treatments (e.g., chemotherapy, radiation therapy)
[cir] Thromboembolic events
[cir] Infection
[cir] Wound dehiscence
[cir] Delayed healing
[cir] Seroma
[cir] Chronic conditions (e.g., rheumatologic diseases)
[cir] Touch sensitivity
[cir] Scarring
Potential Effect Modifiers:
Age
Stage of breast cancer
First occurrence versus recurrent breast cancer
Type of chemotherapy (for KQ 2a) or radiation therapy (for KQ
2b)
Immediate versus delayed reconstruction
Single-stage (direct to reconstruction) versus multi-stage
(with tissue expander) reconstruction
Unilateral versus bilateral reconstruction
Timing
Any
Setting
Any, including single- and multicenter
Design
RCTs, N>=10 per group
NRCSs, N>=30 per group
Case-control studies, N>=100 per group
Single group studies, N>=500
Studies may be prospective or retrospective
Exclude: case reports and series of individually-reported case
reports
Key Question 3 (Type of Implant Material)
Population(s)
Adult (>=18 years old) women who are undergoing (or have
undergone) mastectomy for any type of breast cancer (or carcinoma in
situ) and have decided to undergo IBR
Either therapeutic or prophylactic mastectomy
Exclude: Studies where >=10% of women underwent breast
reconstruction (combined across reasons):
[cir] For solely cosmetic purposes (i.e., augmentation)
[cir] for revision reconstruction (i.e., after a previous
reconstruction for breast cancer)
Interventions
IBR using one type of implant material
[cir] Saline
[cir] Silicone
[cir] Other materials
[cir] Either smooth or textured
[cir] Either single- or multistage
[cir] Any anatomic plane of implant placement
[cir]
With or without use of human ADM
[cir] With or without mastectomy and reconstruction of the
contralateral breast (i.e., unilateral or bilateral)
[cir] With or without symmetry procedure (e.g., mastopexy) in the
contralateral breast
Comparators
IBR using another type of implant material
Outcomes
Quality of life
Physical well-being (e.g., pain, discomfort)
Psychosocial well-being (e.g., self-esteem, emotionality,
normality)
Sexual well-being
Patient satisfaction with aesthetics (i.e., satisfaction with
breast)
Patient satisfaction with outcome (e.g., satisfaction with
care)
Planned staged surgeries for reconstruction
Recurrence of breast cancer
Harms
[cir] Mortality
[cir] Unplanned repeat hospitalization
[cir] Duration of unplanned repeat hospitalization
[cir] Unplanned repeat surgeries--for revision of reconstruction
(e.g., for asymmetry)
[cir] Unplanned repeat surgeries--for complications (e.g., for
infection, bleeding) *
[cir] Pain, including chronic pain
[cir] Analgesic (e.g., opioid) use
[cir] Necrosis, such as of the nipple
[cir] Animation deformity
[cir] Implant-related infections
[cir] Implant rupture, including asymptomatic rupture
[cir] Implant deflation
[cir] Implant malposition
[cir] Need for explant surgery
[cir] Capsular contracture
[cir] New neoplasms (e.g., BIA-ALCL)
[cir] Complications that cause delays in other cancer-related
treatments (e.g., chemotherapy, radiation therapy)
[cir] Thromboembolic events
[cir] Wound dehiscence
[cir] Delayed healing
[cir] Seroma
[cir] Chronic conditions (e.g., rheumatologic diseases)
[cir] Touch sensitivity
[cir] Scarring
[[Page 39907]]
[cir] Red breast syndrome
Potential Effect Modifiers
Age
Stage of breast cancer
First occurrence versus recurrent breast cancer
Immediate versus delayed reconstruction
Single-stage (direct to reconstruction) versus multistage
(with tissue expander) reconstruction
Unilateral versus bilateral reconstruction
Surface of implant (smooth versus textured)
Shape of implant (round versus anatomic/teardrop)
Size of implant (volume)
Timing
Any
Setting
Any, including single- and multicenter
Design
RCTs, N>=10 per group
NRCSs, N>=30 per group
Case-control studies, N>=100 per group
Single group studies, N>=500
Studies may be prospective or retrospective
Exclude: case reports and series of individually-reported case
reports
Key Question 4 (Anatomic Plane of Implant Placement)
Population(s)
Adult (>=18 years old) women who are undergoing (or have
undergone) mastectomy for any type of breast cancer (or carcinoma in
situ) and have decided to undergo IBR
Either therapeutic or prophylactic mastectomy
Exclude: Studies where >=10% of women underwent breast
reconstruction (combined across reasons):
[cir] for solely cosmetic purposes (i.e., augmentation)
[cir] for revision reconstruction (i.e., after a previous
reconstruction for breast cancer)
Interventions
IBR with implant placement in one anatomic plane
[cir] Prepectoral placement
[cir] Partial submuscular placement
[cir] Total submuscular placement
[cir] Either single- or multi-stage
[cir] Any type of implant material, either smooth or textured
[cir] With or without use of human ADM
[cir] With or without mastectomy and reconstruction of the
contralateral breast (i.e., unilateral or bilateral)
[cir] With or without symmetry procedure (e.g., mastopexy) in the
contralateral breast
Comparators
IBR with implant placement in a different anatomic plane
Outcomes
Quality of life
Physical well-being (e.g., pain, discomfort)
Psychosocial well-being (e.g., self-esteem, emotionality,
normality)
Sexual well-being
Patient satisfaction with aesthetics (i.e., satisfaction with
breast)
Patient satisfaction with outcome (e.g., satisfaction with
care)
Planned staged surgeries for reconstruction
Recurrence of breast cancer
Harms
[cir] Mortality
[cir] Unplanned repeat hospitalization
[cir] Duration of unplanned repeat hospitalization
[cir] Unplanned repeat surgeries--for revision of reconstruction
(e.g., for asymmetry)
[cir] Unplanned repeat surgeries--for complications (e.g., for
infection, bleeding)*
[cir] Pain, including chronic pain
[cir] Analgesic (e.g., opioid) use
[cir] Necrosis, such as of the nipple
[cir] Animation deformity
[cir] Implant-related infections
[cir] Implant rupture, including asymptomatic rupture
[cir] Implant deflation
[cir] Implant malposition
[cir] Need for explant surgery
[cir] Capsular contracture
[cir] New neoplasms (e.g., BIA-ALCL)
[cir] Complications that cause delays in other cancer-related
treatments (e.g., chemotherapy, radiation therapy)
[cir] Thromboembolic events*
[cir] Infection
[cir] Wound dehiscence
[cir] Delayed healing
[cir] Seroma
[cir] Chronic conditions (e.g., rheumatologic diseases)
[cir] Touch sensitivity
[cir] Scarring
[cir] Red breast syndrome
Potential Effect Modifiers:
Age
Stage of breast cancer
First occurrence versus recurrent breast cancer
Immediate versus delayed reconstruction
Single-stage (direct to reconstruction) versus multistage
(with tissue expander) reconstruction
Unilateral versus bilateral reconstruction
Surface of implant (smooth versus textured)
Shape of implant (round versus anatomic/teardrop)
Size of implant (volume)
Timing
Any
Setting
Any, including single- and multicenter
Design
RCTs, N>=10 per group
NRCSs, N>=30 per group
Case-control studies, N>=100 per group
Single group studies, N>=500
Studies may be prospective or retrospective
Exclude: case reports and series of individually-reported case
reports
Key Question 5 (Use of Human ADM)
Population(s)
Adult (>=18 years old) women who are undergoing (or have
undergone mastectomy) for any type of breast cancer (or carcinoma in
situ) and have decided to undergo IBR
Either therapeutic or prophylactic mastectomy
Exclude: Studies where >=10% of women underwent breast
reconstruction (combined across reasons):
[cir] for solely cosmetic purposes (i.e., augmentation)
[cir] for revision reconstruction (i.e., after a previous
reconstruction for breast cancer)
Interventions
IBR with use of human ADM
[cir] Either single- or multistage
[cir] Any anatomic plane of implant placement
[cir] Any type of implant material, either smooth or textured
[cir] With or without mastectomy and reconstruction of the
contralateral breast (i.e., unilateral or bilateral)
[cir] With or without symmetry procedure (e.g., mastopexy) in the
contralateral breast
Comparators
IBR without use of human or nonhuman ADM
Outcomes
Quality of life
Physical well-being (e.g., pain, discomfort)
[[Page 39908]]
Psychosocial well-being (e.g., self-esteem, emotionality,
normality)
Sexual well-being
Patient satisfaction with aesthetics (i.e., satisfaction with
breast)
Patient satisfaction with outcome (e.g., satisfaction with
care)
Planned staged surgeries for reconstruction
Recurrence of breast cancer
Harms
[cir] Mortality
[cir] Unplanned repeat hospitalization
[cir] Duration of unplanned repeat hospitalization
[cir] Unplanned repeat surgeries--for revision of reconstruction
(e.g., for asymmetry)
[cir] Unplanned repeat surgeries--for complications (e.g., for
infection, bleeding)
[cir] Pain, including chronic pain
[cir] Analgesic (e.g., opioid) use
[cir] Necrosis, such as of the nipple
[cir] Animation deformity
[cir] Implant-related infections
[cir] Implant rupture, including asymptomatic rupture
[cir] Implant deflation
[cir] Implant malposition
[cir] Need for explant surgery
[cir] Capsular contracture
[cir] New neoplasms (e.g., BIA-ALCL)
[cir] Complications that cause delays in other cancer-related
treatments (e.g., chemotherapy, radiation therapy)
[cir] Thromboembolic events
[cir] Infection
[cir] Wound dehiscence
[cir] Delayed healing
[cir] Seroma
[cir] Chronic conditions (e.g., rheumatologic diseases)
[cir] Touch sensitivity
[cir] Scarring
[cir] Red breast syndrome
Potential Effect Modifiers
Age
Stage of breast cancer
First occurrence versus recurrent breast cancer
Immediate versus delayed reconstruction
Single-stage (direct to reconstruction) versus multi-stage
(with tissue expander) reconstruction
Unilateral versus bilateral reconstruction
Anatomic plane of implant placement (prepectoral versus
partial submuscular versus total submusclar)
Surface of implant (smooth versus textured)
Shape of implant (round versus anatomic/teardrop)
Size of implant (volume)
Brand of human ADM (e.g., Alloderm[supreg], FlexHD[supreg],
BellaDerm[supreg], AlloMax[supreg], Cortiva[supreg], DermACELL[supreg])
Timing
Any
Setting
Any, including single- and multicenter
Design
RCTs, N>=10 per group
NRCSs, N>=30 per group
Case-control studies, N>=100 per group
Single group studies, N>=500
Studies may be prospective or retrospective
Exclude: case reports and series of individually-reported case
reports
Key Question 6 (Different Flap Types For AR)
Population(s)
Adult (>=18 years old) women who are undergoing (or have
undergone mastectomy) for any type of breast cancer (or carcinoma in
situ) and have decided to undergo AR
Either therapeutic or prophylactic mastectomy
Exclude: Studies where >=10% of women underwent breast
reconstruction (combined across reasons):
[cir] for solely cosmetic purposes (i.e., augmentation)
[cir] for revision reconstruction (i.e., after a previous
reconstruction for breast cancer)
Interventions
AR using one flap (either free flap or pedicled), for example:
[cir] Deep inferior epigastric perforator (DIEP)
[cir] Latissimus dorsi (LD)
[cir] Transverse rectus abdominis myocutaneous (TRAM)
[cir] Superficial inferior epigastric artery perforator (SIEA)
[cir] Gluteal artery perforator (GAP)
[cir] Transverse musculocutaneous gracilis (TMG)
[cir] Transverse upper gracilis (TUG)
[cir] Profundal artery perforator (PAP)
[cir] With or without mastectomy and reconstruction of the
contralateral breast (i.e., unilateral or bilateral)
[cir] With or without symmetry procedure (e.g., mastopexy) in the
contralateral breast
[cir] Exclude: Non-autologous flap transplants (i.e., cadaveric or
xenotransplant)
[cir] Exclude: Exclusive lipofilling/autologous fat reconstruction
Comparators
AR using a different flap (either free flap or pedicled)
Combination of IBR and AR
Exclude: Non-autologous flap transplants (i.e., cadaveric or
xenotransplant)
Exclude: Exclusive lipofilling/autologous fat reconstruction
Outcomes
Quality of life
Physical well-being (e.g., pain, discomfort)
Psychosocial well-being (e.g., self-esteem, emotionality,
normality)
Sexual well-being
Patient satisfaction with aesthetics (i.e., satisfaction with
breast)
Patient satisfaction with outcome (e.g., satisfaction with
care)
Planned staged surgeries for reconstruction
Duration of initial hospitalization
Recurrence of breast cancer
Harms
[cir] Mortality
[cir] Unplanned repeat hospitalization
[cir] Duration of unplanned repeat hospitalization
[cir] Unplanned repeat surgeries--for revision of reconstruction
(e.g., for asymmetry)
[cir] Unplanned repeat surgeries--for complications (e.g., for
infection, bleeding)
[cir] Pain, including chronic pain
[cir] Analgesic (e.g., opioid) use
[cir] Necrosis, such as of the nipple or of the flap
[cir] Harms to area of flap harvest (e.g., hernia, bulge formation)
[cir] Complications that lead to delays in other cancer-related
treatments (e.g., chemotherapy, radiation therapy)
[cir] Thromboembolic events
[cir] Infection
[cir] Wound dehiscence
[cir] Delayed healing
[cir] Seroma
[cir] Touch sensitivity
[cir] Scarring
Potential Effect Modifiers
Age
Stage of breast cancer
First occurrence versus recurrent breast cancer
Immediate versus delayed reconstruction
Single-stage (direct to reconstruction) versus multi-stage
(with tissue expander) reconstruction
Unilateral versus bilateral reconstruction
Timing
Any
[[Page 39909]]
Setting
Any, including single- and multicenter
Design
RCTs, N>=10 per group
NRCSs, N>=30 per group
Case-control studies, N>=100 per group
Single group studies, N>=500
Studies may be prospective or retrospective
Exclude: case reports and series of individually-reported case
reports
Dated: June 26, 2020.
Virginia Mackay-Smith,
Associate Director.
[FR Doc. 2020-14237 Filed 7-1-20; 8:45 am]
BILLING CODE 4160-90-P
