Supplemental Evidence and Data Request on Breast Reconstruction After Mastectomy

Published date02 July 2020
Citation85 FR 39904
Record Number2020-14237
SectionNotices
CourtAgency For Healthcare Research And Quality,Health And Human Services Department
Federal Register, Volume 85 Issue 128 (Thursday, July 2, 2020)
[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]
                =======================================================================
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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: 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                published and unpublished pertinent scientific information will improve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
                

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