Supplemental Evidence and Data Request on Breast Reconstruction After Mastectomy, 39904-39909 [2020-14237]

Download as PDF 39904 Federal Register / Vol. 85, No. 128 / Thursday, July 2, 2020 / Notices Control Act (Act) (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the applications are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)). The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board’s Freedom of Information Office at https://www.federalreserve.gov/foia/ request.htm. Interested persons may express their views in writing on the standards enumerated in paragraph 7 of the Act. Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue, NW, Washington DC 20551–0001, not later than July 17, 2020. A. Federal Reserve Bank of St. Louis (David L. Hubbard, Senior Manager) P.O. Box 442, St. Louis, Missouri 63166–2034. Comments can also be sent electronically to Comments.applications@stls.frb.org: 1. Kyle Townsend, Linden, Tennessee, and Valerie Townsend, Parsons, Tennessee; individually and as members of the Townsend Family Control Group, also of Parsons, Tennessee, a group acting in concert to retain voting shares of Townsend Financial Corporation and thereby indirectly retain voting shares of Farmers Bank, both of Parsons, Tennessee. Board of Governors of the Federal Reserve System, June 29, 2020. Yao-Chin Chao, Assistant Secretary of the Board. [FR Doc. 2020–14322 Filed 7–1–20; 8:45 am] khammond on DSKJM1Z7X2PROD with NOTICES BILLING CODE 6210–01–P VerDate Sep<11>2014 21:18 Jul 01, 2020 Jkt 250001 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 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 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. E:\FR\FM\02JYN1.SGM 02JYN1 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) VerDate Sep<11>2014 21:18 Jul 01, 2020 Jkt 250001 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 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 39905 • 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 E:\FR\FM\02JYN1.SGM 02JYN1 39906 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 VerDate Sep<11>2014 21:18 Jul 01, 2020 Jkt 250001 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 PO 00000 Frm 00038 Fmt 4703 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 E:\FR\FM\02JYN1.SGM 02JYN1 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 VerDate Sep<11>2014 21:18 Jul 01, 2020 Jkt 250001 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 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 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) E:\FR\FM\02JYN1.SGM 02JYN1 39908 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) VerDate Sep<11>2014 21:18 Jul 01, 2020 Jkt 250001 • 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

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[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.

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review on 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