82_FR_17496 82 FR 17428 - Supplemental Evidence and Data Request on Systematic Review of Breastfeeding Programs and Policies, Breastfeeding Uptake, and Maternal Health Outcomes in Developed Countries

82 FR 17428 - Supplemental Evidence and Data Request on Systematic Review of Breastfeeding Programs and Policies, Breastfeeding Uptake, and Maternal Health Outcomes in Developed Countries

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality

Federal Register Volume 82, Issue 68 (April 11, 2017)

Page Range17428-17430
FR Document2017-07157

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 of Systematic Review of Breastfeeding Programs and Policies, Breastfeeding Uptake, and Maternal Health Outcomes in Developed Countries, which is currently being conducted by the AHRQ's Evidence-based Practice CentersProgram. Access to published and unpublished pertinent scientific information will improve the quality of this review.

Federal Register, Volume 82 Issue 68 (Tuesday, April 11, 2017)
[Federal Register Volume 82, Number 68 (Tuesday, April 11, 2017)]
[Notices]
[Pages 17428-17430]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-07157]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Systematic Review of 
Breastfeeding Programs and Policies, Breastfeeding Uptake, and Maternal 
Health Outcomes in Developed Countries

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for supplemental evidence and data submissions.

-----------------------------------------------------------------------

SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review of Systematic 
Review of Breastfeeding Programs and Policies, Breastfeeding Uptake, 
and Maternal Health Outcomes in Developed Countries, which is currently 
being conducted by the AHRQ's Evidence-based Practice CentersProgram. 
Access to published and unpublished pertinent scientific information 
will improve the quality of this review.

DATES: Submission Deadline on or before May 11, 2017.

ADDRESSES: 
    Email submissions: src.org">SEADS@epc-src.org.
    Print submissions: Mailing Address: Portland VA Research 
Foundation, Scientific Resource Center, ATTN: Scientific Information 
Packet Coordinator, P.O. Box 69539, Portland, OR 97239.
    Shipping Address (FedEx, UPS, etc.): Portland VA Research 
Foundation, Scientific Resource Center, ATTN: Scientific Information 
Packet

[[Page 17429]]

Coordinator, 3710 SW U.S. Veterans Hospital Road, Mail Code: R&D 71, 
Portland, OR 97239.

FOR FURTHER INFORMATION CONTACT: Ryan McKenna, Telephone: 503-220-8262 
ext. 51723 or Email: src.org">SEADS@epc-src.org.

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 Systematic Review of 
Breastfeeding Programs and Policies, Breastfeeding Uptake, and Maternal 
Health Outcomes in Developed Countries. 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 Systematic Review of Breastfeeding Programs and 
Policies, Breastfeeding Uptake, and Maternal Health Outcomes in 
Developed Countries, including those that describe adverse events. The 
entire research protocol, including the key questions, is also 
available online at: https://effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=2455
    This is to notify the public that the EPC Program would find the 
following information on Systematic Review of Breastfeeding Programs 
and Policies, Breastfeeding Uptake, and Maternal Health Outcomes in 
Developed Countries 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, please provide 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 will be very beneficial to the EPC Program. The 
contents of all submissions will be made available to the public upon 
request. 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 Web 
site and available for public comment for a period of 4 weeks. If you 
would like to be notified when the draft is posted, please sign up for 
the email list at: https://www.effectivehealthcare.ahrq.gov/index.cfm/join-the-email-list1/.
    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.

The Key Questions

    KQ 1a. What is the effectiveness and harms of programs and policies 
on initiation, duration, and exclusivity of breastfeeding?
    KQ 1b. To what extent do the effectiveness and harms of programs 
and policies on initiation, duration, and exclusivity of breastfeeding 
differ for subpopulations of women defined by sociodemographic factors 
(e.g., age, race, ethnicity, socioeconomic status)?
    KQ 1c. To what extent do intervention-related characteristics 
(e.g., type of breast pump provided--manual or electric; delivery 
personnel) influence the initiation, duration, and exclusivity of 
breast feeding?
    KQ 2a. What are the comparative benefits and harms for maternal 
health outcomes among women who breastfeed for different intensities 
and durations?
    KQ 2b. To what extent do benefits and harms for maternal health 
outcomes differ for subpopulations of women defined by age, race, 
ethnicity, and comorbidity?

Population(s)

    KQs 1, 2: Childbearing women and adolescents; we will also search 
for evidence on subgroups of women defined by age, race, ethnicity, 
comorbidity, and socioeconomic status (including insurance status and 
payer type).

Interventions/Exposure

    KQ 1: Community, workplace, and health care system-based 
interventions aimed at promoting and supporting breastfeeding, 
including the following: Health plan benefits, state and federal 
policies or programs (e.g., WIC programs), hospital implementation of 
the BFHI, workplace or school-based programs, and others. For studies 
assessing the effectiveness of BFHI, we will include studies evaluating 
full and partial implementation (at least 3 steps) of the 10 steps.
    KQ 2: Exposure to breastfeeding.

Comparators

    KQ 1: No intervention (or usual practice); comparisons of two 
interventions that differ in content or intensity.
    KQ 2: No breastfeeding; shorter duration of breastfeeding (e.g., 
breastfeeding for 1 month vs. 12 months) and/or less intensive 
breastfeeding (e.g., exclusive breastfeeding vs. mixed feeding or 
formula feeding).

Outcomes

    KQ 1: Rates of breastfeeding initiation; duration and exclusivity 
of breastfeeding, adverse effects of interventions (e.g., guilt about 
not breastfeeding, workplace discrimination, and other reported harms).
    KQ 2: Postpartum depression, breast cancer, ovarian cancer, 
osteoporosis, cardiovascular outcomes (e.g., stroke, myocardial 
infarction), postpartum weight change, type 2 diabetes, hypertension.

Timing

    KQs 1, 2: We will have no minimum study duration or length of 
follow up.

Settings

    KQs 1, 2: Studies conducted in a developed country [``very high'' 
(KQs 1, 2) and ``high'' (KQ 1) human development index per the United 
Nations Development Programme 40.

[[Page 17430]]

Study Design

    KQ 1: Randomized and non-randomized controlled clinical trials; 
prospective cohort studies with concurrent control groups; systematic 
reviews; for studies assessing policy or system-level interventions, we 
will also include pre-post studies with repeated outcome measures 
before and after the intervention.
    KQ 2: Randomized and non-randomized controlled clinical trials; 
cohort studies; case-control studies; systematic reviews.

Sharon B. Arnold,
Acting Director.
[FR Doc. 2017-07157 Filed 4-10-17; 8:45 am]
 BILLING CODE 4160-90-P



                                                17428                                     Federal Register / Vol. 82, No. 68 / Tuesday, April 11, 2017 / Notices

                                                Method of Collection                                                        due AHRQ notifies principal                                    federally mandated programs and
                                                  To achieve the goals of this project,                                     investigators and vendors via email.                           regulations.
                                                the following data collections will be                                         The ARRS is an automated, user-                             Estimated Annual Respondent Burden
                                                implemented:                                                                friendly resource that is utilized by
                                                  AHRQ Research Reporting System                                            AHRQ staff for preparing, distributing,                          Exhibit 1 shows the estimated
                                                (ARRS)—Grantees and vendors use the                                         and reviewing reporting requests to                            annualized burden hours for the
                                                ARRS system to report project progress                                      grantees and vendors for the purpose of                        respondents. It will take grantees and
                                                and important preliminary findings for                                      information sharing. AHRQ personnel                            vendors an estimated 10 minutes to
                                                grants and contracts funded by the                                          are able to systematically search the                          enter the necessary data into the ARRS
                                                Agency. Grantees and vendors submit                                         information collected and stored in the                        System and reporting will occur four
                                                progress reports on a monthly or                                            ARRS database. Personnel will also use                         times annually. The total annualized
                                                quarterly basis which are reviewed by                                       the information to address internal and/                       burden hours are estimated to be 333
                                                AHRQ personnel. All users access the                                        or external requests for information                           hours.
                                                ARRS system through a secure online                                         regarding grant progress, preliminary                            Exhibit 2 shows the estimated
                                                interface which requires a user I.D. and                                    findings, and other requests, such as                          annualized cost burden for the
                                                password entered through the ARRS                                           Freedom of Information Act requests                            respondents. The total estimated cost
                                                login screen. When status reports are                                       and producing responses related to                             burden for respondents is $12,454.

                                                                                                               EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                           Number of
                                                                                                                                                                          Number of                           Hours per         Total
                                                                                                 Form name                                                                               responses per
                                                                                                                                                                         respondents                          response      burden hours
                                                                                                                                                                                           respondent

                                                Data entry into ARRS ......................................................................................                        500                 4            10/60            333

                                                      Total ..........................................................................................................             500               N/A             N/A             333


                                                                                                                EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
                                                                                                                                                                                                               Average
                                                                                                                                                                          Number of       Total burden                       Total cost
                                                                                                 Form name                                                                                                   hourly wage
                                                                                                                                                                         respondents         hours                            burden
                                                                                                                                                                                                                rate *

                                                Data entry into ARRS ......................................................................................                        500               333           $37.40        $12,454

                                                      Total ..........................................................................................................             500               333             N/A          12,454
                                                   * Based upon the average wages for Healthcare Practitioner and Technical Occupations (29–0000), ‘‘National Compensation Survey: Occupa-
                                                tional Wages in the United States, May 2015,’’ U.S. Department of Labor, Bureau of Labor Statistics, http://www.bls.gov/oes/current/oes_
                                                nat.htm#29-0000.


                                                Request for Comments                                                        comments will become a matter of                               scientific information submissions from
                                                                                                                            public record.                                                 the public. Scientific information is
                                                  In accordance with the Paperwork                                                                                                         being solicited to inform our review of
                                                Reduction Act, comments on AHRQ’s                                           Sharon B. Arnold,
                                                                                                                                                                                           Systematic Review of Breastfeeding
                                                information collection are requested                                        Acting Director.                                               Programs and Policies, Breastfeeding
                                                with regard to any of the following: (a)                                    [FR Doc. 2017–07156 Filed 4–10–17; 8:45 am]                    Uptake, and Maternal Health Outcomes
                                                Whether the proposed collection of                                          BILLING CODE 4160–90–P                                         in Developed Countries, which is
                                                information is necessary for the proper                                                                                                    currently being conducted by the
                                                performance of AHRQ health care                                                                                                            AHRQ’s Evidence-based Practice
                                                research and health care information                                        DEPARTMENT OF HEALTH AND                                       CentersProgram. Access to published
                                                dissemination functions, including                                          HUMAN SERVICES                                                 and unpublished pertinent scientific
                                                whether the information will have                                                                                                          information will improve the quality of
                                                practical utility; (b) the accuracy of                                      Agency for Healthcare Research and
                                                                                                                                                                                           this review.
                                                AHRQ’s estimate of burden (including                                        Quality
                                                                                                                                                                                           DATES: Submission Deadline on or
                                                hours and costs) of the proposed                                                                                                           before May 11, 2017.
                                                collection(s) of information; (c) ways to                                   Supplemental Evidence and Data
                                                                                                                            Request on Systematic Review of                                ADDRESSES:
                                                enhance the quality, utility and clarity                                                                                                     Email submissions: SEADS@epc-
                                                of the information to be collected; and                                     Breastfeeding Programs and Policies,
                                                                                                                            Breastfeeding Uptake, and Maternal                             src.org.
                                                (d) ways to minimize the burden of the                                                                                                       Print submissions: Mailing Address:
                                                collection of information upon the                                          Health Outcomes in Developed
                                                                                                                            Countries                                                      Portland VA Research Foundation,
                                                respondents, including the use of                                                                                                          Scientific Resource Center, ATTN:
srobinson on DSK5SPTVN1PROD with NOTICES




                                                automated collection techniques or                                          AGENCY:  Agency for Healthcare Research                        Scientific Information Packet
                                                other forms of information technology.                                      and Quality (AHRQ), HHS.                                       Coordinator, P.O. Box 69539, Portland,
                                                  Comments submitted in response to                                         ACTION: Request for supplemental                               OR 97239.
                                                this notice will be summarized and                                          evidence and data submissions.                                   Shipping Address (FedEx, UPS, etc.):
                                                included in the Agency’s subsequent                                                                                                        Portland VA Research Foundation,
                                                request for OMB approval of the                                             SUMMARY:  The Agency for Healthcare                            Scientific Resource Center, ATTN:
                                                proposed information collection. All                                        Research and Quality (AHRQ) is seeking                         Scientific Information Packet


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                                                                               Federal Register / Vol. 82, No. 68 / Tuesday, April 11, 2017 / Notices                                           17429

                                                Coordinator, 3710 SW U.S. Veterans                         D A list of ongoing studies that your                KQ 2b. To what extent do benefits
                                                Hospital Road, Mail Code: R&D 71,                       organization has sponsored for this                   and harms for maternal health outcomes
                                                Portland, OR 97239.                                     indication. In the list, please provide the           differ for subpopulations of women
                                                FOR FURTHER INFORMATION CONTACT:
                                                                                                        ClinicalTrials.gov trial number or, if the            defined by age, race, ethnicity, and
                                                Ryan McKenna, Telephone: 503–220–                       trial is not registered, the protocol for             comorbidity?
                                                8262 ext. 51723 or Email: SEADS@epc-                    the study including a study number, the
                                                                                                                                                              Population(s)
                                                src.org.                                                study period, design, methodology,
                                                                                                        indication and diagnosis, proper use                     KQs 1, 2: Childbearing women and
                                                SUPPLEMENTARY INFORMATION: The                          instructions, inclusion and exclusion                 adolescents; we will also search for
                                                Agency for Healthcare Research and                      criteria, and primary and secondary                   evidence on subgroups of women
                                                Quality has commissioned the                            outcomes.                                             defined by age, race, ethnicity,
                                                Evidence-based Practice Centers (EPC)                      D Description of whether the above                 comorbidity, and socioeconomic status
                                                Program to complete a review of the                     studies constitute ALL Phase II and                   (including insurance status and payer
                                                evidence for Systematic Review of                       above clinical trials sponsored by your               type).
                                                Breastfeeding Programs and Policies,                    organization for this indication and an
                                                Breastfeeding Uptake, and Maternal                                                                            Interventions/Exposure
                                                                                                        index outlining the relevant information
                                                Health Outcomes in Developed                            in each submitted file.                                 KQ 1: Community, workplace, and
                                                Countries. AHRQ is conducting this                         Your contribution will be very                     health care system-based interventions
                                                systematic review pursuant to Section                   beneficial to the EPC Program. The                    aimed at promoting and supporting
                                                902(a) of the Public Health Service Act,                contents of all submissions will be made              breastfeeding, including the following:
                                                42 U.S.C. 299a(a).                                      available to the public upon request.                 Health plan benefits, state and federal
                                                   The EPC Program is dedicated to                      Materials submitted must be publicly                  policies or programs (e.g., WIC
                                                identifying as many studies as possible                 available or able to be made public.                  programs), hospital implementation of
                                                that are relevant to the questions for                  Materials that are considered                         the BFHI, workplace or school-based
                                                each of its reviews. In order to do so, we              confidential; marketing materials; study              programs, and others. For studies
                                                are supplementing the usual manual                      types not included in the review; or                  assessing the effectiveness of BFHI, we
                                                and electronic database searches of the                 information on indications not included               will include studies evaluating full and
                                                literature by requesting information                    in the review cannot be used by the EPC               partial implementation (at least 3 steps)
                                                from the public (e.g., details of studies               Program. This is a voluntary request for              of the 10 steps.
                                                conducted). We are looking for studies                  information, and all costs for complying                KQ 2: Exposure to breastfeeding.
                                                that report on Systematic Review of                     with this request must be borne by the                Comparators
                                                Breastfeeding Programs and Policies,                    submitter.
                                                Breastfeeding Uptake, and Maternal                         The draft of this review will be posted              KQ 1: No intervention (or usual
                                                Health Outcomes in Developed                            on AHRQ’s EPC Program Web site and                    practice); comparisons of two
                                                Countries, including those that describe                available for public comment for a                    interventions that differ in content or
                                                adverse events. The entire research                     period of 4 weeks. If you would like to               intensity.
                                                protocol, including the key questions, is               be notified when the draft is posted,                   KQ 2: No breastfeeding; shorter
                                                also available online at: https://                      please sign up for the email list at:                 duration of breastfeeding (e.g.,
                                                effectivehealthcare.ahrq.gov/search-for-                https://                                              breastfeeding for 1 month vs. 12
                                                guides-reviews-and-reports/                             www.effectivehealthcare.ahrq.gov/                     months) and/or less intensive
                                                ?pageaction=displayproduct                              index.cfm/join-the-email-list1/.                      breastfeeding (e.g., exclusive
                                                &productID=2455                                            The systematic review will answer the              breastfeeding vs. mixed feeding or
                                                   This is to notify the public that the                following questions. This information is              formula feeding).
                                                EPC Program would find the following                    provided as background. AHRQ is not                   Outcomes
                                                information on Systematic Review of                     requesting that the public provide
                                                                                                        answers to these questions.                             KQ 1: Rates of breastfeeding initiation;
                                                Breastfeeding Programs and Policies,
                                                                                                                                                              duration and exclusivity of
                                                Breastfeeding Uptake, and Maternal                      The Key Questions                                     breastfeeding, adverse effects of
                                                Health Outcomes in Developed
                                                                                                           KQ 1a. What is the effectiveness and               interventions (e.g., guilt about not
                                                Countries helpful:
                                                                                                        harms of programs and policies on                     breastfeeding, workplace
                                                   D A list of completed studies that                   initiation, duration, and exclusivity of              discrimination, and other reported
                                                your organization has sponsored for this                breastfeeding?                                        harms).
                                                indication. In the list, please indicate                   KQ 1b. To what extent do the                         KQ 2: Postpartum depression, breast
                                                whether results are available on                        effectiveness and harms of programs                   cancer, ovarian cancer, osteoporosis,
                                                ClinicalTrials.gov along with the                       and policies on initiation, duration, and             cardiovascular outcomes (e.g., stroke,
                                                ClinicalTrials.gov trial number.                        exclusivity of breastfeeding differ for               myocardial infarction), postpartum
                                                   D For completed studies that do not                  subpopulations of women defined by                    weight change, type 2 diabetes,
                                                have results on ClinicalTrials.gov,                     sociodemographic factors (e.g., age, race,            hypertension.
                                                please provide a summary, including                     ethnicity, socioeconomic status)?
                                                the following elements: Study number,                      KQ 1c. To what extent do                           Timing
                                                study period, design, methodology,                      intervention-related characteristics (e.g.,             KQs 1, 2: We will have no minimum
                                                indication and diagnosis, proper use                    type of breast pump provided—manual
srobinson on DSK5SPTVN1PROD with NOTICES




                                                                                                                                                              study duration or length of follow up.
                                                instructions, inclusion and exclusion                   or electric; delivery personnel)
                                                criteria, primary and secondary                                                                               Settings
                                                                                                        influence the initiation, duration, and
                                                outcomes, baseline characteristics,                     exclusivity of breast feeding?                          KQs 1, 2: Studies conducted in a
                                                number of patients screened/eligible/                      KQ 2a. What are the comparative                    developed country [‘‘very high’’ (KQs 1,
                                                enrolled/lost to follow-up/withdrawn/                   benefits and harms for maternal health                2) and ‘‘high’’ (KQ 1) human
                                                analyzed, effectiveness/efficacy, and                   outcomes among women who breastfeed                   development index per the United
                                                safety results.                                         for different intensities and durations?              Nations Development Programme 40.


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                                                17430                          Federal Register / Vol. 82, No. 68 / Tuesday, April 11, 2017 / Notices

                                                Study Design                                            SUPPLEMENTARY INFORMATION:       The                    Your contribution will be very
                                                  KQ 1: Randomized and non-                             Agency for Healthcare Research and                    beneficial to the EPC Program. The
                                                randomized controlled clinical trials;                  Quality has commissioned the                          contents of all submissions will be made
                                                prospective cohort studies with                         Evidence-based Practice Centers (EPC)                 available to the public upon request.
                                                concurrent control groups; systematic                   Program to complete a review of the                   Materials submitted must be publicly
                                                reviews; for studies assessing policy or                evidence for Lower Limb Prosthesis                    available or able to be made public.
                                                system-level interventions, we will also                (LLP). AHRQ is conducting this                        Materials that are considered
                                                include pre-post studies with repeated                  systematic review pursuant to Section                 confidential; marketing materials; study
                                                outcome measures before and after the                   902(a) of the Public Health Service Act,              types not included in the review; or
                                                intervention.                                           42 U.S.C. 299a(a).                                    information on indications not included
                                                  KQ 2: Randomized and non-                                The EPC Program is dedicated to                    in the review cannot be used by the EPC
                                                randomized controlled clinical trials;                  identifying as many studies as possible               Program. This is a voluntary request for
                                                cohort studies; case-control studies;                   that are relevant to the questions for                information, and all costs for complying
                                                systematic reviews.                                     each of its reviews. In order to do so, we            with this request must be borne by the
                                                                                                        are supplementing the usual manual                    submitter.
                                                Sharon B. Arnold,                                       and electronic database searches of the                 The draft of this review will be posted
                                                Acting Director.                                        literature by requesting information                  on AHRQ’s EPC Program Web site and
                                                [FR Doc. 2017–07157 Filed 4–10–17; 8:45 am]             from the public (e.g., details of studies             available for public comment for a
                                                BILLING CODE 4160–90–P                                  conducted). We are looking for studies                period of 4 weeks. If you would like to
                                                                                                        that report on Lower Limb Prosthesis,                 be notified when the draft is posted,
                                                                                                        including those that describe adverse                 please sign up for the email list at:
                                                DEPARTMENT OF HEALTH AND                                events. The entire research protocol,                 https://www.effectivehealthcare.
                                                HUMAN SERVICES                                          including the key questions, is also                  ahrq.gov/index.cfm/join-the-email-list1/
                                                                                                        available online at: https://                         .
                                                Agency for Healthcare Research and                      effectivehealthcare.ahrq.gov/search-for-                The systematic review will answer the
                                                Quality                                                 guides-reviews-and-reports/                           following questions. This information is
                                                                                                        ?pageaction=displayproduct&product                    provided as background. AHRQ is not
                                                Supplemental Evidence and Data                                                                                requesting that the public provide
                                                                                                        ID=2451
                                                Request on Lower Limb Prosthesis                                                                              answers to these questions.
                                                                                                           This is to notify the public that the
                                                AGENCY:  Agency for Healthcare Research                 EPC Program would find the following                  The Key Questions
                                                and Quality (AHRQ), HHS.                                information on Lower Limb Prosthesis
                                                                                                        helpful:                                              Key Question 1
                                                ACTION: Request for supplemental
                                                evidence and data submissions.                             D A list of completed studies that                    What assessment techniques used to
                                                                                                        your organization has sponsored for this              measure functional ability of adults
                                                SUMMARY:    The Agency for Healthcare                   indication. In the list, please indicate              with major lower limb amputation have
                                                Research and Quality (AHRQ) is seeking                  whether results are available on                      been evaluated in the published
                                                scientific information submissions from                 ClinicalTrials.gov along with the                     literature?
                                                the public. Scientific information is                   ClinicalTrials.gov trial number.                         I. What are the measurement
                                                being solicited to inform our review of                    D For completed studies that do not                properties of these techniques,
                                                Lower Limb Prosthesis, which is                         have results on ClinicalTrials.gov,                   including: Reliability, validity,
                                                currently being conducted by the                        please provide a summary, including                   responsiveness, minimal detectable
                                                AHRQ’s Evidence-based Practice                          the following elements: study number,                 change, and minimal important
                                                Centers Program. Access to published                    study period, design, methodology,                    difference?
                                                and unpublished pertinent scientific                    indication and diagnosis, proper use                     II. What are the characteristics of the
                                                information will improve the quality of                 instructions, inclusion and exclusion                 participants in studies evaluating
                                                this review.                                            criteria, primary and secondary                       measurement properties of assessment
                                                DATES: Submission Deadline on or                        outcomes, baseline characteristics,                   techniques?
                                                before May 11, 2017.                                    number of patients screened/eligible/                 Key Question 2
                                                ADDRESSES:                                              enrolled/lost to follow-up/withdrawn/
                                                                                                                                                                What prediction tools used to predict
                                                  Email submissions: SEADS@epc-                         analyzed, effectiveness/efficacy, and
                                                                                                                                                              functional outcomes in adults with
                                                src.org.                                                safety results.
                                                                                                                                                              major lower limb amputation have been
                                                  Print submissions:                                       D A list of ongoing studies that your
                                                                                                                                                              evaluated in the published literature?
                                                  Mailing Address: Portland VA                          organization has sponsored for this                     I. What are their characteristics,
                                                Research Foundation, Scientific                         indication. In the list, please provide the           including technical quality (reliability,
                                                Resource Center, ATTN: Scientific                       ClinicalTrials.gov trial number or, if the            validity, responsiveness), minimal
                                                Information Packet Coordinator, P.O.                    trial is not registered, the protocol for             detectable change, and minimal
                                                Box 69539, Portland, OR 97239.                          the study including a study number, the               important difference?
                                                  Shipping Address (FedEx, UPS, etc.):                  study period, design, methodology,                      II. What are the characteristics of the
                                                Portland VA Research Foundation,                        indication and diagnosis, proper use                  participants in these studies?
                                                Scientific Resource Center, ATTN:                       instructions, inclusion and exclusion
                                                Scientific Information Packet                           criteria, and primary and secondary                   Key Question 3
srobinson on DSK5SPTVN1PROD with NOTICES




                                                Coordinator, 3710 SW U.S. Veterans                      outcomes.                                                What functional outcome
                                                Hospital Road, Mail Code: R&D 71,                          D Description of whether the above                 measurement tools used to assess adults
                                                Portland, OR 97239.                                     studies constitute ALL Phase II and                   who use a lower limb prosthesis (LLP)
                                                FOR FURTHER INFORMATION CONTACT:                        above clinical trials sponsored by your               have been evaluated in the published
                                                Ryan McKenna, Telephone: 503–220–                       organization for this indication and an               literature?
                                                8262 ext. 51723 or Email: SEADS@epc-                    index outlining the relevant information                 I. What are their characteristics,
                                                src.org.                                                in each submitted file.                               including technical quality (reliability,


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Document Created: 2017-04-11 00:48:38
Document Modified: 2017-04-11 00:48:38
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionRequest for supplemental evidence and data submissions.
DatesSubmission Deadline on or before May 11, 2017.
ContactRyan McKenna, Telephone: 503-220-8262 ext. 51723 or Email: [email protected]
FR Citation82 FR 17428 

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