82_FR_17498 82 FR 17430 - Supplemental Evidence and Data Request on Lower Limb Prosthesis

82 FR 17430 - Supplemental Evidence and Data Request on Lower Limb Prosthesis

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

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

Page Range17430-17433
FR Document2017-07158

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 Lower Limb Prosthesis, which is currently being conducted by the AHRQ's Evidence- based Practice Centers Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.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 17430-17433]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-07158]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Lower Limb Prosthesis

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 Lower Limb 
Prosthesis, which is currently being conducted by the AHRQ's Evidence-
based Practice Centers Program. Access to published and unpublished 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">[email protected]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 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">[email protected]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 Lower Limb Prosthesis 
(LLP). 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 Lower Limb Prosthesis, 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=2451
    This is to notify the public that the EPC Program would find the 
following information on Lower Limb Prosthesis 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

Key Question 1

    What assessment techniques used to measure functional ability of 
adults with major lower limb amputation have been evaluated in the 
published literature?
    I. What are the measurement properties of these techniques, 
including: Reliability, validity, responsiveness, minimal detectable 
change, and minimal important difference?
    II. What are the characteristics of the participants in studies 
evaluating measurement properties of assessment techniques?

Key Question 2

    What prediction tools used to predict functional outcomes in adults 
with major lower limb amputation have been evaluated in the published 
literature?
    I. What are their characteristics, including technical quality 
(reliability, validity, responsiveness), minimal detectable change, and 
minimal important difference?
    II. What are the characteristics of the participants in these 
studies?

Key Question 3

    What functional outcome measurement tools used to assess adults who 
use a lower limb prosthesis (LLP) have been evaluated in the published 
literature?
    I. What are their characteristics, including technical quality 
(reliability,

[[Page 17431]]

validity, responsiveness), minimal detectable change, and minimal 
important difference?
    II. What are the characteristics of the participants in these 
studies?

Key Question 4

    In adults who use an LLP, how do the relative effects on 
ambulatory, functional, and patient-centered outcomes of different 
prosthetic components or levels of components/prostheses vary based on 
study participant characteristics?
    Prosthetic components include: Foot/ankle; knee; socket; liner; 
suspension; pylon; other.
    Study participant characteristics of interest include: K level; 
level of amputation; etiology of amputation; prior function (prior to 
new or replacement LLP); current function; expected potential function/
level of activity and activities (e.g., athletics, uneven surface 
walking); time since amputation; initial vs. subsequent limb LLP; 
unilateral vs bilateral LLP; time since last assessment; age; 
comorbidities that may affect use of LLP (e.g., congestive heart 
failure, vascular dysfunction, skin ulceration/damage, visual 
dysfunction, peripheral neuropathy, local cancer treatment, other lower 
limb disease); type, setting, and description of rehabilitation, 
physical therapy, training; peri-amputation surgery information, 
including surgical details, inpatient rehabilitation details, wound 
status; residence setting; use of assistive devices; comfort of 
existing prosthesis (for patients receiving replacement LLP); 
psychosocial characteristics; family (etc.) support system; training 
and acclimation with LLP.
    I. What assessment techniques that have been evaluated for 
measurement properties were used in these studies?
    A. How do the characteristics of the participants in eligible 
studies that used these specific assessment techniques compare to the 
characteristics of the participants in the studies that evaluated the 
assessment techniques (as per Key Question 1II)?
    B. What is the association between these pre-prescription 
assessment techniques and validated outcomes with the LLP in these 
studies?
    II. What prediction tools that have been evaluated for measurement 
properties were used in these studies?
    A. How do the characteristics of the participants in eligible 
studies that used these specific prediction tools compare to the 
characteristics of the participants in the studies that evaluated the 
prediction tools (as per Key Question 2II)?
    B. What is the association between pre-prescription assessment 
techniques and validated outcomes with the LLP in these studies?
    III. What functional outcomes that have been for measurement 
properties were used in these studies?
    A. How do the characteristics of the participants in eligible 
studies that used these specific functional outcomes compare to the 
characteristics of the participants in the studies that evaluated the 
outcomes (as per Key Question 3II)?

Key Question 5

    How do the patients' pre-prescription expectations of ambulation 
align with their functional outcomes?
    I. How does the level of agreement vary based on the 
characteristics listed in Key Question 4, including level of 
componentry incorporated into their LLP?

Key Question 6

    What is the level of patient satisfaction with the process of 
accessing a LLP (including experiences with both providers and payers)?
    I. How does the level of patient satisfaction vary based on the 
characteristics listed in Key Question 4, including level of 
componentry incorporated into their LLP?

Key Question 7

    At 6 months, 1 year, and 5 years after receipt of a LLP, 
(accounting for intervening mortality, subsequent surgeries or 
injuries) what percentage of individuals maintain bipedal ambulation; 
use their prostheses only for transfers; are housebound vs. ambulating 
in community; have abandoned their prostheses; have major problems with 
prosthesis.
    I. How do these percentages vary based on the following 
characteristics?

A. Patient residence and setting
    i. Living situation (e.g., homebound, institutionalized, community 
ambulation)
    ii. Setting for rehabilitation, physical therapy, or training 
(e.g., in-home or at facility)
B. Patient characteristics
    i. Age
    ii. Level of amputation
    iii. Number of lower limbs amputated (unilateral vs. bilateral)
    iv. Prior level of function (prior to onset of extremity 
disability)
    v. Current level of function
    vi. Etiology of amputation
    vii. Time since amputation
    viii. Comorbidities (e.g., diabetes, CVD, PVD)
    ix. Operative treatment
    x. Use of assistive device
    xi. Cosmesis of the prosthesis
    xii. Comfort of the prosthesis
    xiii. Other
C. Prosthetic componentry

    II. What were the reasons for suboptimal use of the prosthetic 
device?

PICOTS (Population, Intervention, Comparator, Outcomes, Timing, 
Setting)

Pertinent to all Key Questions:

Population
I. Adults with lower limb amputation who are being evaluated for or 
already have an LLP
    A. Lower limb amputees who require or have a lower limb prosthesis
II. Exclude if study includes only participants with battle-related 
trauma
III. Exclude if study includes only congenital amputations (and not 
otherwise Medicare eligible)
IV. Exclude if study includes only children <=18 years old
    A. If a study has a mixed population (related to battle trauma, 
congenital amputations, or pediatrics) and they report subgroup data 
based on these factors, include analyses of relevant populations 
(exclude substudy data on excluded populations). If study reports only 
combined data (e.g., adults and children), include overall study, but 
note issue related to population.
V. Exclude if study conducted in low income or low resource country
Intervention
I. Custom fabricated lower limb prosthesis
II. Specific prosthetic component, including foot/ankle, knee, socket, 
liner, pylon and suspension, or components with specific 
characteristics (e.g., shock absorbing, torque, multiaxial, computer 
assisted, powered, flexion, microprocessor)
III. New or existing definitive or replacement prosthetics
IV. Exclude initial or preparatory prosthetics (used temporarily prior 
to definitive or replacement prostheses immediately after amputation 
surgery)
V. Exclude studies comparing only rehabilitation, physical therapy, or 
training techniques or regimens
VI. Exclude evaluation of orthotics and of implanted devices
Comparators, Outcomes
I. Variable by Key Question
Study Design
I. Published, peer reviewed study

[[Page 17432]]

II. Any language (that can be read by research team or machine 
translated)
III. No publication or study date restriction
IV. Exclude case reports
Setting
I. Patients homebound, institutionalized, community ambulation, any 
residence
II. Clinical or laboratory setting (for evaluation of specific 
ambulatory function outcomes)
III. Rehabilitation setting (e.g., physical therapy clinic, in-home)
IV. Exclude exclusively post-acute (post-surgical) setting or inpatient 
rehabilitation (immediately post-amputation)

Key Question-Specific Criteria

Key Questions 1-3

Population
I. As per criteria pertinent to all Key Questions
II. Also allow studies of amputees, whether or not they use LLPs (Key 
Questions 1 & 2)
Predictors/Tools/Tests/etc. (Key Questions 1 & 2)
I. Assessment techniques (that are used prior to prescription) (Key 
Question 1)
    A. Tests, scales, questionnaires that assess current functional or 
health status
    B. Include patient history and physical examination
    C. Measures of physical function and functional capacity (e.g., 
parallel bar ambulation without LLP)
    D. Exclude single factors (e.g., time since surgery, fasting blood 
glucose)
II. Predictor tools (used prior to prescription to predict functional 
outcomes with prosthesis) (Key Question 2)
    A. Tests, scales, questionnaires
    B. Exclude single factors (e.g., time since surgery, fasting blood 
glucose)
Outcomes
I. Functional, patient centered, or ambulatory outcomes per Key 
Question 4
Study Design
I. Any assessment of validity, reliability, reproducibility, and 
related characteristics
II. Exclude studies of validation of translations of non-English 
scales, indexes, etc.
III. Any study design
IV. No minimum sample size (except not case reports)
V. No minimum followup time

Key Question 4

Population, Intervention
I. As per criteria pertinent to all Key Questions
Comparators
II. LLPs with different components (e.g., feet/ankles, knees, sockets, 
pylons, liners, suspension), or that differ in other ways
Outcomes
I. Functional or patient-centered outcomes (measured or related to 
status in the community)
    A. Quality of life
    B. Disability measures
    C. Activities of daily living
    D. Mobility measures, including use of prostheses only for 
transfers
    E. Self-care
    F. Pain
    G. Fatigue post-use (e.g., end of day)
    H. Daily activity
    I. Time LLP worn per day
    J. Falls
    K. Satisfaction with LLP
    L. Exclude (simple) preference
II. Ambulatory functional outcomes
    A. Gait speed, step count, walk distance
    B. Uneven or wet surface, low lighting walking
    C. Ramps and incline traversing
    D. Step/stair climbing function
    E. Ambulatory function measured in the community setting (e.g., 
self-report or activity monitors)
    F. Achievement of bipedal ambulation
    G. Other patient-centered ambulatory function measures
    H. Exclude biomechanical measures
III. Adverse effects of LLP
    A. Skin ulcers/infections, (injuries from) falls due to mechanical 
failure, etc.
    B. Other problems with prosthesis
Study Design
I. Direct comparison between any two components
II. Must include an analysis or reporting of differences in relative 
effect between components by a patient characteristic of interest (see 
text of Key Question 4) or sufficient participant-level data to make 
such an analysis
III. No minimum sample size (other than no case reports)
IV. No minimum followup time

Key Question 5

Population
I. As per criteria pertinent to all Key Questions
Predictor
I. Any measure of preprescription expectation of ambulation
Outcome
I. Functional, patient-centered, and ambulatory outcomes per Key 
Question 4 (Not adverse effects)
Study Design
I. Any study design, including qualitative studies
II. No minimum sample size (other than no case reports)
III. No minimum followup time

Key Question 6

Population
I. As per criteria pertinent to all Key Questions
Intervention
I. Accessing (or attempting to access) a LLP
Outcomes
I. Satisfaction with the process of accessing a LLP
Study Design
I. Any study design, including qualitative studies
II. No minimum sample size (other than no case reports)
III. No minimum followup time

Key Question 7

Population
I. As per criteria pertinent to all Key Questions
Intervention
I. Prescription for a LLP
Outcomes
I. Maintain bipedal ambulation
II. Use of prostheses only for transfers
III. Housebound vs. ambulating in community
IV. Abandonment of prostheses
V. Major problems with prosthesis
Study Design
I. Either longitudinal with follow up since original lower limb 
prosthesis prescription or cross-sectional at timepoint after 
amputation or prescription
II. Minimum follow up time
    A. >=6 month follow up from time of prescription, or
    B. >=1 year follow up from time of amputation, if no data reported 
about time since prescription
III. Minimum sample size
    A. If subgroup analyses reported (based on bullet characteristics 
in text of Key Question 7I), N>=10 per

[[Page 17433]]

subgroup (thus, N>=20 total) [this number may change depending on 
available data]
    B. If no subgroup analyses reported, N>=100 total [this number may 
change depending on available data]

Sharon B. Arnold,
Acting Director.
[FR Doc. 2017-07158 Filed 4-10-17; 8:45 am]
 BILLING CODE 4160-90-P



                                                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,


                                           VerDate Sep<11>2014   20:18 Apr 10, 2017   Jkt 241001   PO 00000   Frm 00024   Fmt 4703   Sfmt 4703   E:\FR\FM\11APN1.SGM   11APN1


                                                                               Federal Register / Vol. 82, No. 68 / Tuesday, April 11, 2017 / Notices                                            17431

                                                validity, responsiveness), minimal                        B. What is the association between                    x. Use of assistive device
                                                detectable change, and minimal                          pre-prescription assessment techniques                  xi. Cosmesis of the prosthesis
                                                important difference?                                   and validated outcomes with the LLP in                  xii. Comfort of the prosthesis
                                                  II. What are the characteristics of the               these studies?                                          xiii. Other
                                                participants in these studies?                            III. What functional outcomes that                  C. Prosthetic componentry
                                                                                                        have been for measurement properties                    II. What were the reasons for
                                                Key Question 4                                                                                                suboptimal use of the prosthetic device?
                                                                                                        were used in these studies?
                                                   In adults who use an LLP, how do the                   A. How do the characteristics of the
                                                relative effects on ambulatory,                                                                               PICOTS (Population, Intervention,
                                                                                                        participants in eligible studies that used            Comparator, Outcomes, Timing,
                                                functional, and patient-centered                        these specific functional outcomes
                                                outcomes of different prosthetic                                                                              Setting)
                                                                                                        compare to the characteristics of the
                                                components or levels of components/                     participants in the studies that                      Pertinent to all Key Questions:
                                                prostheses vary based on study                          evaluated the outcomes (as per Key
                                                participant characteristics?                                                                                  Population
                                                                                                        Question 3II)?
                                                   Prosthetic components include: Foot/                                                                       I. Adults with lower limb amputation
                                                ankle; knee; socket; liner; suspension;                 Key Question 5                                              who are being evaluated for or
                                                pylon; other.                                             How do the patients’ pre-prescription                     already have an LLP
                                                   Study participant characteristics of                 expectations of ambulation align with                    A. Lower limb amputees who require
                                                interest include: K level; level of                     their functional outcomes?                                  or have a lower limb prosthesis
                                                amputation; etiology of amputation;                       I. How does the level of agreement                  II. Exclude if study includes only
                                                prior function (prior to new or                         vary based on the characteristics listed                    participants with battle-related
                                                replacement LLP); current function;                     in Key Question 4, including level of                       trauma
                                                expected potential function/level of                    componentry incorporated into their                   III. Exclude if study includes only
                                                activity and activities (e.g., athletics,               LLP?                                                        congenital amputations (and not
                                                uneven surface walking); time since                                                                                 otherwise Medicare eligible)
                                                amputation; initial vs. subsequent limb                 Key Question 6                                        IV. Exclude if study includes only
                                                LLP; unilateral vs bilateral LLP; time                    What is the level of patient                              children ≤18 years old
                                                since last assessment; age; comorbidities               satisfaction with the process of                         A. If a study has a mixed population
                                                that may affect use of LLP (e.g.,                       accessing a LLP (including experiences                      (related to battle trauma, congenital
                                                congestive heart failure, vascular                      with both providers and payers)?                            amputations, or pediatrics) and they
                                                dysfunction, skin ulceration/damage,                      I. How does the level of patient                          report subgroup data based on these
                                                visual dysfunction, peripheral                          satisfaction vary based on the                              factors, include analyses of relevant
                                                neuropathy, local cancer treatment,                     characteristics listed in Key Question 4,                   populations (exclude substudy data
                                                other lower limb disease); type, setting,               including level of componentry                              on excluded populations). If study
                                                and description of rehabilitation,                      incorporated into their LLP?                                reports only combined data (e.g.,
                                                physical therapy, training; peri-                                                                                   adults and children), include
                                                                                                        Key Question 7                                              overall study, but note issue related
                                                amputation surgery information,
                                                including surgical details, inpatient                     At 6 months, 1 year, and 5 years after                    to population.
                                                rehabilitation details, wound status;                   receipt of a LLP, (accounting for                     V. Exclude if study conducted in low
                                                residence setting; use of assistive                     intervening mortality, subsequent                           income or low resource country
                                                devices; comfort of existing prosthesis                 surgeries or injuries) what percentage of             Intervention
                                                (for patients receiving replacement                     individuals maintain bipedal
                                                                                                                                                              I. Custom fabricated lower limb
                                                LLP); psychosocial characteristics;                     ambulation; use their prostheses only
                                                                                                                                                                    prosthesis
                                                family (etc.) support system; training                  for transfers; are housebound vs.
                                                                                                                                                              II. Specific prosthetic component,
                                                and acclimation with LLP.                               ambulating in community; have
                                                                                                                                                                    including foot/ankle, knee, socket,
                                                   I. What assessment techniques that                   abandoned their prostheses; have major
                                                                                                                                                                    liner, pylon and suspension, or
                                                have been evaluated for measurement                     problems with prosthesis.
                                                                                                                                                                    components with specific
                                                properties were used in these studies?                    I. How do these percentages vary
                                                                                                                                                                    characteristics (e.g., shock
                                                   A. How do the characteristics of the                 based on the following characteristics?
                                                                                                                                                                    absorbing, torque, multiaxial,
                                                participants in eligible studies that used              A. Patient residence and setting                            computer assisted, powered,
                                                these specific assessment techniques                      i. Living situation (e.g., homebound,                     flexion, microprocessor)
                                                compare to the characteristics of the                        institutionalized, community                     III. New or existing definitive or
                                                participants in the studies that                             ambulation)                                            replacement prosthetics
                                                evaluated the assessment techniques (as                   ii. Setting for rehabilitation, physical            IV. Exclude initial or preparatory
                                                per Key Question 1II)?                                       therapy, or training (e.g., in-home or                 prosthetics (used temporarily prior
                                                   B. What is the association between                        at facility)                                           to definitive or replacement
                                                these pre-prescription assessment                       B. Patient characteristics                                  prostheses immediately after
                                                techniques and validated outcomes with                    i. Age                                                    amputation surgery)
                                                the LLP in these studies?                                 ii. Level of amputation                             V. Exclude studies comparing only
                                                   II. What prediction tools that have                    iii. Number of lower limbs amputated                      rehabilitation, physical therapy, or
                                                been evaluated for measurement                               (unilateral vs. bilateral)                             training techniques or regimens
                                                properties were used in these studies?
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                                                                                                          iv. Prior level of function (prior to               VI. Exclude evaluation of orthotics and
                                                   A. How do the characteristics of the                      onset of extremity disability)                         of implanted devices
                                                participants in eligible studies that used                v. Current level of function
                                                these specific prediction tools compare                   vi. Etiology of amputation                          Comparators, Outcomes
                                                to the characteristics of the participants                vii. Time since amputation                          I. Variable by Key Question
                                                in the studies that evaluated the                         viii. Comorbidities (e.g., diabetes,
                                                prediction tools (as per Key Question                        CVD, PVD)                                        Study Design
                                                2II)?                                                     ix. Operative treatment                             I. Published, peer reviewed study


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                                                17432                          Federal Register / Vol. 82, No. 68 / Tuesday, April 11, 2017 / Notices

                                                II. Any language (that can be read by                   V. No minimum followup time                           Predictor
                                                      research team or machine                                                                                I. Any measure of preprescription
                                                                                                        Key Question 4
                                                      translated)                                                                                                  expectation of ambulation
                                                III. No publication or study date                       Population, Intervention
                                                      restriction                                                                                             Outcome
                                                                                                        I. As per criteria pertinent to all Key
                                                IV. Exclude case reports                                     Questions                                        I. Functional, patient-centered, and
                                                Setting                                                                                                            ambulatory outcomes per Key
                                                                                                        Comparators                                                Question 4 (Not adverse effects)
                                                I. Patients homebound,                                  II. LLPs with different components (e.g.,
                                                      institutionalized, community                                                                            Study Design
                                                                                                             feet/ankles, knees, sockets, pylons,
                                                      ambulation, any residence                              liners, suspension), or that differ in           I. Any study design, including
                                                II. Clinical or laboratory setting (for                                                                             qualitative studies
                                                                                                             other ways
                                                      evaluation of specific ambulatory                                                                       II. No minimum sample size (other than
                                                      function outcomes)                                Outcomes                                                    no case reports)
                                                III. Rehabilitation setting (e.g., physical             I. Functional or patient-centered                     III. No minimum followup time
                                                      therapy clinic, in-home)                                outcomes (measured or related to
                                                IV. Exclude exclusively post-acute                                                                            Key Question 6
                                                                                                              status in the community)
                                                      (post-surgical) setting or inpatient                 A. Quality of life                                 Population
                                                      rehabilitation (immediately post-                    B. Disability measures
                                                      amputation)                                                                                             I. As per criteria pertinent to all Key
                                                                                                           C. Activities of daily living                           Questions
                                                Key Question-Specific Criteria                             D. Mobility measures, including use
                                                                                                              of prostheses only for transfers                Intervention
                                                Key Questions 1–3                                          E. Self-care                                       I. Accessing (or attempting to access) a
                                                Population                                                 F. Pain                                                 LLP
                                                                                                           G. Fatigue post-use (e.g., end of day)
                                                I. As per criteria pertinent to all Key                    H. Daily activity                                  Outcomes
                                                     Questions                                             I. Time LLP worn per day
                                                II. Also allow studies of amputees,                                                                           I. Satisfaction with the process of
                                                                                                           J. Falls                                                accessing a LLP
                                                     whether or not they use LLPs (Key                     K. Satisfaction with LLP
                                                     Questions 1 & 2)                                      L. Exclude (simple) preference                     Study Design
                                                Predictors/Tools/Tests/etc. (Key                        II. Ambulatory functional outcomes                    I. Any study design, including
                                                Questions 1 & 2)                                           A. Gait speed, step count, walk                          qualitative studies
                                                                                                              distance                                        II. No minimum sample size (other than
                                                I. Assessment techniques (that are used
                                                                                                           B. Uneven or wet surface, low lighting                   no case reports)
                                                     prior to prescription) (Key Question
                                                                                                              walking                                         III. No minimum followup time
                                                     1)
                                                                                                           C. Ramps and incline traversing
                                                   A. Tests, scales, questionnaires that                                                                      Key Question 7
                                                                                                           D. Step/stair climbing function
                                                     assess current functional or health
                                                                                                           E. Ambulatory function measured in                 Population
                                                     status
                                                                                                              the community setting (e.g., self-
                                                   B. Include patient history and                                                                             I. As per criteria pertinent to all Key
                                                                                                              report or activity monitors)
                                                     physical examination                                                                                          Questions
                                                                                                           F. Achievement of bipedal ambulation
                                                   C. Measures of physical function and
                                                                                                           G. Other patient-centered ambulatory               Intervention
                                                     functional capacity (e.g., parallel
                                                                                                              function measures
                                                     bar ambulation without LLP)                                                                              I. Prescription for a LLP
                                                                                                           H. Exclude biomechanical measures
                                                   D. Exclude single factors (e.g., time
                                                                                                        III. Adverse effects of LLP                           Outcomes
                                                     since surgery, fasting blood glucose)
                                                                                                           A. Skin ulcers/infections, (injuries               I. Maintain bipedal ambulation
                                                II. Predictor tools (used prior to
                                                                                                              from) falls due to mechanical                   II. Use of prostheses only for transfers
                                                     prescription to predict functional
                                                                                                              failure, etc.                                   III. Housebound vs. ambulating in
                                                     outcomes with prosthesis) (Key
                                                                                                           B. Other problems with prosthesis                        community
                                                     Question 2)
                                                   A. Tests, scales, questionnaires                     Study Design                                          IV. Abandonment of prostheses
                                                   B. Exclude single factors (e.g., time                                                                      V. Major problems with prosthesis
                                                                                                        I. Direct comparison between any two
                                                     since surgery, fasting blood glucose)                    components                                      Study Design
                                                Outcomes                                                II. Must include an analysis or reporting             I. Either longitudinal with follow up
                                                                                                              of differences in relative effect                     since original lower limb prosthesis
                                                I. Functional, patient centered, or
                                                                                                              between components by a patient                       prescription or cross-sectional at
                                                     ambulatory outcomes per Key
                                                                                                              characteristic of interest (see text of               timepoint after amputation or
                                                     Question 4
                                                                                                              Key Question 4) or sufficient                         prescription
                                                Study Design                                                  participant-level data to make such             II. Minimum follow up time
                                                I. Any assessment of validity, reliability,                   an analysis                                        A. ≥6 month follow up from time of
                                                      reproducibility, and related                      III. No minimum sample size (other than                     prescription, or
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                                                      characteristics                                         no case reports)                                   B. ≥1 year follow up from time of
                                                II. Exclude studies of validation of                    IV. No minimum followup time                                amputation, if no data reported
                                                      translations of non-English scales,               Key Question 5                                              about time since prescription
                                                      indexes, etc.                                                                                           III. Minimum sample size
                                                III. Any study design                                   Population                                               A. If subgroup analyses reported
                                                IV. No minimum sample size (except                      I. As per criteria pertinent to all Key                     (based on bullet characteristics in
                                                      not case reports)                                      Questions                                              text of Key Question 7I), N≥10 per


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                                                                               Federal Register / Vol. 82, No. 68 / Tuesday, April 11, 2017 / Notices                                           17433

                                                     subgroup (thus, N≥20 total) [this                  can be found at: https://                             Planning Performance Improvement and
                                                     number may change depending on                     www.regulations.gov/ Docket No. CDC–                  Measurement System Database.
                                                     available data]                                    2016–0067.                                               OMB No. 0915–0384—Extension.
                                                   B. If no subgroup analyses reported,                                                                          Abstract: The purpose of the Rural
                                                                                                          Dated: April 6, 2017.
                                                     N≥100 total [this number may                                                                             Health Network Development Planning
                                                                                                        Frank Hearl,
                                                     change depending on available                                                                            Program (Network Planning) is to assist
                                                                                                        Chief of Staff, National Institute for                in the development of an integrated
                                                     data]                                              Occupational Safety and Health, Centers for           health care network, specifically for
                                                Sharon B. Arnold,                                       Disease Control and Prevention.
                                                                                                                                                              entities that do not have a history of
                                                Acting Director.                                        [FR Doc. 2017–07275 Filed 4–10–17; 8:45 am]
                                                                                                                                                              formal collaborative efforts. Health care
                                                [FR Doc. 2017–07158 Filed 4–10–17; 8:45 am]             BILLING CODE 4163–19–P                                networks can be an effective strategy to
                                                BILLING CODE 4160–90–P                                                                                        help smaller rural health care providers
                                                                                                                                                              and health care service organizations
                                                                                                        DEPARTMENT OF HEALTH AND                              align resources, achieve economies of
                                                DEPARTMENT OF HEALTH AND                                HUMAN SERVICES                                        scale and efficiency, and address
                                                HUMAN SERVICES                                                                                                challenges more effectively as a group
                                                                                                        Health Resources and Services
                                                                                                        Administration                                        than as single providers. This program
                                                Centers for Disease Control and                                                                               promotes the planning and development
                                                Prevention                                                                                                    of healthcare networks in order to: (1)
                                                                                                        Agency Information Collection
                                                [CDC–2016–0067; Docket Number NIOSH                     Activities: Proposed Collection: Public               achieve efficiencies; (2) expand access
                                                270–A]                                                  Comment Request Information                           to, coordinate, and improve the quality
                                                                                                        Collection Request Title: Rural Health                of essential health care services; and (3)
                                                Issuance of Final Publication                           Network Development Planning                          strengthen the rural health care system
                                                                                                        Performance Improvement and                           as a whole.
                                                AGENCY:  National Institute for                                                                                  The goals of the Network Planning
                                                Occupational Safety and Health                          Measurement System Database, OMB
                                                                                                        No. 0915–0384-Extension                               program are centered around
                                                (NIOSH) of the Centers for Disease                                                                            approaches that will aid providers in
                                                Control and Prevention (CDC),                           AGENCY: Health Resources and Services                 better serving their communities given
                                                Department of Health and Human                          Administration (HRSA), Department of                  the changes taking place in health care,
                                                Services (HHS).                                         Health and Human Services.                            as providers move from focusing on the
                                                ACTION: Notice of issuance of final                     ACTION: Notice.                                       volume of services to focusing on the
                                                publication.                                                                                                  value of services. The Network Planning
                                                                                                        SUMMARY:    In compliance with the                    program brings together key parts of a
                                                SUMMARY:    NIOSH announces the                         requirement for opportunity for public                rural health care delivery system,
                                                availability of the following publication:              comment on proposed data collection                   particularly those entities that may not
                                                ‘‘NIOSH Center for Motor Vehicle                        projects of the Paperwork Reduction Act               have collaborated in the past under a
                                                Safety: Results from 2016 Midcourse                     of 1995, HRSA announces plans to                      formal relationship, to establish and
                                                Review’’ [DHHS (NIOSH) Publication                      submit an Information Collection                      improve local capacity and coordination
                                                Number 2017–139].                                       Request (ICR), described below, to the                of care. The program supports 1 year of
                                                DATES: The technical report was                         Office of Management and Budget                       planning with the primary goal of
                                                published on March 24, 2017.                            (OMB). Prior to submitting the ICR to                 helping networks create a foundation for
                                                ADDRESSES: This document may be                         OMB, HRSA seeks comments from the                     their infrastructure and focusing
                                                obtained at the following link: https://                public regarding the burden estimate,                 member efforts to address important
                                                www.cdc.gov/niosh/docs/2017-139/.                       below, or any other aspect of the ICR.                regional or local community health
                                                FOR FURTHER INFORMATION CONTACT:                        DATES: Comments on this Information                   needs.
                                                David Fosbroke, NIOSH Division of                       Collection Request must be received no                   Need and Proposed Use of the
                                                Safety Research, Room H–1808, 1095                      later than June 12, 2017.                             Information: Performance measures for
                                                Willowdale Rd., Morgantown, WV                                                                                the Network Planning program serve the
                                                                                                        ADDRESSES: Submit your comments to
                                                26505. Telephone: (304) 285–6010 (not                                                                         purpose of quantifying awardee-level
                                                                                                        paperwork@hrsa.gov or mail the HRSA
                                                a toll free number). Email:                                                                                   data that conveys the successes and
                                                                                                        Information Collection Clearance
                                                def2@cdc.gov.                                                                                                 challenges associated with the grant
                                                                                                        Officer, Room 14N39, 5600 Fishers
                                                                                                                                                              award. The approved measures
                                                SUPPLEMENTARY INFORMATION:     On August                Lane, Rockville, MD 20857.
                                                                                                                                                              encompass the following principal topic
                                                15, 2016, NIOSH published a notice of                   FOR FURTHER INFORMATION CONTACT: To                   areas: network infrastructure, network
                                                public web meeting and request for                      request more information on the                       collaboration, sustainability, and
                                                comments on the ‘‘NIOSH Center for                      proposed project or to obtain a copy of               network assessment.
                                                Motor Vehicle Safety: Midcourse                         the data collection plans and draft                      Likely Respondents: The respondents
                                                Review of Strategic Plan’’ in the Federal               instruments, email paperwork@hrsa.gov                 for these measures are Network
                                                Register [81 FR 54094]. The purpose of                  or call the HRSA Information Collection               Planning program award recipients.
                                                this midcourse review was to seek                       Clearance Officer at (301) 443–1984.                     Burden Statement: Burden in this
                                                external input via public comments and                  SUPPLEMENTARY INFORMATION: When                       context means the time expended by
                                                invited stakeholder reviews to shape                    submitting comments or requesting                     persons to generate, maintain, retain,
srobinson on DSK5SPTVN1PROD with NOTICES




                                                priorities for the NIOSH Center for                     information, please include the                       disclose, or provide the information
                                                Motor Vehicle Safety for the next 2                     information request collection title for              requested. This includes the time
                                                years and proceeding toward developing                  reference, in compliance with section                 needed to review instructions; to
                                                a new 10-year strategic plan. All                       3506(c)(2)(A) of the Paperwork                        develop, acquire, install, and utilize
                                                comments received were reviewed and                     Reduction Act of 1995.                                technology and systems for the purpose
                                                considered in finalizing the current                       Information Collection Request Title:              of collecting, validating, and verifying
                                                document. Comments for Docket 270–A                     Rural Health Network Development                      information, processing and


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Document Created: 2017-04-11 00:48:33
Document Modified: 2017-04-11 00:48:33
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 17430 

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