[Federal Register Volume 82, Number 68 (Tuesday, April 11, 2017)]
[Notices]
[Pages 17430-17433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07158]


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

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 Access to published and unpublished 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">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 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 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