Supplemental Evidence and Data Request on Platelet-rich Plasma for Wound Care in the Medicare Population, 16362-16364 [2020-05994]
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16362
Federal Register / Vol. 85, No. 56 / Monday, March 23, 2020 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Platelet-rich Plasma for
Wound Care in the Medicare
Population
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for Supplemental
Evidence and Data Submissions.
AGENCY:
The Agency for Healthcare
Research and Quality (AHRQ) is seeking
scientific information submissions from
the public. Scientific information is
being solicited to inform our review on
Platelet-rich Plasma for Wound Care in
the Medicare Population, which is
currently being conducted by the
AHRQ’s Evidence-based Practice
Centers (EPC) Program. Access to
published and unpublished pertinent
scientific information will improve the
quality of this review.
DATES: Submission Deadline on or
before 30 days after the date of
publication of this notice in the Federal
Register.
ADDRESSES: Email submissions: epc@
ahrq.hhs.gov.
Print submissions:
Mailing Address: Center for Evidence
and Practice Improvement, Agency for
Healthcare Research and Quality,
ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A,
Rockville, MD 20857
Shipping Address (FedEx, UPS, etc.):
Center for Evidence and Practice
Improvement, Agency for Healthcare
Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers
Lane, Mail Stop 06E77D, Rockville,
MD 20857
FOR FURTHER INFORMATION CONTACT:
Jenae Benns, Telephone: 301–427–1496
or Email: epc@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency for Healthcare Research and
Quality has commissioned the
Evidence-based Practice Centers (EPC)
Program to complete a review of the
evidence for Platelet-rich Plasma for
Wound Care in the Medicare
Population. 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
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:26 Mar 20, 2020
Jkt 250001
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 Platelet-rich Plasma for
Wound Care in the Medicare
Population, including those that
describe adverse events. The entire
research protocol is available online at:
https://www.ahrq.gov/sites/default/files/
wysiwyg/research/findings/ta/
topicrefinement/platelet-rich-plasmaprotocol.pdf.
This is to notify the public that the
EPC Program would find the following
information on Platelet-rich Plasma for
Wound Care in the Medicare Population
helpful:
D A list of completed studies that your
organization has sponsored for this
indication. In the list, please indicate
whether results are available on
ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
D For completed studies that do not
have results on ClinicalTrials.gov, a
summary, including the following
elements: Study number, study period,
design, methodology, indication and
diagnosis, proper use instructions,
inclusion and exclusion criteria,
primary and secondary outcomes,
baseline characteristics, number of
patients screened/eligible/enrolled/lost
to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
D A list of ongoing studies that your
organization has sponsored for this
indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including a study number, the
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, and primary and secondary
outcomes.
D Description of whether the above
studies constitute ALL Phase II and
above clinical trials sponsored by your
organization for this indication and an
index outlining the relevant information
in each submitted file.
Your contribution is very beneficial to
the Program. Materials submitted must
be publicly available or able to be made
public. Materials that are considered
confidential; marketing materials; study
types not included in the review; or
information on indications not included
in the review cannot be used by the EPC
Program. This is a voluntary request for
information, and all costs for complying
with this request must be borne by the
submitter.
The draft of this review will be posted
on AHRQ’s EPC Program website and
available for public comment for a
period of 4 weeks. If you would like to
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
be notified when the draft is posted,
please sign up for the email list at:
https://www.effective
healthcare.ahrq.gov/email-updates.
The systematic review will answer the
following questions. This information is
provided as background. AHRQ is not
requesting that the public provide
answers to these questions.
Key Questions (KQ)
Comparative Effectiveness Questions
KQ 1. What are the benefits and
harms of treatment strategies including
PRP alone with or without other wound
care treatments compared to other
wound care treatments in patients with
diabetic, venous and pressure chronic
wounds, for patient oriented outcomes
such as at least the following:
Completely closed/healed wounds (skin
closure with complete reepithelialization without drainage or
dressing requirements), time to
complete wound closure, wound
reoccurrence, risk of developing wound
infection, amputation, hospitalization
(frequency and duration), return to
baseline activities and function,
reduction of wound size, pain, opioid
medication use, exudate and odor,
quality of life and adverse effects.
KQ 1.a. Describe the risk of bias in the
studies examined by chronic wound
type and study design.
KQ 1.b. What are the differences in
formulation techniques and components
between these preparations? What are
the differences in application
techniques, frequency of application
and ‘‘dosage’’ (amounts applied)?
KQ 1.c. What are the study
characteristics (such as those listed
below) in each included investigation
for each chronic wound type treated by
PRP?
a. Comparator (if standard care,
describe in detail)
b. Study inclusion/exclusion criteria
and patient characteristics of enrollees,
including at least age, gender, and
general health (e.g., status of HbA1c,
diabetes, peripheral vascular disease,
obesity, smoking, renal), wound
characteristics, and prior and
concurrent wound treatments.
c. Wound characteristics of enrollees
including at least wound type, wound
size/depth/duration/severity, vascular
status, infection status and whether
there were inter- and intra-rater checks
of wound measurements.
d. Basic study design and conduct
information including at least method of
patient enrollment, care setting, and use
of run-in period
e. Definition of wound characteristics:
Definition of ‘‘failure to heal’’, and
E:\FR\FM\23MRN1.SGM
23MRN1
Federal Register / Vol. 85, No. 56 / Monday, March 23, 2020 / Notices
definition of a successfully healed
wound (re-epithelialization)
f. Method of applying skin PRP
including provider, frequency of
application, definition of standard of
care, and handling of infections
g. Measurement and assessment
methods including method of
assessment(s); frequency and time
points for assessment(s) (including long
term assessments for durability of heal);
and blinding of assessors
Contextual Questions
KQ 2. What types of PRP preparations
are currently being marketed in US
medical practices (gel, liquid, etc.)?
Future Research Questions:
PICOTS elements
Inclusion criteria
Populations .................
Adult patients (18 years and older) with .............................
• Lower extremity diabetic wounds .............................
• Lower extremity venous ulcers .................................
• Pressure wounds in any location ..............................
Intervention .................
Any preparation of autologous platelet-rich plasma with or
without other treatments.
Any other wound care without PRP ....................................
• Completely closed/healed wounds (skin closure with
complete re-epithelialization without drainage or dressing requirements versus failure to heal).
• Time to complete wound closure.
• Healing durability (Time to wound reoccurrence).
• Wound infection (improvement of wound infection or reduced risk of developing wound infection).
• Amputation.
• Hospitalization.
• Return to baseline activities of daily living and function.
• Wound size.
• Pain.
• Opioid medication use.
• Quality of life.
• Adverse effects.
Comparators ...............
Outcomes ....................
Timing .........................
Settings .......................
Study design ...............
Subgroup analysis ......
jbell on DSKJLSW7X2PROD with NOTICES
KQ 1.d. Based on the included
studies, what are the patient
characteristics commonly considered for
the initiation and continuation/
discontinuation of PRP in patients with
chronic wounds?
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Frm 00051
KQ 3. What PRP preparations are
currently being investigated in ongoing
trials?
KQ 4. What best practices in study
design could be used to produce high
quality evidence on PRP?
KQ 5. What are the evidence gaps
found in this body of research?
PICOTS (Populations, Interventions,
Comparators, Outcomes, Timing,
Settings)
Exclusion criteria
Any .......................................................................................
KQ 1 .....................................................................................
• Original data .............................................................
• Any sample size ........................................................
• RCTs .........................................................................
• Comparative observational studies ...........................
• Relevant systematic reviews, or meta-analyses
(used for identifying additional studies).
• Age.
• Gender.
• Settings.
• Comorbidities (e.g., status of HbA1c, diabetes, peripheral vascular disease, obesity, smoking, renal disease,
liver disease).
• Wound characteristics (wound type, area, depth, volume, duration, severity, vascular status, infection status,
and prior and concurrent wound treatments).
• Anatomical location (lower extremity diabetic wounds
only).
• PRP formulation techniques.
• PRP components.
• PRP application techniques.
• PRP frequency.
• PRP ‘‘dosage’’ (amounts applied).
• PRP offloading procedures (e.g., total contact casting,
removable CAM WalkerTM, irremovable offloading devices).
• Use of immunosuppressant medication.
• Nutrition status.
• Pain medication (opioids, others).
18:42 Mar 20, 2020
16363
Fmt 4703
Sfmt 4703
•
•
•
•
Animals.
Children (age <18 years).
Wounds of other etiologies.
Studies with mixed, non stratified diabetic wounds/venous ulcers/pressure wounds.
• Traumatic wounds.
• Peripheral arterial disease (PAD) related wounds in non
diabetics (i.e., diabetic wounds are to be included regardless of the presence of PAD, but PAD alone
wounds without diabetes are a reason of exclusion).
• Wounds <4 weeks.
None.
None.
None.
None.
In vitro studies, non-original data (e.g.narrative reviews,
editorials, letters, or erratum), single-arm observational
studies, case series, qualitative studies, cost-benefit
analysis, cross-sectional (i.e., non-longitudinal) studies,
before-after studies that do not have a comparison
group, survey.
E:\FR\FM\23MRN1.SGM
23MRN1
16364
Federal Register / Vol. 85, No. 56 / Monday, March 23, 2020 / Notices
PICOTS elements
Inclusion criteria
Exclusion criteria
Publications .................
Studies published in English only ........................................
Foreign language studies.
Abbreviations: KQ = key question; PICOTS = populations, interventions, comparators, outcomes, timing, and settings; RCT = randomized controlled trial.
Dated: March 17, 2020.
Virginia Mackay-Smith,
Associate Director, Office of the Director,
AHRQ.
[FR Doc. 2020–05994 Filed 3–20–20; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–20–0881]
Agency Forms Undergoing Paperwork
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has submitted the information
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the Laboratory Response Network’’ to
the Office of Management and Budget
(OMB) for review and approval. CDC
previously published a ‘‘Proposed Data
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notice on October 18, 2019 to obtain
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is particularly interested in comments
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including the validity of the
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collected;
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use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
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of the information collection plan and
instruments, call (404) 639–7570.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
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‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
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Data Calls for the Laboratory
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Control and Prevention (CDC).
Background and Brief Description
The LRN Program Office maintains a
database of information for each
member laboratory that includes contact
information as well as staff and
equipment inventories. However, during
emergency response, the LRN Program
Office may conduct a Special Data Call
to obtain additional information from
LRN Member Laboratories in regards to
biological preparedness. The LRN has
not used the Generic 0920–0881 in the
previous three years but it is critical that
the LRN retain its ability to survey its
members in a timely fashion during
emergencies. Special Data calls may be
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distributed by broadcast emails or by
survey tools (i.e., Survey Monkey). This
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generic clearance. CDC requests
approval for 68 annual burden hours.
There is no cost to respondents other
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call.
jbell on DSKJLSW7X2PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Public Health Laboratorians ...........................
Special Data Call ............................................
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E:\FR\FM\23MRN1.SGM
Number of
responses per
respondent
136
23MRN1
1
Average
burden per
response
(in hours)
30/60
]]>Agencies
[Federal Register Volume 85, Number 56 (Monday, March 23, 2020)]
[Notices]
[Pages 16362-16364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05994]
[[Page 16362]]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Platelet-rich Plasma
for Wound Care in the Medicare Population
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 on Platelet-rich
Plasma for Wound Care in the Medicare Population, which is currently
being conducted by the AHRQ's Evidence-based Practice Centers (EPC)
Program. Access to published and unpublished pertinent scientific
information will improve the quality of this review.
DATES: Submission Deadline on or before 30 days after the date of
publication of this notice in the Federal Register.
ADDRESSES: Email submissions: [email protected].
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement, Agency
for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857
Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice
Improvement, Agency for Healthcare Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD
20857
FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496
or Email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for Platelet-rich Plasma
for Wound Care in the Medicare Population. 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 Platelet-rich Plasma for Wound Care in the Medicare
Population, including those that describe adverse events. The entire
research protocol is available online at: https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/ta/topicrefinement/platelet-rich-plasma-protocol.pdf.
This is to notify the public that the EPC Program would find the
following information on Platelet-rich Plasma for Wound Care in the
Medicare Population helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this indication. In the list, please indicate whether
results are available on ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
[ssquf] For completed studies that do not have results on
ClinicalTrials.gov, a summary, including the following elements: Study
number, study period, design, methodology, indication and diagnosis,
proper use instructions, inclusion and exclusion criteria, primary and
secondary outcomes, baseline characteristics, number of patients
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
[ssquf] A list of ongoing studies that your organization has
sponsored for this indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including a study number, the study period,
design, methodology, indication and diagnosis, proper use instructions,
inclusion and exclusion criteria, and primary and secondary outcomes.
[ssquf] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this indication and an index outlining the relevant information in each
submitted file.
Your contribution is very beneficial to the Program. Materials
submitted must be publicly available or able to be made public.
Materials that are considered confidential; marketing materials; study
types not included in the review; or information on indications not
included in the review cannot be used by the EPC Program. This is a
voluntary request for information, and all costs for complying with
this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program
website and available for public comment for a period of 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/email-updates.
The systematic review will answer the following questions. This
information is provided as background. AHRQ is not requesting that the
public provide answers to these questions.
Key Questions (KQ)
Comparative Effectiveness Questions
KQ 1. What are the benefits and harms of treatment strategies
including PRP alone with or without other wound care treatments
compared to other wound care treatments in patients with diabetic,
venous and pressure chronic wounds, for patient oriented outcomes such
as at least the following: Completely closed/healed wounds (skin
closure with complete re-epithelialization without drainage or dressing
requirements), time to complete wound closure, wound reoccurrence, risk
of developing wound infection, amputation, hospitalization (frequency
and duration), return to baseline activities and function, reduction of
wound size, pain, opioid medication use, exudate and odor, quality of
life and adverse effects.
KQ 1.a. Describe the risk of bias in the studies examined by
chronic wound type and study design.
KQ 1.b. What are the differences in formulation techniques and
components between these preparations? What are the differences in
application techniques, frequency of application and ``dosage''
(amounts applied)?
KQ 1.c. What are the study characteristics (such as those listed
below) in each included investigation for each chronic wound type
treated by PRP?
a. Comparator (if standard care, describe in detail)
b. Study inclusion/exclusion criteria and patient characteristics
of enrollees, including at least age, gender, and general health (e.g.,
status of HbA1c, diabetes, peripheral vascular disease, obesity,
smoking, renal), wound characteristics, and prior and concurrent wound
treatments.
c. Wound characteristics of enrollees including at least wound
type, wound size/depth/duration/severity, vascular status, infection
status and whether there were inter- and intra-rater checks of wound
measurements.
d. Basic study design and conduct information including at least
method of patient enrollment, care setting, and use of run-in period
e. Definition of wound characteristics: Definition of ``failure to
heal'', and
[[Page 16363]]
definition of a successfully healed wound (re-epithelialization)
f. Method of applying skin PRP including provider, frequency of
application, definition of standard of care, and handling of infections
g. Measurement and assessment methods including method of
assessment(s); frequency and time points for assessment(s) (including
long term assessments for durability of heal); and blinding of
assessors
KQ 1.d. Based on the included studies, what are the patient
characteristics commonly considered for the initiation and
continuation/discontinuation of PRP in patients with chronic wounds?
Contextual Questions
KQ 2. What types of PRP preparations are currently being marketed
in US medical practices (gel, liquid, etc.)?
Future Research Questions:
KQ 3. What PRP preparations are currently being investigated in
ongoing trials?
KQ 4. What best practices in study design could be used to produce
high quality evidence on PRP?
KQ 5. What are the evidence gaps found in this body of research?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing,
Settings)
------------------------------------------------------------------------
PICOTS elements Inclusion criteria Exclusion criteria
------------------------------------------------------------------------
Populations................ Adult patients (18 Animals.
years and older) Children
with. (age <18 years).
Lower Wounds of
extremity diabetic other etiologies.
wounds. Studies
Lower with mixed, non
extremity venous stratified diabetic
ulcers. wounds/venous
Pressure ulcers/pressure
wounds in any wounds.
location. Traumatic
wounds.
Peripheral
arterial disease
(PAD) related
wounds in non
diabetics (i.e.,
diabetic wounds are
to be included
regardless of the
presence of PAD,
but PAD alone
wounds without
diabetes are a
reason of
exclusion).
Wounds <4
weeks.
Intervention............... Any preparation of ....................
autologous platelet-
rich plasma with or
without other
treatments.
Comparators................ Any other wound care None.
without PRP.
Outcomes................... Completely None.
closed/healed wounds
(skin closure with
complete re-
epithelialization
without drainage or
dressing
requirements versus
failure to heal).
Time to
complete wound
closure.
Healing
durability (Time to
wound reoccurrence).
Wound
infection
(improvement of
wound infection or
reduced risk of
developing wound
infection).
Amputation..
Hospitalization.
Return to
baseline activities
of daily living and
function.
Wound size..
Pain........
Opioid
medication use.
Quality of
life.
Adverse
effects.
Timing..................... None.
Settings................... Any.................. None.
Study design............... KQ 1................. In vitro studies,
Original non-original data
data. (e.g.narrative
Any sample reviews,
size. editorials,
RCTs........ letters, or
Comparative erratum), single-
observational arm observational
studies. studies, case
Relevant series, qualitative
systematic reviews, studies, cost-
or meta-analyses benefit analysis,
(used for cross-sectional
identifying (i.e., non-
additional studies). longitudinal)
studies, before-
after studies that
do not have a
comparison group,
survey.
Subgroup analysis.......... Age.........
Gender......
Settings....
Comorbidities (e.g.,
status of HbA1c,
diabetes, peripheral
vascular disease,
obesity, smoking,
renal disease, liver
disease).
Wound
characteristics
(wound type, area,
depth, volume,
duration, severity,
vascular status,
infection status,
and prior and
concurrent wound
treatments).
Anatomical
location (lower
extremity diabetic
wounds only).
PRP
formulation
techniques.
PRP
components.
PRP
application
techniques.
PRP
frequency.
PRP
``dosage'' (amounts
applied).
PRP
offloading
procedures (e.g.,
total contact
casting, removable
CAM WalkerTM,
irremovable
offloading devices).
Use of
immunosuppressant
medication.
Nutrition
status.
Pain
medication (opioids,
others).
[[Page 16364]]
Publications............... Studies published in Foreign language
English only. studies.
------------------------------------------------------------------------
Abbreviations: KQ = key question; PICOTS = populations, interventions,
comparators, outcomes, timing, and settings; RCT = randomized
controlled trial.
Dated: March 17, 2020.
Virginia Mackay-Smith,
Associate Director, Office of the Director, AHRQ.
[FR Doc. 2020-05994 Filed 3-20-20; 8:45 am]
BILLING CODE 4160-90-P
