Supplemental Evidence and Data Request on Platelet-rich Plasma for Wound Care in the Medicare Population
| Published date | 23 March 2020 |
| Citation | 85 FR 16362 |
| Record Number | 2020-05994 |
| Section | Notices |
| Court | Agency For Healthcare Research And Quality,Health And Human Services Department |
Federal Register, Volume 85 Issue 56 (Monday, March 23, 2020)
[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]]
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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.
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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public. Scientific
information is being solicited to inform our review on 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 Access to published and unpublished pertinent scientific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)
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PICOTS elements Inclusion criteria Exclusion criteria
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Populations................ Adult patients (18 Animals.
years and older) Children
with. (age 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 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.
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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
