[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]



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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 Access to published and unpublished pertinent scientific 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

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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).

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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