[Federal Register Volume 79, Number 138 (Friday, July 18, 2014)]
[Notices]
[Pages 42016-42018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-16667]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Scientific Information Request on Management of Postpartum
Hemorrhage
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for scientific information 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 of Management of
Postpartum Hemorrhage, which is currently being conducted by the
Evidence-based Practice Centers for the AHRQ Effective Health Care
Program. Access to
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published and unpublished pertinent scientific information will improve
the quality of this review. AHRQ is conducting this systematic review
pursuant to Section 1013 of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003, Public Law 108-173, and
Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).
DATES: Submission Deadline on or before August 18, 2014.
ADDRESSES:
Online submissions: http://effectivehealthcare.AHRQ.gov/index.cfm/submit-scientific-information-packets/. Please select the study for
which you are submitting information from the list to upload your
documents.
Email submissions: src.org">SIPS@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. 58653 or Email: src.org">SIPS@epc-src.org.
SUPPLEMENTARY INFORMATION: AHRQ has commissioned the Effective Health
Care (EHC) Program Evidence-based Practice Centers to complete a review
of the evidence for Management of Postpartum Hemorrhage.
The EHC 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 Management of Postpartum Hemorrhage, including those
that describe adverse events. The entire research protocol, including
the key questions, is also available online at: http://effectivehealthcare.AHRQ.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=1918.
This notice is to notify the public that the EHC program would find
the following information on Management of Postpartum Hemorrhage
helpful:
A list of completed studies that your company has
sponsored for this indication. In the list, please indicate whether
results are available on ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
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.
A list of ongoing studies that your company 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.
Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your company for this
indication and an index outlining the relevant information in each
submitted file.
Your contribution will be very beneficial to the EHC Program. Since
the contents of all submissions will be made available to the public
upon request, materials submitted must be publicly available or can 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 EHC
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 EHC 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: http://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 entire research
protocol, is also available online at: http://effectivehealthcare.AHRQ.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=1918.
The Key Questions (KQ)
KQ1. What is the evidence for the comparative effectiveness of
interventions for management of postpartum hemorrhage?
a. What is the comparative effectiveness of interventions intended
to treat postpartum hemorrhage likely due to atony?
b. What is the comparative effectiveness of interventions intended
to treat postpartum hemorrhage likely due to retained placenta?
c. What is the comparative effectiveness of interventions intended
to treat postpartum hemorrhage likely due to genital tract trauma?
d. What is the comparative effectiveness of interventions intended
to treat postpartum hemorrhage likely due to uncommon causes (e.g.,
coagulopathies, uterine inversion, subinvolution)?
KQ2.What is the evidence for choosing one intervention over another
and when to proceed to subsequent interventions for management of
postpartum hemorrhage?
KQ3. What are the comparative harms, including adverse events,
associated with interventions for management of postpartum hemorrhage?
KQ4. What is the comparative effectiveness of interventions to
treat acute blood loss anemia after stabilization of postpartum
hemorrhage?
KQ5. What systems-level interventions are effective in improving
management of postpartum hemorrhage?
PICOTS (Population, Intervention, Comparator, Outcomes, Timing, and
Setting)
Population
KQ1-3: Women with postpartum hemorrhage (PPH) immediately
post-birth to 12 weeks postpartum following pregnancy >24 weeks
gestation.
KQ4: Women with stabilized PPH and acute blood loss anemia
KQ 1-5: All modes of birth
Intervention(s)
KQ1-3, 5
[cir] Compression techniques (external uterine massage, bimanual
compression, aortic compression)
[cir] Medications (oxytocin [Pitocin], prostaglandin El
[Misoprostol, Cytotec], methylergonovine [Methergine], prostaglandin
15-methyl F2a [Hemabate], prostaglandin E2 [Dinoprostone], recombinant
factor Vila [NovoSeven], and tranexamic acid [Cyklokapron])
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[cir] Devices (Bakri postpartum balloon, Foley catheter,
Sengstaken-Blakemore tube, Rusch balloon)
[cir] Procedures (manual removal of placenta, manual evacuation of
clot, uterine tamponade, uterine artery embolization, laceration
repair)
[cir] Surgeries (curettage, uterine artery ligation, uterine
hemostatic compression suturing, hysterectomy)
[cir] Blood and fluid products
[cir] Anti-shock garment
[cir] Systems-level interventions (e.g., implementation of
protocols, training)
KQ4
[cir] Interventions for acute blood loss anemia (e.g., iron
replacement, erythropoietin)
Comparator
Different intervention (any intervention compared with any
other intervention)
Placebo
Outcomes
Intermediate outcomes
[cir] Blood loss
[cir] Transfusion
[cir] ICU admission
[cir] Anemia
[cir] Length of stay
Final outcomes
[cir] Mortality
[cir] Uterine preservation
[cir] Future fertility
[cir] Breastfeeding
[cir] Psychological impact
[cir] Harms
Timing
Immediately post-birth to 12 weeks postpartum
Primary (< 24 hours postpartum) or secondary (>= 24 hours
postpartum)
Setting
All birth settings (hospital, birth center, home)
Dated: July 1, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014-16667 Filed 7-17-14; 8:45 am]
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