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[Federal Register Volume 79, Number 170 (Wednesday, September 3, 2014)]
[Notices]
[Pages 52337-52339]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20689]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality

Scientific Information Request on Diagnosis of Gout

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 Diagnosis of 
Gout, which is currently being conducted by the Evidence-based Practice 
Centers for the AHRQ Effective Health Care Program. Access to 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and unpublished pertinent scientific information will improve the 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 October 3, 2014.

ADDRESSES: Online submissions: http://effectiveheathcare.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">src.org">SIPS@epc-src.org.
    Print submissions:
    Mailing Address: Portland VA Research Foundation, Scientific 
Resource Center, ATTN: Scientific Information Packet Coordinator, PO 
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">src.org">SIPS@epc-src.org.

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Effective Health Care (EHC) Program 
Evidence-based Practice Centers to complete a review of the evidence 
for Diagnosis of Gout.
    The EHC Program is dedicated to identifying as many studies as 
possible

[[Page 52338]]

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 Diagnosis of Gout, 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=1937.
    This notice is to notify the public that the EHC Program would find 
the following information on Diagnosis of Gout helpful:
     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.
     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 followup/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
     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.
     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 EHC Program. 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-guide-reviews-and-reports/?pageaction=displayproduct&productID=1937.

Key Questions

Key Question 1

     What is the accuracy of clinical signs and symptoms and 
other diagnostic tests (such as serum uric acid, ultrasound, CT scan, 
DECT, and plain x-ray), alone or in combination, compared to synovial 
fluid analysis in the diagnosis of acute gouty arthritis, and how does 
the accuracy affect clinical decision making, clinical outcomes and 
complications, and patient centered outcomes?
     How does the diagnostic accuracy of clinical signs and 
symptoms and other tests vary by affected joint site and number of 
joints?
     Does the accuracy of diagnostic tests for gout vary by 
duration of symptoms (i.e., time from the beginning of a flare)
     Does the accuracy of synovial fluid aspiration and crystal 
analysis differ by i) the type of practitioner who is performing the 
aspiration and ii) the type of practitioner who is performing the 
crystal analysis?

Key Question 2

    What are the adverse effects associated with each diagnostic test 
(including pain, infection at the aspiration site, radiation exposure) 
or harms (related to false positives, false negatives, indeterminate 
results) associated with tests used to diagnose gout?

PICOTS (Population, Intervention(s), Comparator, Outcome, Timing, 
Setting)

Population(s) (KQ1 and 2)

 Adults (18 years and over) presenting with symptoms (e.g., an 
acute episode of joint inflammation) suggestive of gout, including the 
following subgroups:
    [cir] Male and female patients
    [cir] Older (65 and over) and younger patients
    [cir] Patients with comorbidities including hypertension, type 2 
diabetes, kidney disease (renal insufficiency)
    [cir] Patients with osteoarthritis, septic arthritis, or previous 
joint trauma
    [cir] Individuals with a family history of gout

Interventions (KQ1, 2)

 Clinical history and physical exam
 Serum uric acid assessment
 US
 DECT
 Plain x-ray
 Joint aspiration by physicians and synovial fluid analysis 
using polarizing microscopy (by physicians or laboratory personnel)
 Combinations of these tests as identified in the literature

Comparators

 Joint synovial fluid aspiration and microscopic assessment for 
monosodium urate crystals (KQ1a-c, 2)
 Joint synovial fluid aspiration and microscopic assessment for 
monosodium urate crystals as performed by a practitioner with a 
different level of expertise or experience, e.g. rheumatologist, 
laboratory personnel (KQ1d)

Outcomes

 Diagnostic accuracy of clinical signs and symptoms, US, DECT, 
plain radiographs compared with joint aspiration and synovial fluid 
analysis (KQ1)
    [cir] Sensitivity/specificity, true positives/true negatives, area 
under the curve
    [cir] Positive, negative predictive value, positive/negative 
likelihood ratios (if prevalence known)
 Clinical decisionmaking
    [cir] Additional testing
    [cir] Pharmacologic/dietary management
 Intermediate outcomes
    [cir] sUA
    [cir] Synovial fluid crystals
    [cir] Radiographic or US changes
 Clinical outcomes
    [cir] Pain, joint swelling and tenderness
    [cir] Patient global assessment, and activity limitations (KQ1,2)
 Adverse effects of the tests, including
    [cir] Pain, infection, radiation exposure
    [cir] Effects of false positive or false negative (KQ2)

Timing

 For clinical outcomes of symptom relief: 1-2 days minimum 
(KQ1)
 Early in a flare vs. later or post-flare (KQ1c)

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 For adverse events: immediate

Settings

 Primary care (outpatient) or acute care setting, 
preferentially
 Outpatient rheumatology practices/academic medical centers

    Dated: August 26, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014-20689 Filed 9-2-14; 8:45 am]
BILLING CODE 4160-90-M
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