Scientific Information Request on Diagnosis of Gout, 52337-52339 [2014-20689]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Notices The Supplemental Draft EIS is being prepared to address substantial changes to the proposed action that are relevant to environmental concerns, as required under NEPA (40 CFR 1502.9), and will assess any new circumstances or information relevant to potential environmental impacts. The Supplemental Draft EIS will incorporate by reference and build upon the analyses presented in the 2012 Draft EIS, and will document the Section 106 process under the National Historic Preservation Act of 1966, as amended (36 CFR Part 800). GSA will prepare the Supplemental Draft EIS in cooperation with DOS, United States Army Corps of Engineers, United States Environmental Protection Agency, and National Guard Bureau. Dates and Addresses: A public scoping period and public scoping meeting for the proposed action were held in October 2011. However, the public may submit comments concerning the proposal for 30 days from the date of this notice. Written comments may be mailed to Abigail Low, GSA Project Manager 20 N 8th Street, Philadelphia, PA 19107, or may be sent via email to FASTC.info@ gsa.gov. More information on the proposed FASTC program is available at www.state.gov/recovery/fastc. Future notices will be published to announce the availability of the Supplemental Draft EIS and additional opportunities for public input. FOR FURTHER INFORMATION CONTACT: Abigail Low, GSA Project Manager; 20 N 8th Street, Philadelphia, PA 19107 (215) 446–4815, FASTC.info@gsa.gov. SUPPLEMENTARY INFORMATION: Background: The purpose of the proposed FASTC at Fort Pickett is to consolidate existing dispersed hardskills training functions into a single suitable location to improve training efficiency and enhance training operations. The proposed FASTC is needed to establish a facility from which DOS Bureau of Diplomatic Security may conduct a wide array of hard-skills security training to meet the increased demand for well trained personnel serving at embassies overseas and select foreign partners. Fort Pickett and Nottoway County’s LRA area in Nottoway County near Blackstone, Virginia was selected as a potential site in July 2011, and a Draft EIS was released in October 2012. In early 2013, the Administration indicated all efforts and work at the proposed site in Fort Pickett Army National Guard Maneuver Training Center and Nottoway County’s LRA area should be put on hold pending VerDate Mar<15>2010 17:40 Sep 02, 2014 Jkt 232001 additional due diligence and reviews at an existing training site in Georgia. As part of the due diligence effort requested by the Administration, DOS conducted site visits to the Federal Law Enforcement Training Center (FLETC) in Glynco, Georgia. During this time period, DOS assessed the scope and size of the FASTC project and determined a smaller platform at Fort Pickett was more fiscally prudent. In April 2014, the Administration reaffirmed the earlier DOS selection of the FASTC proposed sites in Fort Picket Army National Guard Maneuver Training Center and the Nottoway County LRA area at a reduced scope of requirements. The project will proceed as a hard-skills only facility. Based on adjustments made to the proposed FASTC Program, DOS has undertaken the preparation of a Master Plan Update that modifies the previous alternatives evaluated in the 2012 Draft EIS. The Master Plan Update concept will be evaluated as Build Alternative 3 in the Supplemental Draft EIS. The alternatives to be fully evaluated in the Supplemental Draft EIS include the No Action Alternative and Build Alternative 3. The proposed location of Build Alternative 3 includes three adjacent land parcels: Fort Pickett Parcels 21/20 and Grid Parcel, and Nottoway County LRA Parcel 9. The Supplemental Draft EIS will assess potential impacts that may result from the modified alternative, including, air quality, noise, land use, socioeconomics, traffic, infrastructure and community services, natural resources, biological resources, cultural resources, and safety and environmental hazards. The analysis will evaluate direct, indirect, and cumulative impacts. Relevant and reasonable measures that could avoid or mitigate environmental effects will also be analyzed. Additionally, GSA will undertake any consultations required by applicable laws or regulations, including the National Historic Preservation Act. No decision will be made to implement any alternative until the NEPA process is completed and a Record of Decision is signed. Dated: August 19, 2014. Myles Vaughan, NEPA Program Manager, Facilities Management & Services Programs Division, U.S. GSA, Mid-Atlantic Region. [FR Doc. 2014–20902 Filed 9–2–14; 8:45 am] BILLING CODE 6820–89–P PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 52337 DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Scientific Information Request on Diagnosis of Gout Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for Scientific Information 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 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-informationpackets/. Please select the study for which you are submitting information from the list to upload your documents. Email submissions: 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: SIPS@epcsrc.org. SUMMARY: The Agency for Healthcare Research and Quality has commissioned the Effective Health Care (EHC) Program Evidencebased 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 SUPPLEMENTARY INFORMATION: E:\FR\FM\03SEN1.SGM 03SEN1 mstockstill on DSK4VPTVN1PROD with NOTICES 52338 Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Notices 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://effective healthcare.ahrq.gov/search-for-guidesreviews-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 VerDate Mar<15>2010 17:40 Sep 02, 2014 Jkt 232001 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-andreports/?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: Æ Male and female patients PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Æ Older (65 and over) and younger patients Æ Patients with comorbidities including hypertension, type 2 diabetes, kidney disease (renal insufficiency) Æ Patients with osteoarthritis, septic arthritis, or previous joint trauma Æ 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) Æ Sensitivity/specificity, true positives/true negatives, area under the curve Æ Positive, negative predictive value, positive/negative likelihood ratios (if prevalence known) • Clinical decisionmaking Æ Additional testing Æ Pharmacologic/dietary management • Intermediate outcomes Æ sUA Æ Synovial fluid crystals Æ Radiographic or US changes • Clinical outcomes Æ Pain, joint swelling and tenderness Æ Patient global assessment, and activity limitations (KQ1,2) • Adverse effects of the tests, including Æ Pain, infection, radiation exposure Æ 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) E:\FR\FM\03SEN1.SGM 03SEN1 Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Notices • 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Scientific Information Request on Emerging Approaches To Diagnosis and Treatment of Non-Muscle-Invasive Bladder Cancer Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for Scientific Information 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 of Emerging Approaches to Diagnosis and Treatment of Non-Muscle-Invasive Bladder Cancer, 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:// effectivehealthcare.AHRQ.gov/ index.cfm/submitscientific-informationpackets/. Please select the study for which you are submitting information from the list to upload your documents. Email submissions: 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: mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:17 Sep 02, 2014 Jkt 232001 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: SIPS@epcsrc.org. SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and Quality has commissioned the Effective Health Care (EHC) Program Evidencebased Practice Centers to complete a review of the evidence for Emerging Approaches to Diagnosis and Treatment of Non-Muscle-Invasive Bladder Cancer. 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 Emerging Approaches to Diagnosis and Treatment of NonMuscle-Invasive Bladder Cancer, including those that describe adverse events. The entire research protocol, including the key questions, is also available online at: http:// effectivehealthcare.AHRQ.gov/searchfor-guides-reviews-and-reports/ ?pageaction=displayproduct&product ID=1941. This notice is to notify the public that the EHC Program would find the following information on Emerging Approaches to Diagnosis and Treatment of Non-Muscle-Invasive Bladder Cancer helpful: • A list of completed studies that your organization has sponsored for this indication. In the list, please indicate whether results are available on ClinicafTrials.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 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, PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 52339 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.AHRO.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://effectivehealth care.AHRO.gov/search-for-guidesreviews-and-reports/ ?pageaction=displayproduct&productID =1941. The Key Questions Key Question 1 What is the diagnostic accuracy of various urinary biomarkers compared with other urinary biomarkers or standard diagnostic methods (cystoscopy, cytology, and imaging) in (1) persons with signs or symptoms warranting evaluation for possible bladder cancer or (2) persons undergoing surveillance for previously treated bladder cancer? • Does the diagnostic accuracy differ according to patient characteristics (e.g., age, sex, ethnicity), or according to the nature of the presenting signs or symptoms? Key Question 2 For patients with non-muscleinvasive bladder cancer, does the use of a formal risk-adapted assessment approach to treatment decisions (e.g., E:\FR\FM\03SEN1.SGM 03SEN1

Agencies

[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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">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">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)

[[Page 52339]]

 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