[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Pages 3817-3818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-01241]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Scientific Information Request on Diagnostic Tests of Right Lower 
Quadrant Pain (Suspected Acute Appendicitis)

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 on medical 
devices used for the diagnosis of right lower quadrant pain (suspected 
acute appendicitis), for example: Magnetic resonance imaging (MRI), 
computed tomography (CT), ultrasound (US), laparoscopic equipment, or 
assays. Scientific information is being solicited to inform our review 
of Diagnosis of Right Lower Quadrant Pain (Suspected Acute 
Appendicitis), 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published and unpublished pertinent scientific information on medical 
devices used for the diagnosis of suspected acute appendicitis will 
improve the quality of this review. AHRQ is conducting this comparative 
effectiveness 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 February 24, 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, 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: Robin Paynter, Research Librarian, 
Telephone: 503-220-8262 ext. 58652 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 Right Lower Quadrant Pain (Suspected Acute 
Appendicitis).
    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 the Diagnosis of Right Lower Quadrant Pain (Suspected 
Acute Appendicitis), 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=1827.
    This notice is to notify the public that the EHC program would find 
the following information on devices for the Diagnosis of Right Lower 
Quadrant Pain (Suspected Acute Appendicitis) helpful:
    [ssquf] A list of completed studies your company has sponsored for 
this indication. In the list, 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 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.
    [ssquf] 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 is very beneficial to the 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 Effective Health Care 
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=1827.

Key Questions (KQ)

KQ 1

    What is the performance of alternative diagnostic tests, alone or 
in combination, for patients with right lower quadrant (RLQ) pain and 
suspected acute appendicitis?
    I. What is the performance and comparative performance of 
alternative diagnostic tests in the following patient populations:
    A. Children
    B. Adults
    C. Non pregnant women of reproductive age

[[Page 3818]]

    D. Pregnant women
    E. The elderly (age greater than or equal to 65 years)
    II. What factors modify the test performance and comparative test 
performance of available diagnostic tests in these populations?

KQ 2

    What is the comparative effectiveness of alternative diagnostic 
tests, alone or in combination, for patients with RLQ pain and 
suspected acute appendicitis?
    I. For the populations listed under Key Question 1a, what is the 
effect of alternative testing strategies on diagnostic thinking, 
therapeutic decision making, clinical outcomes, and resource 
utilization?
    II. What factors modify the comparative effectiveness of testing 
for patients with RLQ pain and suspected acute appendicitis?

KQ 3

    What are the harms of diagnostic tests per se, and what are the 
treatment-related harms of test-directed treatment for tests used to 
diagnose RLQ pain and suspected acute appendicitis?

PICOTS (Population, Interventions, Comparators, Outcomes, Timing, 
Setting)

 Population(s)

    I. Patients with acute RLQ abdominal pain (less than or equal to 7 
days duration) for whom appendicitis is considered in the differential 
diagnosis
    II. Separate analyses will be performed for the following 
populations:
    A. Children (age less than 18 years); additional analyses will be 
performed for younger children (less than 2 years and 2-5 years of age)
    B. Adults (age greater than or equal to 18 years)
    C. Non pregnant women of reproductive age
    D. Pregnant women
    E. Elderly (age greater than or equal to 65 years)

Interventions

    I. Diagnostic tests (alone or in combination) for diagnosing 
appendicitis
    A. Clinical signs (e.g., psoas sign, obturator sign, Rovsing sign, 
McBurney sign)
    B. Clinical symptoms (e.g., fever, migrating pain, guarding)
    C. Laboratory tests (e.g., white blood cell count, C-reactive 
protein concentration, left shift)
    D. Clinical prediction or decision rules (e.g., Alvarado score, 
Pediatric Appendicitis Score, other predictive models)
    E. Imaging tests (e.g., US; multidetector or helical CT with or 
without contrast administered orally, rectally, or intravenously; MRI 
with or without contrast; abdominal X-ray)
    F. Nuclear imaging studies
    G. Diagnostic laparoscopy

Comparators

    Alternative tests or test combinations (as listed above), clinical 
observation

Outcomes

    I. Test performance (e.g., sensitivity, specificity, accuracy, 
proportion of ``negative'' appendectomies) using pathology or clinical 
followup as the reference standard
    II. Intermediate outcomes
    A. Impact on diagnostic thinking (e.g., change in diagnosis after 
testing; change in subsequent diagnostic approach after obtaining 
initial test results)
    B. Impact on therapeutic decision making (e.g., change in treatment 
plan after testing; time from admission to surgery)
    III. Final health or patient-centered outcomes
    A. Bowel perforation (ruptured appendix)
    B. Fistula formation
    C. Infectious complications (abscess formation, peritonitis, 
sepsis, stump appendicitis)
    D. Delay in diagnosis (time from presentation to definitive 
diagnosis; time from presentation to initiation of treatment; time from 
presentation to resolution of pain)
    E. Length of hospital stay
    F. Fetal/maternal outcomes (for pregnant women; including premature 
labor, pregnancy loss, fetal morbidity, fetal mortality, maternal 
morbidity, maternal mortality)
    G. Mortality
    IV. Adverse effects of intervention(s)
    A. Direct harms of testing (e.g., harms from exposure to ionizing 
radiation, allergic reactions/kidney injury caused by contrast agents)
    B. Harms of test-directed treatment (indirect)

Timing

    Studies will be considered regardless of duration of followup.

Setting

    All health care settings will be considered.

    Dated: January 14, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014-01241 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-90-P