[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Notices]
[Pages 37595-37596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13761]



[[Page 37595]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Scientific Information Request on Treatment Strategies for 
Patients With Lower Extremity Chronic Venous Disease (LECVD)

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 Treatment 
Strategies for Patients with Lower Extremity Chronic Venous Disease 
(LECVD), which is currently being conducted by the AHRQ's Evidence-
based Practice Centers (EPC) Programs. Access to published and 
unpublished pertinent scientific information will improve the quality 
of this review. AHRQ is conducting this systematic review pursuant to 
Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).

DATES: Submission Deadline on or before July 11, 2016.

ADDRESSES: 
    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. 51723 or Email: src.org">SIPS@epc-src.org.

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Programs to complete a review of the evidence for Treatment Strategies 
for Patients with Lower Extremity Chronic Venous Disease (LECVD). 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 Treatment Strategies for Patients with Lower Extremity 
Chronic Venous Disease (LECVD), including those that describe adverse 
events. The entire research protocol, including the key questions, is 
also available online at: http://www.AHRQ.gov/sites/default/files/wysiwyg/research/findings/ta/topicrefinement/lecvd_protocol.pdf.
    This notice is to notify the public that the EPC Program would find 
the following information on Treatment Strategies for Patients with 
Lower Extremity Chronic Venous Disease (LECVD) helpful:
    [ballot] 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.
    [ballot] 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.
    [ballot] 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.
    [ballot] 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 ECP 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 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 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: https://subscriptions.ahrq.gov/accounts/USAHRQ/subscriber/new?topic_id=USAHRQ_18.
    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 available online at: http://www.AHRQ.gov/sites/default/files/wysiwyg/research/findings/ta/topicrefinement/lecvd_protocol.pdf.
    KQ 1: Narrative review of the diagnostic methods and diagnostic 
criteria for all adult patients (symptomatic and asymptomatic) with LE 
varicose veins, LE chronic venous insufficiency/incompetence/reflux, 
and/or LE chronic venous thrombosis/obstruction (including post-
thrombotic syndrome).
    KQ 2: Regarding treatments for all adult patients (symptomatic and 
asymptomatic) with LE varicose veins and/or LE chronic venous 
insufficiency/incompetence/reflux:
    I. What is the comparative effectiveness of exercise, medical 
therapy, weight reduction, mechanical compression therapy, and invasive 
procedures (i.e., surgical and endovascular procedures) on health 
outcomes?
    II. What diagnostic method(s) and criteria were used in each study?
    III. How does the comparative effectiveness of treatment vary by 
patient characteristics, including age, sex, risk factors, 
comorbidities, characteristics of disease, anatomic segment affected, 
and characteristics of the therapy (e.g., exercise intensity, type of 
mechanical compression)?
    IV. What are the comparative safety concerns associated with each 
treatment strategy (e.g., adverse drug reactions, bleeding)? Do the 
safety concerns vary by patient subgroup (age, sex, race, risk factors, 
comorbidities, anatomic segment, or disease severity)?
    KQ 3: Regarding treatments for all adult patients (symptomatic and 
asymptomatic) with LE chronic venous thrombosis/obstruction (including 
post-thrombotic syndrome):
    I. What is the comparative effectiveness of exercise, medical 
therapy, mechanical compression therapy, and invasive procedures (i.e., 
surgical and endovascular procedures) on health outcomes?
    II. What diagnostic method(s) and criteria were used in each study?

[[Page 37596]]

    III. How does the comparative effectiveness of treatment vary by 
patient characteristics, including age, sex, risk factors, 
comorbidities, characteristics of disease, anatomic segment affected, 
and characteristics of the therapy (e.g., exercise intensity, type of 
mechanical compression)?
    IV. What are the comparative safety concerns associated with each 
treatment strategy (e.g., adverse drug reactions, bleeding)? Do the 
safety concerns vary by patient subgroup (age, sex, race, risk factors, 
comorbidities, anatomic segment, or disease severity)?

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

KQ 1: Diagnosis

I. Population(s):
    A. Adults (over age 18) with the diagnosis of LE varicose veins, LE 
chronic venous insufficiency/incompetence/reflux, and/or LE chronic 
venous thrombosis/obstruction (including post-thrombotic syndrome)
II. Diagnostic Measures:
    A. Air plethysmography, LE venous duplex ultrasonography (with and 
without compression), invasive venography, magnetic resonance 
venography, computed tomographic venography, serum D-dimer testing, 
Villalta score
III. Comparators:
    A. Diagnostic modalities listed above (air plethysmography, LE 
duplex venous ultrasonography [with and without compression], invasive 
venography, magnetic resonance venography, computed tomographic 
venography, serum D-dimer testing, Villalta score) will be compared to 
one another
IV. Outcomes:
    A. Sensitivity, specificity, positive predictive value, negative 
predictive value, inter -rater reliability, internal consistency, test 
-retest reliability, false positives, false negatives, and positive and 
negative likelihood ratios for each diagnostic measure listed above 
will be compared
V. Timing:
    A. Not applicable
VI. Settings:
    A. All clinical settings, including inpatient and outpatient

KQs 2-3: Treatment

I. Population(s):
    A. KQ 2: A symptomatic or symptomatic adults (over age 18) with the 
diagnosis of LE varicose veins and/or LE chronic venous insufficiency/
incompetence/reflux:
    i. Subgroup analysis: age, race/ethnicity, sex, body weight, CEAP 
classification, VCSS classification, severity of disease, anatomic 
segment affected (e.g., iliofemoral, infrainguinal), known malignancy, 
presence of LE ulcer
    A. KQ 3: A symptomatic or symptomatic adults(over age 18) with the 
diagnosis of LE chronic venous thrombosis/obstruction (including post-
thrombotic syndrome):
    i. Subgroup analysis: age, race/ethnicity, sex, body weight, CEAP 
classification, VCSS classification, Villalta score, severity of 
disease, anatomic segment affected (e.g., iliofemoral, infrainguinal), 
known malignancy, presence of LE ulcer
II. Interventions:
    A. KQ 2: lifestyle interventions (e.g ., smoking cessation, leg 
elevation, weight reduction, exercise), medical therapy, local skin 
care/wound care, mechanical compression therapy, and invasive 
procedures (i.e., surgical and endovascular procedures)
    i. Medical therapies: diuretics, aspirin, pentoxifylline, 
prostacyclins, zinc sulfate
    ii. Invasive surgical/endovascular procedures: sclerotherapy 
(liquid, foam, glue), radiofrequency ablation, thermal ablation, 
chemical ablation, ambulatory phlebectomy, transilluminated powered 
phlebectomy, venous ligation, venous excision
    B. KQ 3: lifestyle interventions (e.g., smoking cessation, leg 
elevation, weight reduction, exercise), medical therapy, local skin 
care/wound care, mechanical compression therapy, and invasive 
procedures (i.e., surgical and endovascular procedures)
    i. Medical therapies: anticoagulants including warfarin, apixaban, 
rivaroxaban, edoxaban, and dabigatran; diuretics
    ii. Invasive surgical/endovascular procedures: endovenous 
angioplasty/stenting, ultrasound accelerated thrombolysis for chronic 
DVT (EkoSonic[supreg] endovascular system), surgical thromboembolectomy
III. Comparators:
    A. Specific treatments will be compared to other included 
treatments as described above or to no treatment (placebo or usual 
care)
IV. Outcomes:
    A. Changes on standardized symptom scores (Villalta score, CEAP 
classification, AVVQ score, and VCSS score); qualitative reduction in 
Ledema; qualitative reduction in LE pain; improvement in LE venous 
hemodynamics/reflux severity as measured by air plethysmography, duplex 
ultrasonography, or invasive venography; venous wound healing, 
recurrent ulceration, patient-reported quality of life (including 
AVVQ), repeat intervention, LE amputation E
    B. Adverse effects of treatment, including: adverse drug reactions; 
bleeding (including intracranial bleeding); venous wound infection; 
contrast nephropathy; radiation-related injuries; exercise-related 
harms; periprocedural complications (vessel dissection, vessel 
perforation, and AV fistula), thrombophlebitis, venous thrombosis 
(including stent thrombosis), venous thromboembolic events (including 
PE), and death
V. Timing:
    A. Studies with all durations of followup will be included in the 
review; for symptomatic patients, we will attempt to categorize studies 
into those that evaluate short-term (<=30 days), intermediate-ter m (31 
days to 6 months), and long-term (> 6 months) events.
VI. Settings:
    A. Any

Sharon B. Arnold,
Deputy Director.
[FR Doc. 2016-13761 Filed 6-9-16; 8:45 am]
 BILLING CODE 4160-90-P