Scientific Information Request on Treatment of Tinnitus, 22324-22326 [2012-8740]

Download as PDF 22324 Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Notices contained in their draft International Classification for Patient Safety (ICPS). Commenting on Common Formats Hospital 1.2 To allow for greater participation by the private sector in the subsequent development of the Common Formats, AHRQ engaged the NQF, a non-profit organization focused on health care quality, to solicit comments and advice to guide the further refinement of the Common Formats. The NQF then convenes an expert panel to review the comments received and provide feedback. The NQF began this process with feedback on AHRQ’s 0.1 Beta release of the Common Formats in 2008. Based upon the expert panel’s feedback, AHRQ, in conjunction with the PSWG, revises and refines the Common Formats. The Agency is specifically interested in obtaining feedback from both the private and public sectors on the new Common Formats—Hospital Version 1.2 to guide the improvement of the formats. Information on how to comment and provide feedback on the Common Formats—Hospital Version 1.2, is available at the NQF Web site for Common Formats: http:// www.Quality.forum.ORG/projects/ commonformats.aspx. The process for updating and refining the formats will continue to be an iterative one. Future versions of the Common Formats will be developed for ambulatory settings, such as ambulatory surgery centers and physician and practitioner offices. More information on the Common Formats can be obtained through AHRQ’s PSO Web site: http://www.PSO.AHRQ.gov/index.html. Dated: April 5, 2012. Carolyn M. Clancy, Director. [FR Doc. 2012–8743 Filed 4–12–12; 8:45 am] BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES pmangrum on DSK3VPTVN1PROD with NOTICES Agency for Healthcare Research and Quality Correction—Solicitation for Nominations for Members of the U.S. Preventive Services Task Force (USPSTF) The original date of publication for this Federal Register notice was March 28, 2012, Volume 77, Number 60, pages 18823–18825. On this publication, Gloria Washington’s email address is incorrect in two places of page 18824 under subheadings ADDRESSES: and FOR VerDate Mar<15>2010 14:16 Apr 12, 2012 Jkt 226001 FURTHER INFORMATION CONTACT:. The correct email address for Gloria Washington is: USPSTFmember nominations@AHRQ.HHS.GOV Dated: April 4, 2012. Carolyn M. Clancy, Director. [FR Doc. 2012–8737 Filed 4–12–12; 8:45 am] BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Scientific Information Request on Treatment of Tinnitus 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 manufacturers of cochlear implants, sound masking devices, hearing aids, and transcranial magnetic stimulation medical devices. Scientific information is being solicited to inform our Comparative Effectiveness Review of Evaluation and Treatment of Tinnitus, 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 this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108–173. DATES: Submission Deadline on or before May 14, 2012. ADDRESSES: Online submissions: http://effectivehealthcare.AHRQ.gov/ index.cfm/submitscientific-informationpackets/. Please select the study for which you are submitting information from the list of current studies and complete the form to upload your documents. Email submissions: ehcsrc@ohsu.edu (please do not send zipped files—they are automatically deleted for security reasons). Print submissions: Robin Paynter, Oregon Health and Science University, Oregon Evidence-based Practice Center, 3181 SW Sam Jackson Park Road, Mail Code: BICC, Portland, OR 97239–3098. SUMMARY: PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: Robin Paynter, Research Librarian, Telephone: 503–494–0147 or Email: ehcsrc@ohsu.edu. SUPPLEMENTARY INFORMATION: In accordance with Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108–173, the Agency for Healthcare Research and Quality has commissioned the Effective Health Care (EHC) Program Evidence-based Practice Centers to complete a comparative effectiveness review of the evidence for evaluation and treatment of tinnitus. 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 systematically requesting information (e.g., details of studies conducted) from medical device industry stakeholders through public information requests, including via the Federal Register and direct postal and/ or online solicitations. We are looking for studies that report on treatment of tinnitus, including those that describe adverse events, as specified in the key questions detailed below. The entire research protocol, including the key questions, is also available online at: http://www.effectivehealthcare.AHRQ. gov/index.cfm/search-for-guidesreviews-and-reports/?pageaction= displayproduct&productid=811#4755. This notice is a request for industry stakeholders to submit the following: • A current product label, if applicable (preferably an electronic PDF file). • Information identifying published randomized controlled trials and observational studies relevant to the clinical outcomes. Please provide both a list of citations and reprints if possible. • Information identifying unpublished randomized controlled trials and observational studies relevant to the clinical outcomes. If possible, please provide a summary that includes 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 withdrawn/follow-up/ analyzed, and effectiveness/efficacy and safety results. • Registered ClinicalTrials.gov studies. Please provide a list including the ClinicalTrials.gov identifier, condition, and intervention. Your contribution is very beneficial to this program. AHRQ is not requesting E:\FR\FM\13APN1.SGM 13APN1 Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Notices and will not consider marketing material, health economics information, or information on other indications. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter. In addition to your scientific information please submit an index document outlining the relevant information in each file along with a statement regarding whether or not the submission comprises all of the complete information available. Please Note: The contents of all submissions, regardless of format, will be available to the public upon request unless prohibited by law. 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/. Key Question (KQ) 1 and PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and Setting) In patients with symptoms of tinnitus (e.g., ringing in the ears, whooshing sounds, etc.) what is the comparative effectiveness of methods used to identify patients for further evaluation or treatment? Population(s) Adult patients presenting with symptoms of tinnitus (e.g., ringing in the ears, whooshing sounds, etc.) Note: ‘‘Adults’’ for all KQs will include individuals 18 years of age and older. pmangrum on DSK3VPTVN1PROD with NOTICES Interventions Direct observation or observation of sound with stethoscope; referral to a health professional with expertise on managing tinnitus (i.e., otolaryngologist, audiologist, neurologist, mental health professional; administration of scales/ questionnaires to assess severity [e.g., Tinnitus Handicap Inventory, Tinnitus Reaction Questionnaire, Tinnitus Functional Index, Visual Analog Scale, and Tinnitus Severity Index, etc.]) Comparators Different clinical evaluation methods used to characterize a diagnosis and measure severity of subjective idiopathic tinnitus. Outcomes Final outcome: No treatment; need for specialized treatment (e.g., audiology, otolaryngology, neurology, mental health care); extent of intervention. VerDate Mar<15>2010 14:16 Apr 12, 2012 Jkt 226001 Timing or followup No restrictions. Setting Primary care; specialty care (audiology, otolaryngology, neurology, mental health care). Key Question 2 and PICOTS In adults with subjective idiopathic (non-pulsatile) tinnitus, what is the comparative effectiveness (and/or potential harms) of medical/surgical, sound treatment/technological, or psychological/behavioral intervention (including combinations of interventions)? Population(s) Adult patients with a diagnosis of subjective idiopathic (non-pulsatile) tinnitus (who are sufficiently bothered by tinnitus that they seek a treatment intervention) Note: For KQs 2 and 3, adults diagnosed with unilateral and/or pulsatile tinnitus need to be evaluated for other medical conditions (such as acoustic neuromas). Our review will include only those cases in which a medically serious underlying pathology as the source of the tinnitus has already been ruled out. Interventions Any treatment/therapy used to reduce/help cope with tinnitus including but not limited to: • Medical/Surgical • Pharmacological treatments • Tricyclic antidepressants (e.g., amitriptyline, nortriptyline, and trimipramine) • Selective serotonin-reuptake inhibitors: Fluoxetine and paroxetine • Other: Trazodone; anxiolytics (e.g., alprazolam); vasodilators and vasoactive substances (e.g., prostaglandin El); intravenous lidocaine; gabapentin; Botox (botulinum toxin type A); and pramipexole) • Laser treatments • TMJ treatment: Dental orthotics and self-care; surgery • Transcranial magnetic stimulation • Complementary and alternative medicine therapies: G. biloba extracts; acupuncture; hyperbaric oxygen therapy; and diet, lifestyle, and sleep modifications (caffeine avoidance, exercise) • Sound Treatments/Technologies • Hearing aids • Cochlear implants • Sound generators/maskers (both wearable and stationary) PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 22325 • Neuromonics • Tinnitus Retraining Therapy • Psychological/Behavioral • Cognitive behavioral therapy • Biofeedback • Education • Relaxation therapies • Progressive Tinnitus Management • Combination therapies • Any combination of tinnitus interventions (e.g., pharmacological treatment with cognitive behavioral therapy) Comparators Placebo; no treatment; wait list; treatment as usual; other intervention/ treatment. Outcomes • Final outcomes 1. Sleep disturbance 2. Discomfort 3. Anxiety 4. Depression 5. Self-reported loudness 6. Quality of life • Adverse effects 1. Worsening of tinnitus 2. Sedation 3. Surgical complications Timing or followup No restrictions. Setting Primary care; specialty care (audiology, otolaryngology, neurology, and mental health care). Key Question 3 and PICOTS For adults with subjective idiopathic tinnitus, what prognostic factors, patient characteristics, and/or symptom characteristics affect final treatment outcomes? Population(s) Adults with a diagnosis of subjective idiopathic tinnitus (sufficiently bothered by tinnitus that they are seeking a treatment intervention). Interventions Any treatment/therapy used to reduce/help cope with tinnitus including but not limited to those described in KQ 2. Comparators • Prognostic factors: Length of time to treatment after onset, audiological factors (degree and type of hearing loss, hyperacusis, loudness tolerance, masking criteria, etc.), head injury, anxiety, mental health disorders, and duration of tinnitus • Patient characteristics: Age, gender, race, medical or mental health E:\FR\FM\13APN1.SGM 13APN1 22326 Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Notices comorbidities, socioeconomic factors, noise exposure (environmental, recreational and work-related [including active and past military duty, and occupational hazards), involvement in litigation, third-party coverage • Symptom characteristics: Origin/ presumed etiology of tinnitus, ototoxicity, tinnitus duration since onset, subcategory of tinnitus, severity of tinnitus Outcomes • Final outcomes 1. Time until improvement 2. Sleep disturbance 3. Discomfort 4. Anxiety 5. Depression 6. Self-reported loudness 7. Quality of life 8. Return to ‘‘normal’’ work • Adverse effects 1. Worsening of tinnitus 2. Sedation 3. Surgical complications forth in Section 552b(c) (4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Matters To Be Discussed: The meeting will include the initial review, discussion, and evaluation of applications received in response to ‘‘Extension of the World Trade Center Health Registry (U50) RFA OH12– 001’’ Contact Person for More Information: George Bockosh, M.S., Scientific Review Officer, CDC/NIOSH, 626 Cochrans Mill Road, Mailstop P–05, Pittsburgh, Pennsylvania 15236, Telephone: (412) 386– 6465 AND Joan Karr, Ph.D., Scientific Review Officer, CDC/NIOSH 1600 Clifton Road, NE., Mailstop E–74, Atlanta, Georgia 30333, Telephone: (404) 498–2506. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dated: April 5, 2012. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. Timing or Followup No restrictions. Setting [FR Doc. 2012–8886 Filed 4–12–12; 8:45 am] Primary care; specialty care (audiology, otolaryngology, neurology, mental health). BILLING CODE 4163–18–P Dated: April 4, 2012 Carolyn M. Clancy, Director, AHRQ. Centers for Disease Control and Prevention [FR Doc. 2012–8740 Filed 4–12–12; 8:45 am] BILLING CODE 4160–90–M Board of Scientific Counselors, National Center for Health Statistics, (BSC, NCHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention pmangrum on DSK3VPTVN1PROD with NOTICES Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review The meeting announced below concerns Extension of the World Trade Center Health Registry (U50) Request for Applications (RFA), OH12–001, initial review. In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting: Time and Date: 1 p.m.–2 p.m., May 16, 2012 (Closed). Place: National Institute of Occupational Safety and Health (NIOSH), 2400 Century Parkway, NE., Atlanta, Georgia 30345, Telephone: (866) 918–5441. Status: The meeting will be closed to the public in accordance with provisions set VerDate Mar<15>2010 14:16 Apr 12, 2012 Jkt 226001 DEPARTMENT OF HEALTH AND HUMAN SERVICES In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC), National Center for Health Statistics (NCHS) announces the following meeting of the aforementioned committee: Times and Dates: 11 a.m.–5:30 p.m., May 17, 2012. 8:30 a.m.–1 p.m., May 18, 2012. Place: NCHS Headquarters, 3311 Toledo Road, Hyattsville, Maryland 20782. Status: This meeting is open to the public; however, visitors must be processed in accordance with established federal policies and procedures. For foreign nationals or nonUS citizens, pre-approval is required (please contact Gwen Mustaf, (301) 458–4500, glm4@cdc.gov or Virginia Cain, vcain@cdc.gov at least 10 days in advance for requirements). All visitors are required to present a valid form of picture identification issued by a state, federal or international government. As required by the Federal Property Management Regulations, Title 41, Code of Federal Regulation, Subpart 101– 20.301, all persons entering in or on Federal PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 controlled property and their packages, briefcases, and other containers in their immediate possession are subject to being xrayed and inspected. Federal law prohibits the knowing possession or the causing to be present of firearms, explosives and other dangerous weapons and illegal substances. The meeting room accommodates approximately 100 people. Purpose: This committee is charged with providing advice and making recommendations to the Secretary, Department of Health and Human Services; the Director, CDC; and the Director, NCHS, regarding the scientific and technical program goals and objectives, strategies, and priorities of NCHS. Matters To Be Discussed: The agenda will include welcome remarks by the Director, NCHS; the initiation of the review of the Office of Research and Methodology; a discussion of vital statistics and an open session for comments from the public. Requests to make oral presentations should be submitted in writing to the contact person listed below. All requests must contain the name, address, telephone number, and organizational affiliation of the presenter. Written comments should not exceed five single-spaced typed pages in length and must be received by April 30, 2012. The agenda items are subject to change as priorities dictate. Contact Person for More Information: Virginia S. Cain, Ph.D., Director of Extramural Research, NCHS/CDC, 3311 Toledo Road, Room 7208, Hyattsville, Maryland 20782, telephone (301) 458–4500, fax (301) 458–4020. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dated: April 5, 2012. Elaine L. Baker, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2012–8887 Filed 4–12–12; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Privacy Act of 1974, as Amended by Public Law 100–503; Notice of a Computer Matching Program Office of Financial Services (OFS), Office of Administration (OA), ACF, HHS. ACTION: Request for public comment on the Public Assistance Reporting Information System (PARIS) notice of a computer matching program between the Department of Veterans Affairs and AGENCY: E:\FR\FM\13APN1.SGM 13APN1

Agencies

[Federal Register Volume 77, Number 72 (Friday, April 13, 2012)]
[Notices]
[Pages 22324-22326]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8740]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Scientific Information Request on Treatment of Tinnitus

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 manufacturers of 
cochlear implants, sound masking devices, hearing aids, and 
transcranial magnetic stimulation medical devices. Scientific 
information is being solicited to inform our Comparative Effectiveness 
Review of Evaluation and Treatment of Tinnitus, 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 this device will improve the 
quality of this comparative effectiveness review. AHRQ is requesting 
this scientific information and conducting this comparative 
effectiveness review pursuant to Section 1013 of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003, Public 
Law 108-173.

DATES: Submission Deadline on or before May 14, 2012.

ADDRESSES:  Online submissions: http://effectivehealthcare.AHRQ.gov/index.cfm/submitscientific-information-packets/. Please select the 
study for which you are submitting information from the list of current 
studies and complete the form to upload your documents.
     Email submissions: ehcsrc@ohsu.edu (please do not send zipped 
files--they are automatically deleted for security reasons).
     Print submissions: Robin Paynter, Oregon Health and Science 
University, Oregon Evidence-based Practice Center, 3181 SW Sam Jackson 
Park Road, Mail Code: BICC, Portland, OR 97239-3098.

FOR FURTHER INFORMATION CONTACT: Robin Paynter, Research Librarian, 
Telephone: 503-494-0147 or Email: ehcsrc@ohsu.edu.

SUPPLEMENTARY INFORMATION: In accordance with Section 1013 of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, 
Public Law 108-173, the Agency for Healthcare Research and Quality has 
commissioned the Effective Health Care (EHC) Program Evidence-based 
Practice Centers to complete a comparative effectiveness review of the 
evidence for evaluation and treatment of tinnitus.
    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 systematically requesting 
information (e.g., details of studies conducted) from medical device 
industry stakeholders through public information requests, including 
via the Federal Register and direct postal and/or online solicitations. 
We are looking for studies that report on treatment of tinnitus, 
including those that describe adverse events, as specified in the key 
questions detailed below. The entire research protocol, including the 
key questions, is also available online at: http://www.effectivehealthcare.AHRQ.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=811#4755.
    This notice is a request for industry stakeholders to submit the 
following:
     A current product label, if applicable (preferably an 
electronic PDF file).
     Information identifying published randomized controlled 
trials and observational studies relevant to the clinical outcomes. 
Please provide both a list of citations and reprints if possible.
     Information identifying unpublished randomized controlled 
trials and observational studies relevant to the clinical outcomes. If 
possible, please provide a summary that includes 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 withdrawn/follow-
up/analyzed, and effectiveness/efficacy and safety results.
     Registered ClinicalTrials.gov studies. Please provide a 
list including the ClinicalTrials.gov identifier, condition, and 
intervention.
    Your contribution is very beneficial to this program. AHRQ is not 
requesting

[[Page 22325]]

and will not consider marketing material, health economics information, 
or information on other indications. This is a voluntary request for 
information, and all costs for complying with this request must be 
borne by the submitter. In addition to your scientific information 
please submit an index document outlining the relevant information in 
each file along with a statement regarding whether or not the 
submission comprises all of the complete information available.

    Please Note: The contents of all submissions, regardless of 
format, will be available to the public upon request unless 
prohibited by law.

    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/.

Key Question (KQ) 1 and PICOTS (Populations, Interventions, 
Comparators, Outcomes, Timing, and Setting)

    In patients with symptoms of tinnitus (e.g., ringing in the ears, 
whooshing sounds, etc.) what is the comparative effectiveness of 
methods used to identify patients for further evaluation or treatment?

Population(s)

    Adult patients presenting with symptoms of tinnitus (e.g., ringing 
in the ears, whooshing sounds, etc.)
    Note: ``Adults'' for all KQs will include individuals 18 years of 
age and older.

Interventions

    Direct observation or observation of sound with stethoscope; 
referral to a health professional with expertise on managing tinnitus 
(i.e., otolaryngologist, audiologist, neurologist, mental health 
professional; administration of scales/questionnaires to assess 
severity [e.g., Tinnitus Handicap Inventory, Tinnitus Reaction 
Questionnaire, Tinnitus Functional Index, Visual Analog Scale, and 
Tinnitus Severity Index, etc.])

Comparators

    Different clinical evaluation methods used to characterize a 
diagnosis and measure severity of subjective idiopathic tinnitus.

Outcomes

    Final outcome: No treatment; need for specialized treatment (e.g., 
audiology, otolaryngology, neurology, mental health care); extent of 
intervention.

Timing or followup

    No restrictions.

Setting

    Primary care; specialty care (audiology, otolaryngology, neurology, 
mental health care).

Key Question 2 and PICOTS

    In adults with subjective idiopathic (non-pulsatile) tinnitus, what 
is the comparative effectiveness (and/or potential harms) of medical/
surgical, sound treatment/technological, or psychological/behavioral 
intervention (including combinations of interventions)?

Population(s)

    Adult patients with a diagnosis of subjective idiopathic (non-
pulsatile) tinnitus (who are sufficiently bothered by tinnitus that 
they seek a treatment intervention)
    Note: For KQs 2 and 3, adults diagnosed with unilateral and/or 
pulsatile tinnitus need to be evaluated for other medical conditions 
(such as acoustic neuromas). Our review will include only those cases 
in which a medically serious underlying pathology as the source of the 
tinnitus has already been ruled out.

Interventions

    Any treatment/therapy used to reduce/help cope with tinnitus 
including but not limited to:

 Medical/Surgical
     Pharmacological treatments
     Tricyclic antidepressants (e.g., amitriptyline, 
nortriptyline, and trimipramine)
     Selective serotonin-reuptake inhibitors: Fluoxetine and 
paroxetine
     Other: Trazodone; anxiolytics (e.g., alprazolam); 
vasodilators and vasoactive substances (e.g., prostaglandin El); 
intravenous lidocaine; gabapentin; Botox (botulinum toxin type A); and 
pramipexole)

 Laser treatments
 TMJ treatment: Dental orthotics and self-care; surgery
 Transcranial magnetic stimulation
 Complementary and alternative medicine therapies: G. biloba 
extracts; acupuncture; hyperbaric oxygen therapy; and diet, lifestyle, 
and sleep modifications (caffeine avoidance, exercise)

 Sound Treatments/Technologies
     Hearing aids
     Cochlear implants
     Sound generators/maskers (both wearable and stationary)
     Neuromonics
     Tinnitus Retraining Therapy
 Psychological/Behavioral
     Cognitive behavioral therapy
     Biofeedback
     Education
     Relaxation therapies
     Progressive Tinnitus Management

 Combination therapies
     Any combination of tinnitus interventions (e.g., 
pharmacological treatment with cognitive behavioral therapy)

Comparators

    Placebo; no treatment; wait list; treatment as usual; other 
intervention/treatment.

Outcomes

 Final outcomes
    1. Sleep disturbance
    2. Discomfort
    3. Anxiety
    4. Depression
    5. Self-reported loudness
    6. Quality of life

 Adverse effects
    1. Worsening of tinnitus
    2. Sedation
    3. Surgical complications

Timing or followup

    No restrictions.

Setting

    Primary care; specialty care (audiology, otolaryngology, neurology, 
and mental health care).

Key Question 3 and PICOTS

    For adults with subjective idiopathic tinnitus, what prognostic 
factors, patient characteristics, and/or symptom characteristics affect 
final treatment outcomes?

Population(s)

    Adults with a diagnosis of subjective idiopathic tinnitus 
(sufficiently bothered by tinnitus that they are seeking a treatment 
intervention).

Interventions

    Any treatment/therapy used to reduce/help cope with tinnitus 
including but not limited to those described in KQ 2.

Comparators

 Prognostic factors: Length of time to treatment after onset, 
audiological factors (degree and type of hearing loss, hyperacusis, 
loudness tolerance, masking criteria, etc.), head injury, anxiety, 
mental health disorders, and duration of tinnitus
 Patient characteristics: Age, gender, race, medical or mental 
health

[[Page 22326]]

comorbidities, socioeconomic factors, noise exposure (environmental, 
recreational and work-related [including active and past military duty, 
and occupational hazards), involvement in litigation, third-party 
coverage
 Symptom characteristics: Origin/presumed etiology of tinnitus, 
ototoxicity, tinnitus duration since onset, subcategory of tinnitus, 
severity of tinnitus

Outcomes

 Final outcomes
    1. Time until improvement
    2. Sleep disturbance
    3. Discomfort
    4. Anxiety
    5. Depression
    6. Self-reported loudness
    7. Quality of life
    8. Return to ``normal'' work
 Adverse effects
    1. Worsening of tinnitus
    2. Sedation
    3. Surgical complications

Timing or Followup

    No restrictions.

Setting

    Primary care; specialty care (audiology, otolaryngology, neurology, 
mental health).

    Dated: April 4, 2012
Carolyn M. Clancy,
Director, AHRQ.
[FR Doc. 2012-8740 Filed 4-12-12; 8:45 am]
BILLING CODE 4160-90-M