[Federal Register Volume 87, Number 155 (Friday, August 12, 2022)]
[Notices]
[Pages 49840-49842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17371]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Cervical Degenerative 
Disease Treatment

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for Supplemental Evidence and Data 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 on Cervical 
Degenerative Disease Treatment, which is currently being conducted by 
the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to 
published and unpublished pertinent scientific information will improve 
the quality of this review.

DATES: Submission Deadline on or before September 12, 2022.

ADDRESSES: 
    Email submissions: [email protected].
    On-line submissions: https://effectivehealthcare.ahrq.gov/get-involved/submit-sead.
    Print submissions:
    Mailing Address: Center for Evidence and Practice Improvement, 
Agency for Healthcare Research and Quality, ATTN: EPC SEADs 
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
    Shipping Address (FedEx, UPS, etc.): Center for Evidence and 
Practice Improvement, Agency for Healthcare Research and Quality, ATTN: 
EPC SEADs Coordinator,5600 Fishers Lane, Mail Stop 06E77D, Rockville, 
MD 20857.

FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496 
or Email: [email protected].

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Center (EPC) 
Program to complete a review of the evidence for Cervical Degenerative 
Disease Treatment. AHRQ is conducting this systematic review pursuant 
to

[[Page 49841]]

Section 902 of the Public Health Service Act, 42 U.S.C. 299a.
    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 Cervical Degenerative Disease Treatment, including those 
that describe adverse events. The entire research protocol is available 
online at: https://effectivehealthcare.ahrq.gov/products/cervical-degenerative-disease/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Cervical Degenerative Disease Treatment 
helpful:
    [ssquf] 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.
    [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 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.
    [ssquf] 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 is very beneficial to the Program. Materials 
submitted must be publicly available or able to 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 
website 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://www.effectivehealthcare.ahrq.gov/email-updates.
    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.

Key Questions* (KQ)

    KQ1. In patients with radiographic spinal cord compression and no 
cervical spondylotic myelopathy, what are the comparative effectiveness 
and harms of surgery compared to non-operative treatment or no 
treatment?
    KQ2. In patients with radiographic spinal cord compression and mild 
to severe myelopathy, what is the effectiveness and harms of surgery 
versus non-operative treatment or no treatment? How do the 
effectiveness and harms vary by level of severity of myelopathy at the 
time of surgery?
    KQ3. In patients with cervical degenerative disease, what are the 
comparative effectiveness and harms of surgical compared to non-
operative treatment?
    KQ4. In patients with cervical degenerative disease, what are the 
comparative effectiveness and harms of therapies added on to surgery 
(pre- or post-operative) compared with the same surgery alone?
    KQ5. In patients with cervical radiculopathy due to cervical 
degenerative disease, what are the comparative effectiveness and harms 
of posterior versus anterior surgery?
    KQ6. In patients with cervical degenerative disease, what are the 
comparative effectiveness and harms of posterior versus anterior 
surgery in patients with greater than or equal to three level disease?
    KQ7. In patients with cervical spondylotic myelopathy due to 
cervical degenerative disease, what are the comparative effectiveness 
and harms of cervical laminectomy and fusion compared to cervical 
laminoplasty in patients?
    KQ8. In patients with cervical spondylotic radiculopathy or 
myelopathy at one or two levels, what are the comparative effectiveness 
and harms of cervical arthroplasty compared to anterior cervical 
discectomy and fusion?
    KQ9. In patients undergoing anterior cervical discectomy and 
fusion, what are the comparative effectiveness and harms of surgery 
based on interbody graft material or device type?
    KQ10. In patients with pseudarthrosis after prior anterior cervical 
fusion surgery, what are the comparative effectiveness and harms of 
posterior approaches compared to revision anterior arthrodesis?
    KQ11. In patients with cervical spondylotic myelopathy, what is the 
prognostic utility of preoperative magnetic resonance imaging (MRI) 
findings for neurologic recovery after surgery?
    KQ12. What is the sensitivity and specificity of imaging assessment 
for identifying symptomatic pseudarthrosis after prior cervical fusion 
surgery?
    KQ13. In patients with cervical spondylotic myelopathy, what are 
the comparative effectiveness and harms of intraoperative 
neuromonitoring (e.g., with somatosensory or motor evoked potential 
measurements) versus no neuromonitoring on clinical outcomes in 
patients undergoing surgery?
    * For purposes of these key questions, we are focusing on 
symptomatic cervical degenerative disc disease; with the exception of 
Key Question 1, evaluation and management of asymptomatic disease is 
beyond the scope of this review.

Contextual Questions (CQ)

    CQ1. What is the prevalence of cervical degenerative disease with 
spinal cord compression in asymptomatic patients?
    CQ2. What is the natural history of untreated spinal cord 
compression in patients with cervical degenerative disease?

[[Page 49842]]



 PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
                                Setting)
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                                       Inclusion           Exclusion
------------------------------------------------------------------------
Population......................   Age 18      Younger
                                   and above with      than 18 years.
                                   symptomatic        *
                                   cervical            Effectiveness and
                                   degenerative        harms of surgery
                                   disease (e.g.,      based on patient
                                   pain,               characteristics,
                                   radiculopathy,      disease
                                   myelopathy) for     characteristics
                                   all KQs except      and radiographic
                                   for KQ1, which      characteristics
                                   includes            (e.g., age,
                                   asymptomatic        gender,
                                   patients.           comorbidities
                                                       [e.g., comorbid
                                                       lumbar disease,
                                                       autoimmune
                                                       disease,
                                                       neurological
                                                       disease, mental
                                                       illness, Down's
                                                       syndrome],
                                                       severity of
                                                       cervical
                                                       degenerative
                                                       disease, Frailty
                                                       Index, sagittal
                                                       vertical aspect,
                                                       degree of
                                                       kyphosis, prior
                                                       treatment [e.g.,
                                                       bracing,
                                                       traction,
                                                       medications,
                                                       massage,
                                                       acupuncture,
                                                       injections,
                                                       chiropractic
                                                       care, spinal
                                                       manipulation],
                                                       duration of pain,
                                                       skill of
                                                       surgeon).
                                                       Patients
                                                       without cervical
                                                       degenerative
                                                       disease.
                                                      
                                                       Nonhumans.
Intervention....................   Cervical   
                                   spine surgery       Preoperative
                                   (e.g.,              imaging using CT
                                   discectomy, disc    or plain films.
                                   replacement,
                                   fusion,
                                   arthroplasty,
                                   laminectomy,
                                   laminoplasty,
                                   corpectomy,
                                   cervical hybrid
                                   surgery,
                                   foraminotomy).
                                   Non-       ..................
                                   surgical
                                   treatments (e.g.,
                                   heat, exercise,
                                   acupuncture,
                                   drugs,
                                   radiofrequency
                                   ablation, steroid
                                   injections,
                                   Botox[supreg] for
                                   neck pain,
                                   psychological
                                   strategies [e.g.,
                                   cognitive
                                   behavioral
                                   therapy],
                                   occupational
                                   therapy,
                                   multidisciplinary
                                   rehabilitation).
                                              ..................
                                   Intraoperative
                                   neuromonitoring.
                                   Imaging    ..................
                                   to identify
                                   symptomatic
                                   pseudarthrosis
                                   after cervical
                                   fusion surgery.
                                              ..................
                                   Preoperative MRI
                                   to predict
                                   neurologic
                                   recovery in
                                   myelopathy.
Comparators.....................   Any        
                                   included            Nonoperative
                                   intervention.       intervention
                                   Placebo,    versus
                                   waitlist, active    nonoperative
                                   control.            intervention
                                                       without surgical
                                                       comparator.
Outcomes........................   Pain,      
                                   sensory function,   Nonvalidated
                                   motor function,     instruments.
                                   gait, quality of
                                   life (e.g., VAS,
                                   NRS, NDI, SF-36,
                                   SF-12, EQ-5Dm,
                                   mJOA score,
                                   Nurick score,
                                   MDI, PROMIS-29,
                                   dysphagia scales,
                                   return to work).
                                   Fusion
                                   rate, reoperation
                                   rate.
                                   Harms      ..................
                                   (e.g.,
                                   withdrawals due
                                   to adverse
                                   events, serious
                                   adverse events,
                                   new symptomatic
                                   adjacent segment
                                   disease,
                                   postoperative
                                   infection, device
                                   failure,
                                   ossification of
                                   the posterior
                                   ligament,
                                   development of
                                   kyphotic
                                   deformity).
                                  
                                   Sensitivity and
                                   specificity of
                                   imaging after
                                   cervical fusion
                                   surgery.
Timing..........................   All time
                                   periods.
Setting.........................  
                                   Inpatient,
                                   outpatient,
                                   ambulatory
                                   surgical centers..
Study Design....................   RCTs,       Pre-post
                                   prospective         single-arm
                                   trials and          studies, case
                                   retrospective       series, case
                                   observational       reports,
                                   studies with a      systematic
                                   control group       reviews published
                                   (study N>=50),      prior to 2007.
                                   current
                                   systematic
                                   reviews for
                                   identification of
                                   additional
                                   studies.
------------------------------------------------------------------------
CT = computed tomography; EQ-5D = EuroQol-5 dimension instrument; KQ =
  key question; MDI = myelopathy disability index; MRI = magnetic
  resonance imaging; mJOA = modified Japanese orthopedic association
  scale; NDI = neck disability index; NRS = numerical pain rating scale;
  PROMIS-29 = patient reported outcome measurement information system;
  RCT = randomized controlled trial; QOL = quality of life; SF = short
  form health survey (12 or 36 items); VAS = visual analogue scale for
  pain.


    Dated: August 9, 2022.
Marquita Cullom,
Associate Director.
[FR Doc. 2022-17371 Filed 8-11-22; 8:45 am]
BILLING CODE 4160-90-P