Notice2022-17371
Supplemental Evidence and Data Request on Cervical Degenerative Disease Treatment
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 12, 2022
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
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 Access to published and unpublished pertinent scientific information will improve the quality of this review.
Full Text
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<title>Federal Register, Volume 87 Issue 155 (Friday, August 12, 2022)</title>
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[Federal Register Volume 87, Number 155 (Friday, August 12, 2022)]
[Notices]
[Pages 49840-49842]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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published and unpublished pertinent scientific information will improve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: <a href="/cdn-cgi/l/email-protection#cda8bdae8daca5bfbce3a5a5bee3aaa2bb"><span class="__cf_email__" data-cfemail="8feaffeccfeee7fdfea1e7e7fca1e8e0f9">[email protected]</span></a>.
On-line submissions: <a href="https://effectivehealthcare.ahrq.gov/get-involved/submit-sead">https://effectivehealthcare.ahrq.gov/get-involved/submit-sead</a>.
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: <a href="/cdn-cgi/l/email-protection#83e6f3e0c3e2ebf1f2adebebf0ade4ecf5"><span class="__cf_email__" data-cfemail="6f0a1f0c2f0e071d1e4107071c41080019">[email protected]</span></a>.
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: <a href="https://effectivehealthcare.ahrq.gov/products/cervical-degenerative-disease/protocol">https://effectivehealthcare.ahrq.gov/products/cervical-degenerative-disease/protocol</a>.
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 <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> along with the
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> trial number.
[ssquf] For completed studies that do not have results on
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>, 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
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> 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: <a href="https://www.effectivehealthcare.ahrq.gov/email-updates">https://www.effectivehealthcare.ahrq.gov/email-updates</a>.
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
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Population...................... <bullet> Age 18 <bullet> Younger
and above with than 18 years.
symptomatic *<bullet>
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).
<bullet> Patients
without cervical
degenerative
disease.
<bullet>
Nonhumans.
Intervention.................... <bullet> Cervical <bullet>
spine surgery Preoperative
(e.g., imaging using CT
discectomy, disc or plain films.
replacement,
fusion,
arthroplasty,
laminectomy,
laminoplasty,
corpectomy,
cervical hybrid
surgery,
foraminotomy).
<bullet> 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).
<bullet> ..................
Intraoperative
neuromonitoring.
<bullet> Imaging ..................
to identify
symptomatic
pseudarthrosis
after cervical
fusion surgery.
<bullet> ..................
Preoperative MRI
to predict
neurologic
recovery in
myelopathy.
Comparators..................... <bullet> Any <bullet>
included Nonoperative
intervention. intervention
<bullet> Placebo, versus
waitlist, active nonoperative
control. intervention
without surgical
comparator.
Outcomes........................ <bullet> Pain, <bullet>
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).
<bullet> Fusion
rate, reoperation
rate.
<bullet> 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).
<bullet>
Sensitivity and
specificity of
imaging after
cervical fusion
surgery.
Timing.......................... <bullet> All time
periods.
Setting......................... <bullet>
Inpatient,
outpatient,
ambulatory
surgical centers..
Study Design.................... <bullet> RCTs, <bullet> 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
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