Supplemental Evidence and Data Request on Cervical Degenerative Disease Treatment, 49840-49842 [2022-17371]
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Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices
confirm that requests are being made by
actual people and not potentially
malicious software code such as bots
and other cybersecurity threats.
User registration will be used for
administrative purposes only including
communication between SRDR platform
administrators and registrant users. This
type of information will not be made
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SRDR platform. In 2020, 1,029 users
registered as Contributors. Registration
will take approximately 1.5 minutes or
0.025 hours per user. We thus calculate
the total burden hours required for
registration for all users annually is
25.73 hours.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate/use the
EXHIBIT 1— ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Form name
Hours per
response
Total burden
hours
Registration of users as Contributors ..............................................................
1,029
1
0.025
25.73
Total ..........................................................................................................
1,029
........................
........................
25.73
Exhibit 2 shows the estimated cost
burden associated with the respondents’
time to participate/use the SRDR
platform. The total cost burden to
respondents is estimated at an average
of $ 1,126.97 annually.
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Form name
Total burden
hours
Average
hourly wage
rate *
Total cost
burden
Registration of users as Commentators or Contributors .................................
1,029
25.73
a $43.80
$1,126.97
Total ..........................................................................................................
1,029
25.73
........................
1,126.97
* National Compensation Survey: Occupational wages in the United States May 2021, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
Available at: https://www.bls.gov/oes/current/oes290000.htm.
a Based on the mean wages for Healthcare Practitioners and Technical Occupations, 29–0000.
jspears on DSK121TN23PROD with NOTICES
Request for Comments
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3520,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) whether the
proposed collection of information is
necessary for the proper performance of
AHRQ’s health care research and health
care information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
VerDate Sep<11>2014
17:38 Aug 11, 2022
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Dated: August 9, 2022.
Marquita Cullom,
Associate Director.
[FR Doc. 2022–17369 Filed 8–11–22; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Cervical Degenerative
Disease Treatment
Agency for Healthcare Research
and Quality (AHRQ), HHS.
AGENCY:
Request for Supplemental
Evidence and Data Submissions.
ACTION:
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 Evidencebased Practice Centers (EPC) Program.
Access to published and unpublished
pertinent scientific information will
improve the quality of this review.
SUMMARY:
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Submission Deadline on or
before September 12, 2022.
ADDRESSES:
Email submissions: epc@
ahrq.hhs.gov.
On-line submissions: https://
effectivehealthcare.ahrq.gov/getinvolved/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.
DATES:
FOR FURTHER INFORMATION CONTACT:
Jenae Benns, Telephone: 301–427–1496
or Email: epc@ahrq.hhs.gov.
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
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Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices
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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:
D 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.
D 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.
D 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.
D 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
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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?
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49841
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?
E:\FR\FM\12AUN1.SGM
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49842
Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)
Inclusion
Exclusion
Population .......................................
• Age 18 and above with symptomatic cervical degenerative disease (e.g., pain, radiculopathy, myelopathy) for all KQs except for KQ1, which includes asymptomatic patients.
Intervention ......................................
• Cervical spine surgery (e.g., discectomy, disc replacement, fusion, arthroplasty, laminectomy,
laminoplasty, corpectomy, cervical hybrid surgery,
foraminotomy).
• Non-surgical treatments (e.g., heat, exercise, acupuncture, drugs, radiofrequency ablation, steroid
injections, Botox® 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.
• Any included intervention .......................................
• Placebo, waitlist, active control ..............................
• Pain, sensory function, motor function, 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.
• All time periods.
• Inpatient, outpatient, ambulatory surgical centers..
• RCTs, prospective trials and retrospective observational studies with a control group (study
N≥50), current systematic reviews for identification of additional studies.
• Younger than 18 years.
*• Effectiveness and harms of surgery based on
patient characteristics, disease characteristics and
radiographic characteristics (e.g., age, gender,
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.
• Preoperative imaging using CT or plain films.
Comparators ....................................
Outcomes ........................................
Timing ..............................................
Setting .............................................
Study Design ...................................
• Nonoperative intervention versus nonoperative
intervention without surgical comparator.
• Nonvalidated instruments.
• Pre-post single-arm studies, case series, case reports, systematic reviews published prior to 2007.
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2022–17371 Filed 8–11–22; 8:45 am]
Centers for Disease Control and
Prevention
BILLING CODE 4160–90–P
jspears on DSK121TN23PROD with NOTICES
[30Day–22–21IO]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘Evaluation
VerDate Sep<11>2014
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Reporting Template for National and
State Tobacco Control Program’’ to the
Office of Management and Budget
(OMB) for review and approval. CDC
previously published a ‘‘Proposed Data
Collection Submitted for Public
Comment and Recommendations’’
notice on October 13, 2021 to obtain
comments from the public and affected
agencies. CDC did not receive comments
related to the previous notice. This
notice serves to allow an additional 30
days for public and affected agency
comments.
E:\FR\FM\12AUN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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)
------------------------------------------------------------------------
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
