Supplemental Evidence and Data Request on The Performance of Fusion Procedures for Degenerative Disease of the Lumbar Spine, 3214-3218 [2025-00548]
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3214
Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices
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[FR Doc. 2025–00599 Filed 1–13–25; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on The Performance of Fusion
Procedures for Degenerative Disease
of the Lumbar Spine
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for Supplemental
Evidence and Data Submission.
AGENCY:
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
The Performance of Fusion Procedures
for Degenerative Disease of the Lumbar
Spine, 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Access to published and unpublished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.
DATES: Submission Deadline on or
before February 13, 2025.
ADDRESSES:
Email submissions: epc@
ahrq.hhs.gov.
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:
Kelly Carper, Telephone: 301–427–1656
or Email: epc@ahrq.hhs.gov.
SUMMARY:
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The
Agency for Healthcare Research and
Quality has commissioned the
Evidence-based Practice Centers (EPC)
Program to complete a review of the
evidence for The Performance of Fusion
Procedures for Degenerative Disease of
the Lumbar Spine. AHRQ is conducting
this review pursuant to 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 The Performance of
Fusion Procedures for Degenerative
Disease of the Lumbar Spine. The entire
research protocol is available online at:
https://effectivehealthcare.ahrq.gov/
products/lumbar-spinal-fusion/protocol.
This is to notify the public that the
EPC Program would find the following
information on The Performance of
Fusion Procedures for Degenerative
Disease of the Lumbar Spine helpful:
D A list of completed studies that your
organization has sponsored for this
topic. 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, if relevant: 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
topic. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including, if relevant, 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 topic and an index
outlining the relevant information in
each submitted file.
Your contribution is very beneficial to
the Program. Materials submitted must
SUPPLEMENTARY INFORMATION:
E:\FR\FM\14JAN1.SGM
14JAN1
Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices
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 topics 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://effectivehealthcare.ahrq.gov/
email-updates.
The 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)
Questions on Surgery (KQ 1–4)
In adults with symptomatic, stable
degenerative lumbar spondylolisthesis
(DLS) with or without radiculopathy or
neurogenic claudication
• Key Question 1. What are the
benefits and harms of surgery with
instrumentation in addition to
decompression compared with
decompression alone?
In symptomatic adults with unstable
or stable DLS with or without
radiculopathy or neurogenic
claudication undergoing instrumented
fusion:
• Key Question 2. What are the
benefits and harms of the addition of an
3215
interbody cage to instrumentation (e.g.,
pedicle screws) compared to use of
instrumentation alone (i.e.,
posterolateral fusion)?
• Key Question 3. What are the
benefits and harms of the use of bone
graft extenders and biologic substitutes
compared to the use of autografts?
In adults with symptomatic,
degenerative lumbar spine disease
undergoing instrumented fusion:
• Key Question 4. Does the use of
intraoperative monitoring (IONM)
decrease perioperative neurological
injuries compared with not using
IONM?
PICOTS (Populations, Interventions,
Comparators, Outcomes, Timing, and
Setting)
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TABLE 1—EPC PROPOSED PICOTS AND CORRESPONDING INCLUSION AND EXCLUSION CRITERIA KEY QUESTIONS 1,2,3
AND 4 ON SURGERY
Inclusion
Exclusion
Population .....................................................................
Key Questions (1–3)
• Symptomatic adult patients with a radiographic
diagnosis (based on dynamic (flexion and extension radiographs) of degenerative lumbar
spondylolisthesis (any grade) who remain
symptomatic following conservative treatment
• Patients with or without evidence of nerve
compression (radiculopathy, neurogenic
claudication)
KQ 1
• Stable (non-mobile, static) DLS (<3 mm slip
on extension/flexion radiographs)
KQ 2, 3
• Patients with unstable or stable DLS on
radiographs
KQ 4
• Patients with symptomatic degenerative lumbar spine disease undergoing fusion of 5 or
fewer levels (stratify by presence of DLS)
Interventions .................................................................
ALL Key Questions
• FDA approved devices or materials (or in
Phase III trials) as applicable to the KQ
• Open and minimally invasive (e.g.,
endoscopic) procedures
KQ 1
• Decompression (discectomy, indirect and direct methods) with instrumented spinal fusion
(e.g., with pedicle screws, interbody cages, or
other hardware)
KQ 2
• Surgical decompression and instrumented
posterolateral fusion (e.g., using pedicle
screws) with addition of interbody cage (expandable or static, ALIF, TLIF, LLIF)
KQ 3
• Decompression and spinal fusion using bone
graft extenders or biologic substitutes
(demineralized bone matrix, cadaveric
allograft, cortical fibers, bone morphogenic
protein, cellular allografts
KQ 4
• IONM (Motor Evoked Potentials (MEP),
Somatosensory Evoked Potentials (SSEP),
Free Running EMG (electromyography) Direct
Stimulation
ALL Key Questions
• Patients <18 years old.
• Asymptomatic patients.
• Other forms of spondylolisthesis are excluded (i.e.,
excluding dysplastic, isthmic, traumatic, and
pathologic causes/forms).
• Patients with osteoporosis, vertebral compression fractures.
• Exclude pts undergoing revisions or repeat
procedures.
• Patients having reoperation/repeat procedures.
KQs 1–3
• Patients without degenerative
spondylolisthesis.
• Studies with <80% of patients have
spondylolisthesis.
KQ 1
• Patients with unstable (dynamic) DLS: (exclude study if stable is not specified, is unclear).
ALL Key Questions
• Devices or materials that are not FDA approved or in Phase III trials (as applicable to
the question) or not available in the U.S.
• Mesenchymal stem cells (MSCs)
• Procedures that don’t include decompression
• Non-instrumented fusions
• Coflex, interspinous fixation
• Minimally invasive lumbar decompression
(MILD) procedure
• Surgical procedures not listed
KQ 4
• Other monitoring formats (e.g., imaging, computer assisted navigation systems, etc.)
• Combinations of graft materials (other than
with autograft)
• Comparison of graft materials with each other
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Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices
TABLE 1—EPC PROPOSED PICOTS AND CORRESPONDING INCLUSION AND EXCLUSION CRITERIA KEY QUESTIONS 1,2,3
AND 4 ON SURGERY—Continued
Inclusion
Comparators .................................................................
Outcomes .....................................................................
Timing ...........................................................................
Settings .........................................................................
Study designs ...............................................................
Exclusion
ALL Key Questions
• FDA approved devices or materials (or in
Phase III trials) as applicable to the KQ
• Open and minimally invasive (e.g.,
endoscopic) procedures
KQ 1
• Decompression alone
KQ 2
• Decompression and instrumented
posterolateral spinal fusion (e.g., using pedicle
screws alone)
KQ 3
• Decompression and instrumented spinal fusion
using autograft
KQ 4
• No use of IONM
ALL Key Questions
• Validated measures for pain and symptoms
Æ Pain (e.g., VAS)
Æ Function (e.g., ODI)
Æ Quality of Life (e.g., SF–36, SF–12)
• Peri- and post-operative harms (including serious AEs/harms, persistent pain, sacro-iliac
joint pain, instrument failure)
Additional outcomes by KQ
KQ 1: Reoperation rates
KQ 2: Fusion (arthrodesis) rates
KQ 3: Fusion (arthrodesis) rates
KQ 4: Persistent neurological damage based on clinical exam (e.g., foot drop)
Key Questions 1–3
• Pain, function, reoperation: 3, 6 and ≥12
months (up to 60 months)
• Reoperation-any time (KQ 2):
• Harms: any time
KQ 4
• Any time during post-operative followup
ALL Key Questions
• Inpatient care followed by care in specialty
and primary care clinics
• Outpatient ambulatory surgery centers
ALL Key Questions
• RCTs for effectiveness/efficacy outcomes
• FDA SSED if there is inadequate information
from published studies
• Studies published in 2000 or later
KQ 1–3: NRSIs will be considered for harms only
and must be specifically designed to evaluate/report on AE/harms and control for confounding and
focused on rare or long-term harms.
KQ 4: NRSIs on effectiveness and harms
ALL Key Questions
• Conservative care, non-operative care, usual
care
• Devices or materials that are not FDA approved or in Phase III trials (as applicable to
the question) or not available in the U.S.
• Mesenchymal stem cells (MSCs)
KQ 1
• Other surgical procedures
KQ 2, 3
• Non-instrumented fusion,
• Instrumentation prior to 2000
• Coflex, interspinous fixation
KQ 3
• Combinations of graft materials with autograft
ALL Key Questions
• Measures of pain, function that are not validated
• Measures/outcomes not listed
• Radiographic parameters (e.g., evidence of
global spinal alignment)
KQ 1
• Re-operation beyond 12 months
KQs 1–3
• Outcomes measured less than 3 months (except harms)
KQ 4
• Alerts and responses to alerts during surgery
ALL Key Questions
• NRSI that do not control for confounding
• NRSI that include historical controls
• NRSI of treatment with fewer than 50 patients
per treatment arm
• Case reports, case-series, single-arm and prepost studies
• Publication types: Conference abstracts or
proceedings, editorials, letters, white papers,
citations that have not been peer-reviewed,
single site reports of multi-site studies
• Studies published prior to 2000
• Studies not in English
KQ 1–3
• Trials with fewer than 15 patients per treatment arm
Serious adverse events are defined as events that are life-threatening or require additional medical attention. AE = adverse event; ALIF = anterior lumbar interbody
fusion; DLS = degenerative lumbar spondylolisthesis; EQ–5D = EuroQol 5D scale; FDA = Food and Drug Administration; IONM = intraoperative neurological monitoring; KQ = Key Question; LLIF = lateral lumbar interbody fusion; MCID = minimum clinically important difference; NRSI = nonrandomized studies of intervention;
ODI = Oswestry Disability Index; RCT = randomized controlled trial; RMD = Roland-Morris Disability Questionnaire; SSED = Summary of Safety and Effectiveness
Data; SF–36/12 = Short Form 36 or 12 questionnaire; TLIF = transforaminal lumbar interbody fusion; U.S. = United States; VAS = visual analog scale.
khammond on DSK9W7S144PROD with NOTICES
KQ 5 and 6: Questions on Non-Surgical
Procedures for Chronic Low Back Pain
Due To Degenerative Spine Disease
Key Question 5. In adult patients with
chronic low-back pain (≥3 months)
resulting from degenerative disease
what are the benefits and harms of
lumbar epidural steroid injections,
intra-articular (facet) injection, medial
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branch blocks, or radio frequency
ablation?
Key Question 6. In adult patients with
chronic low-back pain (≥3 months)
resulting from degenerative disease of
the lumbar spine, does symptomatic
improvement to therapeutic challenge
with lumbar epidural steroid injections,
intra-articular (facet) injection, medial
branch blocks or radio frequency
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Sfmt 4703
ablation predict positive outcomes after
lumbar fusion surgery?
Special populations and factors for
Key Questions 5 and 6: Age, sex, BMI,
presence of psychological
comorbidities, presence of medical
comorbidities, baseline pain severity,
presence and type of concomitant
degenerative lumbar spine disease,
presence and severity of DLS.
E:\FR\FM\14JAN1.SGM
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Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices
3217
TABLE 2—EPC PROPOSED PICOTS AND CORRESPONDING INCLUSION AND EXCLUSION CRITERIA: KEY QUESTIONS 5 AND
6 ON SPECIFIC PROCEDURES IN PATIENTS WITH CHRONIC LOW BACK PAIN DUE TO DEGENERATIVE SPINE DISEASE
Inclusion
Exclusion
Population .....................................................................
KQ 5, 6
• Adult patients with chronic low-back pain (≥3
months duration) resulting from degenerative
disease
Interventions .................................................................
KQ 5,
•
•
•
•
6
Epidural steroid injections (ESI)
Intra-articular (facet) injections
Radiofrequency Ablation (RFA)
Medial branch blocks
KQ 5,
•
•
•
•
•
KQ 5,
•
•
•
•
•
•
•
Comparators .................................................................
Outcomes .....................................................................
Timing ...........................................................................
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Settings .........................................................................
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KQ 5
• Other nonoperative treatment, no treatment,
sham
KQ 6
• No therapeutic challenge; (prognostic/predictive modeling study)
KQ 5 and 6: Harms (e.g., serious peri-procedural and
post-procedural harms)
KQ 5
• Validated measures for pain and symptoms
Æ Pain (e.g., VAS, NRS)
Æ Function (e.g., ODI)
Æ Quality of Life (e.g., SF–36, SF12)
KQ 6
• Response to challenge: Improvement in symptoms vs. non-improvement; [stratify other outcomes by response]
• Validated measures for pain and symptoms
following fusion surgery
Æ Pain (e.g., VAS, NRS)
Æ Function (e.g., ODI)
Æ Quality of Life (e.g., SF–36, SF–12)
Æ Symptoms associated with neural compression
• Successful arthrodesis [as radiographically determined via x-ray/computed tomography or by
proxy (e.g., lack of revision, pedicle screw
loosening)]
KQ 5 and 6
• Serious harms—periprocedural
KQ 5
• 3-month and 6-month periods following the
procedure
KQ 6
• Outcomes measured at 3, 6 and ≥12 months
after surgical procedure (up to 24 months)
KQ 5
• Outpatient
KQ 6
• Outpatient care for therapeutic challenge. Inpatient care followed by care in specialty and
primary care clinics for surgical procedure
• Outpatient ambulatory surgery centers for surgery
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KQ 5,
•
6
Patients with acute or subacute LBP
Patients with disc herniation
Patients with failed back surgery syndrome
Sacroiliac pain
Patients having reoperation
6
Discoblock, provocative discography
Neuromodulation (e.g., spinal cord, dorsal column, dorsal root stimulation, peripheral nerve
stimulation)
Injections: exclude other biologics (e.g., PRP),
intradiscal injections
Minimally invasive lumbar decompression
(MILD), percutaneous decompression
Selective nerve root blocks
Intraosseous basivertebral nerve ablation
Combinations of procedures; Studies evaluating additive benefits of one procedure with
another
6
Combinations of procedures; Studies evaluating additive benefits of one procedure to another
KQ 5
• For ESI, exclude comparison with disc procedures (e.g., discography); comparisons of
medications
• For RFA exclude comparisons of different
types of neurotomy (conventional vs. pulsed
[cooled] RF; RF vs. alcohol ablation)
KQ 5, 6
• Measures of pain, function that are not validated
• Measures/outcomes not listed
E:\FR\FM\14JAN1.SGM
14JAN1
3218
Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices
TABLE 2—EPC PROPOSED PICOTS AND CORRESPONDING INCLUSION AND EXCLUSION CRITERIA: KEY QUESTIONS 5 AND
6 ON SPECIFIC PROCEDURES IN PATIENTS WITH CHRONIC LOW BACK PAIN DUE TO DEGENERATIVE SPINE DISEASE—
Continued
Inclusion
Study designs ...............................................................
Exclusion
KQ 5
• RCTS for effectiveness/efficacy outcomes
• Prospective NRSIs that control for confounding
will be considered for effectiveness in the absence of RCTs
• NRSIs for harms must be specifically designed
to evaluate/report on serious AE/harms and
that control for confounding OR focused on
rare or long-term harms
KQ 6
• Predictive/prognostic modeling studies evaluating the association of procedure response
impact on outcomes that control for confounding
KQ 5,
•
•
•
6
NRSI that do not control for confounding
NRSI that include historical controls
NRSI with fewer than 50 patients per treatment arm
• Case reports, case-series, single-arm and prepost studies
• Publication types: Conference abstracts or
proceedings, editorials, letters, white papers,
citations that have not been peer-reviewed,
single site reports of multi-site studies
• Studies not in English
Serious adverse events are defined as events that are life-threatening or anything needing additional medical attention. AE = adverse event; DLS = degenerative
lumbar spondylolisthesis; EQ–5D = EuroQol 5D scale; ESI = epidural steroid injection; FDA = Food and Drug Administration; IONM = intraoperative neuro monitoring;
KQ = Key Question; LBP = low back pain; MCID = minimum clinically important difference; NRSI = nonrandomized studies of intervention; ODI = Oswestry Disability
Index; RCT = randomized controlled trial; RF = radiofrequency ablation; RMD = Rolland-Morris Disability Questionnaire; SSED = Summary of Safety and Effectiveness Data; SF–36/12 = Short Form 36 or 12 questionnaire; VAS = visual analog scale.
Dated: January 7, 2025.
Marquita Cullom,
Associate Director.
[FR Doc. 2025–00548 Filed 1–13–25; 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 Primary Hypofractionated
Radiation Therapy for Localized
Prostate Cancer: A Systematic Review
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for Supplemental
Evidence and Data Submission.
AGENCY:
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
Primary Hypofractionated Radiation
Therapy for Localized Prostate Cancer:
A Systematic Review, 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 February 13, 2025.
ADDRESSES:
Email submissions: epc@
ahrq.hhs.gov.
Print submissions:
Mailing Address: Center for Evidence
and Practice Improvement, Agency for
Healthcare Research and Quality, Attn:
khammond on DSK9W7S144PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
22:42 Jan 13, 2025
Jkt 265001
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:
Kelly Carper, Telephone: 301–427–1656
or Email: epc@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency for Healthcare Research and
Quality has commissioned the
Evidence-based Practice Centers (EPC)
Program to complete a review of the
evidence for Primary Hypofractionated
Radiation Therapy for Localized
Prostate Cancer: A Systematic Review.
AHRQ is conducting this review
pursuant to 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 Primary Hypofractionated
Radiation Therapy for Localized
Prostate Cancer: A Systematic Review.
The entire research protocol is available
online at: https://effectivehealthcare.
ahrq.gov/products/hypofractionatedradiation-therapy/protocol.
This is to notify the public that the
EPC Program would find the following
information on Primary
Hypofractionated Radiation Therapy for
Localized Prostate Cancer: A Systematic
Review helpful:
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D A list of completed studies that your
organization has sponsored for this
topic. 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, if relevant: 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
topic. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including, if relevant, 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 topic 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 topics not included in
the review cannot be used by the EPC
Program. This is a voluntary request for
information, and all costs for complying
E:\FR\FM\14JAN1.SGM
14JAN1
Agencies
[Federal Register Volume 90, Number 8 (Tuesday, January 14, 2025)]
[Notices]
[Pages 3214-3218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00548]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on The Performance of
Fusion Procedures for Degenerative Disease of the Lumbar Spine
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for Supplemental Evidence and Data Submission.
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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 The Performance
of Fusion Procedures for Degenerative Disease of the Lumbar Spine,
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 February 13, 2025.
ADDRESSES:
Email submissions: [email protected].
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: Kelly Carper, Telephone: 301-427-1656
or Email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for The Performance of
Fusion Procedures for Degenerative Disease of the Lumbar Spine. AHRQ is
conducting this review pursuant to 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 The Performance of Fusion Procedures for Degenerative
Disease of the Lumbar Spine. The entire research protocol is available
online at: https://effectivehealthcare.ahrq.gov/products/lumbar-spinal-fusion/protocol.
This is to notify the public that the EPC Program would find the
following information on The Performance of Fusion Procedures for
Degenerative Disease of the Lumbar Spine helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this topic. 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, if
relevant: 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 topic. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including, if relevant, 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 topic and an index outlining the relevant information in each
submitted file.
Your contribution is very beneficial to the Program. Materials
submitted must
[[Page 3215]]
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 topics 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://effectivehealthcare.ahrq.gov/email-updates.
The 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)
Questions on Surgery (KQ 1-4)
In adults with symptomatic, stable degenerative lumbar
spondylolisthesis (DLS) with or without radiculopathy or neurogenic
claudication
Key Question 1. What are the benefits and harms of surgery
with instrumentation in addition to decompression compared with
decompression alone?
In symptomatic adults with unstable or stable DLS with or without
radiculopathy or neurogenic claudication undergoing instrumented
fusion:
Key Question 2. What are the benefits and harms of the
addition of an interbody cage to instrumentation (e.g., pedicle screws)
compared to use of instrumentation alone (i.e., posterolateral fusion)?
Key Question 3. What are the benefits and harms of the use
of bone graft extenders and biologic substitutes compared to the use of
autografts?
In adults with symptomatic, degenerative lumbar spine disease
undergoing instrumented fusion:
Key Question 4. Does the use of intraoperative monitoring
(IONM) decrease perioperative neurological injuries compared with not
using IONM?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
Setting)
Table 1--EPC Proposed PICOTS and Corresponding Inclusion and Exclusion Criteria Key Questions 1,2,3 and 4 on
Surgery
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Inclusion Exclusion
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Population....................... Key Questions (1-3) ALL Key Questions
Symptomatic adult patients Patients <18 years old.
with a radiographic diagnosis (based Asymptomatic patients.
on dynamic (flexion and extension Other forms of
radiographs) of degenerative lumbar spondylolisthesis are excluded
spondylolisthesis (any grade) who (i.e., excluding dysplastic,
remain symptomatic following isthmic, traumatic, and pathologic
conservative treatment causes/forms).
Patients with or without Patients with osteoporosis,
evidence of nerve compression vertebral compression fractures.
(radiculopathy, neurogenic Exclude pts undergoing
claudication) revisions or repeat procedures.
KQ 1 Patients having reoperation/
Stable (non-mobile, static) repeat procedures.
DLS (<3 mm slip on extension/flexion KQs 1-3
radiographs) Patients without
KQ 2, 3 degenerative spondylolisthesis.
Patients with unstable or Studies with <80% of
stable DLS on radiographs patients have spondylolisthesis.
KQ 4 KQ 1
Patients with symptomatic Patients with unstable
degenerative lumbar spine disease (dynamic) DLS: (exclude study if
undergoing fusion of 5 or fewer stable is not specified, is
levels (stratify by presence of DLS) unclear).
Interventions.................... ALL Key Questions ALL Key Questions
FDA approved devices or Devices or materials that
materials (or in Phase III trials) as are not FDA approved or in Phase III
applicable to the KQ trials (as applicable to the
Open and minimally invasive question) or not available in the
(e.g., endoscopic) procedures U.S.
KQ 1 Mesenchymal stem cells
Decompression (discectomy, (MSCs)
indirect and direct methods) with Procedures that don't
instrumented spinal fusion (e.g., include decompression
with pedicle screws, interbody cages, Non-instrumented fusions
or other hardware) Coflex, interspinous
KQ 2 fixation
Surgical decompression and Minimally invasive lumbar
instrumented posterolateral fusion decompression (MILD) procedure
(e.g., using pedicle screws) with Surgical procedures not
addition of interbody cage listed
(expandable or static, ALIF, TLIF, KQ 4
LLIF) Other monitoring formats
KQ 3 (e.g., imaging, computer assisted
Decompression and spinal navigation systems, etc.)
fusion using bone graft extenders or Combinations of graft
biologic substitutes (demineralized materials (other than with
bone matrix, cadaveric allograft, autograft)
cortical fibers, bone morphogenic Comparison of graft
protein, cellular allografts materials with each other
KQ 4
IONM (Motor Evoked Potentials
(MEP), Somatosensory Evoked
Potentials (SSEP), Free Running EMG
(electromyography) Direct Stimulation
[[Page 3216]]
Comparators...................... ALL Key Questions ALL Key Questions
FDA approved devices or Conservative care, non-
materials (or in Phase III trials) as operative care, usual care
applicable to the KQ Devices or materials that
Open and minimally invasive are not FDA approved or in Phase III
(e.g., endoscopic) procedures trials (as applicable to the
KQ 1 question) or not available in the
Decompression alone U.S.
KQ 2 Mesenchymal stem cells
Decompression and (MSCs)
instrumented posterolateral spinal KQ 1
fusion (e.g., using pedicle screws Other surgical procedures
alone) KQ 2, 3
KQ 3 Non-instrumented fusion,
Decompression and Instrumentation prior to
instrumented spinal fusion using 2000
autograft Coflex, interspinous
KQ 4 fixation
No use of IONM KQ 3
Combinations of graft
materials with autograft
Outcomes......................... ALL Key Questions ALL Key Questions
Validated measures for pain Measures of pain, function
and symptoms that are not validated
[cir] Pain (e.g., VAS) Measures/outcomes not listed
[cir] Function (e.g., ODI) Radiographic parameters
[cir] Quality of Life (e.g., SF-36, SF- (e.g., evidence of global spinal
12) alignment)
Peri- and post-operative
harms (including serious AEs/harms,
persistent pain, sacro-iliac joint
pain, instrument failure)
Additional outcomes by KQ
KQ 1: Reoperation rates
KQ 2: Fusion (arthrodesis) rates
KQ 3: Fusion (arthrodesis) rates
KQ 4: Persistent neurological damage
based on clinical exam (e.g., foot
drop)
Timing........................... Key Questions 1-3 KQ 1
Pain, function, reoperation: Re-operation beyond 12
3, 6 and >=12 months (up to 60 months
months) KQs 1-3
Reoperation-any time (KQ 2): Outcomes measured less than
Harms: any time 3 months (except harms)
KQ 4 KQ 4
Any time during post- Alerts and responses to
operative followup alerts during surgery
Settings......................... ALL Key Questions .....................................
Inpatient care followed by
care in specialty and primary care
clinics
Outpatient ambulatory surgery
centers
Study designs.................... ALL Key Questions ALL Key Questions
RCTs for effectiveness/ NRSI that do not control for
efficacy outcomes confounding
FDA SSED if there is NRSI that include historical
inadequate information from published controls
studies NRSI of treatment with fewer
Studies published in 2000 or than 50 patients per treatment arm
later Case reports, case-series,
KQ 1-3: NRSIs will be considered for single-arm and pre-post studies
harms only and must be specifically Publication types:
designed to evaluate/report on AE/ Conference abstracts or proceedings,
harms and control for confounding and editorials, letters, white papers,
focused on rare or long-term harms. citations that have not been peer-
KQ 4: NRSIs on effectiveness and harms reviewed, single site reports of
multi-site studies
Studies published prior to
2000
Studies not in English
KQ 1-3
Trials with fewer than 15
patients per treatment arm
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Serious adverse events are defined as events that are life-threatening or require additional medical attention.
AE = adverse event; ALIF = anterior lumbar interbody fusion; DLS = degenerative lumbar spondylolisthesis; EQ-
5D = EuroQol 5D scale; FDA = Food and Drug Administration; IONM = intraoperative neurological monitoring; KQ =
Key Question; LLIF = lateral lumbar interbody fusion; MCID = minimum clinically important difference; NRSI =
nonrandomized studies of intervention; ODI = Oswestry Disability Index; RCT = randomized controlled trial; RMD
= Roland-Morris Disability Questionnaire; SSED = Summary of Safety and Effectiveness Data; SF-36/12 = Short
Form 36 or 12 questionnaire; TLIF = transforaminal lumbar interbody fusion; U.S. = United States; VAS = visual
analog scale.
KQ 5 and 6: Questions on Non-Surgical Procedures for Chronic Low Back
Pain Due To Degenerative Spine Disease
Key Question 5. In adult patients with chronic low-back pain (>=3
months) resulting from degenerative disease what are the benefits and
harms of lumbar epidural steroid injections, intra-articular (facet)
injection, medial branch blocks, or radio frequency ablation?
Key Question 6. In adult patients with chronic low-back pain (>=3
months) resulting from degenerative disease of the lumbar spine, does
symptomatic improvement to therapeutic challenge with lumbar epidural
steroid injections, intra-articular (facet) injection, medial branch
blocks or radio frequency ablation predict positive outcomes after
lumbar fusion surgery?
Special populations and factors for Key Questions 5 and 6: Age,
sex, BMI, presence of psychological comorbidities, presence of medical
comorbidities, baseline pain severity, presence and type of concomitant
degenerative lumbar spine disease, presence and severity of DLS.
[[Page 3217]]
Table 2--EPC Proposed PICOTS and Corresponding Inclusion and Exclusion Criteria: Key Questions 5 and 6 on
Specific Procedures in Patients With Chronic Low Back Pain Due To Degenerative Spine Disease
----------------------------------------------------------------------------------------------------------------
Inclusion Exclusion
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Population....................... KQ 5, 6 KQ 5, 6
Adult patients with chronic Patients with acute or
low-back pain (>=3 months duration) subacute LBP
resulting from degenerative disease Patients with disc
herniation
Patients with failed back
surgery syndrome
Sacroiliac pain
Patients having reoperation
Interventions.................... KQ 5, 6 KQ 5, 6
Epidural steroid injections Discoblock, provocative
(ESI) discography
Intra-articular (facet) Neuromodulation (e.g.,
injections spinal cord, dorsal column, dorsal
Radiofrequency Ablation (RFA) root stimulation, peripheral nerve
Medial branch blocks stimulation)
Injections: exclude other
biologics (e.g., PRP), intradiscal
injections
Minimally invasive lumbar
decompression (MILD), percutaneous
decompression
Selective nerve root blocks
Intraosseous basivertebral
nerve ablation
Combinations of procedures;
Studies evaluating additive benefits
of one procedure with another
Comparators...................... KQ 5 KQ 5, 6
Other nonoperative treatment, Combinations of procedures;
no treatment, sham Studies evaluating additive benefits
KQ 6 of one procedure to another
No therapeutic challenge; KQ 5
(prognostic/predictive modeling For ESI, exclude comparison
study) with disc procedures (e.g.,
discography); comparisons of
medications
For RFA exclude comparisons
of different types of neurotomy
(conventional vs. pulsed [cooled]
RF; RF vs. alcohol ablation)
Outcomes......................... KQ 5 and 6: Harms (e.g., serious peri- KQ 5, 6
procedural and post-procedural harms) Measures of pain, function
KQ 5 that are not validated
Validated measures for pain Measures/outcomes not listed
and symptoms
[cir] Pain (e.g., VAS, NRS)
[cir] Function (e.g., ODI)
[cir] Quality of Life (e.g., SF-36,
SF12)
KQ 6
Response to challenge:
Improvement in symptoms vs. non-
improvement; [stratify other outcomes
by response]
Validated measures for pain
and symptoms following fusion surgery
[cir] Pain (e.g., VAS, NRS)
[cir] Function (e.g., ODI)
[cir] Quality of Life (e.g., SF-36, SF-
12)
[cir] Symptoms associated with neural
compression
Successful arthrodesis [as
radiographically determined via x-ray/
computed tomography or by proxy
(e.g., lack of revision, pedicle
screw loosening)]
Timing........................... KQ 5 and 6
Serious harms--periprocedural
KQ 5
3-month and 6-month periods
following the procedure
KQ 6
Outcomes measured at 3, 6 and
>=12 months after surgical procedure
(up to 24 months)
Settings......................... KQ 5
Outpatient
KQ 6
Outpatient care for
therapeutic challenge. Inpatient care
followed by care in specialty and
primary care clinics for surgical
procedure
Outpatient ambulatory surgery
centers for surgery
[[Page 3218]]
Study designs.................... KQ 5 KQ 5, 6
RCTS for effectiveness/ NRSI that do not control for
efficacy outcomes confounding
Prospective NRSIs that NRSI that include historical
control for confounding will be controls
considered for effectiveness in the NRSI with fewer than 50
absence of RCTs patients per treatment arm
NRSIs for harms must be Case reports, case-series,
specifically designed to evaluate/ single-arm and pre-post studies
report on serious AE/harms and that Publication types:
control for confounding OR focused on Conference abstracts or proceedings,
rare or long-term harms editorials, letters, white papers,
KQ 6 citations that have not been peer-
Predictive/prognostic reviewed, single site reports of
modeling studies evaluating the multi-site studies
association of procedure response Studies not in English
impact on outcomes that control for
confounding
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Serious adverse events are defined as events that are life-threatening or anything needing additional medical
attention. AE = adverse event; DLS = degenerative lumbar spondylolisthesis; EQ-5D = EuroQol 5D scale; ESI =
epidural steroid injection; FDA = Food and Drug Administration; IONM = intraoperative neuro monitoring; KQ =
Key Question; LBP = low back pain; MCID = minimum clinically important difference; NRSI = nonrandomized
studies of intervention; ODI = Oswestry Disability Index; RCT = randomized controlled trial; RF =
radiofrequency ablation; RMD = Rolland-Morris Disability Questionnaire; SSED = Summary of Safety and
Effectiveness Data; SF-36/12 = Short Form 36 or 12 questionnaire; VAS = visual analog scale.
Dated: January 7, 2025.
Marquita Cullom,
Associate Director.
[FR Doc. 2025-00548 Filed 1-13-25; 8:45 am]
BILLING CODE 4160-90-P