Notice2023-18984
Supplemental Evidence and Data Request on Diagnosis and Treatment of Tethered Spinal Cord
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
September 1, 2023
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 Diagnosis and Treatment of Tethered Spinal Cord, 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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 88 Issue 169 (Friday, September 1, 2023)</title>
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[Federal Register Volume 88, Number 169 (Friday, September 1, 2023)]
[Notices]
[Pages 60464-60466]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-18984]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Diagnosis and Treatment
of Tethered Spinal Cord
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 Diagnosis and
Treatment of Tethered Spinal Cord, 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published and unpublished pertinent scientific information will improve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 October 2, 2023.
ADDRESSES:
Email submissions: <a href="/cdn-cgi/l/email-protection#1075607350717862613e7878633e777f66"><span class="__cf_email__" data-cfemail="4326332003222b31326d2b2b306d242c35">[email protected]</span></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.
[[Page 60465]]
FOR FURTHER INFORMATION CONTACT: Kelly Carper, Telephone: 301-427-1656
or Email: <a href="/cdn-cgi/l/email-protection#7d180d1e3d1c150f0c5315150e531a120b"><span class="__cf_email__" data-cfemail="bbdecbd8fbdad3c9ca95d3d3c895dcd4cd">[email protected]</span></a>.
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 Diagnosis and
Treatment of Tethered Spinal Cord. 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 Diagnosis and Treatment of Tethered Spinal Cord. The
entire research protocol is available online at: <a href="https://effectivehealthcare.ahrq.gov/products/tethered-spinal-cord/protocol">https://effectivehealthcare.ahrq.gov/products/tethered-spinal-cord/protocol</a>.
This is to notify the public that the EPC Program would find the
following information on Diagnosis and Treatment of Tethered Spinal
Cord 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 <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, 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
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> 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 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: <a href="https://www.effectivehealthcare.ahrq.gov/email-updates">https://www.effectivehealthcare.ahrq.gov/email-updates</a>.
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)
KQ 1: What is the accuracy of radiographic and other diagnostic
criteria in diagnosing tethered spinal cord?
KQ 2: What are the benefits and harms of prophylactic surgery for
asymptomatic tethered spinal cord patients?
KQ 3: What are the effectiveness, comparative effectiveness and
harms of surgical and non-surgical treatments for symptomatic tethered
spinal cord?
a. Stratified by symptom type, intensity, and patient age?
b. Are effects modified by use of special surgical equipment or
techniques?
KQ 4: Among individuals who experience retethering after spinal
detethering surgery, what are the benefits, harms and long-term
outcomes of another surgery compared with no treatment?
a. Are individual factors with which a patient presents (such as
primary symptoms, symptom intensity, age, etc.) associated with better
or worse outcomes after repeat surgery?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
Setting)
Table 1--Eligibility Criteria
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Element Inclusion criteria Exclusion criteria
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Population................ KQ1: Pediatric or Tethering of the
adult patients spine as an adverse
assessed for event associated
tethered spinal cord. with an intervention
KQ2: Pediatric or (not patients being
adult patients with treated for tethered
tethered spinal cord spinal cord).
and no symptoms or
marginally
symptomatic without
functional deficits.
KQ3: Pediatric or
adult patients with
symptomatic tethered
spinal cord.
KQ4: Pediatric or
adult patients who
experience
retethering after
spinal detethering
surgery.
Interventions............. KQ1: Screening and Interventions and
diagnostic approaches not
approaches, tools, addressing tethered
and criteria such as spinal cord.
physical
examination,
urodynamic studies,
(MRI), myelogram,
computed tomography
(CT) scan, computed
axial tomography
(CAT) scan, or
ultrasound.
KQ2: Prophylactic or
early surgery.
KQ3: Surgical or non-
surgical treatment
or management
interventions such
as surgical
detethering, or
other surgery (e.g.,
spine-shortening
vertebral osteotomy,
spinal cord
transection),
physical therapy,
bladder therapy for
bladder function, or
bracing.
KQ4: Surgical
interventions such
as repeat
detethering,
revision
detethering, spine-
shortening vertebral
osteotomy, vertebral
column shortening,
spinal cord
transection, or
other surgery.
[[Page 60466]]
Comparators............... KQ1: Confirmation of KQ 1: no comparator.
diagnosis by a .....................
neurosurgeon or For KQ 2-4, Studies
neurologist. without comparator
KQ2-4: No surgery, except for studies
sham surgery, no for an adverse event
treatment, or of interest.
alternative
treatments for
effectiveness
outcomes; no
comparator is
required for studies
reporting adverse
events of interest
(eligible adverse
events will be
determined with the
help of the TEP).
Outcomes.................. KQ1: Diagnostic Provider satisfaction
performance (e.g., and frequency of
diagnostic accuracy procedures.
measured as
concordance with
neurosurgeon or
neurologist
diagnosis); adverse
events of the
diagnostic
procedure; and
clinical impact of a
correct or incorrect
diagnosis such as
(e.g., overtreatment
due to misdiagnosis,
delayed treatment,
or undertreatment
due to missed
diagnosis).
KQ2-4: Patient health
and other patient
effects such as leg
weakness, leg
numbness, leg pain,
other pain, gait,
walking difficulty,
bowel incontinence,
bladder
incontinence,
scoliosis,
disability, adverse
events,
postoperative
complications,
infection, 30-day
complication rate,
morbidity, quality
of life, or general
health status, as
well as process
measures such as
repeat surgery.
Timing.................... No restrictions N/A.
regarding the timing
or duration of the
intervention or the
follow up.
Setting................... Settings compatible Very low resource
with US healthcare countries or
settings, no conflict zones.
restrictions
regarding the
clinical setting.
Study Design.............. KQ1: Diagnostic Secondary data, but
accuracy and systematic reviews
diagnostic impact will be retained for
analyses. reference-mining.
KQ2-4: Randomized
controlled trials
(RCTs), clinical
trials without
randomization,
cohort studies
comparing two
cohorts, controlled
post-only studies,
and case-control
studies.
Experimental single
arm trials and
observational case
series, with or
without structured
pre- and post-
intervention data,
need to report on
neurological status
or bladder or bowel
function to be
eligible.
Other limiters............ Data published in Data reported in
journal manuscript abbreviated format
and trial records. (e.g., conference
abstracts).
------------------------------------------------------------------------
Note: KQ key question, TEP technical expert panel.
Dated: August 29, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023-18984 Filed 8-31-23; 8:45 am]
BILLING CODE 4160-90-P
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