Supplemental Evidence and Data Request on Diagnosis and Treatment of Tethered Spinal Cord, 60464-60466 [2023-18984]
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Federal Register / Vol. 88, No. 169 / Friday, September 1, 2023 / Notices
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[FR Doc. 2023–18986 Filed 8–31–23; 8:45 am]
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[FR Doc. 2023–18943 Filed 8–31–23; 8:45 am]
BILLING CODE 6820–14–P
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 for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submissions.
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
Diagnosis and Treatment of Tethered
Spinal Cord, 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Access to published and unpublished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 October 2, 2023.
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.
SUMMARY:
E:\FR\FM\01SEN1.SGM
01SEN1
Federal Register / Vol. 88, No. 169 / Friday, September 1, 2023 / Notices
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 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:
https://effectivehealthcare.ahrq.gov/
products/tethered-spinal-cord/protocol.
This is to notify the public that the
EPC Program would find the following
information on Diagnosis and
Treatment of Tethered Spinal Cord
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
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,
60465
please sign up for the email list at:
https://www.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)
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
Element
Inclusion criteria
Exclusion criteria
Population ................
KQ1: Pediatric or adult patients assessed for tethered spinal cord.
KQ2: Pediatric or adult patients with tethered 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.
KQ1: Screening and diagnostic approaches, tools, and criteria such as 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.
Tethering of the spine as an adverse event associated with
an intervention (not patients being treated for tethered
spinal cord).
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Interventions ............
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Interventions and approaches not addressing tethered spinal cord.
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Federal Register / Vol. 88, No. 169 / Friday, September 1, 2023 / Notices
TABLE 1—ELIGIBILITY CRITERIA—Continued
Element
Inclusion criteria
Comparators ............
KQ1: Confirmation of diagnosis by a neurosurgeon or neurologist.
KQ2–4: No surgery, sham surgery, no treatment, or 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).
KQ1: Diagnostic performance (e.g., diagnostic accuracy
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.
No restrictions regarding the timing or duration of the intervention or the follow up.
Settings compatible with US healthcare settings, no restrictions regarding the clinical setting.
KQ1: Diagnostic accuracy and diagnostic impact analyses
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 postintervention data, need to report on neurological status or
bladder or bowel function to be eligible.
Data published in journal manuscript and trial records ........
Outcomes ................
Timing ......................
Setting .....................
Study Design ...........
Other limiters ...........
Exclusion criteria
KQ 1: no comparator.
For KQ 2–4, Studies without comparator except for studies
for an adverse event of interest.
Provider satisfaction and frequency of procedures.
N/A.
Very low resource countries or conflict zones.
Secondary data, but systematic reviews will be retained for
reference-mining.
Data reported in abbreviated format (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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
ACTION: Notice.
AGENCY:
Findings of research
misconduct have been made against
Surangi (Suranji) Jayawardena, Ph.D.
(Respondent), who was an Assistant
Professor of Chemistry, University of
Alabama in Huntsville (UAH).
Respondent engaged in research
misconduct in grant applications
submitted for U.S. Public Health Service
(PHS) funds, specifically R21 AI154256,
R21 AI152064, R21 AI149142, and R15
AI146978 submitted to the National
Institute of Allergy and Infectious
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SUMMARY:
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Diseases (NIAID), National Institutes of
Health (NIH). The administrative
actions, including supervision for a
period of four (4) years, were
implemented beginning on August 18,
2023, and are detailed below.
FOR FURTHER INFORMATION CONTACT:
Sheila Garrity, JD, MPH, MBA, Director,
Office of Research Integrity, 1101
Wootton Parkway, Suite 240, Rockville,
MD 20852, (240) 453–8200.
SUPPLEMENTARY INFORMATION: Notice is
hereby given that the Office of Research
Integrity (ORI) has taken final action in
the following case:
Surangi (Suranji) Jayawardena, Ph.D.,
University of Alabama in Huntsville:
Based on the report of an investigation
conducted by UAH, an admission by
Respondent, and additional analysis
conducted by ORI in its oversight
review, ORI found that Surangi (Suranji)
Jayawardena, Ph.D., who was an
Assistant Professor of Chemistry, UAH,
engaged in research misconduct in grant
applications submitted for PHS funds,
specifically R21 AI154256, R21
AI152064, R21 AI149142, and R15
AI146978 submitted to NIAID, NIH.
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Frm 00037
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ORI found that Respondent engaged
in research misconduct by intentionally,
knowingly, or recklessly falsifying and/
or fabricating data in twelve (12) figure
panels in the following four (4) NIH
grant applications:
• R21 AI154256, ‘‘Designing artificial
glycoforms to inhibit binding of
Clostridioides difficile flagellin to
TLR5,’’ submitted to NIAID, NIH, on
October 16, 2019, withdrawn on
November 5, 2019
• R21 AI152064, ‘‘Multivalent
glycoconjugates to inhibit binding of
Clostridioides difficile flagella to TLR5,’’
submitted to NIAID, NIH, on June 14,
2019, administratively withdrawn on
November 1, 2021
• R21 AI149142, ‘‘Rapid Low-cost
Diagnostics Assay for Mycobacteria
through Magnetic Concentration,’’
submitted to NIAID, NIH, on February
15, 2019, administratively withdrawn
on July 1, 2021
• R15 AI146978, ‘‘BACTERIA
HOMING–IN GLYCAN SENSING,’’
submitted to NIAID, NIH, on October
25, 2018, administratively withdrawn
on March 1, 2021
E:\FR\FM\01SEN1.SGM
01SEN1
]]>Agencies
[Federal Register Volume 88, Number 169 (Friday, September 1, 2023)]
[Notices]
[Pages 60464-60466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18984]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: [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.
[[Page 60465]]
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 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: https://effectivehealthcare.ahrq.gov/products/tethered-spinal-cord/protocol.
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 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 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://www.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)
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
------------------------------------------------------------------------
Element Inclusion criteria Exclusion criteria
------------------------------------------------------------------------
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
