[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]


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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published and unpublished pertinent scientific information will improve 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: [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
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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