Notice2024-28933
Supplemental Evidence and Data Request on Recurrent Nephrolithiasis in Adults and Children: Comparative Effectiveness of Preventive Medical Strategies
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Published
December 10, 2024
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 Recurrent Nephrolithiasis in Adults and Children: Comparative Effectiveness of Preventive Medical Strategies, 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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 89 Issue 237 (Tuesday, December 10, 2024)</title>
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[Federal Register Volume 89, Number 237 (Tuesday, December 10, 2024)]
[Notices]
[Pages 99265-99267]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-28933]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Recurrent
Nephrolithiasis in Adults and Children: Comparative Effectiveness of
Preventive Medical Strategies
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 Recurrent
Nephrolithiasis in Adults and Children: Comparative Effectiveness of
Preventive Medical Strategies, 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published and unpublished pertinent scientific information will improve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 January 9, 2025.
ADDRESSES:
Email submissions: <a href="/cdn-cgi/l/email-protection#b2d7c2d1f2d3dac0c39cdadac19cd5ddc4"><span class="__cf_email__" data-cfemail="e2879281a2838a9093cc8a8a91cc858d94">[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.
FOR FURTHER INFORMATION CONTACT: Kelly Carper, Telephone: 301-427-1656
or Email: <a href="/cdn-cgi/l/email-protection#9ffaeffcdffef7edeeb1f7f7ecb1f8f0e9"><span class="__cf_email__" data-cfemail="2441544764454c56550a4c4c570a434b52">[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 Recurrent
Nephrolithiasis in Adults and Children: Comparative Effectiveness of
Preventive Medical Strategies. 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
[[Page 99266]]
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 Recurrent Nephrolithiasis in
Adults and Children: Comparative Effectiveness of Preventive Medical
Strategies. The entire research protocol is available online at:
<a href="https://effectivehealthcare.ahrq.gov/products/kidney-stones/protocol">https://effectivehealthcare.ahrq.gov/products/kidney-stones/protocol</a>.
This is to notify the public that the EPC Program would find the
following information on Recurrent Nephrolithiasis in Adults and
Children: Comparative Effectiveness of Preventive Medical Strategies
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://effectivehealthcare.ahrq.gov/email-updates">https://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 comparative effectiveness of preventive treatment
with diet or pharmacologic agents in nonpregnant children and adults
with history of nephrolithiasis?
a. Does effectiveness vary by stone composition, diet assessment,
blood or urine chemistry, or genetic testing performed prior to
treatment?
b. Does effectiveness vary by blood or urine chemistry or genetic
testing performed as followup after treatment is initiated?
KQ 2: What are the comparative harms of preventive treatment with
diet or pharmacologic agents in nonpregnant children and adults with
history of nephrolithiasis?
a. Do harms vary by stone composition, diet assessment, blood or
urine chemistry, or genetic testing performed prior to treatment?
b. Do harms vary by blood or urine chemistry or genetic testing
performed as followup after treatment is initiated?
KQ 3: What is the comparative effectiveness of surveillance imaging
strategies in nonpregnant children and adults with history of
nephrolithiasis?
a. Does effectiveness vary with preventive treatment?
b. Does effectiveness vary by timing of imaging?
KQ 4: What are the comparative harms of surveillance imaging
strategies in nonpregnant children and adults with history of
nephrolithiasis?
a. Do harms vary with preventive treatment?
b. Do harms vary by timing of imaging?
Contextual Question (CQ)
CQ 1: What is the natural history of kidney stone recurrence in
children and adults?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
Setting)
Detailed Inclusion and Exclusion Criteria for Systematic Review
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Category Include Exclude
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Populations........................ All KQs: Nonpregnant children and All KQs: Children and adults without
adults with a history of a history of nephrolithiasis;
nephrolithiasis. pregnant persons; persons receiving
treatment for acute renal colic or
for stone removal or expulsion.
Interventions...................... KQ 1, 1a, 1b, 2, 2a, 2b: Dietary and/ KQs 1, 2: Nondietary and
or pharmacological treatment, nonpharmacological interventions,
including dietary supplements and including behavioral interventions
FDA-approved prescription or OTC aimed to improve treatment
drugs (Appendix A). adherence; interventions for the
KQ 1a, 2a: Eligible interventions acute treatment of kidney stones
along with evaluation of stone (e.g., surgery, lithotripsy,
composition, dietary intake, genetic medical expulsion therapy).
testing, or blood or urine Prescriptions drugs and OTC
chemistries before treatment is medications that are not FDA-
started. approved or available in the United
KQ 1b, 2b: Eligible interventions States.
along with evaluation of genetic KQ 3, 4: Imaging not used
testing or blood and urine specifically for surveillance of
chemistries after treatment kidney stones.
initiation.
KQ 3, 3a, 3b, 4, 4a, 4b: Followup
imaging when used for routine
surveillance (CT scan, renal
ultrasound, abdominal radiograph) to
detect radiographic stone
recurrence, size, composition,
location, or shape.
Comparators........................ KQ 1, 1a, 1b, 2, 2a, 2b: Placebo, All KQs: No comparator (single arm
usual diet, no preventive treatment study).
(for effectiveness); other eligible
intervention (for comparative
effectiveness).
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KQ 3, 3a, 3b, 4, 4a, 4b: Eligible
followup imaging for routine
surveillance of kidney stones, no
followup imaging.
Outcomes........................... All KQs: Patient-centered health KQ 1, 1a, 1b, 3, 3a, 3b: Blood or
outcomes: Incident symptomatic urine chemistry measures, urine
stones, urinary tract obstruction supersaturation measures, acute
with acute renal impairment, end- pain.
stage renal disease, urinary tract
infection, stone-removal procedures/
surgery, procedure-related
morbidity, emergency department
visits and hospitalizations, quality
of life, missed school or work,
preventive treatment-related adverse
events, imaging-related adverse
events, serious adverse events,
discontinuations due to adverse
events.
Intermediate outcomes: Growth of
existing stones, incident
radiographic stones, radiation
exposure, incidental imaging
findings.
Timing............................. KQ 1, 3: Studies that measure KQ 1, 3: Studies of less than 12-
outcomes at least 12 months after months duration.
baseline.
KQ 2, 4: Followup not limited........
Setting............................ Outpatient clinical settings Inpatient settings; Countries with
including primary care, urology, HDI other than very high.
nephrology, or other specialty stone
clinics; countries with HDI\12\ of
very high (Appendix B).
Study Designs, Publication Types, All KQs: Published in peer-reviewed All KQs: Interrupted time series,
and Language. literature, unpublished studies with case series, narrative reviews,
enough information about methods to editorials, and commentaries are
determine risk of bias; English not eligible; systematic reviews
language. RCTs; for comparisons are not eligible but will be
lacking sufficient RCT evidence, reviewed to determine whether any
NRSIs with concurrent comparator included studies are eligible.
group and primary study aim/outcome Studies with fewer than 30
to assess a dietary or pharmacologic participants at baseline per study
intervention or surveillance imaging arm. Studies published in languages
approach are eligible. other than English.
KQ 2: Studies designed to report
epidemiologic associations between
dietary factors and stone
incidence.
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CT = computed tomography; FDA = U.S. Food and Drug Administration; HDI = United Nations Development Programme
Human Development Index; KQ = key question; NRSI = nonrandomized study of intervention; OTC = over-the-
counter; RCT = randomized controlled trial.
Dated: December 4, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-28933 Filed 12-9-24; 8:45 am]
BILLING CODE 4160-90-P
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