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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 [www.gpo.gov]
[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published and unpublished pertinent scientific information will improve 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: [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 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: 
https://effectivehealthcare.ahrq.gov/products/kidney-stones/protocol.
    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 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://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 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
----------------------------------------------------------------------------------------------------------------
              Category                              Include                                Exclude
----------------------------------------------------------------------------------------------------------------
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).

[[Page 99267]]

 
                                     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.
----------------------------------------------------------------------------------------------------------------
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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