89 FR 237 pgs. 99265-99267 - Supplemental Evidence and Data Request on Recurrent Nephrolithiasis in Adults and Children: Comparative Effectiveness of Preventive Medical Strategies
Type: NOTICEVolume: 89Number: 237Pages: 99265 - 99267
Pages: 99265, 99266, 99267FR document: [FR Doc. 2024-28933 Filed 12-9-24; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Agency for Healthcare Research and Quality
Official PDF Version: PDF Version
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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.
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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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: 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.
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 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.
[top] The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for
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:
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.
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.
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.
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)
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| Category | Include | Exclude |
|---|---|---|
| Populations | All KQs: Nonpregnant children and adults with a history of nephrolithiasis | All KQs: Children and adults without a history of 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/or pharmacological treatment, including dietary supplements and FDA-approved prescription or OTC drugs (Appendix A) KQ 1a, 2a: Eligible interventions along with evaluation of stone composition, dietary intake, genetic testing, or blood or urine chemistries before treatment is started KQ 1b, 2b: Eligible interventions along with evaluation of genetic testing or blood and urine chemistries after treatment 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 | KQs 1, 2: Nondietary and nonpharmacological interventions, including behavioral interventions aimed to improve treatment adherence; interventions for the acute treatment of kidney stones ( e.g., surgery, lithotripsy, medical expulsion therapy). Prescriptions drugs and OTC medications that are not FDA-approved or available in the United States. KQ 3, 4: Imaging not used specifically for surveillance of kidney stones. |
| Comparators | KQ 1, 1a, 1b, 2, 2a, 2b: Placebo, usual diet, no preventive treatment (for effectiveness); other eligible intervention (for comparative effectiveness) | All KQs: No comparator (single arm study). |
| 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 outcomes: Incident symptomatic stones, urinary tract obstruction with acute renal impairment, end-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 | KQ 1, 1a, 1b, 3, 3a, 3b: Blood or urine chemistry measures, urine supersaturation measures, acute pain. |
| Intermediate outcomes: Growth of existing stones, incident radiographic stones, radiation exposure, incidental imaging findings | ||
| Timing | KQ 1, 3: Studies that measure outcomes at least 12 months after baseline KQ 2, 4: Followup not limited. | KQ 1, 3: Studies of less than 12-months duration. |
| Setting | Outpatient clinical settings including primary care, urology, nephrology, or other specialty stone clinics; countries with HDI 12 of very high (Appendix B) | Inpatient settings; Countries with HDI other than very high. |
| Study Designs, Publication Types, and Language | All KQs: Published in peer-reviewed literature, unpublished studies with enough information about methods to determine risk of bias; English language. RCTs; for comparisons lacking sufficient RCT evidence, NRSIs with concurrent comparator group and primary study aim/outcome to assess a dietary or pharmacologic intervention or surveillance imaging approach are eligible | All KQs: Interrupted time series, case series, narrative reviews, editorials, and commentaries are not eligible; systematic reviews are not eligible but will be reviewed to determine whether any included studies are eligible. Studies with fewer than 30 participants at baseline per study arm. Studies published in languages 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