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Kidney-Stone-Prevention Executive

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Kidney-Stone-Prevention Executive Comparative Effectiveness Review Number 61 Effective Health Care Program Recurrent Nephrolithiasis in Adults: Comparative Effectiveness of Preventive Medical Strategies Executive Summary Introduction Effective Health Care Program Nephrolithiasis is a condition in which The Effective Health Care Program hard masses (kidney stones) form within was initiated in 2005 to provide the urinary tract. These stones form valid evidence about the comparative from crystals that separate out of the effectiveness of different medical urine. Formation may occur when the interventions. The object is to help urinary concentration of crystal-forming consumers, health care providers, substances (e.g., calcium, oxalate, uric and others in making informed acid) is high and/or that of substances choices among treatment alternatives. that inhibit stone formation (e.g., citrate) Through its Comparative Effectiveness is low. Reviews, the program supports The lifetime incidence of kidney stones systematic appraisals of existing is approximately 13 percent for men scientific evidence regarding and 7 percent for women.1,2 Reports treatments for high-priority health conflict regarding whether incidence is conditions. It also promotes and rising overall but consistently report generates new scientific evidence by rising incidence in women and a falling identifying gaps in existing scientific male-to-female ratio.3-5 Although evidence and supporting new research. stones may be asymptomatic,6 potential The program puts special emphasis consequences include abdominal and on translating findings into a variety flank pain, nausea and vomiting, urinary of useful formats for different tract obstruction, infection, and stakeholders, including consumers. procedure-related morbidity. Following The full report and this summary are an initial stone event, the 5-year available at www.effectivehealthcare. recurrence rate in the absence of specific ahrq.gov/reports/final.cfm. treatment is 35 to 50 percent.7 Direct medical expenditures associated with kidney stones may exceed $4.5 billion calcium phosphate, with most remaining annually in the United States.1,8 patients having either struvite or uric acid Approximately 80 percent of adults with stones.9 Many patients with kidney stones kidney stones have stones consisting have low urine volume and/or one or more predominately of calcium oxalate and/or biochemical abnormalities, including Effective Health Care 1 hypercalciuria, hyperuricosuria, hyperoxaluria, This systematic review and meta-analysis attempts to hypocitraturia, and either low or high urine pH.10,11 comprehensively address these questions. We developed In many patients, kidney stones are caused by an an analytic framework that incorporated six Key Questions interaction between genetic inheritance and environmental and specified the patient populations, interventions, exposure.12 Genetic factors are thought to account for comparisons, outcomes, and harms of interest (Figure 1 in about half the risk of developing kidney stones.12 Dietary the full report). The Key Questions were: factors associated with increased stone risk include Key Question 1. In adults with a history of nephrolithiasis, low fluid intake, low calcium intake, and high fructose do results of baseline stone composition and blood and intake, while evidence is mixed for increased animal urine chemistries predict the effectiveness of diet and/or protein, increased sodium, increased sucrose, and low pharmacological treatment on final health outcomes and magnesium.13-17 intermediate stone outcomes, and reduce treatment adverse Risk of kidney stones also may be increased by medical effects? conditions such as primary hyperparathyroidism,18 Key Question 2. In adults with a history of nephrolithiasis, obesity,19 diabetes,20 gout,21 and intestinal what is the effectiveness and comparative effectiveness malabsorption,22 and by anatomic abnormalities such as of different dietary therapies on final health outcomes and medullary sponge kidney and horseshoe kidney. intermediate stone outcomes? Previous systematic reviews of randomized controlled Key Question 3. In adults with a history of nephrolithiasis, trials (RCTs) of dietary and pharmacological therapies what is the evidence that dietary therapies to reduce risk have reported that increased fluid intake,23 thiazide of recurrent stone episodes are associated with adverse diuretics,24-26 and citrate pharmacotherapy26,27 reduce effects? stone recurrence, but that evidence was insufficient Key Question 4. In adults with a history of nephrolithiasis, regarding the efficacy of other pharmacological what is the effectiveness and comparative effectiveness treatments.24,26,28,29 Results of these reviews were limited of different pharmacological therapies on final health in that they did not: (1) include more recent RCTs; outcomes and intermediate stone outcomes? (2) compare different pharmacological treatments with each other; (3) compare combinations of pharmacological Key Question 5. In adults with a history of nephrolithiasis, treatments with monotherapy; (4) explicitly account what is the evidence that pharmacological therapies to for the effect of fluid and dietary co-interventions on reduce risk of recurrent stone episodes are associated with pharmacological treatment efficacy; and/or (5) address adverse effects? the potential impact of patient demographics and Key Question 6. In adults with a history of nephrolithiasis comorbidities on treatment outcomes. being treated to prevent stone recurrence, do results of Clinical guidelines recommend that patients who followup blood and urine biochemistry measures predict experience kidney stones undergo a laboratory evaluation, final health outcomes and intermediate stone outcomes? including analysis of stone composition and possibly of urine and blood biochemistries.30 Unclear, however, Methods is whether pretreatment laboratory test results predict effectiveness of treatment on stone recurrence and other Data Sources clinical health outcomes, or whether treatment tailored to We searched MEDLINE® from January 1, 1948, through pretreatment laboratory results is associated with better the third week of November 2011 and the Cochrane clinical health outcomes than empiric therapy. Nor have Central Register of Controlled Trials (CENTRAL) followup biochemical test results been proven as valid through the fourth quarter of 2011 to identify RCTs of surrogates for predicting the effectiveness of treatment in treatments to prevent recurrent nephrolithiasis. Appendix preventing stone recurrence. A of the full report contains the full search strategy. We Clinical uncertainty exists regarding the effectiveness, also reviewed reference lists of included studies, previous comparative effectiveness, and adverse effects of dietary systematic reviews, and relevant clinical guidelines. With and pharmacological preventive treatments; the value of Google Scholar we performed forward citation searching urine and blood biochemical measures for initiating and/ of key included RCTs. To identify unpublished RCTs, or modifying treatment; and the potential impact of patient we searched ClinicalTrials.gov, Web of Science, and and stone characteristics on important treatment outcomes. sought industry scientific information packets for relevant 2 regulatory documents and reports of conducted trials. we included trials to prevent recurrent kidney stones that We selected studies based on prespecified inclusion and reported only followup blood and/or urine biochemical exclusion criteria (Appendix B of the full report). Two measures as efficacy outcomes, and prospective reviewers evaluated each study at the title or abstract stage observational studies in cohorts of at least 100 patients and at the full text article stage to determine eligibility for being treated to prevent recurrent kidney stones, with inclusion in the review. a minimum duration of 3 months for both study types. We did not evaluate these additional types of studies for We restricted the review to studies published in full text adverse effects of dietary treatments under the assumptions in English that enrolled adults age 18 years or older with that we were unlikely to find diet studies with similar a history of one or more past kidney stone episodes. We compositions to those of eligible trials, dietary adverse excluded studies of children, and those that addressed effects seemed low, and the likelihood of finding reported acute pain management and treatment to promote adverse effects in lower quality diet studies was low. expulsion of ureteral stones. Eligible studies could include patients with or without residual stones or stone fragments. Data Extraction and Quality Assessment In an attempt to distinguish the effect of secondary prevention from lithotripsy, we excluded studies with One reviewer extracted and a second reviewer verified participants who had undergone lithotripsy fewer than data for each study, including participant entry criteria, 90 days earlier unless participants were documented to be intervention and control regimens, followup duration, stone free at baseline. We considered studies conducted in participant characteristics, stone recurrence and other all settings and geographic locations. clinical health outcomes, followup urine and blood measurements, adverse events, and adherence. Two For questions related to the efficacy of diet therapy, reviewers also assessed each eligible RCT for risk we included RCTs of at least 12 months duration that of bias
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