Guidelines for Conducting HIV Research with Human Subjects at a U.S. Military Medical Center
In: IRB: ethics & human research, Band 14, Heft 1, S. 7
ISSN: 2326-2222
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In: IRB: ethics & human research, Band 14, Heft 1, S. 7
ISSN: 2326-2222
IMPORTANCE: Concern about the renal effects of nonsteroidand al anti-inflammatory drugs (NSAIDs) among young, healthy adults has been limited, but more attention may be warranted given the prevalent use of these agents. OBJECTIVE: To test for associations between dispensed NSAIDs and incident acute kidney injury and chronic kidney disease while controlling for other risk factors. DESIGN, SETTING, AND PARTICIPANTS: This retrospective, longitudinal cohort study used deidentified medical and administrative data on 764 228 active-duty US Army soldiers serving between January 1, 2011, and December 31, 2014. Analysis was conducted from August 1 to November 30, 2018. All individuals new to Army service were included in the analysis. Persons already serving in January 2011 were required to have at least 7 months of observable time to eliminate those with kidney disease histories. EXPOSURES: Mean total defined daily doses of prescribed NSAIDs dispensed per month in the prior 6 months. MAIN OUTCOMES AND MEASURES: Incident outcomes were defined by diagnoses documented in health records and a military-specific digital system. RESULTS: Among the 764 228 participants (655 392 [85.8%] men; mean [SD] age, 28.6 [7.9] years; median age, 27.0 years [interquartile range, 22.0-33.0 years]), 502 527 (65.8%) were not dispensed prescription NSAIDs in the prior 6 months, 137 108 (17.9%) were dispensed 1 to 7 mean total defined daily doses per month, and 124 594 (16.3%) received more than 7 defined daily doses per month. There were 2356 acute kidney injury outcomes (0.3% of participants) and 1634 chronic kidney disease outcomes (0.2%) observed. Compared with participants who received no medication, the highest exposure level was associated with significantly higher adjusted hazard ratios (aHRs) for acute kidney injury (aHR, 1.2; 95% CI, 1.1-1.4) and chronic kidney disease (aHR, 1.2; 95% CI, 1.0-1.3), with annual outcome excesses per 100 000 exposed individuals totaling 17.6 cases for acute kidney injury and 30.0 cases for chronic kidney ...
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RATIONALE & OBJECTIVE: The US Military Health System (MHS) is a global health care network with a diverse population that is more representative of the US population than other study cohorts and with fewer disparities in health care access. We aimed to examine the prevalence of chronic kidney disease (CKD) in the MHS and within demographic subpopulations. STUDY DESIGN: Multiple cross-sectional analyses of demographic and claims-based data extracted from the MHS Data Repository, 1 for each fiscal year from 2006-2015. SETTING & POPULATION: Multicenter health care network including active-duty military, retirees, and dependents. The average yearly sample size was 3,285,348 individuals. EXPOSURES: Age, sex, race, active-duty status, and active-duty rank (a surrogate for socioeconomic status). OUTCOME: CKD, defined as the presence of matching International Classification of Diseases, Ninth Revision, codes on either 1 or more inpatient or 2 or more outpatient encounters. ANALYTICAL APPROACH: t test for continuous variables and χ(2) test for categorical variables; multivariable logistic regression for odds ratios. RESULTS: For 2015, the mean (standard deviation) age was 38 (16). Crude CKD prevalence was 2.9%. Age-adjusted prevalence was 4.9% overall—1.9% active-duty and 5.4% non–active-duty individuals. ORs for CKD were calculated with multiple imputations to account for missing data on race. After adjustment, the ORs for CKD (all P < 0.001) were 1.63 (95% CI, 1.62-1.64) for an age greater than 40 years, 1.16 (95% CI, 1.15-1.17) for Black race, 1.15 (95% CI, 1.14-1.16) for senior enlisted rank, 0.94 (95% CI, 0.93-0.95) for women, and 0.50 (95% CI, 0.49-0.51) for active-duty status. LIMITATIONS: Retrospective study based on International Classification of Diseases, Ninth Revision, coding. CONCLUSIONS: Within the MHS, older age, Black race, and senior enlisted rank were associated with a higher risk of CKD, whereas female sex and active-duty status were associated with a lower risk.
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