Pharmacotherapy
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To categorize institutional review board (IRB) challenges and solutions encountered in a multicenter practice-based research network (PBRN) study and to assess the impact of IRB requirements on the willingness of individual principal investigators (PIs) to participate in future PBRN studies. ⋯ Significant time and resources were required to address various challenges associated with IRB approval, which had a negative impact on an individual PI's willingness to participate in future PBRN projects. A revision of current rules and regulations regarding the protection of human subjects for practice-based studies, improvement in IRB processes, and support from coordinating centers may decrease the burden associated with IRB approval and increase participation in practice-based research.
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To evaluate the performance of kidney function estimation equations and to determine the frequency of drug dose discordance in an older population. ⋯ The MDRD and CKD-EPI equations significantly overestimated creatinine clearance (mClcr and CG) in elderly individuals. This leads to dose calculation errors for many drugs, particularly in individuals with severe renal impairment. Thus equations estimating glomerular filtration rate should not be substituted in place of the CG equation in older adults for the purpose of renal dosage adjustments. In addition, the common practice of rounding or replacing low Scr values with an arbitrary value of 1.0 mg/dl for use in the CG equation should be avoided. Additional studies that evaluate alternative eGFR equations in the older populations that incorporate pharmacokinetic and pharmacodynamic outcomes measures are needed.