Dataset Information

Pharmacokinetic assessment in patients receiving continuous RRT: perspectives from the Kidney Health Initiative.

ABSTRACT: The effect of AKI and modern continuous RRT (CRRT) methods on drug disposition (pharmacokinetics) and response has been poorly studied. Pharmaceutical manufacturers have little incentive to perform pharmacokinetic studies in patients undergoing CRRT because such studies are neither recommended in existing US Food and Drug Administration (FDA) guidance documents nor required for new drug approval. Action is urgently needed to address the knowledge deficit. The Kidney Health Initiative has assembled a work group composed of clinicians and scientists representing academia, the FDA, and the pharmaceutical and dialysis industries with expertise related to pharmacokinetics, AKI, and/or CRRT. The work group critically evaluated key considerations in the assessment of pharmacokinetics and drug dosing in CRRT, practical constraints related to conducting pharmacokinetic studies in critically ill patients, and the generalizability of observations made in the context of specific CRRT prescriptions and specific patient populations in order to identify efficient study designs capable of addressing the knowledge deficit without impeding drug development. Considerations for the standardized assessment of pharmacokinetics and development of corresponding drug dosing recommendations in critically ill patients with AKI receiving CRRT are proposed.

SUBMITTER: Nolin TD

PROVIDER: S-EPMC4284416 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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Pharmacokinetic assessment in patients receiving continuous RRT: perspectives from the Kidney Health Initiative.

Nolin Thomas D TD Aronoff George R GR Fissell William H WH Jain Lokesh L Madabushi Rajnikanth R Reynolds Kellie K Zhang Lei L Huang Shiew Mei SM Mehrotra Rajnish R Flessner Michael F MF Leypoldt John K JK Witcher Jennifer W JW Zineh Issam I Archdeacon Patrick P Roy-Chaudhury Prabir P Goldstein Stuart L SL

Clinical journal of the American Society of Nephrology : CJASN 20140904 1

The effect of AKI and modern continuous RRT (CRRT) methods on drug disposition (pharmacokinetics) and response has been poorly studied. Pharmaceutical manufacturers have little incentive to perform pharmacokinetic studies in patients undergoing CRRT because such studies are neither recommended in existing US Food and Drug Administration (FDA) guidance documents nor required for new drug approval. Action is urgently needed to address the knowledge deficit. The Kidney Health Initiative has assembl ...[more]

PMID: 25189923

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Project description:PURPOSE:Individuals with mental illnesses have higher morbidity rates and reduced life expectancy compared to the general population. Understanding how patients and providers perceive the need for prevention, as well as the barriers and beliefs that may contribute to insufficient care, are important for improving service delivery tailored to this population. DESIGN:Cross-sectional; mixed methods. SETTING:An integrated health system and a network of federally qualified health centers and safety net clinics. PARTICIPANTS:Interviews (n = 30) and surveys (n = 249) with primary care providers. Interviews (n = 158) and surveys (n = 160) with patients diagnosed with schizophrenia, bipolar, anxiety, or major depressive disorders. MEASURES:Semi-structured interviews and surveys. ANALYSIS:Thematic analysis for qualitative data; frequencies for quantitative data. RESULTS:More than half (n = 131, 53%) of clinicians believed patients with mental illnesses care less about preventive care than the general population, yet 88% (n = 139) of patients reported interest in improving health. Most providers (n = 216, 88%) lacked confidence that patients with mental illnesses would follow preventive recommendations; 82% (n = 129) of patients reported they would try to change lifestyles if their doctor recommended. Clinicians explained that their perception of patients' chaotic lives and lack of interest in preventive care contributed to their fatalistic attitudes on care delivery to this population. Clinicians and patients agreed on substantial need for additional support for behavior changes. Clinicians reported providing informational support by keeping messages simple; patients reported a desire for more detailed information on reasons to complete preventive care. Patients also detailed the need for assistive and tangible support to manage behavioral health changes. CONCLUSIONS:Our results suggest a few clinical changes could help patients complete preventive care recommendations and improve health behaviors: improving clinician-patient collaboration on realistic goal setting, increasing visit time or utilizing behavioral health consultants that bridge primary and specialty mental health care, and increasing educational and tangible patient support services.

Dataset Information

Pharmacokinetic assessment in patients receiving continuous RRT: perspectives from the Kidney Health Initiative.

Publications

Pharmacokinetic assessment in patients receiving continuous RRT: perspectives from the Kidney Health Initiative.

Similar Datasets

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