Invasiveness of pharmacokinetic studies in children: a systematic review

Objectives: To explore whether pharmacokinetic (PK) studies in paediatric patients are becoming less invasive. This will be evaluated by analysing the number of samples and volume of blood collected for each study within four different decades. Methods: A systematic literature review was performed...

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Main Authors: Altamimi, Mohammed, Choonara, Imti, Sammons, Helen
Format: Article
Published: BMJ Publishing Group 2016
Online Access:https://eprints.nottingham.ac.uk/37193/
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author Altamimi, Mohammed
Choonara, Imti
Sammons, Helen
author_facet Altamimi, Mohammed
Choonara, Imti
Sammons, Helen
author_sort Altamimi, Mohammed
building Nottingham Research Data Repository
collection Online Access
description Objectives: To explore whether pharmacokinetic (PK) studies in paediatric patients are becoming less invasive. This will be evaluated by analysing the number of samples and volume of blood collected for each study within four different decades. Methods: A systematic literature review was performed to identify PK papers describing number of samples and volume of blood collected in studies of children aged 0–18 years. The following databases were searched: MEDLINE (1946 to December 2015), EMBASE (1974 to December 2015), International Pharmaceutical Abstracts (1970 to December 2015), CINAHL and Cochrane Library. Results: A total of 549 studies were identified between 1974 and 2015. There were 52 studies between 1976 and 1985, 105 between 1986 and 1995, 201 between 1996 and 2005 and 191 between 2006 and 2015. The number of blood samples collected per participant increased between the first two decades (p=0.013), but there was a decrease in the number of samples in the subsequent two decades (p=0.044 and p<0.001, respectively). Comparing the first and last decades, there has been no change in the number of blood samples collected. There were no significant differences in volume collected per sample or total volume per child in any of the age groups. There was however a significant difference in the frequency of blood sampling between population PK studies (median 5 (IQR 3–7)) and non-population PK studies (median 8 (IQR 6–10); p=<0.001). Conclusions: The number of blood samples collected for PK studies in children rose in 1985–1995 and subsequently declined. There was no overall change in the volume of blood collected over the 4 decades. The usage of population PK methods reduces the frequency of blood sampling in children.
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spelling nottingham-371932024-08-15T15:19:37Z https://eprints.nottingham.ac.uk/37193/ Invasiveness of pharmacokinetic studies in children: a systematic review Altamimi, Mohammed Choonara, Imti Sammons, Helen Objectives: To explore whether pharmacokinetic (PK) studies in paediatric patients are becoming less invasive. This will be evaluated by analysing the number of samples and volume of blood collected for each study within four different decades. Methods: A systematic literature review was performed to identify PK papers describing number of samples and volume of blood collected in studies of children aged 0–18 years. The following databases were searched: MEDLINE (1946 to December 2015), EMBASE (1974 to December 2015), International Pharmaceutical Abstracts (1970 to December 2015), CINAHL and Cochrane Library. Results: A total of 549 studies were identified between 1974 and 2015. There were 52 studies between 1976 and 1985, 105 between 1986 and 1995, 201 between 1996 and 2005 and 191 between 2006 and 2015. The number of blood samples collected per participant increased between the first two decades (p=0.013), but there was a decrease in the number of samples in the subsequent two decades (p=0.044 and p<0.001, respectively). Comparing the first and last decades, there has been no change in the number of blood samples collected. There were no significant differences in volume collected per sample or total volume per child in any of the age groups. There was however a significant difference in the frequency of blood sampling between population PK studies (median 5 (IQR 3–7)) and non-population PK studies (median 8 (IQR 6–10); p=<0.001). Conclusions: The number of blood samples collected for PK studies in children rose in 1985–1995 and subsequently declined. There was no overall change in the volume of blood collected over the 4 decades. The usage of population PK methods reduces the frequency of blood sampling in children. BMJ Publishing Group 2016-07-18 Article PeerReviewed Altamimi, Mohammed, Choonara, Imti and Sammons, Helen (2016) Invasiveness of pharmacokinetic studies in children: a systematic review. BMJ Open, 6 . e010484/1-e010484/6. ISSN 2044-6055 http://bmjopen.bmj.com/content/6/7/e010484.abstract
spellingShingle Altamimi, Mohammed
Choonara, Imti
Sammons, Helen
Invasiveness of pharmacokinetic studies in children: a systematic review
title Invasiveness of pharmacokinetic studies in children: a systematic review
title_full Invasiveness of pharmacokinetic studies in children: a systematic review
title_fullStr Invasiveness of pharmacokinetic studies in children: a systematic review
title_full_unstemmed Invasiveness of pharmacokinetic studies in children: a systematic review
title_short Invasiveness of pharmacokinetic studies in children: a systematic review
title_sort invasiveness of pharmacokinetic studies in children: a systematic review
url https://eprints.nottingham.ac.uk/37193/
https://eprints.nottingham.ac.uk/37193/