Pediatric Drugs

, Volume 19, Issue 3, pp 223–233

Methodology Used to Assess Acceptability of Oral Pediatric Medicines: A Systematic Literature Search and Narrative Review

  • Punam Mistry
  • Hannah Batchelor
  • On behalf of SPaeDD-UK project
Systematic Review

DOI: 10.1007/s40272-017-0223-7

Cite this article as:
Mistry, P., Batchelor, H. & On behalf of SPaeDD-UK project Pediatr Drugs (2017) 19: 223. doi:10.1007/s40272-017-0223-7

Abstract

Background

Regulatory guidelines require that any new medicine designed for a pediatric population must be demonstrated as being acceptable to that population. There is currently no guidance on how to conduct or report on acceptability testing.

Aim

Our objective was to undertake a review of the methods used to assess the acceptability of medicines within a pediatric population and use this review to propose the most appropriate methodology.

Methods

We used a defined search strategy to identify literature reports of acceptability assessments of medicines conducted within pediatric populations and extracted information about the tools used in these studies for comparison across studies.

Results

In total, 61 articles were included in the analysis. Palatability was the most common (54/61) attribute measured when evaluating acceptability. Simple scale methods were most commonly used, with visual analog scales (VAS) and hedonic scales used both separately and in combination in 34 of the 61 studies. Hedonic scales alone were used in 14 studies and VAS alone in just five studies. Other tools included Likert scales; forced choice or preference; surveys or questionnaires; observations of facial expressions during administration, ease of swallowing, or ability to swallow the dosage; prevalence of complaints or refusal to take the medicine; and time taken for a nurse to administer the medicine.

Conclusions

The best scale in terms of validity, reliability, feasibility, and preference to use when assessing acceptability remains unclear. Further work is required to select the most appropriate method to justify whether a medicine is acceptable to a pediatric population.

Supplementary material

40272_2017_223_MOESM1_ESM.pdf (107 kb)
Supplementary material 1 (PDF 107 kb)
40272_2017_223_MOESM2_ESM.pdf (150 kb)
Supplementary material 2 (PDF 150 kb)

Funding information

Funder NameGrant NumberFunding Note
Innovate UK

    Copyright information

    © Springer International Publishing Switzerland 2017

    Authors and Affiliations

    1. 1.Pharmacy and Therapeutics, Institute of Clinical Sciences, College of Medical and Dental SciencesUniversity of BirminghamEdgbastonUK

    Personalised recommendations