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Evaluation of patient-reported outcome measurements as a reliable tool to measure acceptability of the taste of paediatric medicines in an inpatient paediatric population.

ABSTRACT: OBJECTIVE:To evaluate the age appropriateness and suitability of patient-reported outcome measures to assess the acceptability of the taste of oral liquid medicines in children. DESIGN AND SETTING:An observational mixed-methods study involving children aged 2-16 years taking oral liquid medicine in paediatric inpatient wards across the West Midlands (UK). Assessment tools included patient-reported scores on the taste of medicines via a five-point Facial Hedonic Scale; a Visual Analogue Scale (VAS); a question, 'Did you think the medicine tasted OK?' and researcher observations of facial expressions and behaviours immediately before, during and after administration. RESULTS:611 children participated. The percent unable to complete the scales was 7% (n=46) for the VAS; 2% (n=15) for the hedonic scale and 1% (n=7) for the question about taste. Significant correlations (Spearman's r) were observed between the patient-reported outcome measures: 0.80 and 0.78 for the taste question and hedonic and VAS, respectively, and 0.84 for the hedonic and VAS. Researcher observations demonstrated the ability of the patient to take the medicine as intended but did not provide sensitive measures of taste. 5% of administrations were not taken as intended by the children. Medicines known to have poor taste (clarithromycin and prednisolone) showed mean hedonic and VAS scores of ?3.5?and >65?mm, respectively. CONCLUSIONS:Patient-reported outcome measures correlate with each other and are a useful means to assess the taste (and acceptability) of medicines. Hedonic scales are better understood by children and should be the first choice tool in the assessment of medicines taste.

SUBMITTER: Mistry P

PROVIDER: S-EPMC6082459 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Evaluation of patient-reported outcome measurements as a reliable tool to measure acceptability of the taste of paediatric medicines in an inpatient paediatric population.

Mistry Punam P Stirling Heather H Callens Claire C Hodson James J Batchelor Hannah H

BMJ open 20180711 7

<h4>Objective</h4>To evaluate the age appropriateness and suitability of patient-reported outcome measures to assess the acceptability of the taste of oral liquid medicines in children.<h4>Design and setting</h4>An observational mixed-methods study involving children aged 2-16 years taking oral liquid medicine in paediatric inpatient wards across the West Midlands (UK). Assessment tools included patient-reported scores on the taste of medicines via a five-point Facial Hedonic Scale; a Visual Ana ...[more]

PMID: 29997143

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Project description:BACKGROUND:Evolving regulatory guidelines recommend routine assessment of the acceptability of pediatric oral medicines throughout clinical development processes. However, such assessment is problematic owing to a lack of standard methods or criteria that define acceptability for children and their caregivers. This research aimed to identify the attributes of acceptability for targeted oral formulation types that are important to children, and to develop content-valid patient- and caregiver-reported outcome acceptability measures for use in the context of clinical drug development. METHODS:A concept-focused literature review and two advisory panel meetings involving researchers, clinicians, and measurement scientists were conducted to identify acceptability attributes that may be relevant to children taking targeted oral medicine formulations. The Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQs), including patient (P-OMAQ-P) and caregiver (P-OMAQ-C) versions, were drafted to assess these attributes. Qualitative concept elicitation (CE) and cognitive debriefing (CD) patient and caregiver interviews were conducted to confirm key acceptability attribute concepts for measurement and to evaluate patient and caregiver ability to understand and respond to the questions. RESULTS:A full-text review of 40 articles identified 24 acceptability attributes that were categorized into 10 overarching domains and organized into a preliminary conceptual model. Feedback from the advisory panel refined the preliminary model. In total, 14 attributes were reported during the CE phase of the interviews (n?=?23 pediatric patients, n?=?13 caregivers); six attributes were included in the final model. The draft P-OMAQ was refined over four waves of CD interviews (n?=?31 pediatric patients, n?=?48 caregivers). The final version of the P-OMAQ-P is a 12-item questionnaire designed for young people aged 8-17?years. The P-OMAQ-C is a 19-item questionnaire designed for adult caregivers of young people aged 6?months to 17?years. There are two versions of each questionnaire: one with a 24-h recall period and one with a 7-day recall period. All items are answered on a 5-point numerical rating scale. CONCLUSIONS:This research supports the content validity of the patient and caregiver versions of the P-OMAQ. Both questionnaires appropriately assess the acceptability of oral medicine formulations from the perspective of pediatric patients and their caregivers.

Project description:Patient-reported outcome measures (PROMs) provide an opportunity for meaningful patient engagement and shared decision-making. The objective of this research programme is to improve health outcomes for paediatric solid organ transplant patients by implementing PROMs into clinical care. The current study aims to create Voxe, a paediatric user-centred electronic PROM platform, by engaging patients and healthcare providers throughout the design and development process. The creation of Voxe will occur over two phases that build on previous research. The user interface design phase employs a 'user-centric' approach to identify end-users' needs and iteratively refine the look and layout of Voxe to meet these needs. Transplant recipients, aged 10-17, and healthcare providers will participate in three rounds of testing (24 participants total). Participants will: (1) complete task-based activities (outcomes-effectiveness and efficiency), (2) complete questionnaires (outcome-satisfaction) and (3) participate in a semi-structured interview. The following phase involves software development and Voxe usability testing. Transplant recipients, aged 8-17, and healthcare providers will participate in four rounds of iterative testing (24-40 participants total). The think-aloud technique will be employed, and participants will describe their thoughts and feelings while interacting with a Voxe prototype. Participants will: (1) log into Voxe and complete tasks (outcomes-time on task, successful task completion, frequency of critical and non-critical errors and error-free rate), (2) complete questionnaires (outcome-satisfaction) and (3) participate in a semi-structured interview. Findings will result in the creation and launch of a user-centred electronic PROM platform. Research ethics board approval has been provided by The Hospital for Sick Children. This research is critical to answering methodological and operational questions to inform Voxe implementation in paediatric clinical settings and facilitate PROM data collection. Future investigations will include an implementation-effectiveness evaluation.

Dataset Information

Evaluation of patient-reported outcome measurements as a reliable tool to measure acceptability of the taste of paediatric medicines in an inpatient paediatric population.

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Evaluation of patient-reported outcome measurements as a reliable tool to measure acceptability of the taste of paediatric medicines in an inpatient paediatric population.

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