Young patients' involvement in a composite endpoint method development on acceptability for paediatric oral dosage forms.
Res Involv Engagem
; 9(1): 108, 2023 Nov 29.
Article
em En
| MEDLINE
| ID: mdl-38031172
Before a new medicine is authorized, its acceptability by children must be investigated according to law. An acceptability testing method combining the outcomes of "swallowability" and "palatability" assessments was recently developed. During a focus group meeting with KIDS Barcelona (young people advisory group, age 1623 years) their opinion on the suitability of the method and the relevance of patient engagement in the medicines development process were assessed with paper-based and electronic questionnaires. Questions on how best to determine palatability and swallowability were asked. The importance of different elements that typically affect acceptability was rated. The order of relevance of those listed acceptability elements was assessed using coloured and numbered stickers and questionnaires. The results showed that the involvement of young people in the medicines and acceptability method development was rated high. The group worked out that a 5-point smiley Likert Scale that allows for marking a choice between total agreement and total disagreement is preferred for assessing acceptability by 611 year old patients. A Visual Analogue Scale (scale consisting of a 10 cm long line on which a mark has to be placed at the desired position, between total agreement and total rejection) is preferred for collecting adolescents' (1218 years) opinion. The ranking of acceptability elements showed that palatability and swallowability of a new medicine are the most relevant parameters, and colour the least. The clarity of the outcome reinforced the benefit of involving young people in the development of medicines relevant for children.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Idioma:
En
Revista:
Res Involv Engagem
Ano de publicação:
2023
Tipo de documento:
Article
País de afiliação:
Suíça
País de publicação:
Reino Unido