QUADRATIC Study
Research type
Research Study
Full title
QUestionnaire study about Adverse Drug ReAcTions In Children (QUADRATIC)
IRAS ID
242352
Contact name
Dan Hawcutt
Contact email
Sponsor organisation
Alder Hey Children's Hospital
Clinicaltrials.gov Identifier
18/NW/0175, North West - Liverpool East REC
Duration of Study in the UK
6 years, 3 months, 31 days
Research summary
All medicines used in children and young people are intended to help and are used to reduce the symptoms they experience or prevent harm from disease. However, with all drugs there is the possibility of unwanted effects (also called “side effects” or “adverse drug reactions (ADRs)”). ADRs place a significant burden on the NHS with 2.5-10.6% of hospital admissions in Europe being due to an ADR and even higher percentages elsewhere in the world. In England approximately 6% of hospital admissions are thought to be caused by an ADR.
People of all ages can be affected by an ADR, with children in particular being more susceptible to adverse drug reactions when compared with their adult counterparts, in terms of both frequency and severity. Studies have shown that up to 5% of paediatric ADRs result in a hospital admission and that nearly two in five of these ADRs resulting in admission are life threatening or fatal.
It is important therefore that ADRs are correctly identified as soon as possible and reported to a central database known as the ‘Yellow Card Scheme’ (YCS).
AIM:
This study aims to play a part in the improvement of pharmacovigilance (drug safety) by increasing understanding of the type, frequency and effect of ADRs in children attending outpatient’s clinics at Alder Hey, as well as improving our understanding of how parents/guardians of these children notice and report them. How socioeconomic factors influence the type and severity of ADRs in children will also be explored.OBJECTIVES:
To undertake a questionnaire study of children and young people (and their families) who attend outpatient’s clinics at Alder Hey Children’s Hospital and Community Clinics.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0175
Date of REC Opinion
4 Jul 2018
REC opinion
Further Information Favourable Opinion