Status
Ongoing
Title
Antipsychotic prescribing and monitoring of physical health in children and adolescents with mental health problems: a cohort study using primary care data
What is the aim of the study and why is it important?
Antipsychotic medications can be prescribed to any child or adolescent with particular mental health issues. These include severe conditions, such as schizophrenia, as well a range of behavioural disorders, learning difficulties, autism and tics. Patients often require long-term treatment, so the drugs may be prescribed for months or years. It is known that antipsychotics have side effects, which include substantial weight gain and increased risk of developing type 2 diabetes. It is also known that young people are at greater risk of experiencing these side effects because their metabolisms may require higher dosages. There is, however, limited evidence about the safety of prescribing antipsychotics to children and young people, because most studies to date have been short-term and have focused on adult patients. These studies have also either included only a limited number of different drugs or have been too small to investigate differences between individual drugs.
Little is known about the extent of or reasons for prescribing of antipsychotics to younger people, or about the procedures followed when this is done. So this study will first investigate antipsychotic prescribing to children and adolescents in real primary care settings in the UK. This will include recorded reasons for prescribing, and for how long patients were prescribed drugs. The data used comes from a national database of GP records, which has been shown to be representative of the general population, so all types of antipsychotics used in the UK – and all population groups and patient characteristics – will be included.
Because of the greater risks of side effects from antipsychotics usage in the younger population, the National Institute of Clinical Excellence (NICE) has recommended regular health monitoring for some younger antipsychotic users. Currently, however, the recommendations are limited to patients with schizophrenia and, even for these patients, it is currently unknown how widely or closely these recommendations have been followed. So we shall also investigate the recorded health monitoring for all younger patients with diagnoses of mental health conditions which have led to, or could lead to, the prescribing of an antipsychotic.
To do this, we shall include in the study a separate group of children and adolescents who weren’t prescribed antipsychotics but had mental health diagnoses similar to the young people who have been prescribed antipsychotics, and then describe recorded health monitoring for weight gain or development of diabetes, by age, gender and ethnicity, and by a range of patient groups. These will include those prescribed drugs vs those not, groups of patients prescribed different types of antipsychotics, and conditions which have specific recommended monitoring regimes vs conditions which do not.
This study will clarify levels of prescribing and use of antipsychotics for the treatment of mental health issues in children and adolescents, the reasons for prescribing and procedures followed, the background levels of health monitoring of younger people with mental health issues and whether these levels change when patients have been prescribed these drugs. The descriptions of recorded monitoring within different groups of patients will show any weaknesses in current practice, reveal any disparities in the treatment of different types of patient, identify areas where more detailed study may be feasible, and facilitate possible requirements for change to current treatment recommendations – in emphasis, breadth of coverage, or both.
How is the research being done?
The study will use records of primary care data from QResearch, collected by about 1500 general practices in England and linked to hospital records. The database contains information about diagnoses, prescriptions and patient-related measures about health and lifestyle, but all data have been anonymised so patients cannot be identified. Its data have been shown to be representative of the general population, including of age, gender and ethnicity.
The study will include all children and young people aged 5 to 18 years of age who were prescribed antipsychotics between 1998 and 2019. We shall examine the medical records in QResearch for these children and young people to find out the nature of their mental health condition and its severity. We shall also include information about their other medical conditions, particularly those which could lead to diabetes.
We shall observe which antipsychotic drugs were prescribed over the study period, for how long they were prescribed, and whether these patterns changed over the time. We shall investigate whether any hospital consultations took place and what diagnoses were recorded before prescribing.
We shall then inspect the GP records to see how often children or adolescents on antipsychotics were weighed or had blood tests, and we shall describe the health monitoring of younger patients on antipsychotics by age, gender and ethnicity, and by different drugs prescribed and different mental health diagnoses. Levels of such health monitoring in patients with similar diagnoses, but not prescribed antipsychotics, will be used to show the extent of monitoring uplift for patients who were prescribed the drugs.
Chief Investigator
Dr Yana Vinogradova
Lead Applicant Organisation Name
Sponsor
University of Oxford
Location of research
University of Nottingham
Date on which research approved
28-Sep-2020
Project reference ID
OX7
Generic ethics approval reference
18/EM/0400
Are all data accessed are in anonymised form?
Yes
Brief summary of the dataset to be released (including any sensitive data)
The data will be released from EMIS GP practices and HES outpatient data. GP data will include records for children aged 5 to 18 will include: age; sex; ethnicity; deprivation; weight; blood tests; diagnoses and symptoms related to mental health problems; other diseases and prescriptions related to diabetes and weight gain problems; prescriptions for antipsychotic drugs. Linked data on hospital consultations will include diagnoses of mental health.
Implications and Impact
The results of our study will for the first time provide comprehensive and detailed information about the prescribing of antipsychotic drugs to children and adolescents, and clarify differences in treatment with respect to necessary health monitoring while patients are exposed to the drugs. The findings will identify any required improvements to clinical practice or to treatment guidelines. It will also highlight possible risks for younger antipsychotic users and stimulate further investigation into the scale of these risks.
Funding Source
NIHR Nottingham Biomedical Research Centre
Public Benefit Statement
Research Team
Dr Yana Vinogradova, University of Nottingham
Prof Julia Hippisley-Cox, University of Oxford
Prof Carol Coupland, University of Nottingham
Prof Richard Morriss, University of Nottingham
Dr Ruth Jack, University of Nottingham
Dr Rebecca Joseph, University of Nottingham
Prof Chris Hollis, University of Nottingham
Access Type
Trusted Research Environment (TRE)