A protocol to assess antipsychotics prescribing and physical health monitoring in children and young people: a cohort study using primary care data from QResearch

Abstract

Antipsychotic medicines are prescribed to children and young people (CYP) with mental health conditions such as schizophrenia, bipolar disorder, behavioural disorders, autism spectrum disorder and tics. The physical side effects of these medicines require monitoring, and this responsibility can be transferred to primary care. This study will describe the trends in antipsychotic prescribing in CYP, identify the mental health conditions, symptoms and comorbidities associated with the prescriptions, and determine the extent of physical health monitoring in primary care both for CYP prescribed antipsychotics and those with mental health conditions without antipsychotic prescriptions. The study will use data from QResearch, a large, anonymised, UK primary care electronic health record database. Records will be linked to secondary care data from hospital episode statistics and socioeconomic deprivation information. People aged 5 to 17 years, who are registered with GPs in England contributing to QResearch between 1 January 2006 and 31 July 2021 will be included. Incidence and prevalence rates will be calculated over the study period, and Poisson regression will be used to estimate incidence rate ratios. Results from this study will identify where improvements to clinical practice or to treatment guidelines may be needed.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

The study was funded by National Institute for Health and Care Research (NIHR) Nottingham Biomedical Research Centre (RC48LF).

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The project has been reviewed in accordance with the QResearch agreement with East Midlands Derby Research Ethics Committee [reference 18/EM/0400] and approved by the QResearch Scientific Committee on 23 September 2020 (N 4154 / 4129).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

To guarantee the confidentiality of patient information, only the authors will have access to the data during the study in accordance with the relevant licence agreements. Access to the QResearch data is according to the information on the QResearch website (www.qresearch.org).

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