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Common infections, mental health problems and healthcare use in people with inflammatory bowel disease: a cohort study protocol
  1. Peter Irving1,2,
  2. Kevin Barrett3,
  3. Daniel Tang4,
  4. Monica Nijher4,
  5. Simon de Lusignan5,6
  1. 1Department of Gastroenterology, Guy's and Saint Thomas' NHS Foundation Trust, London, UK
  2. 2School of Immunology and Microbial Sciences, King's College London, London, UK
  3. 3New Road Surgery, Croxley Green, Hertfordshire, UK
  4. 4Pfizer Ltd, Tadworth, UK
  5. 5Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
  6. 6Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC), London, United Kingdom
  1. Correspondence to Professor Simon de Lusignan, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; simon.delusignan{at}phc.ox.ac.uk

Abstract

Introduction People with inflammatory bowel disease (IBD) are at increased risk of pneumonia and herpes zoster, yet other common infection types have not been explored. Anxiety and depression are more prevalent in IBD; however, the impact of these conditions on primary care healthcare use in IBD is not known.

Methods and analysis We will perform two retrospective studies using a large English population-based primary care cohort to compare the following outcomes in people with IBD and matched controls: incident infections (Study 1) and prevalent mental health problems and healthcare use, overall and in those with and without mental health problems (Study 2). All adults registered with general practices contributing to Royal College of General Practitioners Research and Surveillance Centre database between 1 January 2014 and 1 January 2019 are eligible. Infection outcomes comprise the incidence of common infections (upper respiratory tract infections, pneumonia, acute bronchitis, influenza and influenza-like illnesses, skin infections, herpes simplex and herpes zoster infections, genital infections, urinary tract infections and gastrointestinal infections) and any viral infection. Mental health and healthcare use outcomes are: prevalence of depressive episodes; anxiety episodes; recurrent depression; rates of primary care and emergency secondary care visits; primary-care issued sick notes (reflecting time off work). Analyses will be adjusted for sociodemographic factors recorded in the primary care record.

Discussion These studies will quantify the infection risk in IBD, the excess burden of anxiety and depression in a population-based IBD cohort, and the impact of mental health conditions on healthcare use and time off work. Greater understanding and awareness of infection risk and common mental health issues will benefit people with IBD and healthcare practitioners and will guide policy makers as allocation of resource may be guided by the real-world information produced by these studies.

Trial registration number NCT03836612.

  • depression & mood disorders
  • anxiety disorders
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Footnotes

  • Contributors All authors made substantial contributions. KB, PI, DT, MN and SdL designed the study, performed the data interpretation, supervised the writing of the statistical analysis and writing of the manuscript and performed a critical revision of the manuscript for important intellectual content. All authors have read and approved the final manuscript.

  • Funding This study was sponsored by Pfizer.

  • Competing interests This study is funded by Pfizer Ltd. KB has received honoraria from Tillots, Thermo Fisher Scientific, Boeringer Ingelheim, Pfizer and Yakult. PI has received lecture fees from AbbVie, Celgene, Falk Pharma, Ferring, MSD, Janssen, Pfizer, Takeda, Tillotts, Sapphire Medical, Sandoz, Shire and Warner Chilcott; financial support for research from MSD, Pfizer and Takeda; advisory fees from AbbVie, Arena, Genentech, Gilead, Hospira, Janssen, Lilly, MSD, Pfizer, Pharmacosmos, Prometheus, Roche, Sandoz, Samsung Bioepis, Takeda, Topivert, VH2, Vifor Pharma, and Warner Chilcott. DT and MN are employees of Pfizer. SdL is Director of RCGP RSC, and he had received funding for projects from Eli Lilly, Astra Zeneca, GSK, Seqirus and Takeda—all through his Universities and none related to this study.

  • Patient consent for publication Not required.

  • Ethics approval Study approval has been granted by the RCGP RSC Study Approvals Committee. The study does not meet the requirements for formal ethics board review as defined using the National Health Service (NHS) Health Research Authority research decision tool (http://www.hra-decisiontools.org.uk/research/). The planned studies are observational studies using the anonymised, routinely collected, data of primary care patients in the UK. This means there is no randomisation and there is no change to treatment or patient care as part of this study. As such explicit written or verbal consent is not required. All primary care practices providing data display messages to their patients informing them that their anonymised data may be used for observational research studies. All patients registered with participating centres are provided with the option to opt out of data sharing for this purpose. Data from patients choosing to opt out of data sharing are not analysed. All patient data are pseudonymised at the point of data extraction for the participating practices. Prior to inclusion in the planned studies data will be fully anonymised by the data custodian so no patient identifiable data will be available to researchers.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data may be obtained from a third party and are not publicly available. The RCGP RSC dataset is held securely at Oxford University and the University of Surrey and can be accessed by bone fide researchers. Approval is on a project-by-project basis (www.rcgp.org.uk/rsc). Ethical approval by an NHS Research Ethics Committee may be needed before any data release/other appropriate approval. Researchers wishing to directly analyse the patient-level pseudonymised data will be required to complete information governance training and work on the data from university secure servers. Patient-level data cannot be taken out of the secure network.

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