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Medication optimisation in severe mental illness (MEDIATE): protocol for a realist review
  1. Ian Maidment1,
  2. Geoff Wong2,
  3. Claire Duddy2,
  4. Rachel Upthegrove3,
  5. Sherifat Oduola4,
  6. Katherine Allen5,
  7. Simon Jacklin6,
  8. Jo Howe1,
  9. Maura MacPhee7
  1. 1College of Health and Life Sciences, Aston University, Birmingham, UK
  2. 2Nuffield Department of Primary Care Health Sciences, Oxford University, Oxford, UK
  3. 3Department of Psychiatry, School of Psychology and College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
  4. 4Health Service Population Research, University of East Anglia, Norwich, UK
  5. 5Birmingham and Solihull Mental Health NHS Foundation Trust, Birmingham, Birmingham, UK
  6. 6School of Pharmacy and Bioengineering, Keele University, Keele, UK
  7. 7School of Nursing, The University of British Columbia, Vancouver, British Columbia, Canada
  1. Correspondence to Dr Ian Maidment; i.maidment{at}


Introduction Severe mental illness (SMI) is associated with significant morbidity and mortality. People living with SMI often receive complex medication regimens. Optimising these regimens can be challenging. Non-adherence is common and addressing it requires a collaborative approach to decision making. MEDIATE uses a realist approach with extensive engagement with experts-by-experience to make sense of the complexities and identify potential solutions.

Realist research is used to unpack and explain complexity using programme theory/theories that contain causal explanations of outcomes, expressed as context–mechanism–outcome–configurations. The programme theory/theories will enable MEDIATE to address its aim of understanding what works, for whom, in what circumstances, to optimise medication use with people living with SMI.

Method and analysis MEDIATE will be conducted over six stages. In stage 1, we will collaborate with our service user/family carer lived experience group (LEG) and practitioner stakeholder group (SG), to determine the focus. In stage 2, we will develop initial programme theories for what needs to be done, by whom, how and why, and in what contexts to optimise medication use. In stage 3, we will develop and run searches to identify secondary data to refine our initial programme theories.

Stage 4 involves selection and appraisal: documents will be screened by title, abstract/keywords and full text against inclusion and exclusion criteria. In stage 5, relevant data will extracted, recorded and coded. Data will be analysed using a realist logic with input from the LEG and SG. Finally, in stage 6, refined programme theories will be developed, identifying causal explanations for key outcomes and the strategies required to change contexts to trigger the key mechanisms that produce these outcomes.

Ethics and dissemination Primary data will not be collected, and therefore, ethical approval is not required. MEDIATE will be disseminated via publications, conferences and form the basis for future grant applications.

PROSPERO registration number CRD42021280980.

  • adult psychiatry
  • qualitative research
  • therapeutics

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  • Contributors IM is the guarantor of the review and lead investigator on MEDIATE. IM, GW, MM and CD contributed equally to designing the review and drafting the methodological details of MEDIATE. KA advised on the PPI aspects of MEDIATE. RU, SO, MM, GW and SJ contributed to the design of MEDIATE participated in study design and knowledge translation. SO, RU, MM and GW on key clinical aspects and SJ on decision-making processes. All authors contributed to drafting the protocol, have read and approved the final manuscript. We acknowledge the contribution of service user advisors via the BSMHFT Lived Experience Action Research (LEAR) group and SURESEARCH Mental Health Network.

  • Funding This study/project is funded by the National Institute for Health Research (NIHR; Programme Development Grant: 203683).

  • Disclaimer The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

  • Competing interests GW is deputy chair of the UK’s National Institute of Health Research Health Technology Assessment Prioritisation Committee: Integrated Community Health and Social Care Panel (A) and a member of Methods Group (A).

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

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