Core Outcome Set for Medication Adherence Trials

• Research type

  Research Study

• Full title

  Developing a Core Outcome Set for trials evaluating medication adherence interventions: a modified Delphi study

• IRAS ID

  313087

• Contact name

  Debi Bhattacharya

• Contact email

  d.bhattacharya@leicester.ac.uk

• Sponsor organisation

  University of Leicester

• Duration of Study in the UK

  0 years, 9 months, 31 days

• Research summary

  One in two patients do not adhere to prescribed medication directions. This non-adherence has been identified by the World Health Organisation as an international priority as it presents a significant public health challenge that causes avoidable mortality and morbidity, and resource utilisation.
  Numerous strategies have been designed to address non-adherence and trials conducted to test their effects. There is, however, no agreed list of outcomes that should be measured in these trials resulting in large variation in the outcomes reported. This means that we are unable to easily compare the findings from different trials or combine them to provide higher quality evidence. This study aims to develop an agreed list of outcomes that should be measured in all adherence trials - this is called a Core Outcome Set.
  We will develop the Core Outcome Set by looking at previous trials related to medication adherence to create a list of all of the different measures that might be relevant to an adherence trial. We will narrow down this long list into those most important to measure using two rounds of online questionnaires with representatives of five stakeholder groups:
  1. Patients
  2. Informal carers
  3. Healthcare practitioners whose role includes medicines management including general practitioners, clinical pharmacists, nurses and other practice staff such as allied health professionals.
  4. Primary care managers (e.g., medicines management lead and practice leads or managers)
  5. Academic researchers with an interest in medication adherence

  We will then convene an online workshop to agree on the most important outcomes to measure and understand the practicalities or how we might measure them in a trial.

• REC name

  London - Camberwell St Giles Research Ethics Committee

• REC reference

  22/PR/0449

• Date of REC Opinion

  6 May 2022

• REC opinion

  Further Information Favourable Opinion