Adverse Drug Event Screening Tool

• Research type

  Research Study

• Full title

  Development and field testing of an Adverse Drug Event Screening Tool (ADE-ST)

• IRAS ID

  202683

• Contact name

  Tobias Dreischulte

• Contact email

  t.dreischulte@dundee.ac.uk

• Sponsor organisation

  NHS Tayside

• Duration of Study in the UK

  2 years, 0 months, 2 days

• Research summary

  BACKGROUND
  Drug therapy plays a major role in the management of many chronic conditions, but it is also a cause of common and severe harm. Early recognition and timely management of ADEs (Adverse Drug Event(s))is crucial, order to reduce drug-related harm and treatment failure, and is an integral part of pharmaceutical care. Routine ADE assessment at scale can also substantially add to our knowledge about post-marketing medication safety. We have developed an Adverse Drug Event Screening Tool (ADE-ST) comprising of a symptom checklist to be self-completed by patients and a follow up questionnaire to be jointly completed by patients and health care professionals.

  AIMS
  The aim of this project are (1) to optimise the design of ADE-ST, (2) to compare its performance in detecting ADEs to unstructured ADE assessment and (3) to evaluate the test-retest reliability of ADE_ST

  DESIGN
  STUDY 1: Iterative optimisation of a pilot version of ADE-ST will be achieved by recruiting up to 20 adult inpatients receiving drug treatment for diabetes or respiratory disease, who will complete the questionnaire under observation by researchers. Patients will be subjected to debriefing interviews, which will inform further optimisation of ADE-ST.
  
  STUDY 2: Up to 100 adult inpatients receiving drug treatment for diabetes or respiratory disease will be subjected to two ADE screening strategies in the following order: (A) An open ended question regarding the presence of ADEs and (B) self-completion of ADE_ST. The study is powered to detect a ≥10% difference in the ADE detection rate of (A) versus (B).

  STUDY 3: Up to 100 adult inpatients receiving drug treatment for diabetes or respiratory disease participating in study 2 will repeat ADE-ST assessment two weeks after the initial assessment. Test-retest reliability will be determined by comparison of findings at time 2 versus time 1.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  16/YH/0136

• Date of REC Opinion

  4 Apr 2016

• REC opinion

  Favourable Opinion