Developing a Core Outcome Set for hospital deprescribing trials

• Research type

  Research Study

• Full title

  Developing a Core Outcome Set for hospital deprescribing trials: a modified Delphi study

• IRAS ID

  288286

• Contact name

  Debi Bhattacharya

• Contact email

  d.bhattacharya@uea.ac.uk

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  Research Summary

  The CompreHensive geriAtRician-led MEdication Review (CHARMER) NIHR PGfAR is a five year programme of work to refine and test a practitioner behaviour change intervention for deprescribing in the hospital setting. This study is the first work package and aims to develop a Core Outcome Set (COS) (standardised collection of outcomes to measure and report in trials in a specific clinical area). We will conduct three rounds of online questionnaires decide which outcomes are the most important to measure in a trial. We will then convene an online workshop to understand how the COS may be operationalised within a trial. We will include participants from four stakeholder groups.

  1. Patients and informal family carers
  2. Healthcare practitioners caring for older people in hospital
  3. Hospital clinical managers
  4. Academic researchers with an interest in older people’s medicine and/or deprescribing

  We will seek a minimum of 160 respondents to the round 1 Delphi questionnaire. We will recruit English acute NHS hospitals via the Clinical Research Network (CRN) in order to recruit stakeholder groups 1-3 via a nominated gatekeeper. We anticipate recruiting between 20-30 hospitals, each providing one representative from stakeholder groups 1-3. Recruitment of stakeholder group 4 will be via a gatekeeper of academic networks associated with the research team.

  Participants will be invited via their gatekeepers who will provide a participant information sheet (PIS) which will include a link to an online survey platform. Participants will be asked to rate the importance of a range of outcomes that could be used to measure effectiveness of a deprescribing intervention. The three Delphi rounds will take place over 3 to 4 months.

  The aforementioned PIS will also invite participants to express an interest in participating in a post-Delphi questionnaire online 90-minute workshop to discuss implementation of the COS in a future trial.

  Summary of Results

  Why we did this research As we get older, our bodies are less able to handle some medicines. Medicines that were once effective and safe may not have as much benefit and may have an increased chance of causing harm. In our previous research we asked older people and their carers about their thoughts on stopping these medicines. They told us that they would like these medicines reviewed by doctors in hospital during their stay and for those no longer needed or that could cause harm to be stopped. This is called ‘proactive deprescribing’ and is different to stopping a medicine after harm has occurred.

  Currently medicines that are no longer needed or may cause more harm than good are not routinely reviewed or stopped during hospital admissions. The CHARMER (CompreHensive geriAtRician led MEdication Review) study will develop and test a way to support geriatricians (consultants working on older people’s medicine wards) and hospital pharmacists to proactively deprescribe for older people whilst they are in hospital. The research team has already explored the reasons why geriatricians and hospital pharmacists do not proactively deprescribe for older people. They used what they learned to develop methods to support and encourage proactive deprescribing.

  In order for us to test whether these methods work, we first needed to find out what we should look at in our research trial. We wanted to develop a list of the most important outcomes that should be measured in research trials of proactive deprescribing for older people in hospital. These outcomes could then be used in our trial and any other research trials that want to test methods for hospital proactive deprescribing for older people. In this way the results of our trial and others can be compared. This set of outcomes is called a Core Outcome Set and is usually between 5-12 outcomes.

  What we did
  We first reviewed published research to identify outcomes previously used by researchers to measure their results in similar trials (such as undertaking reviews of medicines) and identified other outcomes we felt could be relevant to hospital proactive deprescribing. This gave us 109 outcomes. We removed overlapping outcomes and those outcomes only related to specific medicines, because the CHARMER intervention is designed to increase proactive deprescribing of any medicine that is inappropriate. This left us with 49 potentially relevant outcomes.

  To reach agreement about the most important outcomes to measure in hospital proactive deprescribing trials we used a recognised method to find out what the people most likely to be affected by a proactive deprescribing trial thought of these outcomes. We identified and contacted four groups of people:
  • older people (who were taking at least 5 medicines) and their carers
  • clinicians involved in the care of older people in hospital (including geriatricians, pharmacists, occupational therapists, physiotherapists, nurses)
  • hospital managers and,
  • researchers with an interest in older people’s medicine or deprescribing

  In total 212 people contributed to this study.
  This involved two rounds of surveys followed by two online workshops, with fewer people involved at each stage. Contributors were asked to rate the importance of each outcome and we used their ratings at each stage to determine the outcomes that went forward to the next stage. This process reduced the number of outcomes to just six outcomes that were considered the most important to include in the Core Outcome Set and were able to be measured satisfactorily in hospitals.

  What we found
  The six outcomes in the Core Outcome Set that should be measured in all research trials looking at proactive deprescribing for older people in hospital under the care of a geriatrician are:
  • Quality of life (a person’s thoughts and feelings about how their current health impacts their daily life)
  • Number of prescribed medicines that are stopped
  • Number of prescribed medicines with dosage reduced
  • Number of hospital stays
  • Adverse drug events (an event when a medicine someone is taking causes harm, including effects when someone is stopping a medicine)
  • Death

  Next steps
  We will publish this work in a research journal and present our findings at a conference so that other people working in this research area know about the Core Outcome Set.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  20/SC/0375

• Date of REC Opinion

  28 Sep 2020

• REC opinion

  Favourable Opinion