Background
Consensus on what outcomes should be included in trials of psychological therapies on acute psychiatric inpatient wards is currently lacking. Inclusion of different viewpoints, including service user perspectives, is crucial in ensuring that future trials measure outcomes which are meaningful and important. Development of a Core Outcome Set (COS), a minimum standardised set of outcomes to be measured and reported, would help improve synthesis and interpretation of clinical trial data in this area.
Methods
Stage 1 of the COS development involved compiling a comprehensive long-list of outcomes from key sources including i) a systematic review of outcomes from published trials, ii) online survey of key stakeholders (service users, carers, healthcare professionals, researchers, and end users of research), iii) qualitative interviews with service users and carers. Stage 2 involved stakeholder groups short-listing the outcomes using consensus methods (e-Delphi survey). The final outcome set was derived from the short-list at a consensus meeting of stakeholders, facilitated by an Independent Chair.
Results
A long-list of 68 outcomes was compiled from the systematic review (n?=?30 trials), online stakeholder survey (n?=?100 participants) and qualitative interviews (n?=?15 participants). Fifty stakeholders took part in the e-Delphi study, where the long-list was cut down to a short-list of 12 outcomes over 2 rounds. Nine stakeholders took part in the final consensus meeting, and after some outcomes were removed and/or amalgamated, a final set of 6 outcomes was recommended for inclusion in the COS. These were Ability to Cope, Hopefulness, Quality of Life, Psychosis Symptoms, Mood, and Self-Harm Behaviours.
Conclusions
Widespread future adoption of the COS will reduce research waste by ensuring that outcomes are more easily comparable across trials, and that the full range of stakeholder priorities are represented in trial outcomes. This makes it more likely that effective therapies will be identified in a timely fashion and successfully implemented in routine clinical practice. The final 6-outcome COS should be feasible to implement given the need keep participant burden to a minimum in inpatient trials. Further work is needed to make recommendations for the best outcome measurement instruments to use, including the use of patient-reported outcomes alongside clinician-rated measures.
Pamela Jacobsen, Katherine Berry, Lucy Clarkson, Rebecca Hiscocks, India Hopkins, Ceri Morgan, Dhaarna Tandon, Ashley-Louise Teale, Natasha Tyler & Lisa Wood
Disease Category: Mental health
Disease Name: Acute mental health
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Psychological & behavioural
- Charities
- Consumers (caregivers)
- Consumers (patients)
- Families
- Policy makers
- Researchers
- Service commissioners
- Service providers
- Service users
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Literature review
- Survey
- Systematic review
This mixed methods study will follow standard methodology for developing a Core Outcome Set (COS), as set out in the COMET Handbook (Williamson et al., 2017) and the Core Outcome Set-STAndards for Development (COS-STAD) (Kirkham et al., 2017).
The three stages to the COS development include:
1. To conduct a systematic review of existing literature and consult with key stakeholders, using an online survey and semi-structured interviews, to develop a long list of possible outcomes.
2. To use Delphi methodology to generate consensus and refine the longlist into a shortlist of outcomes.
3. To finalise the outcome list at a consensus meeting.
To include all ‘experts’ and ensure everyone has equal contribution, the population will include service users, informal carers, healthcare professionals, researchers/trialists, and end users of research.
All key stakeholders will be consulted via an online survey (approximately 15 minutes) and a small sample of service users/informal carers will complete semi-structured interviews (approximately 30-60 minutes). Following this, Delphi methodology will be used to generate consensus and refine the longlist into a shortlist of outcomes. This will involve two surveys (approximately 30 minutes in total). The outcome list will be finalised at a consensus meeting (30-60 minutes).