PRECIS-2: Precisely how can this tool help investigators design trials to achieve practical answers to 'real-world' questions?

Target audience:
Anybody in the trial team involved in designing randomisedcontrolled trials: people new to clinical trial design and those who are experienced. This includes primary investigators, trial managers, Statisticians, research nurses, doctors and therapists. The PRECIS-2 tool can be used as a way of talking to each other about testing an intervention through designing a pragmatic trial.

Learning objectives:
Explore what PRECIS-2 is and how it is being used through presentations and an interactive session in which participants try out the tool.

Designing clinical trials is challenging and there is a risk that trial-design decisions such as the choice of outcome, eligibility criteria or comparator could render the trial irrelevant to its intended users. The PRECIS-2 tool: Designing trials that are fit for purpose was published in the BMJ 2015 and describes a tool to help clinical trial designers think more carefully about the impact their design decisions have on the applicability of the trial results. The PRECIS-2 tool is being increasingly cited, is being used by the National Institute of Health (USA) to assess proposed trial designs, is named by the UK’s National Institute of Health Research as one of eight 'useful papers' for trialists and is recommended by the Irish Health Review Board to support grant applications. The PRECIS-2 tool was developed and validated together with over 80 international trialists, clinicians and policy makers.

This interactive workshop will introduce the key design domains that need to be considered to ensure that a trial is relevant to those you hope will use its results. We will then describe how the tool can facilitate decision making and conversations among investigators and other stakeholders, and small group work will give workshop participants the opportunity for hands-on experience of applying the tool to a trial. Current projects using the PRECIS-2 tool will be used to illustrate different applications of PRECIS-2 and highlight how it can be applied to a wide range of trials. The workshop facilitators will lead an interactive discussion of how workshop participants could use the tool in their own trial design work, including how to handle challenges such as cluster designs and trials with multiple arms. The possible uses of the tool in future pragmatic and comparative effectiveness trial research will also be discussed.

This workshop will give participants a chance to expand their understanding of the different design considerations for pragmatic and explanatory trials, understand the consequences of design decisions on applicability as well as explore how the tool may be applied prospectively in designing trials. The structure of the workshop will be as follows:

Pragmatic trials – Lara Fairall (10/20 mins).
Introduction to the PRECIS-2 tool and the domains (Kirsty) – (30 mins) including work in pilot and feasibility trials and at the Primary Care Trials Unit (PCTU) London using PRECIS-2 in cluster randomisation at 2 levels/ multi-level trials.

Coffee break

Group exercise
- Introduce example. Brief explanation of what we are doing (10 mins).
- Materials: Handouts with PRECIS-2 information sheet for everyone (BMJ table with all domains) plus information on our example trial.
- Small group work: We will divide participants into small groups of around 6-8 people. Each group will be asked to prioritise 3 PRECIS-2 domains (e.g. Eligibility, and recruitment and setting) for the trial example and asked to look at other domains if they have time. All domains will therefore be covered by the workshop group without being rushed. Workshop facilitators will move between groups to help the discussion as needed (20 mins).
- Feedback from each group – A representative of each group will feedback on how the group scored each domain: what they used to reach this score, difficulties they had, things they would like to discuss with facilitators and other participants, strengths and weaknesses of the tool. Other groups will be invited to comment (30 mins).

Open discussion (30 mins) on the PRECIS-2 tool to close the workshop.

Discuss participants’ experience and ideas for use of tool.
Final comments from the workshop facilitators.

This workshop is being hosted by the Knowledge Translation Unit, Cape Town Lung Institute. Refreshments are being sponsored by the South African Medical Research Council.

Venue: Lung Institute, George Street, Mowbray http://lunginstitute.co.za/