News

What Do We Know About Implementation Fidelity?

Rebecca Barnes, Catherine Jameson and colleagues at the University of Bristol are working on a new systematic review funded by the NIHR School for Primary Care Research that will map current methods for evaluating implementation fidelity in primary care trials. It will also assess the evidence for these methods.

This fits well with Trial Forge’s approach of identifying knowledge gaps and suggesting methodological studies to fill the gaps.

Primary care is vulnerable to implementation fidelity problems. Primary care trials often use cluster designs and complex interventions involving multiple providers and fidelity is often not evaluated.

The Bristol team is working with patients, research-active primary care staff, and researchers with experience of primary care trials for the review. If you are a trialist or researcher with experience of assessing fidelity in the context of primary care, and are happy to share your experiences, please do get in touch. We hope the findings will highlight evidence gaps and inform best practice for the evaluation of implementation fidelity in the design and delivery of future primary care trials.

The review team are Dr Rebecca Barnes (PI), Dr Alyson Huntley, Dr Alison Heawood, Dr Athene Lane, Ms Cindy Mann and Dr Catherine Jameson.

Contact: Rebecca.Barnes@bristol.ac.uk or Catherine.Jameson@bristol.ac.uk

Prioritising Recruitment Research
Randomised trials are extremely important but recruiting participants can be extremely hard. High quality evidence to make recruitment less of a challenge is thin on the ground, which is odd given how central successful recruitment is to trials.

The PRIORITY (Prioritising recruitment in randomised trials) project aims to collect a wide range of views on what the most important research questions are in trial recruitment. A survey is now open across Ireland and the UK, giving everyone the chance to submit their questions about recruitment to randomised controlled trials.

The process is very similar to a James Lind Alliance (JLA; http://www.jla.nihr.ac.uk) priority setting process, unsurprising since JLA is one of the partners behind the recruitment survey. Trial Forge is also involved. Once we have collected enough answers to the survey, we will begin a process of putting them in order of priority for future research. The end result will be a “Top 10” list of priorities for future research into the way people join trials, all or some of which we will promote through Trial Forge.

The survey is at http://priorityresearch.ie/survey/

More information about the PRIORITY project is at https://www.hrb-tmrn.ie/priority-prioritising-recruitment-in-randomised-trials/

Putting Research Methodology Into Practice
We’ve just got funding from the Chief Scientist Office (CSO) of Scotland to find out what sort of evidence researchers need to design effective trial recruitment strategies and how that evidence should be presented to them. This will make it easier for researchers to design evidence-based recruitment strategies and highlight what sort of evidence future research should provide.

Randomised trials are central to evidence-based health but how we design and run them is far from evidence-based. Many design and process decisions are made without evidence to support them, either because evidence does not exist, or because it is not available in a useful form. The problem is nowhere better illustrated than trial recruitment, where evidence of benefit exists for just a handful of techniques. How this evidence is presented takes no account of what users actually need when designing their recruitment strategies.

Our new work involves speaking to trial teams across the UK, and a few in other countries, to hear how they develop their recruitment strategies now, what types of information they find useful and what would be the most effective way of presenting research information about recruitment to them. The work starts on 1st July 2016 and is part of Heidi Gardner’s (@heidirgardner) PhD – ‘Making clinical trials more efficient: consolidating, communicating and improving knowledge of participant recruitment interventions’.

We have a Trial Forge PhD opportunity through the University of Aberdeen’s Elphinstone Scholarships. Trial Forge aims to improve the efficiency of randomised trials, particularly by reducing gaps in research evidence related to efficient ways of designing, running, analysing and reporting trials.

The exact focus of the work will depend on the skills and interests of the student but topics that could be covered include:

developing effective participant recruitment strategies;
effective training of trial staff;
improving retention of trial participants;
reducing the burden of data collection;
reducing the impact of protocol changes; and,
auto-updating of systematic reviews.
More details are at http://www.abdn.ac.uk/clsm/graduate/research-areas/applied-health-sciences.php

Deadline is 31st May 2016.

RETENTION IS IN THE TOP 3 OF TRIALISTS’ WORRIES.
York Trials Unit is leading a Study Within a Trial (SWAT) of an embedded RCT comparing two types of text messaging to improve response rates to postal questionnaire follow-up of patients in a RCT.

York’s previous SWATs of text messaging have found a modest effect. They now wish to see if personalising the message improves effectiveness and are looking for trials to work with. We want to test this intervention in a wide range of trials and participant groups and collate the results through Trial Forge. The results would then go into the Cochrane review of interventions to improve recruitment (http://bit.ly/1Q7NPuA).

The registration will soon be on the SWAT database (http://bit.ly/20ZqazA).

It you’d like to join this evaluation, email Adwoa Hughes-Morley at the York Trials Unit (adwoa.hughes-