A resource toolkit for ID RCTs
We hope you enjoy this toolkit and find it a useful resource. The Toolkit has been developed as a result of a three year PhD study exploring the methodological and practical challenges and barriers inherent in conducting Randomised Controlled Trials (RCTs) with adults with intellectual disabilities (ID). The content of the toolkit is a mixture of the findings of the PhD combined with contributions from a large group of international experts in ID RCTs. The range of barriers and challenges highlighted in the 'Challenges and Barriers' section represents a consensus among these experts about what they consider to be the most important barriers and challenges that you may face when embarking on an ID RCT. Being aware of these challenges in advance may save you considerable time, effort and costs. These experts however, would be the first to stress that with creativity and flexibility, many of these challenges can be overcome.
Who is this toolkit for?
The toolkit is a useful resource for you if you are:
A researcher in the ID field and are interested in conducting an RCT
A researcher, planning on conducting an RCT and want to include people with ID in your trial
A member of an ethics committee and wish to gain a greater insight into the practicalities of conducting an ID-RCT
A member of a funding body review panel and wish to gain a greater insight into the practicalities of conducting an ID-RCT
How to use this toolkit
The toolkit provides a range of resources and information in an easy to navigate website. The main sections of the website are found in the navigation bar at the top right hand corner of the screen .
The TOOLKIT DEVELOPMENT page describes the process that led to the development of this toolkit.
The CHALLENGES AND BARRIERS page presents a series of challenges and barriers that you may face along 11 various stages of planning and conducting an RCT.
The RESOURCES page introduces a series of strategies and resources to help you face the challenges and barriers highlighted in the toolkit. Toolkit users are also encouraged to contribute towards the content of the toolkit by either sharing challenges and/or contributing resources (example leaflets, consent forms etc).
A ‘LIVING DOCUMENT’ - the toolkit is a living document and should be seen as a ‘community resource’. Its continued success will be influenced by contributions within the research community.
What is an Intellectual Disability?
'Intellectual Disability' is a term used to describe literally hundreds of different disorders, many of which may have a genetic, medical or psycho-social cause. Despite the wide range of causes, the range of disabilities all share common challenges or limitations in both intellectual functioning (cognitive reasoning, learning, problem solving etc) and in adaptive behavior (which may include communication, social skills, self-care etc). These difficulties become apparent before the age of 18……
What is a Randomised Controlled Trial?
Randomised Controlled Trials (RCTs) are often referred to as the 'gold standard' in evaluating interventions, treatments or services. "This is in part because RCTs offer levels of rigour that many other methodologies lack. The three central principles of the RCT methodology are Randomisation, Control and Trial or testing of an intervention"
Randomisation
A sample that is representative of the population being studied is randomly assigned to either a Treatment Group or a Control Group. It is proposed that this process of randomisation negates any possible influence of factors outside of the study design and the treatment of interest.
Control
Measures are taken to reduce the potential influence of outside variables, to isolate and examine the effect of the intervention under investigation.
CLICK ON IMAGE TO ENLARGE
Trial
A treatment or intervention is tested within a specified framework to assess its effectiveness and/or efficiency. This requires a well-defined, and adhered to, protocol; the use of appropriate outcome measures; and the use of appropriate statistical methods.
Proponents of RCTs believe that it is the ability to reduce outside influences and isolate the effects of the intervention under study that allows RCTs to assess the effectiveness of an intervention with the greatest of accuracy. Although not everyone agrees that RCTs are the most useful methodology for testing effectiveness, they are certainly the most influential methodology currently. For further reading see Mulhall et al. (2018) in the resource section.
Why are RCTs so important?
The past 30 years has seen more and more people with ID living in community housing rather than living in institutions. We know that people with ID are prone to higher rates of ill-health, they typically die much earlier than non-disabled people, and they are at higher risk of having multiple health problems at the same time. Because of these health problems, people with ID have a much higher chance of taking prescribed medications. There is evidence to suggest that many of these ill-health problems, and early deaths, are amenable to appropriate health interventions, and thus are largely avoidable. Unfortunately however, it is becoming increasing recognised that there is actually very evidence that many of the medications and interventions provided to people with ID are safe or effective. This is partly because people with ID are routinely excluded from clinical trials, and partly because trials specifically for people with ID are not common.
If we are to start to address the health inequalities experienced by people with ID, then we need to develop a robust evidence-base that helps clinical staff decide upon the best, safest and most effective interventions currently available.
“Useful Quotes are always useful”