This toolkit has been developed as part of a larger, three year PhD project that explored the practical and methodological challenges that may be faced when conducting randomised controlled trials with adults with intellectual disabilities. The study was undertaken by Peter Mulhall, was supervised by Dr Laurence Taggart, Dr Toni McAloon & Prof Vivien Coates, and was hosted through the Centre for Intellectual and Developmental Disorders (CIDD) at the Ulster University. The overall project had four phases, the last of which was the development of this toolkit.
The whole project could not have been possible without the generosity of a great number of ID researchers who gave their time and contributed their experiences throughout the course of this project. Our hope is that the content of the toolkit continues to grow and people share more insights, experiences and resources through the toolkit.
Phase 1:
The first stage in the development of the toolkit was a review of the literature concerning conducting randomised controlled trials with people with intellectual disabilities (ID). We initially reviewed barriers and challenges in conducting general research with people with ID, and then began to focus on conducting randomised controlled trials.
Phase 2:
The second phase of this study entailed conducting a systematic review of the RCTs that had been conducted with adult participants, across the world, and reported from the years 2000 to 2017. When conducting the systematic review, we had anticipated a number of challenges but they were not being reported in the trials reports. This made us wonder if there may be other barriers or challenges that were not being reported in trials reports. This question led us to phase 2.
Phase 3:
In phase three, a series of one-to-one interviews were conducted with twelve international ID RCT researchers. During the interviews we explored the real-life experiences of the researchers when they had been conducting ID RCTs. We found a number of practical and methodological barriers and challenges that had not often been reported previously in the trials literature.
Feedback during the PhD study overwhelmingly suggested that a resource toolkit for researchers interested in conducting ID RCTs, or who were conducting mainstream trials and wanted to include people with ID, would be a useful thing. The systematic review and the interviews were highlighting a large number of wide-ranging issues. We needed to know which issues (barriers and challenges) were the most important to include in the toolkit. Thus, we needed to gain a consensus from a wider pool of international experts in the field - people who had 'real life' experience of conducting these trial and who had valuable 'real-life' knowledge to share.
A report detailing the interviews study and its findings can be found HERE.
Phase 4:
In phase 4 we conducted a survey of some of the world's leading experts in the field of ID RCTs. We used a technique called a Delphi Survey. With this technique the experts get to contribute their insights into the content of the survey and then collectively they agree on the relative importance of each of the survey items.
In the first round of the survey each of the experts were asked an open-ended question about what they thought were the main barriers and challenges that they had experienced and that they thought would be important to include in a toolkit. Their contributions were added to those identified in the earlier systematic review and interviews, to create a list of 79 barriers and challenges. In the second round of the survey, they were asked to rate how important it was for each of the 79 items to be included in the toolkit. If more than 70% of the panel of experts rated an item as being "important" or "very important" then the item was added to the toolkit. Those items which did not achieve a high enough level of agreement were presented for reconsideration again in a third round. After round three, a total of 64 barriers were agreed upon. A further 6 barriers did not reach the required 70% agreement level however, a number of the experts were consistent in their opinion that these six items were important and so have been added as cautionary notes.
A report detailing the Delphi Survey and its findings can be found HERE.
Just the beginning....
It is our hope that the development of this toolkit continues as more people make use of it, and contribute towards it's content. We have included the ability for researchers to share resources (information leaflets, consent forms, links to published papers etc) in the Resources page.
Sharing the 'experience-base'
The field of Intellectual Disability research is very good at sharing the outcomes from it's research ('Evidence-Base) but it could develop further in its sharing of 'real-life' experiences of conducting research ('Experience-Base'). Hopefully this toolkit presents an opportunity for ID researchers, and the research community at large, to begin to address this shortfall in sharing.
If you have any feedback about this toolkit, any topics you would like added or any resources that you would like to share with the community then visit our contact page.
Acknowledgement: Funding for the PhD project was generously provided by the Department of Education & Learning for Northern Ireland (DELNI).