Challenges & Barriers along the RCT Pathway
Randomised Controlled Trials are often used to test complex interventions. Although fundamentally straightforward, the practicalities of conducting an RCT can become increasingly complex when including people with intellectual or communication disabilities. Some of the challenges and barriers, which add to the complexity, are common to many RCTs and some are more specific to RCTs with participants who have disabilities. This image shows the core components of an RCT, some of the common challenges and barriers when conducting ID-RCTs and some use strategies for addressing these barriers. For a more detailed discussion see the various sections below the image.
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Each Randomised Controlled Trial will produce its own unique challenges. Despite these uniquenesses, all RCTs have some common stages. Below are 11 sections along the RCT pathway, from concept to completion. This list is not exhaustive and these stages may not manifest in all trials. A cautionary note, a pool of international ID RCT experts contributed to the list of barriers and challenges presented below. They believe that these are some of the most important challenges for you to be made aware off. There is no suggestion that you will definitely face each of these challenges. However, it is our hope that being aware of these challenges and knowing some useful strategies to over come them, will help you plan, conduct, and report upon more robust clinical trials.
Planning
- Planning an ID trial may take longer due to the additional needs of the participants, and the need to make reasonable adjustments to programs and resources.
recruitment
- The majority of ID-trials are not permitted to recruit directly to people with ID, and must go through a series of ‘gatekeepers’.
co-participant factors
- People with ID often rely on a number of people for their participation in a trial, therefore burden on participants can have an exponential impact on a carers, staff or family.
outcome measures
- Many outcome measures do not have reliability and validity in the ID populations.
Funding
- Because of the need for multi-site studies and reasonable adjustments, some funders may not see ID-RCTs as cost effective.
Population factors
- People with ID often have a range of co-morbidities, this can be a challenge during recruitment and can be a source of bias during data collection.
protocol fidelity
- Maintaining good study compliance can be a challenge in an ID trial.
- It can be challenging to ensure that caregivers follow the intervention protocol.
attitudes & perceptions
- There is a lack of recognition of the health inequalities faced by people with ID and this can pose a challenge at all stages of the research process.
Ethics & Consent
- Getting informed consent in an ID trial is more challenging than with a non-disabled trial.
systems & agency factors
- Services can be multi-layered and each layer can either be a facilitator or a barrier to recruitment, retention and data collection.
technical understanding
- Explaining the need for a control group may be a practical challenge. Many people, including funders, staff and carers do not like the prospect of participation without receiving some intervention. This can be a barrier to funding and recruitment.
Some additional cautionary notes:
The following barriers and challenges did not reach the 70% agreement level in the survey. However, a number of experts did think that these are important and were consistent in this view, therefore they are included as cautionary notes in the toolkit.
- It can be difficult to get funding as some funders do not think ID trials are worth funding.
- Costs requested by universities to cover academic staff involvement in trials can add considerably to the cost of a trial.
- Conducting an ID trial may entail a researcher having access to areas of a participant’s life that a non-disability researcher may not have to access – there is a higher risk of a participant disclosing criminal behaviour (either as a victim or perpetrator).
- Some people do not understand the purpose and process of randomisation and this can be a barrier to funding, ethics, and recruitment.
- There is a perception that, for a number of possible reasons, it can be difficult to get an ID-related paper published in a high impact journal.
- Due to misconceptions about country-specific differences, it can be difficult to get a trial conducted in one country published in a journal based in another country.