Article

Overcoming the barriers experienced in conducting a medication trial in adults with aggressive challenging behaviour and intellectual disabilities

Imperial College London, Dept. of Psychological Medicine, UK.
Journal of Intellectual Disability Research (Impact Factor: 2.41). 08/2009; 54(1):17-25. DOI: 10.1111/j.1365-2788.2009.01195.x
Source: PubMed

ABSTRACT

Aggressive challenging behaviour in people with intellectual disability (ID) is frequently treated with antipsychotic drugs, despite a limited evidence base.
A multi-centre randomised controlled trial was undertaken to investigate the efficacy, adverse effects and costs of two commonly prescribed antipsychotic drugs (risperidone and haloperidol) and placebo.
The trial faced significant problems in recruitment. The intent was to recruit 120 patients over 2 years in three centres and to use a validated aggression scale (Modified Overt Aggression Scale) score as the primary outcome. Despite doubling the period of recruitment, only 86 patients were ultimately recruited.
Variation in beliefs over the efficacy of drug treatment, difficulties within multidisciplinary teams and perceived ethical concerns over medication trials in this population all contributed to poor recruitment. Where appropriate to the research question cluster randomised trials represent an ethically and logistically feasible alternative to individually randomised trials.

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Available from: Patricia C. Oliver, Jul 25, 2014
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    • "Clearly, a more facilitatory attitude is needed when supporting such studies, apart from assisting recruitment by methods such as cluster randomized trials (Barbui & Cipriani, 2011). It is not easy to overcome the many barriers that these studies face (Rendell et al. 2007; Oliver-Africano et al. 2010) but those responsible for local research governance in NHS organizations have the capacity to reduce them greatly. Local checking processes have evolved quite differently, with one organization asking for specific activities to be completed under the guise of research governance checks, despite others not undertaking the same activities. "
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    Full-text · Article · Jul 2014 · Psychological Medicine
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    • "Clearly, a more facilitatory attitude is needed when supporting such studies, apart from assisting recruitment by methods such as cluster randomized trials (Barbui & Cipriani, 2011). It is not easy to overcome the many barriers that these studies face (Rendell et al. 2007; Oliver-Africano et al. 2010) but those responsible for local research governance in NHS organizations have the capacity to reduce them greatly. Local checking processes have evolved quite differently, with one organization asking for specific activities to be completed under the guise of research governance checks, despite others not undertaking the same activities. "
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    Full-text · Article · May 2013 · Epidemiology and Psychiatric Sciences
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    • "The RCTs that have taken place have been limited by under-recruitment [7-11] or high drop-out rates [12]. Researchers have previously reported numerous barriers to conducting RCTs that include difficulties in communication, accessing participants through gatekeepers such as paid carers, lack of understanding about clinical trial processes amongst care agencies, and obtaining informed consent from service users [13-15]. The latter is particularly important in the UK in light of the Mental Capacity Act (2005) [16] which not only presumes capacity from the outset but also seeks to ensure that every effort is made for service users to receive appropriate support in order to make an informed decision. "
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