Autism spectrum disorders place a tremendous burden on the sufferers and their families and carers. Parents are often desperate for treatments that might help, but are not receiving the best possible guidance from research that has already been done, because of a lack of consistency in the outcomes used in this research and the subsequent difficulties in comparing, contrasting, and combining the results. What is needed is agreement on a set of outcomes that would be measured routinely in all similar trials, as has been highlighted in a recent Cochrane review which is featured in the Cochrane journal club.
For the last year, The Cochrane library has included a monthly journal club providing relevant materials for a selected Cochrane review. Occasionally, the clinical topic is accompanied by a methodological one. This has just happened for the review of selective serotonin reuptake inhibitors (SSRIs) for people with autism, highlighting the problems arising from the lack of consistency in the outcomes measured in the trials that were eligible for the review. This journal club, which includes details of the review along with a slideshow, podcast, discussion points and related articles, uses the specifics of the review to provide a helpful introduction to the general need for core outcome sets.
The Australia-based authors of the Cochrane review sought to investigate the benefits and harms of SSRIs when used by people with autism, but struggled because the seven trials they identified didn’t report outcomes that were similar enough to allow results to be combined. The same team experienced the same problems in an earlier review of autism, looking at the drug secretin. In the SSRIs review, the seven trials reported seventeen different standardised outcome measures, 14 of which were reported by only one study. In the secretin review, a total of 25 established standardised outcome measures for core features of autism, communication, behaviour, visio-spatial skills, effect, and adverse events were reported across the 14 included studies. However, looking across this wealth of data, the authors found that the highest number of trials reporting the same outcome measured in the same way was four.
They concluded that a core set of standard outcome measures, which might vary for different age groups, is needed to speed the process of finding reliable answers to the treatment uncertainties faced by people with autism and those who care for them. As a minimum, these core sets would require a measure of global functioning; along with other validated measures that are most relevant to the area or behaviour that is expected to improve with the treatment. These would include diagnostic features of autism, disruptive behaviour, social interaction, obsessive compulsive symptoms, speech and language ability, as well as quality of life and stress indices for the person with autism and their carers.
The COMET Initiative is keen to help with these efforts. It aims to collate relevant resources in a publically available, searchable database; to provide guidance on methods for developing core outcome sets; and to develop reporting standards for such studies. If you have information about core outcome sets in autism which you would like to share with COMET, please send it to Liz Gargon at COMET (email@example.com).
Mike Clarke is the director of the UK Cochrane Centre