Showing posts with label intervention. Show all posts
Showing posts with label intervention. Show all posts

Sunday, 30 August 2015

Opportunity cost: A new red flag for evaluating interventions for neurodevelopmental disorders

Back in 2012, I wrote a blogpost offering advice to parents who were trying to navigate their way through the jungle of alternative interventions for children with dyslexia. I suggested a set of questions that should be asked of any new intervention, and identified a set of 'red flags', i.e., things that should make people think twice before embracing a new treatment.

The need for an update came to mind as I reflected on the Arrowsmith program, an educational approach that has been around in Canada since the 1980s, but has recently taken Australia and New Zealand by storm. Despite credulous press coverage in the UK, Arrowsmith has not, as far as I know, taken off here. Australia, however, is a different story, with Arrowsmith being taken up by the Catholic Education Office in Sydney after they found 'dramatic results' in a pilot evaluation.

For those who remember the Dore programme, this seems like an action replay. Dore was big in both the UK and Australia in the period around 2007-2008. Like Arrowsmith, it used the language of neuroscience, claiming that its approach treated the underlying brain problem, rather than the symptoms of conditions such as dyslexia and ADHD. Parents were clamouring for it, it was widely promoted in the media, and many people signed up for long-term payment plans to cover a course of treatment. People like me, who worked in the area of neurodevelopmental disorders, were unimpressed by the small amount of published data on the program, and found the theoretical account of brain changes unconvincing (see this critique). However, we were largely ignored until a Four Corners documentary was made by Australian ABC, featuring critics as well as advocates of Dore. Soon after, the company collapsed, leaving both employees of Dore and many families who had signed up to long-term financial deals, high and dry. It was a thoroughly dismal episode in the history of intervention for children with neurodevelopmental problems.

With Arrowsmith, we seem to be at the start of a similar cycle in Australia. Parents, hearing about the wondrous results of the program, are lobbying for it to be made more widely available. There are even stories of parents moving to Canada so that their child can reap the benefits of Arrowsmith. Yet Arrowsmith ticks many of the 'red flags' that I blogged about, lacks any scientific evidence for efficacy, and has attracted criticism from mainstream experts in children's learning difficulties. As with Dore, the Arrowsmith people seem to have learned that if you add some sciency-sounding neuroscience terms to justify what you do, people will be impressed. It is easy to give the impression that you are doing something much more remarkable than just training skills through repetition.

They also miss the point that, as Rabbitt (2015, p 235) noted regarding brain-training in general: "Many researchers have been frustrated to find that ability on any particular skill is surprisingly specific and often does not generalise even to other quite similar situations." There's little point in training children to type numbers into a computer rapidly if all that happens is that they get better at typing numbers into a computer. For this to be a viable educational strategy, you'd need to show that this skill had knock-on effects on other learning. That hasn't been done, and all the evidence from mainstream psychology suggests it would be unusual to see such transfer of training effects.

Having failed to get a reply to a request for more information from the Catholic Education Office in Sydney, I decided to look at the evidence for the program that was cited by Arrowsmith's proponents. An ongoing study by Dr Lara Boyd of the University of British Columbia features prominently on their website, but, alas, Dr Boyd was unresponsive to an email request for more information. It would seem that in the thirty-five years Arrowsmith has been around, there have been no properly conducted trials of its effectiveness, but there are a few reports of uncontrolled studies looking at children's cognitive scores and attainments before and after the intervention. One of the most comprehensive reviews is in the D.Phil. thesis of Debra Kemp-Koo from the University of Saskatchewan in 2013. In her introduction, Dr Kemp-Koo included an account of a study of children attending the private Arrowsmith school in Toronto:
All of the students in the study completed at least one year in the Arrowsmith program with most of them completing two years and some of them completing three years. At the end of the study many students had completed their Arrowsmith studies and left for other educational pursuits. The other students had not completed their Arrowsmith studies and continued at the Arrowsmith School. Most of the students who participated in the study were taking 6 forty minute modules of Arrowsmith programming a day with 1 forty minute period a day each of English and math at the Arrowsmith School. Some of the students took only Arrowsmith programming or took four modules of Arrowsmith programming with the other half of their day spent at the Arrowsmith school or another school in academic instruction (p. 34-35; my emphasis).
Two of my original red flags concerned financial costs, but I now realise it is important to consider opportunity costs: i.e., if you enlist your child in this intervention, what opportunities are they going to miss out as a consequence? For many of the interventions I've looked at, the time investment is not negligible, but Arrowsmith seems in a league of its own. The cost of spending one to three years working on unevidenced, repetitive exercises is to miss out on substantial parts of a regular academic curriculum. As Kemp-Koo (2013) remarked:
The Arrowsmith program itself does not focus on academic instruction, although some of these students did receive some academic instruction apart from their Arrowsmith programming. The length of time away from academic instruction could increase the amount of time needed to catch up with the academic instruction these students have missed. (p. 35; my emphasis).

References
Kemp-Koo, D. (2013). A case study of the Learning Disabilities Association of Saskatchewan (LDAS) Arrowsmith Program. Doctor of Philosophy thesis, University of Saskatchewan, Saskatoon.  

Rabbitt, P. M. A. (2015). The aging mind. London and New York: Routledge.

Thursday, 21 March 2013

Blogging as post-publication peer review: reasonable or unfair?



In a previous blogpost, I criticised a recent paper claiming that playing action video games improved reading in dyslexics. In a series of comments below the blogpost, two of the authors, Andrea Facoetti and Simone Gori, have responded to my criticisms. I thank them for taking the trouble to spell out their views and giving readers the opportunity to see another point of view. I am, however, not persuaded by their arguments, which make two main points. First, that their study was not methodologically weak and so Current Biology was right to publish it, and second, that it is unfair, and indeed unethical, to criticise a scientific paper in a blog, rather than through the regular scientific channels.
Regarding the study methodology, as noted above, the principal problem with the study by Franceschini et al was that it was underpowered, with just 10 participants per group.  The authors reply with an argument ad populum, i.e. many other studies have used equally small samples. This is undoubtedly true, but it doesn’t make it right. They dismiss the paper I cited by Christley (2010) on the grounds that it was published in a low impact journal. But the serious drawbacks of underpowered studies have been known about for years, and written about in high- as well as low-impact journals (see references below).
The response by Facoetti and Gori illustrates the problem I had highlighted. In effect, they are saying that we should believe their result because it appeared in a high-impact journal, and now that it is published, the onus must be on other people to demonstrate that it is wrong. I can appreciate that it must be deeply irritating for them to have me expressing doubt about the replicability of their result, given that their paper passed peer review in a major journal and the results reach conventional levels of statistical significance. But in the field of clinical trials, the non-replicability of large initial effects from small trials has been demonstrated on numerous occasions, using empirical data - see in particular the work of Ioannidis, referenced below. The reasons for this ‘winner’s curse’ have been much discussed, but its reality is not in doubt. This is why I maintain that the paper would not have been published if it had been reviewed by scientists who had expertise in clinical trials methodology. They would have demanded more evidence than this.
The response by the authors highlights another issue: now that the paper has been published, the expectation is that anyone who has doubts, such as me, should be responsible for checking the veracity of the findings. As we say in Britain, I should put up or shut up. Indeed, I could try to get a research grant to do a further study. However, I would probably not be allowed by my local ethics committee to do one on such a small sample and it might take a year or so to do, and would distract me from my other research. Given that I have reservations about the likelihood of a positive result, this is not an attractive option. My view is that journal editors should have recognised this as a pilot study and asked the authors to do a more extensive replication, rather than dashing into print on the basis of such slender evidence. In publishing this study, Current Biology has created a situation where other scientists must now spend time and resources to establish whether the results hold up.
To establish just how damaging this can be, consider the case of the FastForword intervention, developed on the basis of a small trial initially reported in Science in 1996. After the Science paper, the authors went directly into commercialization of the intervention, and reported only uncontrolled trials. It took until 2010 for there to be enough reasonably-sized independent randomized controlled trials to evaluate the intervention properly in a meta-analysis, at which point it was concluded that it had no beneficial effect. By this time, tens of thousands of children had been through the intervention, and hundreds of thousands of research dollars had been spent on studies evaluating FastForword.
I appreciate that those reporting exciting findings from small trials are motivated by the best of intentions – to tell the world about something that seems to help children. But the reality is that, if the initial trial is not adequately powered, it can be detrimental both to science and to the children it is designed to help, by giving such an imprecise and uncertain estimate of the effectiveness of treatment.
Finally, a comment on whether it is fair to comment on a research article in a blog, rather than going through the usual procedure of submitting an article to a journal and having it peer-reviewed prior to publication. The authors’ reactions to my blogpost are reminiscent of Felicia Wolfe-Simon’s response to blog-based criticisms of a paper she published in Science: "The items you are presenting do not represent the proper way to engage in a scientific discourse”. Unlike Wolfe-Simon, who simply refused to engage with bloggers, Facoetti and Gori show willingness to discuss matters further, and present their side of the story, but they nevertheless it is clear they do not regard a blog as an appropriate place to debate scientific studies. 
I could not disagree more. As was readily demonstrated in the Wolfe-Simon case, what has come to be known as ‘post-publication peer review’ via the blogosphere can allow for new research to be rapidly discussed and debated in a way that would be quite impossible via traditional journal publishing. In addition, it brings the debate to the attention of a much wider readership. Facoetti and Gori feel I have picked on them unfairly: in fact, I found out about their paper because I was asked for my opinion by practitioners who worked with dyslexic children. They felt the results from the Current Biology study sounded too good to be true, but they could not access the paper from behind its paywall, and in any case they felt unable to evaluate it properly. I don’t enjoy criticising colleagues, but I feel that it is entirely proper for me to put my opinion out in the public domain, so that this broader readership can hear a different perspective from those put out in the press releases. And the value of blogging is that it does allow for immediate reaction, both positive and negative. I don’t censor comments, provided they are polite and on-topic, so my readers have the opportunity to read the reaction of Facoetti and Gori. 
I should emphasise that I do not have any personal axe to grind with the study's authors, who I do not know personally. I’d be happy to revise my opinion if convincing arguments are put forward, but I think it is important that this discussion takes place in the public domain, because the issues it raises go well beyond this specific study.

References
Button, K. S., Ioannidis, J. P. A., Mokrysz, C., Nosek, B. A., Flint, J., Robinson, E. S. J., & Munafo, M. R. (2013). Power failure: why small sample size undermines the reliability of neuroscience. Nature Reviews Neuroscience, advance online publication. doi: 10.1038/nrn3475
Ioannidis, J. P. A. (2005). Why most published research findings are false. PLoS Medicine, 2(8), e124. doi: 10.1371/journal.pmed.0020124
Ioannidis, J. P. (2008). Why most discovered true associations are inflated. Epidemiology 19(5), 640-648.
Ioannidis JP, Pereira TV, & Horwitz RI (2013). Emergence of large treatment effects from small trials--reply. JAMA : the journal of the American Medical Association, 309 (8), 768-9 PMID: 23443435

Sunday, 10 March 2013

High-impact journals: where newsworthiness trumps methodology

Here’s a paradox: Most scientists would give their eye teeth to get a paper in a high impact journal, such as Nature, Science, or Proceedings of the National Academy of Sciences. Yet these journals have had a bad press lately, with claims that the papers they publish are more likely to be retracted than papers in journals with more moderate impact factors. It’s been suggested that this is because the high impact journals treat newsworthiness as an important criterion for accepting a paper. Newsworthiness is high when a finding is both of general interest and surprising, but surprising findings have a nasty habit of being wrong.

A new slant on this topic was provided recently by a paper by Tressoldi et al (2013), who compared the statistical standards of papers in high impact journals with those of three respectable but lower-impact journals. It’s often assumed that high impact journals have a very high rejection rate because they adopt particularly rigorous standards, but this appears not to be the case. Tressoldi et al focused specifically on whether papers reported effect sizes, confidence intervals, power analysis or model-fitting. Medical journals fared much better than the others, but Science and Nature did poorly on these criteria. Certainly my own experience squares with the conclusions of Tressoldi et al (2013), as I described in the course of discussion about an earlier blogpost.

Last week a paper appeared in Current Biology (impact factor = 9.65) with the confident title: “Action video games make dyslexic children read better.” It's a classic example of a paper that is on the one hand highly newsworthy, but on the other, methodologically weak. I’m not usually a betting person, but I’d be prepared to put money on the main effect failing to replicate if the study were repeated with improved methodology. In saying this, I’m not suggesting that the authors are in any way dishonest. I have no doubt that they got the results they reported and that they genuinely believe they have discovered an important intervention for dyslexia. Furthermore, I’d be absolutely delighted to be proved wrong: There could be no better news for children with dyslexia than to find that they can overcome their difficulties by playing enjoyable computer games rather than slogging away with books. But there are good reasons to believe this is unlikely to be the case.

An interesting way to evaluate any study is to read just the Introduction and Methods, without looking at Results and Discussion. This allows you to judge whether the authors have identified an interesting question and adopted an appropriate methodology to evaluate it, without being swayed by the sexiness of the results. For the Current Biology paper, it’s not so easy to do this, because the Methods section has to be downloaded separately as Supplementary Material. (This in itself speaks volumes about the attitude of Current Biology editors to the papers they publish: Methods are seen as much less important than Results). On the basis of just Introduction and Methods, we can ask whether the paper would be publishable in a reputable journal regardless of the outcome of the study.

On the basis of that criterion, I would argue that the Current Biology paper is problematic, purely on the basis of sample size. There were 10 Italian children aged 7 to 13 years in each of two groups: one group played ‘action’ computer games and the other was a control group playing non-action games (all games from Wii's Rayman Raving Rabbids - see here for examples). Children were trained for 9 sessions of 80 minutes per day over two weeks. Unfortunately, the study was seriously underpowered. In plain language, with a sample this small, even if there is a big effect of intervention, it would be hard to detect it. Most interventions for dyslexia have small-to-moderate effects, i.e. they improve performance in the treated group by .2 to .5 standard deviations. With 10 children per group, the power is less than .2, i.e. there’s a less than one in five chance of detecting a true effect of this magnitude. In clinical trials, it is generally recommended that the sample size be set to achieve power of around .8. This is only possible with a total sample of 20 children if the true effect of intervention is enormous – i.e. around 1.2 SD, meaning there would be little overlap between the two groups’ reading scores after intervention. Before doing this study there would have been no reason to anticipate such a massive effect of this intervention, and so use of only 10 participants per group was inadequate. Indeed, in the context of clinical trials, such a study would be rejected by many ethics committees (IRBs) because it would be deemed unethical to recruit participants for a study which had such a small chance of detecting a true effect.

But, I hear you saying, this study did find a significant effect of intervention, despite being underpowered. So isn’t that all the more convincing? Sadly, the answer is no. As Christley (2010) has demonstrated, positive findings in underpowered studies are particularly likely to be false positives when they are surprising – i.e., when we have no good reason to suppose that there will be a true effect of intervention. This seems particularly pertinent in the case of the Current Biology study – if playing active computer games really does massively enhance children’s reading, we might have expected to see a dramatic improvement in reading levels in the general population in the years since such games became widely available.

The small sample size is not the only problem with the Current Biology study. There are other ways in which it departs from the usual methodological requirements of a clinical trial: it is not clear how the assignment of children to treatments was made or whether assessment was blind to treatment status, no data were provided on drop-outs, on some measures there were substantial differences in the variances of the two groups, no adjustment appears to have been made for the non-normality of some outcome measures, and a follow-up analysis was confined to six children in the intervention group. Finally, neither group showed significant improvement in reading accuracy, where scores remained 2 to 3 SD below the population mean (Tables S1 and S3): the group differences were seen only for measures of reading speed.

Will any damage be done? Probably not much – some false hopes may be raised, but the stakes are not nearly as high as they are for medical trials, where serious harm or even death can result from wrong results. There is concern, however, that quite apart from the implications for families of children with reading problems, there is another issue here, about the publication policies of high-impact journals. These journals wield immense power. It is not overstating the case to say that a person’s career may depend on having a publication in a journal like Current Biology (see this account – published, as it happens, in Current Biology!). But, as the dyslexia example illustrates, a home in a high-impact journal is no guarantee of methodological quality. Perhaps this should not surprise us: I looked at the published criteria for papers on the websites of Nature, Science, PNAS and Current Biology. None of them mentioned the need for strong methodology or replicability; all of them emphasised “importance” of the findings.

Methods are not a boring detail to be consigned to a supplement: they are crucial in evaluating research. My fear is that the primary goal of some journals is media coverage, and consequently science is being reduced to journalism, and is suffering as a consequence.

References

Brembs, B., & Munafò, M. R. (2013). Deep impact: Unintended consequences of journal rank. arXiv:1301.3748.

Christley, R. M. (2010). Power and error: increased risk of false positive results in underpowered studies. The Open Epidemiology Journal, 3, 16-19.

Halpern, S. D.,  Karlawish, J. T, & Berlin, J. A. (2002). The continuing unethical conduct of underpowered clinical trials. Journal of the American Medical Association, 288(3), 358-362. doi: 10.1001/jama.288.3.358

Lawrence, P. A. (2007). The mismeasurement of science. Current Biology, 17(15), R583-R585. doi: 10.1016/j.cub.2007.06.014

Tressoldi, P., GiofrĂ©, D., Sella, F., & Cumming, G. (2013). High Impact = High Statistical Standards? Not Necessarily So. PLoS ONE, 8 (2) DOI: 10.1371/journal.pone.0056180

Friday, 24 February 2012

Neuroscientific interventions for dyslexia: red flags

I’m often asked for my views about interventions for dyslexia and related disorders. In recent years there has been a proliferation of interventions offered on the web, many of which claim to treat the brain basis of dyslexia. In theory, this seems a great idea; rather than slogging away at teaching children to read, fix the underlying brain problem. If your child is struggling at school, it can be very tempting to try something that claims to re-organise or stimulate the brain. The problem, though, is sorting the wheat from the chaff. There's no regulation of educational interventions and it can be hard for parents to judge whether it is worth investing time and money in a new approach.
My aim here is to provide some objective criteria that can be used. First, there is scientific evaluation: does the intervention have a plausible basis, and how has it been tested? Where claims are made about changing the brain, are they based on solid neuroscientific research? Second, there are red flags, some of which I listed in a previous post on ‘Pioneering treatment or quackery?” Here I've gathered these together so that there is a ready checklist that can be applied when a new intervention surfaces.

1. Who is behind the treatment and what are their credentials?
What you should look for here are relevant qualifications, particularly a higher degree (preferably doctorate) from an academic institution with a good reputation. Red flags are:
  • No information about who is involved ▶#1 
  • Intervention developed by someone with no academic credentials ▶#2 
  • Citation of spurious credentials; affiliation with organisations that have very lax membership criteria, e.g., Royal Society of Medicine ▶#3 
  • A lack of publications in peer-reviewed journals. Publications only in books counts as a red flag, because there is no quality control. ▶#4
It can be hard for a lay person to evaluate point #3, because some people cite qualifications that sound impressive but have no credibility. Academics in the field, however, can quickly identify whether a string of letters is indicative of prestige, or whether they are a smokescreen for lack of formal qualifications.
As far as #4 is concerned, relevant information can be obtained checking an author against a database such as Web of Science. However, access to such databases is largely restricted to academic institutions. Google Scholar is widely available, though its results are not restricted to peer-reviewed literature.

2. Is there a credible scientific basis to the treatment?
This is often difficult for a lay person to evaluate. Google Scholar may be helpful in tracking down articles that discuss the background to the intervention. Ideally, one is looking for a review by someone who is independent of those who developed it and who has good academic credentials. If no relevant journal articles are found on Google Scholar this is a red flag ▶#5. If a journal article is found, try to find whether the journal is a mainstream peer-reviewed publication.

3. Who is the intervention recommended for?

It is implausible that the whole gamut of neurodevelopmental problems has a single underlying cause, and it is unlikely that they will all respond to the same intervention. If an intervention claims to be effective for a host of diverse disorders, then this is a red flag ▶#6.

4. Is there evidence from controlled trials that the intervention is effective?
If there is such evidence, the main website for the intervention should describe it and provide links to the sources. No mention of controlled trials ▶#7, and heavy reliance on testimonials ▶#8 are both red flags. Chldren's progress should be measured on standardized and reliable psychometric tests, i.e. measures that have been developed for this purpose where normal range performance has been established. Failure to provide such information is another red flag ▶#9. It is not uncommon to find reference to trials with no controls, i.e. children’s progress is monitored before and after the intervention, and improvements are described. This is not adequate evidence of efficacy, for reasons I have covered in detail here: essentially, improvement in test scores can arise because of practice on the tests, maturation, statistical variation or expectation effects. If scores from before and after treatment are presented as evidence for efficacy, with no reference to control data, this is another red flag ▶#10, because it indicates that the practitioners do not understand the basic requirements of treatment evaluation.
If the evidence comes solely from children tested by people with a commercial interest, there may even be malpractice, with scores massaged to look better than they are. When there were complaints about an US intervention, Learning RX, ex-employees claimed that they had been encouraged to alter children's test scores to make their progress look better than it was (see comment from 6th Dec 2009). One hopes this is not common, but it is important to be alert to the possibility and to ensure those administering psychological tests are appropriately qualified, and if necessary get an independent assessment.
The strongest evidence for effectiveness comes from randomised controlled trials, which adopt stringent methods that have become the norm in clinical medicine. Where several trials have been conducted, then it is possible to combine the findings in a systematic review, which uses rigorous standards to evaluate evidence to avoid bias that can arise if there is ‘cherrypicking’ of studies. This level of evidence is very rare in behavioural interventions for neurodevelopmental disorders because the studies are expensive and time-consuming to do.

5. What is the attitude of those promoting the intervention to conventional approaches?
The question that an advocate for a new treatment has to answer is, if this is such a good thing, why hasn’t it been picked up by mainstream practitioners?
An answer that implies some kind of conspiracy by the mainstream to suppress a new development is a red flag ▶#11. This kind of argument is widely used by alternative medicine practitioners who maintain that others have vested interests (e.g. payments from pharmaceutical companies). This doesn’t hold water: basically, if a treatment is effective, then it makes no financial sense to reject it, given that people will pay good money for something that works.
Another red flag ▶#12 is if the new intervention is promoted alongside other alternative medicine methods that do not have good supportive evidence. This suggests that the practitioners do not take an evidence-based approach.


6. Are the costs transparent and reasonable?
Lack of information about costs on the website is a red flag ▶#13, especially if you can only get information by phoning (hence allowing the practitioner to adopt a hard sell approach). Is there any provision for a refund if the intervention is ineffective? If someone tells you their treatment has a 90% success rate, then they should be willing to give you your money back if it doesn't work. Another red flag is if you are asked to sign up in advance for a long-term treatment plan ▶#14. For example, in the case of the Dore programme, there were instances of families tied into credit agreements and forced to pay even if they don’t continue with the intervention.  

I’ll illustrate by applying the criteria to Sensory Activation Solutions. This is just one example of neuroscientific interventions on offer on the web. I've singled it out because I was recently asked my opinion after a new SAS Centre opened in Milton Keynes this month.
1. Who is behind the treatment and what are their credentials?
The SAS website states Sensory Activation Solutions (SAS) is the 'brainwave' of Steven MichaĂ«lis and KaĹ›ka Gozdek-MichaĂ«lis and is the culmination of over 30 years of study and work relating to how we learn and how we can be more effective in life. I tried various approaches to search terms but was not able to find any publications by either person on Google Scholar. This is worrying: one would expect 30 years of study to yield some peer-reviewed papers. 
The biography of Steven Michaëlis does not mention any academic qualifications. He has a background in sound processing and computer technologies and has trained as a group counsellor. The website states that: Kaśka Gozdek-Michaëlis is an inter-faith, cross-cultural lecturer, writer, psychotherapist and life-coach with over 25 years experience. She gained a Master Degree in Oriental Studies at the prestigious University of Warsaw, Poland. She is the author of two books in Polish, 'Develop your genius mind' and 'Super-possibilities of your mind'.
Overall, the originators of the treatment are up-front about their background and do not hide behind spurious qualifications. However, neither of them appears to have any training in brain science or neurodevelopmental disorders, and their methods have not been subject to peer review. Two red flags:▶#2 ▶#4 

2. Is there a credible scientific basis to the treatment?
There were no entries in Google Scholar for "Sensory activation solutions", so I read the section on The science behind the SAS programs. This provided a quite complex story, about how playing sounds through headphones "activates the auditory processing centres in the brain... leading to less sensory overload, faster understanding, better verbal expression and improved reading and writing." It is a truism that playing sounds to people will activate auditory centres of the brain: that's what hearing is. The key question is whether the sounds used by SAS do anything special. There are numerous components to the SAS package, including use of vision, touch, taste, smell and proprioception "to reduce sensory overload." Sensory overload is a problem for some children, notably a subset of those with autistic spectrum disorder. But it's not generally viewed as problematic for children with dyslexia. It's also claimed that by presenting different auditory stimuli to the left and right ears, the SAS method can promote right-ear dominance and inter-hemispheric integration. In a video presentation, MichaĂ«lis explains this aspect of the theory further, picking up on some old ideas about cerebral lateralisation, interhemispheric communication and rapid auditory processing. To those who don't know the literature, this will sound convincing, but his account is oversimplistic, and makes leaps from theory to intervention with no evidence. For example, with current methods of imaging it would be possible to test whether SAS stimuli alter children's cerebral lateralisation, but there's no indication of any studies investigating this. Overall, the account of the brain bases of dyslexia is out of line with contemporary neuroscientific research. One red flag: ▶#5

3. Who is the intervention recommended for?
SAS is described as appropriate for attention deficit disorder,  hyper-activity,  dyslexia, dyscalculia, hearing and speech disorders,  stammering,  autism,  Asperger's Syndrome,  Down Syndrome,  global developmental delay, Cerebral Palsy, eating disorders, sleeping disorders. In the video it is also recommended for acquired aphasia. One red flag: ▶#6

4. Is there evidence from controlled trials that the intervention is effective?
The "research" section of the website cites descriptive statistics only, largely based on parent satisfaction indices. There is no evidence that psychometrically sound measures were used to evaluate progress. 
There is a small scientific literature on Auditory Integration training (AIT), which has many features in common with aspects of the SAS package; most  studies focussed on autism, where there is little evidence of efficacy (Sinha et al, 2006). The American Speech-Language-Hearing Association concluded a review of AIT thus: Despite approximately one decade of practice in this country, this method has not met scientific standards for efficacy and safety that would justify its inclusion as a mainstream treatment for these disorders. Four red flags: ▶#7 ▶#8 ▶#9 ▶#10

 5. What is the attitude of those promoting the intervention to conventional approaches?
The 'resources' section of the website contained a wealth of information about other kinds of intervention, both mainstream and alternative. 

 6. Are the costs transparent and reasonable? 
The website was quite complicated to navigate, and I may have missed something, but I could not find any information about costs of treatment, only a phone number. It's not possible therefore to say if costs are reasonable. It seems unlikely that clients would be tied in to long-term contracts, as treatment duration seems quite short, lasting weeks rather than months. One red flag: ▶#13

Overall, you can see that SAS earns nine red flags on my evaluation scale.

I suspect no intervention is perfect, and if you have a child who is struggling at school you may want to go ahead and try an intervention regardless of red flags. My goal here is not to stop people trying new interventions, but to ensure that they do so with their eyes open. If practitioners make claims about changing the brain, then they can expect to have those claims scrutinised by neuroscientists. The list of red flags is intended to help people make informed decisions: it may also serve the purpose of indicating to practitioners what they need to do to win confidence of the scientific community.  

Reference
Sinha, Y., Silove, N., Wheeler, D., & Williams, K. (2006). Auditory integration training and other sound therapies for autism spectrum disorders: a systematic review Archives of Disease in Childhood, 91 (12), 1018-1022 DOI: 10.1136/adc.2006.094649

P.S. 6th March 2013: Here are some additional tips for spotting bad science more generally: