The SMILES trial: do undisclosed recruitment practices explain the remarkably large effect? (2018) Molendijk et al.

Cheshire · Dec 29, 2018

Abstract
The SMILES trial showed substantial improvement of depressive symptoms following seven consultations on healthy dieting. The very large effect size on depression reduction seems remarkable and we suggest that selectively induced expectancy and a loss of blinding have contributed to the observed effect.
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Open access here.

Many similarities with the PACE flaws:

The primary outcome in the SMILES trial was change in the severity of depression symptoms, in this case assessed via the interviewer-rated Montgomery–Åsberg Depression Rating Scale (MADRS) [10]. Such outcomes are subjective in nature (the participant is queried about symptoms), and thus susceptible to expectancy effects (defined as results biased by the communication of the expected results [11, 12, 13, 14]). When the intervention is non-pharmacological – herein the advice of following a healthy diet – the blinding of conditions in an RCT is hardly possible. In order to minimize expectancy bias, the authors describe that they masked the hypothesis and used a neutral recruitment strategy. Participants were approached (in social media, local newspapers, and radio interviews) with the following message: “We are trialing the effect of an educational and counseling program focusing on diet that may help improve the symptoms of depression” ([1], p. 2). The paper further states that “several strategies were employed to reduce the risk of bias” ([1], p. 5) and that “significant effort was made to mask our hypothesis” ([1], p. 10).
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In this letter, we argue that there is a mismatch between the reported and the actual recruitment strategy, which becomes clear when comparing the reported and actual recruitment strategies. Through a hyperlink to an external website on the study’s recruitment website [15] (note that there are some differences with current and previous versions), potential participants are presented to a ‘fruit smiley’, composed out of two green apples as eyes, a mandarin as nose, and a banana with the edges pointing up as a smiling mouth [16]. Messages such as: “Bananas look like a smile but can also help you smile because they contain tryptophan which is a mood stabilizer” and “Banana, brazil nuts, broccoli, they all have something in common apart from starting with the letter B. They all contain nutrients which can stabilize mood” are presented alongside. Since no benefits of the control conditioning (befriending) were described, we think that this is anything but a neutral description, which has likely affected expectancy in participants. The study hypothesis was provided at recruitment to potential participants ‘on a platter’, so to speak. Website visitors also learned that “the fear that we are eating our way to depression is prompting governments to take action” [15]. This was accompanied by testimonials, such as “The solution to my depression is good quality food”.In a local newspaper article entitled ‘Diet, Depression, Hope’ [17], published in the recruitment catchment area at time of enrolment, the senior author wrote “if you eat a healthier diet then it reduces your risk on depression”. This article was accompanied by an invitation to participate in the trial and contact details. In summary, the report of the SMILES trial does not seem to adequately describe how study recruitment took place in practice.
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Trish · Dec 29, 2018

So we now have a SMILE trial for LP in kids with ME, and a SMILES trial for diet changes for people with depression with a smiley face made out of fruit. I detect a correlation between infantile trial names and bad science.

I wonder what would be the effect of calling a trial the FROWN trial, the GRIMACE trial, or perhaps even the EVIL trial.

Michiel Tack · Dec 29, 2018

There recently was an IMAGINE trial in the Lancet Gastrology claiming that hypnotherapy decreases symptoms in irritable bowel syndrome (don't think it was discussed here). Unblinded with subjective outcomes of course. It also reminded me of the PACE-trial. See for example this quote:

We chose the adequate relief questionnaire as the primary outcome measure, because this subjective outcome adequately reflects the effect of IBS symptoms on individual patients, independently of symptom severity. In functional disorders, the perception of symptoms is as important as actual symptom severity. In our trial, better adequate relief scores were not accompanied by significant improvements in IBS symptom scores. The explanation for this finding might be that, in contrast to educational therapy, hypnotherapy improves the perception of IBS symptoms without having a major effect on symptom severity. Thus, the main effect of hypnotherapy might be diminishing the impact of symptoms on patients by changing their mind-set and improving internal coping mechanisms.
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Trish · Dec 29, 2018

In functional disorders, the perception of symptoms is as important as actual symptom severity.
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No it bloody well isn't.

Jonathan Edwards · Dec 29, 2018

Trish said: ↑

No it bloody well isn't.
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Where does that snippet come from @Trish ? It is a real howler.

Trish · Dec 29, 2018

Jonathan Edwards said: ↑

Where does that snippet come from @Trish ? It is a real howler.
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Second sentence in the section Michiel quoted in the post before mine. From the IMAGINE trial. The whole paragraph he quoted is an expanded version of the same thing.

Michiel Tack · Dec 29, 2018

Trish said: ↑

No it bloody well isn't.
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Yeah, how cynical that they chose to call their trial IMAGINE and make such statements in their main paper.

Sly Saint · Dec 29, 2018

Michiel Tack said: ↑

Yeah, how cynical that they chose to call their trial IMAGINE and make such statements in their main paper.
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.....maybe the researchers are John Lennon fans?

' ......imagine all the people, living life in PACE' (?)

rvallee · Dec 29, 2018

Trish said: ↑

So we now have a SMILE trial for LP in kids with ME, and a SMILES trial for diet changes for people with depression with a smiley face made out of fruit. I detect a correlation between infantile trial names and bad science.

I wonder what would be the effect of calling a trial the FROWN trial, the GRIMACE trial, or perhaps even the EVIL trial.
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I had to check and the study name specifically says it's for adults. They're trying to convince depressive adults that a smiley face banana will cure them, or something. And it seems like PACE set a sort of precedent with its newsletter with quotes promising a cure during the trial. That this was not severely punished made it acceptable moving forward. Very bad.

Can't they do those studies without being extra condescending? I get it, some people require some extra coddling but this assumption that everyone who doesn't have a medical degree is a drooling idiot is a bit grating and very misguided.

All I could think of:

Snow Leopard · Dec 29, 2018

Trish said: ↑

I wonder what would be the effect of calling a trial the FROWN trial, the GRIMACE trial, or perhaps even the EVIL trial.
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Best I could do on short notice:
Exercise promoted Viley to cause Injury and Lethargy trial.

Sean · Jan 1, 2019

In functional disorders, the perception of symptoms is as important as actual symptom severity.
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From completely unfounded speculation to The Indisputable Truth, in one step.

Nice work if you can get it.

strategist · Jan 1, 2019

In functional disorders, the perception of symptoms is as important as actual symptom severity.
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Statements like these make it clear that it's time for patients to take on a larger role in medicine and speak for themselves.

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The SMILES trial: do undisclosed recruitment practices explain the remarkably large effect? (2018) Molendijk et al.

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