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<!DOCTYPE html>
<html lang="en"><head>
<script src="Festschrift_Ellen_files/libs/clipboard/clipboard.min.js"></script>
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<meta name="generator" content="quarto-1.3.450">
<meta name="author" content="Professor Argyris Stringaris, MD, PhD, FRCPsych">
<title>Fundamental Flaws in the Appraisal of Adolescent Depression Treatment</title>
<meta name="apple-mobile-web-app-capable" content="yes">
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<section id="title-slide" class="quarto-title-block center">
<h1 class="title">Fundamental Flaws in the Appraisal of Adolescent Depression Treatment</h1>
<p class="subtitle">In honour of Dr Ellen Leibenluft</p>
<div class="quarto-title-authors">
<div class="quarto-title-author">
<div class="quarto-title-author-name">
Professor Argyris Stringaris, MD, PhD, FRCPsych
</div>
</div>
</div>
</section>
<section id="overview" class="slide level2">
<h2>Overview</h2>
<ul>
<li><p>Importance of Adolescent Depression</p></li>
<li><p>How Do We Treat Adolescent Depression?</p></li>
<li><p>The Problem With Comparing Treatments</p></li>
<li><p>Vast Differences in the Control Conditions between Treatment Types.</p></li>
<li><p>Dubious Control Groups for Psychotherapy</p></li>
<li><p>Understanding Human Expectations and Psychiatric Treatments</p></li>
</ul>
</section>
<section id="what-i-learnt-from-ellen" class="slide level2">
<h2>What I learnt from Ellen</h2>
<img data-src="ArgyrisandEllen.png" class="r-stretch"></section>
<section id="what-i-learnt-from-ellen-1" class="slide level2">
<h2>What I learnt from Ellen</h2>
<p>Ellen,</p>
<ul>
<li><p>gave meaning to the concept of irritability and more generally that of negative and aggressive <strong>mood</strong>, something with vast public health implications.</p></li>
<li><p>injected rationality into an extraordinary debate that of the US “Pediatric Bipolar”, and curbing excesses that came from very powerful places.</p></li>
<li><p>is consistently a <strong>Clinical Researcher</strong> with an instinct for what matters to patients and public.</p></li>
<li><p>worked together with an extraordinary team of people and bringing out the most of each.</p></li>
<li><p>is an extraordinary writer.</p></li>
<li><p>has a keen sense and knowledge of history and therefore human fallibility.</p></li>
</ul>
</section>
<section id="importance-of-adolescent-depression" class="slide level2">
<h2>Importance of Adolescent Depression</h2>
<img data-src="adolescent_mental_health.jpeg" class="r-stretch quarto-figure-left"></section>
<section id="how-do-we-treat-adolescent-depression" class="slide level2">
<h2>How Do We Treat Adolescent Depression?</h2>
<img data-src="NICE_1.png" class="r-stretch quarto-figure-left"><p class="caption">National Institute of Clinical Excellence Guidelines</p></section>
<section id="how-do-we-treat-adolescent-depression-1" class="slide level2">
<h2>How Do We Treat Adolescent Depression</h2>
<img data-src="NICE_2.png" class="r-stretch quarto-figure-left"><p class="caption">National Institute of Clinical Excellence Guidelines</p></section>
<section id="how-do-we-treat-adolescent-depression-2" class="slide level2">
<h2>How Do We Treat Adolescent Depression</h2>
<img data-src="AACAP_1.png" class="r-stretch quarto-figure-left"><p class="caption">American Academy of C&A Psychiatry Practice Parameter</p></section>
<section id="how-do-we-treat-adolescent-depression-3" class="slide level2">
<h2>How do We Treat Adolescent Depression</h2>
<img data-src="AACAP_2.png" class="r-stretch quarto-figure-left"></section>
<section id="comparing-treatments" class="slide level2">
<h2>Comparing Treatments</h2>
<p>These recommendations are not based on head to head trials between modalities.</p>
<ul>
<li>only one head-to-head trial exists in adolescent depression.</li>
<li>comparisons rely on the comparison of the results of randomised controlled trials (RCTs) of each modality against RCTs of the other.</li>
<li>In other words, they rest on comparison of comparisons.</li>
</ul>
</section>
<section id="comparing-treatments-clinical-importance" class="slide level2">
<h2>Comparing Treatments: Clinical Importance</h2>
<p>This has potentially vast implications for the health of the public:</p>
<ul>
<li><p>As a patient/carer: which treatment should I/my child take?</p></li>
<li><p>As a health professional: you can take A or/over B</p></li>
<li><p>As a public health official: doctors should …</p></li>
</ul>
</section>
<section id="the-problem-with-comparing-treatments" class="slide level2">
<h2>The Problem With Comparing Treatments</h2>
<ul>
<li><p>In antidepressant studies, the control is the placebo pill</p></li>
<li><p>In psychotherapy studies controls vary substantially</p>
<p>What is tested is:</p></li>
</ul>
<p><span class="math display">\[Effect_{Med} = Effect_{Psy}\]</span></p>
<p>where <em>Effect</em> denotes the effect on depression that either medication (<em>Med</em> ) or psychotherapy (<em>Psy</em>) have.</p>
</section>
<section id="the-problem-with-comparing-treatments-1" class="slide level2">
<h2>The Problem With Comparing Treatments</h2>
<p>In particular, it relies on the equality of controls:</p>
<p><span class="math display">\[Effect_{MedActive} - Effect_{MedControls} = Effect_{PsyActive} - Effect_{PsyControls}\]</span></p>
<p>or:</p>
<p><span class="math display">\[ Effect_{MedControls} = Effect_{PsyControls}\]</span></p>
</section>
<section id="the-problem-with-comparing-treatments-2" class="slide level2">
<h2>The Problem with Comparing Treatments</h2>
<img data-src="appendicitis.png" width="340" class="r-stretch quarto-figure-left"><p>Compare: antibiotics vs surgery:</p>
<ul>
<li><p>Antibiotics improvement rate: 40% on active; 2% on control</p></li>
<li><p>Surgery improvement rate: 80% on active, 42% on control</p></li>
</ul>
</section>
<section id="the-problem-with-comparing-treatments-3" class="slide level2">
<h2>The Problem with Comparing Treatments</h2>
<p>Compare: antibiotics vs surgery:</p>
<ul>
<li><p>Antibiotics improvement rate: 40% on active; 0% on control</p></li>
<li><p>Surgery improvement rate: 80% on active, 40% on control</p></li>
</ul>
<p>Would you tell your patient that these are equally good treatments?</p>
</section>
<section id="comparing-treatments-mechanistic-implications" class="slide level2">
<h2>Comparing Treatments: Mechanistic Implications</h2>
<p>If there is variability in control arms, then:</p>
<ul>
<li><p>is it random?</p></li>
<li><p>does it tell us something about how treatments work? e.g. :</p>
<ul>
<li><p>what are the psychological mechanisms of placebo?</p></li>
<li><p>why would people find other control groups unfavourable?</p></li>
</ul></li>
<li><p>more generally, what is an appropriate counterfactual to treatment?</p></li>
</ul>
</section>
<section id="assessing-treatment-comparisons-methods" class="slide level2">
<h2>Assessing Treatment Comparisons: Methods</h2>
<ul>
<li><p>Extracted baseline and follow up means and sds for each study (where available) from all randomised controlled trials (RCTs) in adolescent depression using medication or psychotherapy.</p></li>
<li><p>Estimated Standardised Mean Differences (SMD) for each study.</p>
<p><span class="math display">\[SMD_{change} = \frac{Mean_{t_{2}} - Mean_{t_{1}}}{\frac{SD_{t{2}} + SD_{t{1}}}2}\ \]</span></p></li>
</ul>
</section>
<section id="assessing-treatment-comparisons-methods-1" class="slide level2">
<h2>Assessing Treatment Comparisons: Methods</h2>
<p>We also needed the estimation of the standard errors. For this we require the test-retest correlation coefficient of the instrument, which is not reported in studies:</p>
<p><span class="math display">\[SE_{change} = \sqrt{\frac{r_{t_{1}t_{2}}}{n} + \frac{SMD^2}{2n}}\]</span></p>
<p>We therefore simulated 1000 datasets with correlations coefficients from a broad distribution and used these for our calculations–the magnitude of <span class="math inline">\(r_{t_{1}t_{2}}\)</span> made very little difference to results.</p>
</section>
<section id="assessing-treatment-comparisons-methods-2" class="slide level2">
<h2>Assessing Treatment Comparisons: Methods</h2>
<p>Random Effects Meta-Regression</p>
<p><span class="math display">\[Y_i = x_i\beta_i + u_i + \epsilon_i\]</span></p>
<p>where</p>
<p><span class="math display">\[ \begin{aligned}
Υ_i &=
\begin{cases}
0 & MedControl: b_0 + u_i + \epsilon_i\\
1 & MedActive: b_0 + b_{1_{i}} + u_i + \epsilon_i \\
2 & PsyActive: b_0 + b_{2_{i}} + u_i + \epsilon_i \\
3 & PsyControl: b_0 + b_{3_{i}} + u_i + \epsilon_i \\
\end{cases}
\end{aligned}\]</span></p>
</section>
<section id="assessing-treatment-comparisons-results" class="slide level2">
<h2>Assessing Treatment Comparisons: Results</h2>
<p>There were 81 studies in total</p>
<ul>
<li><p>antidepressants: 28 active arms and 25 control arms of antidepressant trials;</p></li>
<li><p>psychotherapy: 55 active arms and 52 control arms from psychotherapy trials.</p></li>
<li><p>Placebo was the control condition for all medication trials</p></li>
<li><p>WL controls, care as usual and several other conditions such as attention control for psychotherapy</p></li>
</ul>
</section>
<section id="assessing-treatment-comparisons-smds-overall" class="slide level2">
<h2>Assessing Treatment Comparisons: SMDs overall</h2>
<img data-src="plot_means_all.png" class="r-stretch quarto-figure-left"></section>
<section id="assessing-treatment-comparisons-smds-cbt-and-sri-only" class="slide level2">
<h2>Assessing Treatment Comparisons: SMDs CBT and SRI only</h2>
<img data-src="plot_means_cbt.png" class="r-stretch quarto-figure-left"></section>
<section id="assessing-treatment-comparisons-smds-no-waitlist" class="slide level2">
<h2>Assessing Treatment Comparisons: SMDs no waitlist</h2>
<img data-src="plot_means_wl.png" class="r-stretch quarto-figure-left"></section>
<section id="assessing-treatment-comparisons-differences" class="slide level2">
<h2>Assessing Treatment Comparisons: differences</h2>
<img data-src="coef_pic.png" width="361" class="r-stretch quarto-figure-left"></section>
<section id="what-were-the-controls" class="slide level2">
<h2>What were the controls?</h2>
<ul>
<li><p>Mostly waitlist (WL) and care-as-usual (CAU).</p></li>
<li><p>Others were attention controls, which were typically poorly matched to active groups.</p></li>
<li><p>Often information was missing on key variables.</p></li>
</ul>
</section>
<section id="what-is-a-good-control" class="slide level2">
<h2>What is a good control?</h2>
<p>Controls should serve as counterfactuals: what would an individual look like if they did not receive treatment?</p>
<p>There should be a <strong>latent true value</strong> of what an individual would look like had they not received the treatment.</p>
</section>
<section id="what-is-a-good-control-1" class="slide level2">
<h2>What is a good control?</h2>
<p>A good control is crucially <strong>ΝΟΤ</strong> being told that you were allocated to:</p>
<ul>
<li><p>simply waiting (WL control)</p></li>
<li><p>getting what they would have gotten anyway (CAU control), which is heterogeneous (and in our field sometimes not much at all).</p></li>
<li><p>receiving a sub-par treatment that the experimenter themselves do not believe in (some ill-designed control).</p>
<p>All this also whilst <strong>knowing</strong> that someone else (other people in the trial) got the “real thing”. This creates negative counterfactual compared to treatment.</p></li>
</ul>
</section>
<section id="are-there-alternative-explanations-for-the-finding" class="slide level2">
<h2>Are there alternative explanations for the finding?</h2>
<ul>
<li><p>could it be due to different instruments used?</p>
<ul>
<li>No, even when using common instruments, such as CDRS and HAM-D, the results were the same.</li>
</ul></li>
<li><p>could there be more regression to the mean in the medication group.</p>
<ul>
<li><p>There could be, the values are higher at baseline in most studies (with common instruments)</p></li>
<li><p>But the difference is very large, even when matching studies with the same baseline values.</p></li>
<li><p>We are thinking of ways of dealing with this statistically at present.</p></li>
</ul></li>
</ul>
</section>
<section id="where-to-next" class="slide level2">
<h2>Where to next?</h2>
<p>At a practical level:</p>
<ul>
<li><p>change guidelines, at the very least they should be toned down.</p></li>
<li><p>impose more rigorous controls on psychotherapy studies.</p></li>
<li><p>actively research the social and neurobiological underpinnings of control conditions. This has to include:</p>
<ul>
<li><p>expectancy effects</p></li>
<li><p>opportunity cost</p></li>
</ul></li>
<li><p>think about the ethical implications of control groups.</p></li>
</ul>
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