tag:theconversation.com,2011:/ca/topics/randomised-controlled-trial-23674/articlesRandomised controlled trial – The Conversation2019-05-19T19:37:55Ztag:theconversation.com,2011:article/1161632019-05-19T19:37:55Z2019-05-19T19:37:55ZNot every school’s anti-bullying program works – some may actually make bullying worse<figure><img src="https://images.theconversation.com/files/275066/original/file-20190517-69178-10kdsvs.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Most anti-bullying programs available to schools haven't been evaluated for effectiveness.</span> <span class="attribution"><span class="source">from shutterstock.com</span></span></figcaption></figure><p>School bullying can have serious consequences for victims including <a href="https://www.ncbi.nlm.nih.gov/pubmed/18250239">depression</a>, <a href="https://www.ncbi.nlm.nih.gov/pubmed/19414712">psychosis</a>, <a href="https://www.bmj.com/content/344/bmj.e2683">self-harm</a> and <a href="https://pediatrics.aappublications.org/content/135/2/e496">suicide</a>. With increasing evidence of harm, a groundswell of school anti-bullying programs and campaigns in <a href="https://bullyingnoway.gov.au/NationalDay/Pages/Participating-schools.aspx">Australia</a> and <a href="https://www.daysoftheyear.com/days/day-of-bullying-prevention/">internationally</a> have vowed to stamp out bullying. </p>
<p>The schools’ intentions are good, but often these programs have not been properly evaluated for effectiveness, and studies show some types of programs can actually make bullying worse.</p>
<h2>School programs</h2>
<p>There is no shortage of <a href="https://beyou.edu.au/resources/programs-directory?query=bullying&sort=asc">anti-bullying programs</a> offered to schools. The <a href="https://jamanetwork.com/journals/jamapediatrics/fullarticle/569481">programs are varied</a> and can include teaching resources and discipline plans, as well as student and teacher training, parent meetings and improved playground supervision. </p>
<p>Most programs <a href="https://beyou.edu.au/resources/programs-directory?query=bullying&sort=asc">cite a theoretical base</a> to support their approach but not an evaluation of the specific program. For instance, educational campaigns in <a href="http://www.upstand.org/">many countries</a>, including Australia and New Zealand, emphasise the role of <a href="https://bullyingnoway.gov.au/NationalDay/ForSchools/LessonPlans/Pages/Stand-Together-2013.aspx">student bystanders</a> in standing up against bullying.</p>
<p>Educational videos show students how they can make a big difference by standing up for the victim when they witness bullying.</p>
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<p>The theory behind using bystanders to address bullying goes back to an <a href="https://psycnet.apa.org/record/2001-05565-005">observational study</a> conducted in 2001. Observational studies are where researchers observe behaviour in a natural setting, rather than placing participants in certain experimental conditions. </p>
<p>In the 2001 study, researchers observed 58 children aged 6-12 intervene in bullying. Most (57%) interventions stopped the bullying. Overall, the study showed bullying often stops when students spontaneously stand up for a bullied peer. Since then, many school-based anti-bullying <a href="https://www.researchgate.net/publication/271623426_Participant_Roles_in_Bullying_How_Can_Peer_Bystanders_Be_Utilized_in_Interventions">programs have emphasised</a> bystander action. </p>
<p>But a 2010 synthesis of <a href="https://link.springer.com/article/10.1007/s11292-010-9109-1">many studies</a> found programs encouraging students to help actually made bullying <em>worse</em>. This study was a meta-analysis, meaning it pulled together results of well-designed studies conducted at that time on the effectiveness of anti-bullying programs. </p>
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Read more:
<a href="https://theconversation.com/is-your-child-less-likely-to-be-bullied-in-a-private-school-44917">Is your child less likely to be bullied in a private school?</a>
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<p>There are several ways to explain these different findings. Firstly, in the <a href="https://psycnet.apa.org/record/2001-05565-005">observational study</a> the effect on bullying was judged in the few seconds after the bystander action. We don’t know if bullying resumed the next day. The meta-analysis included studies that examined bullying weeks or months later. We know from <a href="https://www.tandfonline.com/doi/abs/10.1207/S1532480XADS0504_03">previous research</a> that actions that seem effective in the short-term can have harmful long-term effects. </p>
<p>There may also be crucial differences between naturally occurring bystander actions and those encouraged by schools. The effectiveness in natural situations may rely on who the student bystander is and their relationship with those involved in bullying. School programs may encourage students with poor skills to get involved which may escalate the situation. </p>
<p>Future research may explain differences between effective and ineffective bystander actions. In the meantime, schools should exercise caution in using this approach. </p>
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<img alt="" src="https://images.theconversation.com/files/275272/original/file-20190519-69195-1hrvr5g.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/275272/original/file-20190519-69195-1hrvr5g.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/275272/original/file-20190519-69195-1hrvr5g.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/275272/original/file-20190519-69195-1hrvr5g.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/275272/original/file-20190519-69195-1hrvr5g.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/275272/original/file-20190519-69195-1hrvr5g.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/275272/original/file-20190519-69195-1hrvr5g.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Bystander involvement can make bullying worse.</span>
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<h2>Difference among programs</h2>
<p>The 2010 <a href="https://link.springer.com/article/10.1007/s11292-010-9109-1">meta-analysis</a> showed that, overall, school-based anti-bullying programs decrease bullying and victimisation by around 20%, with similar reductions for <a href="https://www.healthevidence.org/view-article.aspx?a=cyberbullying-intervention-prevention-programs-effective-systematic-meta-34286">cyber-bullying</a>. But this and other <a href="https://www.sciencedirect.com/science/article/pii/S0190740915301286">meta-analyses report</a> substantial differences <em>between</em> programs. </p>
<p>Another recent meta-analysis looked separately at anti-bullying programs in primary schools and high schools. On average, programs in primary schools were effective. But in high schools, anti-bullying programs were <a href="https://psycnet.apa.org/record/2015-03725-001">just as likely</a> to make bullying <em>worse</em> as they were to improve it. The exact reason for these differences is not known.</p>
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Read more:
<a href="https://theconversation.com/i-dont-want-to-be-teased-why-bullied-children-are-reluctant-to-seek-help-from-teachers-74357">'I don’t want to be teased' – why bullied children are reluctant to seek help from teachers</a>
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<p>There are many reasons why efforts to change behaviour may have <a href="https://academic.oup.com/joc/article-abstract/57/2/293/4102644">unintended negative effects</a>. Perhaps the emphasis on stopping bullying in high schools provokes student who bully and undermines the reputation of students who are bullied. </p>
<h2>So, which programs work?</h2>
<p>The 2010 <a href="https://link.springer.com/article/10.1007/s11292-010-9109-1">meta-analysis</a> showed programs that reduce bullying are likely to take more time to implement, involve parent meetings, firm disciplinary methods and improved playground supervision. </p>
<p>It can be hard for schools to know what programs are effective because this takes a lot of time. There are independent scientific organisations that evaluate evidence for program effectiveness. These include <a href="https://www.blueprintsprograms.org/images/standards_of_evidence.jpg">Blueprints</a> (US) and the <a href="https://guidebook.eif.org.uk/eif-evidence-standards">Early Intervention Foundation</a> (UK).</p>
<p>To really know if a program works, research needs to compare outcomes over time between students who receive the program and students who don’t. It is also best to randomly allocate students or schools to receiving the program or not, to help ensure the groups are equivalent in the first place. These types of studies are called randomised controlled trials.</p>
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Read more:
<a href="https://theconversation.com/randomised-control-trials-what-makes-them-the-gold-standard-in-medical-research-78913">Randomised control trials: what makes them the gold standard in medical research?</a>
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<p>Programs that have been shown to be effective by randomised controlled trials include the Friendly Schools Program and Positive Behaviour for Learning. The <a href="https://beyou.edu.au/resources/programs-directory/friendly-schools-plus">Friendly Schools Plus program</a> helps schools build supportive practices, teach social skills and build partnerships with parents. A <a href="https://www.tandfonline.com/doi/abs/10.1080/01411920903420024">randomised controlled trial showed</a> this program reduced victimisation and observations of bullying over three years. </p>
<p>Positive Behaviour for Learning <a href="https://pbl.schools.nsw.gov.au/">helps schools improve discipline</a> by teaching expected behaviour and establishing clear rewards and consequences. It is widely used in Australian schools. A randomised controlled trial <a href="https://www.ncbi.nlm.nih.gov/pubmed/22312173">found this program</a> reduced bullying in primary schools. </p>
<p>Schools are under great pressure to visibly take action against bullying. However, caution is needed, especially in high schools, because many programs that sound like a good idea can make bullying worse. Schools should stick with what they know works and only adopt new programs that have been adequately evaluated.</p><img src="https://counter.theconversation.com/content/116163/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dr Karyn Healy is a researcher affiliated with the Parenting and Family Support Centre at The University of Queensland and a psychologist with many years experience working with schools and families to address bullying. Karyn is co-author of a family intervention for children bullied at school; however, family interventions are not the focus of this article. Karyn is a member of the Queensland Anti-Cyberbullying Committee, but not a spokesperson for this committee; this paper presents only her own professional views. Karyn has no conflict of interest in relation to the school anti-bullying programs described in this article. </span></em></p>Many anti-bullying programs in schools rely on witnesses to stand up to bullies. This is good in theory but an evaluation of such programs has found in some cases, interference can worsen the problem.Karyn Healy, Researcher, The University of QueenslandLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1169802019-05-16T15:11:48Z2019-05-16T15:11:48ZUltra-processed food causes weight gain – firm evidence at last<figure><img src="https://images.theconversation.com/files/274620/original/file-20190515-60570-1rum0h2.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/191566283?src=rUOWgxwA6RHl4LyMQwoJ-Q-1-0&size=medium_jpg">Darryl Brooks/Shutterstock</a></span></figcaption></figure><p>We know we should eat less junk food, such as crisps, industrially made pizzas and sugar-sweetened drinks, because of their high calorie content. These “ultra-processed” foods, as they are <a href="https://www.ncbi.nlm.nih.gov/pubmed/19366466">now called</a> by nutritionists, are high in sugar and fat, but is that the only reason they cause weight gain? An important <a href="https://www.cell.com/cell-metabolism/fulltext/S1550-4131(19)30248-7">new trial</a> from the US National Institute of Health (NIH) shows there’s a lot more at work here than calories alone.</p>
<p>Studies have <a href="https://www.ncbi.nlm.nih.gov/pubmed/29071481">already found</a> an association between junk foods and weight gain, but this link has never been investigated with a randomised controlled trial (RCT), the gold standard of clinical studies. </p>
<p>In the NIH’s RCT, 20 adults aged about 30 were randomly assigned to either a diet of ultra-processed foods or a “control” diet of unprocessed foods, both eaten as three meals plus snacks across the day. Participants were allowed to eat as much as they wished. </p>
<p>After two weeks on one of the diets, they were switched to the other for a further two weeks. This type of crossover study improves the reliability of the results since each person takes part in both arms of the study. The study found that, on average, participants ate 500 calories more per day when consuming the ultra-processed diet, compared to when eating the diet of unprocessed foods. And on the ultra-processed diet, they gained weight – almost a kilogram. </p>
<p>Although we know that ultra-processed foods can be quite addictive, the participants reported finding the two diets equally palatable, with no awareness of having a greater appetite for the ultra-processed foods than for the unprocessed foods, despite consuming 500 calories more of them per day. </p>
<p>Unconscious over-consumption of ultra-processed foods is <a href="https://www.ncbi.nlm.nih.gov/pubmed/21094194">often attributed to snacking</a>. But in this study, most of the excess calories were consumed during breakfast and lunch, not as snacks.</p>
<h2>Slow eating, not fast food</h2>
<p>A crucial clue as to why the ultra-processed foods caused greater calorie consumption may be that participants ate the ultra-processed meals faster and so consumed more calories per minute. This can cause excess calorie intake before the body’s signals for satiety or fullness <a href="https://www.ncbi.nlm.nih.gov/pubmed/20351697">have time to kick in</a>.</p>
<p>An important satiety factor in unprocessed foods is dietary fibre. Most ultra-processed foods contain little fibre (most or all of it is lost during their manufacture) and so are easier to eat fast. </p>
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<img alt="" src="https://images.theconversation.com/files/274621/original/file-20190515-60549-1a1jlwn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/274621/original/file-20190515-60549-1a1jlwn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/274621/original/file-20190515-60549-1a1jlwn.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/274621/original/file-20190515-60549-1a1jlwn.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/274621/original/file-20190515-60549-1a1jlwn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/274621/original/file-20190515-60549-1a1jlwn.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/274621/original/file-20190515-60549-1a1jlwn.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Fibre is important for satiety.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/126705143?src=Wvrf-_WOO9iX44b8vLlPJQ-1-1&size=medium_jpg">Robyn Mackenzie/Shutterstock</a></span>
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<p>Anticipating this, the NIH researchers equalised the fibre content of their two diets by adding a fibre supplement to the ultra-processed diet in drinks. But fibre supplements are not the same thing as fibre in unprocessed foods. </p>
<p>Fibre in unprocessed food is an integral part of the food’s structure – or the food matrix, as it’s called. And an intact food matrix slows down how quickly we consume calories. For instance, it takes us far longer to chew through a whole orange with its intact food matrix than it does to gulp down the equivalent calories as orange juice. </p>
<p>An interesting message emerging from this <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3973680/">and other studies</a> seems to be that to regulate calorie intake, we must retain food structure, like the natural food matrix of unprocessed foods. This obliges us to eat more slowly, allowing time for the body’s satiety mechanisms to activate before we have eaten too much. This mechanism does not operate with ultra-processed foods since the food matrix is lost during manufacture. </p>
<p>Finding time for a meal of unprocessed foods eaten slowly can be a real challenge for many. But the importance of seated mealtimes is an approach vigorously defended in some countries, such as France, where a succession of small courses ensures a more leisurely – and pleasurable – way of eating. And it may also be an important antidote to the weight gain caused by grabbing a quick meal of ultra-processed foods.</p><img src="https://counter.theconversation.com/content/116980/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Richard Hoffman does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Robust new study finds weight gain may be due to more than just the calories.Richard Hoffman, Lecturer in Nutritional Biochemistry, University of HertfordshireLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1005792018-08-15T23:02:57Z2018-08-15T23:02:57ZThe real promise of LSD, MDMA and mushrooms for medical science<figure><img src="https://images.theconversation.com/files/229652/original/file-20180727-106496-1ceklm9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Scientific pursuits need to be coupled with a humanist tradition — to highlight not just how psychedelics work, but why that matters. </span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><p>Psychedelic science is making a comeback. </p>
<p>Scientific publications, therapeutic breakthroughs and cultural endorsements suggest that <a href="https://www.theglobeandmail.com/life/health-and-fitness/article-after-decades-of-dormancy-psychedelic-research-makes-a-comeback/">the historical reputation of psychedelics</a> — such as lysergic acid diethylamide (LSD), mescaline (from the peyote cactus) and psilocybin (mushrooms) — as dangerous or inherently risky have unfairly overshadowed a more optimistic interpretation. </p>
<p>Recent publications, like Michael Pollan’s <a href="https://www.penguinrandomhouse.com/books/529343/how-to-change-your-mind-by-michael-pollan/9781594204227/"><em>How to Change your Mind</em></a>, showcase the creative and potentially therapeutic benefits that psychedelics have to offer — for mental health challenges like depression and addiction, <a href="http://www.sciencemag.org/news/2016/12/hallucinogenic-drugs-help-cancer-patients-deal-%20their-fear-death">in palliative care settings</a> and for personal development. </p>
<p>Major scientific journals have published articles showing <a href="http://www.maps.org/resources/psychedelic-bibliography">evidence-based reasons for supporting research in psychedelic studies</a>. These include evidence that <a href="http://journals.sagepub.com/doi/full/10.1177/0269881116675513">pscilocybin significantly reduces anxiety in patients with life-threatening illnesses</a> like cancer, that MDMA (3,4-methylenedioxy-methamphetaminecan; also known as ecstasy) <a href="http://journals.sagepub.com/doi/abs/10.1177/0269881112464827">improves outcomes for people suffering from PTSD</a> and that <a href="http://journals.sagepub.com/doi/abs/10.1177/0269881111420188">psychedelics can produce sustained feelings of openness that are both therapeutic and personally enriching</a>. </p>
<p>Other researchers are investigating the traditional uses of plant medicines, such as ayahuasca, and exploring <a href="https://www.sciencedirect.com/science/article/abs/pii/S0361923016300454#!">the neurological and psychotherapeutic benefits of combining Indigenous knowledge with modern medicine</a>.</p>
<p>I am a medical historian, exploring why we now think that psychedelics may have a valuable role to play in human psychology, and why over 50 years ago, during the heyday of psychedelic research, we rejected that hypothesis. What has changed? What did we miss before? Is this merely a flashback?</p>
<h2>Healing trauma, anxiety, depression</h2>
<p>In 1957, the word <em>psychedelic</em> officially entered the English lexicon, introduced by <a href="https://nyaspubs.onlinelibrary.wiley.com/doi/abs/10.1111/j.1749-6632.1957.tb40738.x">British-trained and Canadian-based psychiatrist Humphry Osmond</a>. </p>
<p>Osmond studied mescaline from the peyote cactus, synthesized by German scientists in the 1930s, and <a href="https://link.springer.com/chapter/10.1007%2F978-1-4614-0959-5_22">LSD, a laboratory-produced substance created by Albert Hofmann at Sandoz in Switzerland</a>. During the 1950s and into the 1960s, more than 1,000 scientific articles appeared as researchers around the world interrogated the potential of these psychedelics for healing addictions and trauma. </p>
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<img alt="" src="https://images.theconversation.com/files/229658/original/file-20180727-106496-gys7ad.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/229658/original/file-20180727-106496-gys7ad.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=401&fit=crop&dpr=1 600w, https://images.theconversation.com/files/229658/original/file-20180727-106496-gys7ad.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=401&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/229658/original/file-20180727-106496-gys7ad.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=401&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/229658/original/file-20180727-106496-gys7ad.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=504&fit=crop&dpr=1 754w, https://images.theconversation.com/files/229658/original/file-20180727-106496-gys7ad.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=504&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/229658/original/file-20180727-106496-gys7ad.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=504&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">In this January 1967 file photo, Timothy Leary addresses a crowd of hippies at the ‘Human Be-In’ that he helped organize in Golden Gate Park, San Francisco, Calif.</span>
<span class="attribution"><span class="source">(AP Photo/Bob Klein)</span></span>
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<p>But, by the end of the 1960s, most legitimate psychedelic research ground to a halt. Some of the research had been deemed unethical, <a href="http://books.wwnorton.com/books/The-Search-for-the-Manchurian-Candidate/">namely mind-control experiments conducted under the auspices of the CIA</a>. Other researchers had been discredited for either unethical or self-aggrandizing use of psychedelics, or both. </p>
<p><a href="https://www.salon.com/2013/12/14/timothy_learys_liberation_and_the_cias_experiments_lsds_amazing_psychedelic_history/">Timothy Leary was perhaps the most notorious character in that regard</a>. Having been dismissed from Harvard University, he launched a recreational career as a self-appointed apostle of psychedelic living. </p>
<p>Drug regulators struggled to balance a desire for scientific research with <a href="https://academic.oup.com/jhmas/article-abstract/69/2/221/748833">a growing appetite for recreational use, and some argued abuse, of psychedelics</a>. </p>
<p>In the popular media, <a href="http://www.saynotodrugs.in/facts-about-lsd/">these drugs came to symbolize hedonism and violence</a>. In the United States, <a href="https://circulatingnow.nlm.nih.gov/2017/03/30/lsd-insight-or-insanity-1968/">the government sponsored films aimed at scaring viewers about the long-term and even deadly consequences of taking LSD</a>. Scientists were hard-pressed to maintain their credibility as popular attitudes began to shift.</p>
<p>Now that interpretation is beginning to change.</p>
<h2>A psychedelics revival</h2>
<p>In 2009, <a href="https://www.theguardian.com/politics/2009/oct/30/drugs-adviser-david-nutt-sacked">Britain’s chief drug adviser, David Nutt, reported that psychedelic drugs had been unfairly prohibited</a>. He argued that substances such as alcohol and tobacco were in fact much more dangerous to consumers than drugs like LSD, ecstasy (MDMA) and mushrooms (psilocybin). </p>
<p>He was fired from his advisory position as a result, but <a href="https://www.sciencedirect.com/science/article/pii/S0140673610614626">his published claims helped to reopen debates on the use and abuse of psychedelics</a>, both in scientific and policy circles.</p>
<p>And Nutt was not alone. Several well-established researchers began joining the chorus of support for new regulations allowing researchers to explore and reinterpret the neuroscience behind psychedelics. Studies ranged from those <a href="http://www.pnas.org/content/113/17/4853.short">looking at the mechanisms of drug reactions</a> to those <a href="https://doi.org/10.1007/s00213-017-4771-x">revisiting the role of psychedelics in psychotherapy</a>.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/231973/original/file-20180814-2903-yn3fhf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/231973/original/file-20180814-2903-yn3fhf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=419&fit=crop&dpr=1 600w, https://images.theconversation.com/files/231973/original/file-20180814-2903-yn3fhf.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=419&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/231973/original/file-20180814-2903-yn3fhf.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=419&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/231973/original/file-20180814-2903-yn3fhf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=526&fit=crop&dpr=1 754w, https://images.theconversation.com/files/231973/original/file-20180814-2903-yn3fhf.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=526&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/231973/original/file-20180814-2903-yn3fhf.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=526&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">In this April 2010 photo, one gram of psilocybin is seen on a scale at New York University, where a study investigated the effects of hallucinogenic drugs on the emotional and psychological state of advanced cancer patients.</span>
<span class="attribution"><span class="source">(AP Photo/Seth Wenig)</span></span>
</figcaption>
</figure>
<p>In 2017, Oakland, Calif., hosted the largest gathering to date of psychedelic scientists and researchers. Boasting attendance of more than 3,000 participants, <a href="http://psychedelicscience.org/">Psychedelic Science 2017</a> brought together researchers and practitioners with a diverse set of interests in reviving psychedelics — from filmmakers to neuroscientists, journalists, psychiatrists, artists, policy advisers, comedians, historians, anthropologists, Indigenous healers and patients. </p>
<p>The conference was co-hosted by the leading organizations dedicated to psychedelics — <a href="http://www.maps.org/resources/psychedelic-bibliography">including the Multidisciplinary Association for Psychedelic Studies (MAPS)</a> and <a href="http://beckleyfoundation.org">The Beckley Foundation</a> — and participants were exposed to cutting-edge research.</p>
<h2>Measuring reaction, not experience</h2>
<p>As a historian, however, I am trained to be cynical about trends that claim to be new or innovative. We learn that often we culturally tend to forget the past, or ignore the parts of the past that seem beyond our borders. </p>
<p>For that reason, I am particularly interested in understanding the so-called psychedelic renaissance and what makes it different from the psychedelic heyday of the 1950s and 1960s.</p>
<p>The historic trials were conducted at the very early stages of the pharmacological revolution, which ushered in new methods for evaluating efficacy and safety, culminating in the randomized controlled trial (RCT). Prior to standardizing that approach, however, most pharmacological experiments relied on case reports and data accumulation that did not necessarily involve blinded or comparative techniques. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/231972/original/file-20180814-2894-1mobpn5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/231972/original/file-20180814-2894-1mobpn5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=392&fit=crop&dpr=1 600w, https://images.theconversation.com/files/231972/original/file-20180814-2894-1mobpn5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=392&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/231972/original/file-20180814-2894-1mobpn5.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=392&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/231972/original/file-20180814-2894-1mobpn5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=492&fit=crop&dpr=1 754w, https://images.theconversation.com/files/231972/original/file-20180814-2894-1mobpn5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=492&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/231972/original/file-20180814-2894-1mobpn5.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=492&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Shaman Pablo Flores pours ayahuasca into a plastic cup during a sacred ceremony in the Peruvian Jungle in May 2018.</span>
<span class="attribution"><span class="source">(AP Photo/Martin Mejia)</span></span>
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<p>Historically, scientists were keen to separate pharmacological substances from their organic cultural, spiritual and healing contexts — the RCT is a classic representation of our attempts to measure reaction rather than to interpret experience. Isolating the drug from an associated ritual might have more readily conveyed an image of progress, or a more genuine scientific approach. </p>
<p>Today, however, psychedelic investigators are beginning <a href="https://www.theglobeandmail.com/opinion/the-profound-power-of-an-amazonian-plant-and-the-respect-it-demands/article27895775/">to question the decision to excise the drug from its Indigenous or ritualized practices</a>. </p>
<p>Over the past 60 years, we have invested more in psychopharmacological research than ever before. American economists estimate <a href="http://www.dx.doi.org/10.1111/j.1468-0009.2005.00347.x">the amount of money spent on psychopharmacology research to be in the billions annually</a>. </p>
<h2>Rethinking the scientific method</h2>
<p>Modern science has focused attention on data accrual — measuring reactions, identifying neural networks and discovering neuro-chemical pathways. It has moved decidedly away from larger philosophical questions of how we think, or what is human consciousness or how human thoughts are evolving. </p>
<p>Some of <a href="http://www.mqup.ca/psychedelic-prophets-products-9780773555068.php">those questions inspired the earlier generation of researchers to embark on psychedelic studies in the first place</a>.</p>
<p>We may now have more sophisticated tools for advancing the science of psychedelics. But psychedelics have always inspired harmony between brain and behaviour, individuals and their environments, and an appreciation for western and non-western traditions mutually informing the human experience. </p>
<p>In other words, scientific pursuits need to be coupled with a humanist tradition — to highlight not just how psychedelics work, but why that matters.</p><img src="https://counter.theconversation.com/content/100579/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Erika Dyck receives funding from Social Sciences and Humanities Council (Canada).</span></em></p>Once associated with mind-control experiments and counter-cultural defiance, psychedelics now show great promise for mental health treatments and may prompt a re-evaluation of the scientific method.Erika Dyck, Professor and Canada Research Chair in the History of Medicine, University of SaskatchewanLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/941092018-03-29T01:08:06Z2018-03-29T01:08:06ZTrust Me, I’m An Expert: Brain-zapping, the curious case of the n-rays and other stories of evidence<figure><img src="https://images.theconversation.com/files/212509/original/file-20180328-109190-wfp2bl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Evidence isn't always as straightforward as it might first seem. </span> <span class="attribution"><span class="source">Mai Lam/The Conversation NY-BD-CC</span>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span></figcaption></figure><p>You’ve had an x-ray before but have you had an n-ray? Of course not, because they’re not real. </p>
<p>But people used to think they were. Scientists had <em>shown</em> they were. And the weird history of n-rays, explored in today’s episode of Trust Me, I’m An Expert, tells us a lot about people’s willingness to believe wrong information – but also how well-designed studies can debunk myths, reveal important truths and bring good evidence to the surface.</p>
<p>Today, we’re bringing you stories on the theme of evidence. We’d love you to listen to the whole thing, but here are a few snippets to get you started.</p>
<h2>What would a digital forensics expert find in your phone’s photo reel?</h2>
<p>Richard Matthews, an expert on forensic identification, was given photos from the phones of two Conversation editors. It was unsettling how much information he was able to unearth from the metadata hidden in these photos.</p>
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<h2>Why would someone be a guinea pig in a science experiment?</h2>
<p>We talk with a woman who was part of a randomised controlled trial on how a new treatment called <a href="https://www.blackdoginstitute.org.au/research/participate-in-our-research/for-people-with-depression/dcs">transcranial direct current stimulation (tDCS)</a> might affect people with depression. And Laurent Billot, a biostatistician and an expert on study design, explains how everyone can benefit when people volunteer to participate in a randomised trial.</p>
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<h2>Sham surgery, double-blinding and scurvy</h2>
<p>Andrew Leigh, the federal member for Fenner and Labor’s shadow assistant treasurer, was a professor of economics in a previous life. </p>
<p>Today he’s talking with Fiona Fidler, an expert on the history of science and the replication crisis, about some of the ideas he explores in his new book <a href="https://www.blackincbooks.com.au/books/randomistas">Randomistas: How radical researchers changed our world.</a></p>
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<h2>The weird history of n-rays</h2>
<p>Conversation editor Madeleine De Gabriele tells us about a form of radiation “discovered” in 1903: n-rays. Later debunked as myth, the n-rays case tells us a lot about how much people are influenced by what they believe to be true. She spoke to Will Grant, who researches public awareness of science.</p>
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<h2>What the studies show about treating depression with a gentle electric current to the head</h2>
<p>We’re ending today’s show with Professor Colleen Loo, who shares with us some of the promising results from the <a href="https://www.blackdoginstitute.org.au/research/participate-in-our-research/for-people-with-depression/dcs">transcranial direct current stimulation (tDCS)</a> study we mentioned earlier:</p>
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<p>For support, call Beyond Blue on 1300 22 4636, Lifeline on 13 11 14 or visit <a href="https://headspace.org.au/?gclid=EAIaIQobChMIstuN3oHK2QIVUY6PCh2ZoA_aEAAYASAAEgL69vD_BwE">Headspace</a>, which has information for schools, young people, and family and friends.</p>
<p>Trust Me, I’m An Expert is out at the start of every month. Find us and subscribe in <a href="https://itunes.apple.com/au/podcast/trust-me-im-an-expert/id1290047736?mt=2">Apple Podcasts</a>, <a href="https://play.pocketcasts.com/">Pocket Casts</a> or wherever you get your podcasts.</p>
<hr>
<h2>Additional audio</h2>
<p>Kindergarten, Unkle Ho, from <a href="https://www.elefanttraks.com/">Elefant Traks</a></p>
<p>Free Music Archive, <a href="http://freemusicarchive.org/music/Teeth_Mountain/Teeth_Mtn_CD-R/Ghost_Science">Ghost Science</a> by Teeth Mountain</p>
<p>Free Music Archive, <a href="http://freemusicarchive.org/music/Blue_Dot_Sessions/The_Contessa/Wisteria">Wisteria</a> by Blue Dot Sessions</p><img src="https://counter.theconversation.com/content/94109/count.gif" alt="The Conversation" width="1" height="1" />
You've had an x-ray before but have you had an n-ray? Of course not, because they're not real. But people used to think they were. Today, on Trust Me, I'm an Expert, we're bringing you stories on the theme of evidence.Sunanda Creagh, Senior EditorMadeleine De Gabriele, Deputy Editor: Energy + EnvironmentLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/932822018-03-15T05:12:31Z2018-03-15T05:12:31ZSpeaking with: Andrew Leigh on why we need more randomised trials in policy and law<figure><img src="https://images.theconversation.com/files/210870/original/file-20180317-104635-kisec6.jpeg?ixlib=rb-1.1.0&rect=0%2C0%2C1175%2C1177&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">AndrewLeigh.com</span>, <span class="license">Author provided</span></span></figcaption></figure><p><a href="https://theconversation.com/randomised-control-trials-what-makes-them-the-gold-standard-in-medical-research-78913">Randomised controlled trials</a> are the gold standard in medical research. Researchers divide participants into two groups using the equivalent of flipping a coin, with one group getting a new treatment and a control group getting either the standard treatment or a placebo. It’s the best way to prove that a new treatment works.</p>
<p>But the benefits of randomised trials aren’t limited to medical applications. Big businesses – like Amazon, Google, <a href="https://theconversation.com/facebook-will-continue-experimenting-on-users-under-closed-guidelines-32510">Facebook</a> and even media organisations – are increasingly <a href="https://theblog.okcupid.com/we-experiment-on-human-beings-5dd9fe280cd5">using randomised trials</a> to test designs and processes that increase their engagement with users and customers. Every time you Google something you’re probably participating in a randomised trial.</p>
<p>And that world of randomisation is the subject of Andrew Leigh’s new book, <a href="https://www.blackincbooks.com.au/books/randomistas">Randomistas: How radical researchers changed our world</a>. Leigh is the current federal member for Fenner, and Labor’s shadow assistant treasurer. But prior to his political life he was a professor of economics at Australian National University.</p>
<p>He spoke with the University of Melbourne’s Fiona Fidler about how we should be using randomised trials more to drive decisions and policy in public life and why we might be missing out on better results in social policy because we’re afraid to test our assertions.</p>
<hr>
<p><em>Andrew Leigh’s <a href="https://www.blackincbooks.com.au/books/randomistas">Randomistas: How radical researchers changed our world</a> is out now from Black Inc books. His podcast on living a health, happy and ethical life, The Good Life, is available on <a href="https://itunes.apple.com/au/podcast/the-good-life-andrew-leigh-in-conversation/id1147502226?mt=2">Apple Podcasts</a> or wherever you stream your podcasts.</em></p>
<p><em><a href="https://itunes.apple.com/au/podcast/speaking-with.../id934267338">Subscribe</a> to The Conversation’s Speaking With podcasts on Apple Podcasts, or <a href="http://tunein.com/radio/Speaking-with---The-Conversation-Podcast-p671452/">follow</a> on Tunein Radio.</em></p>
<p><strong>Music</strong></p>
<ul>
<li><a href="http://freemusicarchive.org/music/Blue_Dot_Sessions/The_Contessa/Wisteria">Free Music Archive: Blue Dot Sessions - Wisteria</a></li>
</ul><img src="https://counter.theconversation.com/content/93282/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Fiona Fidler receives funding from the Australian Research Council and IARPA.</span></em></p>Economist, author and MP Andrew Leigh spoke to Fiona Fidler about how we should be using randomised trials more to drive decisions and policy in public life.Fiona Fidler, Associate Professor, School of Historical and Philosophical Studies, The University of MelbourneLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/847892017-10-31T15:41:07Z2017-10-31T15:41:07ZWhy evidence-based healthcare has lost its way<figure><img src="https://images.theconversation.com/files/190154/original/file-20171013-11696-5s9t01.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">This works for everyone...on average.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/333362684?src=3ltEK8Jyx8G3d1uqFTh9JA-1-16&size=medium_jpg">Irenaphoto/Shutterstock</a></span></figcaption></figure><p>Without <a href="http://www.sciencedirect.com/science/article/pii/S0146000597800134">evidence-based healthcare</a>, medicine is not much better than folklore. </p>
<p>In the bad old days, clinical decisions were based largely on the experience and wisdom of doctors and other healthcare professionals, but treatments given in this manner sometimes did more harm than good. Evidence-based healthcare (EBHC) on the other hand uses population data to figure out the best treatments for different illnesses. </p>
<p>But although population data signal towards some regularity in large groups of people, they may only be just that – a signal – and not something that is evidence of clinical effectiveness in individual patients.</p>
<h2>Population studies</h2>
<p>EBHC explicitly trusts knowledge produced by some research methods more than it does others, and it is this knowledge that doctors should use when making decisions about which treatment is best for their patient.</p>
<p>The favoured methods are wide-scale population studies which can track the effects of a treatment over time in large numbers of people. Ideally, these methods should compare the treatment against an alternative, or a placebo (methods such as randomised controlled trials do this). These methods help reduce the inherent biases of human judgement. </p>
<p>Paradoxically, however, it could be the very emphasis which is placed on these methods which has created barriers to EBHC’s own core concern – to find the best evidence for patient care.</p>
<h2>How it lost its way</h2>
<p>Although population studies have been helping doctors make treatment decisions for decades, there are still many areas where disease is increasing, for example <a href="https://www.ncbi.nlm.nih.gov/pubmed/24590181">back pain and arthritis</a>. This might be because we need to do better studies. However, the <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1182327/">truthfulness</a> of studies is not necessarily related to <a href="http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2753.2012.01855.x/full">how good they are</a>. </p>
<p>There is, of course, some irony in using scientific methods to judge the value of scientific methods. We may need other ways to think about the issues here. So, a little philosophy: the theoretical basis of population studies boils down to a <a href="http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2753.2012.01908.x/full">specific idea of causation</a> (causation is, after all, what this whole thing is about – working out what treatment causes what effect). This idea is famously linked to the 18th-century Scottish philosopher <a href="https://plato.stanford.edu/entries/hume/">David Hume</a>. </p>
<p>Hume said that causation was nothing more than beliefs brought about by continually observing similar responses between two events (cause and effect). This is essentially what all population studies do. He also said that if the cause was not there, then neither would the effect. This is essentially what randomised controlled trials, specifically, try to establish. </p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/190155/original/file-20171013-11684-10msj6s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/190155/original/file-20171013-11684-10msj6s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=738&fit=crop&dpr=1 600w, https://images.theconversation.com/files/190155/original/file-20171013-11684-10msj6s.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=738&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/190155/original/file-20171013-11684-10msj6s.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=738&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/190155/original/file-20171013-11684-10msj6s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=927&fit=crop&dpr=1 754w, https://images.theconversation.com/files/190155/original/file-20171013-11684-10msj6s.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=927&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/190155/original/file-20171013-11684-10msj6s.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=927&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Scottish philosopher, David Hume.</span>
<span class="attribution"><a class="source" href="https://commons.wikimedia.org/w/index.php?curid=1367760">Allan Ramsay</a></span>
</figcaption>
</figure>
<p>Hume, however, was troubled by the thought that causation must be more than this because his theory did not include anything about the causal matter itself – the real-world, complex, messy stuff which exists in individual situations rather than at population-level and which glues the cause and effect together. Only the observed outcomes are considered. Knowing outcomes might be all we need, but with the methods valued by EBHC, the outcomes relate to groups, not individuals.</p>
<p>So could EBHC be leading us to an incomplete picture of what works for an individual? Some people think that this might be the case, and even suggest that the movement <a href="http://www.bmj.com/content/348/bmj.g3725">is in crisis</a>. Perhaps now is the perfect time to re-evaluate what best evidence for clinical effectiveness is, while considering the specific needs and context of each individual patient.</p>
<h2>Can EBHC find its way again?</h2>
<p>If Hume’s worries are right, and there is more to the story of causation than just regularly observed events, then we are indeed able to move forwards. Healthcare is undoubtedly a complex world. In complexity, the behaviour of things become difficult to predict and are highly context sensitive. The growing gap between scientific research and real-world complexity has been <a href="https://www.nature.com/news/beware-the-creeping-cracks-of-bias-1.10600">highlighted before</a>. </p>
<p>Population data is not infallible, and it could very well be that something which appears to be working for the whole group is not actually effective for individuals. Though this kind of data may offer a probability of outcome, it may not tell of other causal factors which will influence the outcome in any particular case. </p>
<p>Assuming then that the effectiveness of an intervention is context-sensitive, it should have a different response in each different situation. For example, exercise might be recommended for low back pain, but its effectiveness will be influenced by the patient’s fitness level, fear of movement, anxiety, sleep pattern, understanding of the exercise and so forth. So the <a href="http://onlinelibrary.wiley.com/doi/10.1111/jep.12713/full">individual context will influence the effectiveness</a> of the treatment. Population studies average a response out. This gives us good data on the population, but it says little about you. </p>
<p>What EBHC now needs is a revision of its systematic and scientific methods. Rather than controlling for the complexity of the real world, these methods should serve to embrace it. My <a href="http://www.sciencedirect.com/science/article/pii/S2468781217301534">latest paper</a> offers strategies for how this might be done, such as identifying data patterns from a range of research methods signalling the variation and complexity of causation, rather, and expanding research partnerships across disciplines to capture and represent the context and complexity of health.</p>
<p>Although elements of these strategies might already be in place, they are so with the prioritising of certain methods over others. This restricts our understanding of causation.</p>
<p>Maybe we have been looking down the EBHC telescope the wrong way, trying to understand the individual by studying the population. If we turn it around, we might progress from knowing what works, to what works for you.</p><img src="https://counter.theconversation.com/content/84789/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Roger Kerry receives funding from the Norwegian Research Council. </span></em></p>Here’s how it could find it again.Roger Kerry, Associate Professor, Physiotherapy & Rehabilitation Science, University of NottinghamLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/834862017-10-02T18:40:57Z2017-10-02T18:40:57ZHow we can overcome the lack of treatment options for rare cancers<figure><img src="https://images.theconversation.com/files/187342/original/file-20170925-17414-6ck9k4.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">It's hard to test therapies for rare cancers because there are too few people to study. </span> <span class="attribution"><span class="source">from www.shutterstock.com.au</span></span></figcaption></figure><p>Rare cancers are just that: rare. This means research into each of these particular types of rare cancers is limited, and so are the treatment options. As a consequence, patients diagnosed with rare cancers face significant challenges.</p>
<p>In November 2016, the Australian Senate <a href="http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Funding_for_Research_into_Cancers/FundingResearchCancers">established a select committee</a> to examine funding for research into cancers with low survival rates. More recently, the health minister announced <a href="https://www.health.gov.au/internet/main/publishing.nsf/Content/0C4D606ED8E85BC0CA258185001EAF82/$File/MRFF_Rare_Cancers_Rare_Diseases_AUG_17.pdf">A$13 million from the Medical Research Future Fund</a> will be used for clinical trials to help achieve better health outcomes for people with rare or uncommon cancers.</p>
<p>The minister also commissioned new work on <a href="https://pharmadispatch.com/news/minister-wants-new-process-for-pan-tumour-medicines">evaluating cancer medicines</a> that treat multiple tumours and have a specific genetic feature (biological marker). This could improve access to therapies that might benefit some patients with rare cancers.</p>
<p>These recent steps are in recognition of the significant challenges associated with undertaking research into rare cancers. By their nature, rare cancers include small and variable patient populations making gold-standard randomised trials challenging or even impossible. </p>
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Read more:
<a href="https://theconversation.com/unfair-if-rare-should-the-pbs-change-the-way-it-lists-cancer-drugs-59157">Unfair if rare: should the PBS change the way it lists cancer drugs?</a>
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<p>The lack of evidence resulting from few or no randomised trials creates challenges for registering and reimbursing new medicines. This ultimately leads to a lack of subsidised medicines for these patients. As a result, the improvements seen in patient outcomes related to new therapies for more common cancers like lung cancer, melanoma and bowel cancer over the last two decades <a href="https://engonetrca2.blob.core.windows.net/assets/uploads/files/JALMT%202016%20Update%20Report_electronic%20FINAL.pdf">do not extend to rare or less common cancers</a>. </p>
<h2>What is a rare cancer?</h2>
<p>The definition of a rare cancer is debatable. The <a href="http://www.rarecare.eu/rarecancers/rarecancers.asp">RARECARE collaboration</a> in Europe uses an operational definition of fewer than six cases per year per 100,000 population. In Australia, the medicines regulator, the Therapeutic Goods Administration (TGA), has recently <a href="https://www.tga.gov.au/publication/orphan-drug-designation-eligibility-criteria">updated the eligibility criteria</a> for medicines treating rare diseases to fewer than five cases of the disease in a population of 10,000 people.</p>
<p>Historically cancers were categorised by the anatomical location, such as the breast or kidney. But with the discovery of new biological markers, common cancers can be grouped into smaller, more homogeneous and genetically similar subsets. So the number of rare cancers will continue to grow as medical technology advances. </p>
<h2>Why don’t they have many available medications?</h2>
<p>The lack of government-approved and subsidised medicines to treat rare cancers primarily stems from the lack of evidence supporting their use. <a href="http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Funding_for_Research_into_Cancers/FundingResearchCancers/Submissions">Submissions to the current inquiry</a> also cited problems such as a lack of research funding; the need for international collaboration; lack of investment by industry; attracting sufficient interest of researchers and recruiting sufficient patients.</p>
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<a href="https://images.theconversation.com/files/187343/original/file-20170925-17397-1e39xbj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/187343/original/file-20170925-17397-1e39xbj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/187343/original/file-20170925-17397-1e39xbj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/187343/original/file-20170925-17397-1e39xbj.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/187343/original/file-20170925-17397-1e39xbj.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/187343/original/file-20170925-17397-1e39xbj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/187343/original/file-20170925-17397-1e39xbj.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/187343/original/file-20170925-17397-1e39xbj.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">It’s hard to recruit enough patients for research studies.</span>
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<p>Even if patients can be identified and recruited to a trial, it’s difficult to generate meaningful data from so few patients. </p>
<p>The lack of evidence presents challenges for new medicines trying to meet registration and reimbursement criteria in Australia. To be registered through the TGA, a new medicine must have demonstrated efficacy and safety. </p>
<p>In order for new medicines to be listed on the Pharmaceutical Benefits Scheme (PBS), it must have a demonstrated benefit over standard treatment, as well as being considered an <a href="https://www.nps.org.au/australian-prescriber/articles/economic-evaluation-of-medicines">efficient use of tax payer dollars</a>. </p>
<p>New medicines for rare cancers are often expensive, especially when randomised trials are not possible. </p>
<h2>What can we do to improve this situation?</h2>
<p>With the changing nature of medicine and research, new opportunities are emerging to address the current inequity. The shift to treating patients based on the genetic profile of their tumour rather than the location of the cancer has increased treatment options for rare cancer patients.</p>
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Read more:
<a href="https://theconversation.com/how-cancer-doctors-use-personalised-medicine-to-target-variations-unique-to-each-tumour-47349">How cancer doctors use personalised medicine to target variations unique to each tumour</a>
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<p>To harness the benefits, changes are required with input from multiple stakeholders, including government, industry, clinicians, researchers and patients. </p>
<p>Better access to new medicines ultimately starts with better research. To achieve this, <a href="http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Funding_for_Research_into_Cancers/FundingResearchCancers/Submissions">experts have called for</a> additional targeted funding, innovative trial designs, and better partnerships between industry and researchers. </p>
<p>There is also the opportunity to collect better “real world” data via platforms such as the <a href="https://myhealthrecord.gov.au/internet/mhr/publishing.nsf/content/home">My Health Record</a>, which could supplement existing research and allow performance monitoring of recently approved new medicines. </p>
<p>Organisations such as <a href="https://engonetrca2.blob.core.windows.net/assets/uploads/files/2017%20Rare%20Solutions%20Report_%20FINAL%20DIGITAL%20VERSION.pdf">Rare Cancers Australia</a> and the <a href="http://www.cancerdrugsalliance.org.au/news/4033/cda-white-paper-improving-access-to-cancer-medicines">Cancer Drugs Alliance</a> are liaising with government regarding changes that could improve access to novel medicines for patients with rare cancers. This includes greater input from patients and more flexibility in the way we evaluate medicines for public reimbursement. </p>
<p>It should also be recognised the problems faced in providing innovative treatments to patients with rare cancer extends <a href="http://www.publish.csiro.au/AH/AH16194">to rare diseases in general</a>. With modern medicine providing the potential to improve outcomes for patients with rare cancers as well as other serious chronic diseases, we need to have <a href="http://www.georgeinstitute.org.au/sites/default/files/funding-innovative-medicines-april-2017.pdf">a broader conversation</a> about what we can afford and what we are willing to pay for new medicines.</p><img src="https://counter.theconversation.com/content/83486/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Colman Taylor is an owner and Director of Health Technology Analysts which provides consulting services to industry and Government. As part of this work, Colman Taylor has undertaken paid consulting work for manufacturers of rare cancer therapies. Neither Colman Taylor nor Health Technology Analysts has received remuneration in relation to the development of this
article. </span></em></p><p class="fine-print"><em><span>Prof Zalcberg is a practicing medical oncologist specializing in gastrointestinal cancer. He receives research funding, travel support and honoraria from government sources, not-for-profit organisations and various pharmaceutical companies. His is also co-founder and current co-Chair of the Cancer Drugs Alliance (CDA; <a href="http://www.cancerdrugsalliance.org.au">www.cancerdrugsalliance.org.au</a>). The CDA receives funding from various pharmaceutical companies. </span></em></p>Rare cancers are hard to research given the few patients that have each type of cancer, so how can we improve treatment for these patients?Colman Taylor, Post-doctoral Research Fellow, The George Institute; Conjoint Senior Lecturer, UNSW; Owner and Director, Health Technology Analysts, University of SydneyJohn Zalcberg, Head, Cancer Research Program, Monash UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/746182017-08-18T00:19:27Z2017-08-18T00:19:27ZControlled experiments won’t tell us which Indigenous health programs are working<p>Described as “one of the simplest, most powerful and revolutionary tools of research”, the randomised controlled trial (<a href="http://au.wiley.com/WileyCDA/WileyTitle/productCd-1405132663.html">RCT</a>) has yielded a great deal of important information in the health sciences. It is usually held up as the “gold standard” for gathering medical evidence.</p>
<p>The RCT can tell us which procedure or treatment is more effective under tightly controlled situations. This evidence is useful and important, but we also need to know things like what people want from health services, which treatments are preferred, and why some people stick to treatment regimes and some people don’t. </p>
<p>These issues are particularly relevant to remote Australia and Aboriginal and Torres Strait Islander health, where <a href="http://closingthegap.pmc.gov.au/">high levels</a> of illness and early death persist, and where what applies to the tightly controlled conditions of a laboratory rarely translates.</p>
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Read more:
<a href="https://theconversation.com/why-are-aboriginal-children-still-dying-from-rheumatic-heart-disease-63814">Why are Aboriginal children still dying from rheumatic heart disease?</a>
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<p>The <a href="https://ministers.dpmc.gov.au/scullion/2017/10m-year-strengthen-ias-evaluation">government is rolling out</a> its A$40 million plan to evaluate Indigenous health programs. The Evidence and Evaluation Framework aims to strengthen reporting, monitoring and evaluation for programs and services provided to Indigenous Australians.</p>
<p>As Indigenous Affairs Minister Nigel Scullion <a href="http://www.abc.net.au/news/2016-11-18/independent-evidence-proves-aboriginal-run-services-can-work/8036690">said last year</a>:</p>
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<p>When you don’t know anything about any of the programs, then you’re just relying on gut feelings, and that’s not good enough.</p>
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<p>So, the framework will provide information about where government money is being spent, what works and why. However, from a Western biomedical perspective, the randomised controlled trial is afforded an elevated position in establishing what works and why. While <a href="https://www.cis.org.au/app/uploads/2017/06/rr28.pdf">some recommend using RCTs</a> to evaluate Indigenous programs, it is critical to keep in mind why this form of evidence-gathering is not always appropriate in this context.</p>
<h2>Randomised controlled trials aren’t real life</h2>
<p>In health and medical research, the RCT involves <a href="http://catalogue.nla.gov.au/Record/6895093">randomly assigning</a> people to different groups and giving the groups different treatments. The random allocation to groups precludes there being systematic differences between participants at the start of the study. </p>
<p>At the end of the study, any differences between the groups can be attributed to the treatment and not some other factor. RCTs, therefore, are an elegant and efficient way of ruling out competing explanations for an observed effect. </p>
<p>However, research participants and scenarios in randomised controlled trials are often unlike the patients and settings to which the evidence will ultimately be applied. For example, RCTs have demonstrated that psychological treatments delivered through the internet <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3636304/">can be effective</a> for a wide range of disorders. But in real-world settings, <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3636304/">adherence rates to internet treatments</a> are very low, so the RCT result has little practical meaning. </p>
<p>The issue of which particular outcome should take priority can also be difficult to resolve through the RCT approach to research. Most RCTs prioritise the clinical perspective, such as a measurable change in a particular health outcome. However, there can be a <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1971011/">mismatch</a> between what doctors view as success and what patients and their loved ones perceive as a positive outcome following drug or other forms of treatment. </p>
<p>For example, it is known anecdotally in Alice Springs that some Aboriginal Australians who could benefit from kidney dialysis treatment prefer, instead, to go back to their community to be on country. While this can be detrimental to their physical health, it has important cultural significance for them. </p>
<p>The RCT approach in this situation would undoubtedly demonstrate the health benefits of kidney dialysis. But understanding this problem in the context of real lives requires different methodologies. Unless we design research programs to consider why people would rather stay on country than receive effective health treatments, Aboriginal health may not improve. </p>
<h2>How best to gather evidence</h2>
<p>Valuable work can be conducted by health professionals and service providers collecting data during their regular daily activities. The model of the <a href="http://journals.sagepub.com/doi/abs/10.1177/0002764206297585">“scientist-practitioner”</a> often observed in clinical psychology could be applied to great effect in remote Australia. </p>
<p>This model promotes a seamless transition between science and practice in which the individual is both researcher and clinician. Scientist-practitioners adopt a critical stance to their clinical practice and routinely demonstrate, through evaluation, the value of the service they are providing. </p>
<p>Such a model was used in a GP practice in rural Scotland. Here, they found one simple change in how appointments were scheduled almost doubled the number of patients (in a six-month period) able to access a psychology service within a reasonable time after referral from their GP.</p>
<p>Rather than clinicians advising patients when to attend the next appointment, systems were organised so patients booked appointments in the same way they would to see a GP. The changes were quantified by clinician-researchers who <a href="https://www.cambridge.org/core/journals/the-cognitive-behaviour-therapist/article/div-classtitlewhen-is-enough-enough-structuring-the-organization-of-treatment-to-maximize-patient-choice-and-controldiv/11A23830CD408A60ED63C9EE995EA134">collected these data</a> in the course of their routine clinical practice.</p>
<p>After this change, patients were able to access the service within two weeks of being referred, rather than waiting for seven months as had been the case. Access to services is typically problematic in rural areas, so discovering a cost-effective means of improving access is an important outcome. </p>
<p>The results were so substantial and sudden that they were unequivocal. A large expensive RCT wasn’t necessary to demonstrate this simple change had made important improvements.</p>
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Read more:
<a href="https://theconversation.com/aboriginal-maori-how-indigenous-health-suffers-on-both-sides-of-the-ditch-48238">Aboriginal – Māori: how Indigenous health suffers on both sides of the ditch</a>
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<p>This sort of approach could easily be applied in remote Australian settings. An RCT is <a href="http://onlinelibrary.wiley.com/doi/10.1002/cpp.1942/abstract#">not the only way</a>, nor even the best way in all situations, to eliminate alternative reasons for the treatment outcomes obtained. Many important questions are ignored or refashioned inappropriately when only one methodology predominates.</p>
<p>Especially in the area of Indigenous health, the health and medical community must be guided by what patients want, not just by what health professionals <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)32573-9/abstract">know how to do</a>.</p><img src="https://counter.theconversation.com/content/74618/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Professor Tim Carey is the Director of the Centre for Remote Health, Flinders University, in Alice Springs. He is currently a CI on an ARC funded project investigating the impact of the 'fly in fly out' workforce in remote communities. Tim is a past Board Director and Vice President of the Australian Psychological Society and is currently Director of the Australian Rural Health Education Network. He is the 2017-18 Fulbright Northern Territory Senior Scholar.</span></em></p>Like all good health care, improving health in remote settings requires an evidence base. But forcing all research questions into the randomised controlled trial model is not the answer.Timothy A. Carey, Professor, Director of the Centre for Remote Health, Flinders UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/591062016-05-24T08:54:44Z2016-05-24T08:54:44ZWhy doing good can do you good<figure><img src="https://images.theconversation.com/files/122731/original/image-20160516-15899-ed3m5g.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Volunteering boosts your health.</span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/cat.mhtml?lang=en&language=en&ref_site=photo&search_source=search_form&version=llv1&anyorall=all&safesearch=1&use_local_boost=1&autocomplete_id=&search_tracking_id=uDj6l1O417_nHrSb33HXwA&searchterm=picking%20up%20litter&show_color_wheel=1&orient=&commercial_ok=&media_type=images&search_cat=&searchtermx=&photographer_name=&people_gender=&people_age=&people_ethnicity=&people_number=&color=&page=1&inline=388089622">Dragon Images/Shutterstock.com</a></span></figcaption></figure><p>We feel good when we do a good deed, so there must be a psychological benefit to helping others? But how can we know for sure? The best way to study the health benefits of kind deeds is to look at studies of volunteering. </p>
<p>In 2011, Daniel George conducted a <a href="http://www.ncbi.nlm.nih.gov/pubmed/21427644">randomised trial</a> with 30 adults in Ohio with mild to moderate dementia. Half the adults spent an hour every two weeks helping young school children with reading, writing and history. The other half (the control group) were assigned to not do any voluntary work. At the end of the five-month study, stress was lowered more in the adults who helped than in the adults who didn’t. </p>
<p>However, the study was small, so in 2012 researchers conducted a <a href="http://bmcpublichealth.biomedcentral.com/articles/10.1186/1471-2458-13-773">meta-analysis</a> where data from several studies are combined and re-analysed in order to provide more reliable statistics. </p>
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<span class="caption">Volunteering may lower your cholesterol.</span>
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<p>The meta-analysis contained five randomised trials with a total of 477 people. They yielded a mixed bag of results. The types of volunteering involved some form of teaching – either tutoring young children or helping people learn English as a second language. The volunteer work seemed to improve things such as mental function, physical activity, strength and stress. </p>
<p>However, it didn’t seem to have a positive effect on general health, the number of falls (among elderly volunteers) and loneliness. To make things more complicated, doing the wrong sort of volunteering – where the volunteer stands the risk of verbal or physical abuse – can be detrimental to the <a href="http://jech.bmj.com/content/58/6/493.full">person’s well-being</a>. Equally, some volunteer work can be <a href="http://europe.newsweek.com/exploitative-selfishness-volunteering-abroad-331703?rm=eu">detrimental</a> to the people the volunteer is trying to help. </p>
<p>A recent, well-conducted <a href="http://www.ncbi.nlm.nih.gov/pubmed/23440253">study</a> in Canada looked at the physical effects of doing voluntary work that benefits both the helper and the helped. It seems to confirm that helping people (in the right way) improves the volunteers’ health – in objective, laboratory-measured ways. </p>
<p>Researchers asked 52 high school students in Canada to volunteer once a week, helping younger students with their homework, sports and other after school activities. For comparison, a control group of 54 students did no volunteer work over the same period. </p>
<p>The researchers then took blood samples from both groups – and measured their body mass index – before and after the study. The blood samples were used to measure biomarkers which predict whether someone is likely to develop cardiovascular disease. At the end of the study, the adolescents who did the volunteer work had greater reductions in all of the biomarkers associated with cardiovascular disease than those in the control group. They also lost more weight.</p>
<h2>How helping helps the helper</h2>
<p>Some volunteering, such as taking a housebound person’s dog for a walk, is physical and can help improve your fitness. But merely connecting with people has <a href="http://www.jeremyhowick.com/latest-updates/love-is-a-drug/">health benefits</a> too. Volunteering may also <a href="http://www.jeremyhowick.com/newsletter/there-is-no-wolf/">reduce stress</a> by taking your mind off problems and helping you <a href="http://www.jeremyhowick.com/newsletter/the-relaxation-response/">relax</a>.</p>
<p>There could also be an evolutionary mechanism. Parts of the brain linked to <a href="http://www.pnas.org/content/103/42/15623.full">dopamine</a> and serotonin production seem to be activated in people who donate money. Our ancient ancestors who helped each other were more likely to survive, so received a dopamine “<a href="http://www.jeremyhowick.com/newsletter/your-natural-dopamine-high/">high</a>” in exchange for altruistic behaviour. Dopamine doesn’t just make us feel good, it is also used as medicine for treating low blood pressure, heart disease, Parkinson’s, attention deficit hyperactivity disorder and drug addiction. </p>
<p>The good news is, you don’t have to quit your job to join Greenpeace or work in a refugee shelter to gain the health benefits of helping others. You could, instead, help the next homeless person you see. Why not offer them a cup of coffee or some clean clothes? Doing these small things will improve the homeless person’s life in a measurable way, and might even make you healthier, too.</p><img src="https://counter.theconversation.com/content/59106/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jeremy Howick has received expenses and payments from Johns Hopkins, the American Society for Neurophysiological Monitoring, and Isis consulting as a consultant about evidence. He has received funding from the Wellcome Trust, the Medical Research Council of the UK, the Economics and Social Science Research Council of the UK, and he is currently a National Institute for Health Research non-clinical research fellow. He has received payment from the Canadian Medical Association Journal for writing a book review, and receives royalties from the publication of his book published by Blackwell/Wiley.</span></em></p>Scientists have found that there are many physical and mental benefits to volunteering.Jeremy Howick, Senior Researcher: placebo effects, epidemiology, evidence-based medicine, University of OxfordLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/588262016-05-19T09:39:09Z2016-05-19T09:39:09ZHow the British defeated Napoleon with citrus fruit<figure><img src="https://images.theconversation.com/files/122893/original/image-20160517-9487-1dhjz9d.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Blockade of Toulon by Thomas Luny.</span> <span class="attribution"><a class="source" href="https://commons.wikimedia.org/w/index.php?curid=7546600">Wikimedia Commons</a></span></figcaption></figure><p>Everyone knows that Britain’s conclusive victory over Napoleon was at Waterloo. The story of that day – the squares of infantry repulsing cavalry charges, the Imperial Guard retreating under murderous musket fire delivered by a red line of soliders, the just-in-time arrival of Field Marshal Blücher’s Prussian army – is one of excitement, horror and heroism. However, Britain’s biggest contribution to Napoleon’s defeat was much less romantic. It involved the first <a href="http://www.medicinenet.com/script/main/art.asp?articlekey=39532">randomised controlled trial</a>. </p>
<p>Without the trial, the years of blockades of French ports by the Royal Navy would not have been practical. The blockade kept the French fleet confined, preventing Napoleon from invading Britain. It gave the British freedom to trade across the world, helping finance not only the British but other European armies and nations. It threatened France’s trade and economy, which forced Napoleon to order the <a href="http://www.britannica.com/event/Continental-System">continental system</a>: a Europe-wide embargo against trade with Britain. He invaded both Spain and Russia to enforce this boycott – actions that ultimately brought about his downfall. </p>
<p>Blockade work was often tedious, always dangerous. Navy frigates, keeping close to the shore, would watch the French ports, using signal ships to notify the main fleet over the horizon if the French were to sail. The ships (and sailors) had to maintain station for months without relief. In 1804-5, Admiral Horatio Nelson spent ten days short of two years on <a href="https://www.kirkusreviews.com/book-reviews/christopher-hibbert-10/nelson-a-personal-history/">HMS Victory</a>, never stepping on dry ground, most of the time enforcing the blockade of Toulon. </p>
<h2>The scourge of scurvy</h2>
<p>The ability of the sailors of the Royal Navy to operate for such long periods at sea was remarkable. For most of the 18th century, ships could only stay at sea for relatively short periods (six to eight weeks), without the sailors developing scurvy. </p>
<p>Victims would feel weak, bleed at the gums, old wounds would break down and they would get infections. In the later stages of scurvy, sailors would have hallucinations and could <a href="http://www.dermnetnz.org/systemic/scurvy.html">go blind before dying</a>.</p>
<p>More sailors died from scurvy than enemy action. In 1744, Commodore George Anson of the Royal Navy returned from a nearly four-year circumnavigation of the globe with just <a href="http://www.mv.helsinki.fi/home/hemila/history/Gordon_1984.pdf">145 men left</a> from the original complement of 1,955. Four died as a result of enemy action. Most of the rest died from scurvy. </p>
<p>This was not unusual – 184,889 sailors were enlisted into the Royal Navy during the Seven Years’ War and 133,708 died or were lost due to sickness, again <a href="http://us.macmillan.com/books/9780312313920">mostly scurvy</a>, and just 1,512 died in combat. There is no way that the navy could have maintained the blockade of France for so long without preventing this disease.</p>
<h2>A breakthrough experiment</h2>
<p>The cause of scurvy was unknown, and many cures were proposed. The Portuguese explorer, Vasco da Gama, made his men <a href="https://dash.harvard.edu/bitstream/handle/1/8852139/Mayberry.html?sequence=2">use urine as a mouthwash</a>, an intervention that did not prevent nearly two-thirds of them dying from scurvy. </p>
<p>The breakthrough experiment – the first randomised controlled trial – was carried out by Scottish Royal Navy surgeon <a href="http://www.thehistorypress.co.uk/publication/Limeys/9780750939935/">James Lind</a> in 1747. After eight weeks at sea on HMS Salisbury, there was an outbreak of scurvy. He took 12 sailors with the disease and, ensuring the cases were as similar to each other as possible, he put them together in the same part of the ship and gave them the same diet. He divided them into six groups and gave each group a different treatment. For example, one group was given a quart of cider every day, another had to drink half a pint of seawater. Two sailors were given two oranges and a lemon daily. After six days, one recovered and returned to duty, the other was deemed well enough to nurse the remaining ten patients.</p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/122894/original/image-20160517-9491-1huqsuk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/122894/original/image-20160517-9491-1huqsuk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=706&fit=crop&dpr=1 600w, https://images.theconversation.com/files/122894/original/image-20160517-9491-1huqsuk.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=706&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/122894/original/image-20160517-9491-1huqsuk.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=706&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/122894/original/image-20160517-9491-1huqsuk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=888&fit=crop&dpr=1 754w, https://images.theconversation.com/files/122894/original/image-20160517-9491-1huqsuk.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=888&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/122894/original/image-20160517-9491-1huqsuk.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=888&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">James Lind by George Chalmers.</span>
<span class="attribution"><a class="source" href="https://upload.wikimedia.org/wikipedia/commons/d/d4/James_Lind_by_Chalmers.jpg">Wikimedia Commons</a></span>
</figcaption>
</figure>
<p>In 1753, Lind <a href="http://www.jameslindlibrary.org/lind-j-1753/">wrote a treatise</a> describing this crucial experiment. While others had previously used citrus fruit to treat scurvy, this trial proved its effectiveness.</p>
<p>We now know that scurvy is caused by lack of vitamin C or ascorbic acid, present in large amounts in citrus fruit. In the Napoleonic wars, all British sailors were issued with lemon juice or other fruit. In 1804, 50,000 gallons were <a href="http://www.thehistorypress.co.uk/publication/Limeys/9780750939935/">purchased by the Royal Navy</a>. The effect was remarkable. In 1809, the Naval Hospital, at Haslar near Portsmouth, did not see a single case of scurvy.</p>
<p>Lind’s controlled trial was essential for the defeat of Napoleon. Without it, the blockade could not have been sustained, Napoleon’s fleet could have disrupted British trade, and, more importantly, allowed the emperor to invade Britain.</p>
<h2>Delayed recognition</h2>
<p>The story isn’t so simple, however. It involved big admiralty egos and political infighting. Lind’s treatise was largely ignored when it was published. It took decades of work by others – notably Thomas Trotter and Gilbert Blane – to fight for <a href="http://www.thehistorypress.co.uk/publication/Limeys/9780750939935/">the adoption of lemon juice</a> by the navy. </p>
<p>It was not until 1795, after Lind’s death, that his findings were fully adopted. Other countries were also slow to follow the British example. Even though Americans knew that British sailors drank lemon juice (the origin of the slang-term “limey”), scurvy remained a major problem for soldiers in the <a href="http://www.faqs.org/health/topics/51/Scurvy.html">American Civil War</a>. </p>
<p>One lesson is that it is not enough to do good science and assume any finding will be instantly adopted. There are many barriers to adoption and people like Blane and Trotter who fight and overcome those barriers are as important to the story as those, like Lind, who make the original discovery.</p><img src="https://counter.theconversation.com/content/58826/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Andrew George is Chair of the National Research Ethics Advisors' Panel of the Health Research Authority</span></em></p>The British blockade of France wouldn’t have worked if it wasn’t for an ingenious experiment conducted half a century earlier.Andrew George, Deputy Vice-Chancellor, Brunel University LondonLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/498072016-03-22T23:57:45Z2016-03-22T23:57:45ZIn defence of observational science: randomised experiments aren’t the only way to the truth<figure><img src="https://images.theconversation.com/files/112064/original/image-20160219-1276-1iak1fb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Observational scientists study subjects in real life, outside a controlled laboratory environment.</span> <span class="attribution"><span class="source">from shutterstock.com</span></span></figcaption></figure><p>Would you volunteer to become vegetarian for the next three decades for the sake of science? What if you were asked to run at least 50 kilometres per week, or live through a natural disaster? </p>
<p>Granted, these are extreme requests. Researchers conducting <a href="https://en.wikipedia.org/wiki/Randomized_controlled_trial">randomised controlled trials</a> often ask volunteers to make far smaller changes to their behaviour: exercise a bit more, eat less sugar or try a new medication.</p>
<p>During these trials, scientists randomly allocate the medicine, treatment or activity being studied to a group of people, and a different intervention or placebo to another group. Then they look for differences in participant outcomes.</p>
<p>Purists believe experiments like this are the only way to gain valuable knowledge, and popular conception of science is intimately connected to experimentation. </p>
<p>Yet some of the most critical scientific questions we face today can’t be investigated through experiment. For instance, we can’t determine whether greenhouse gas emissions are really causing climate change by not producing them for several decades and recording the results. </p>
<p>Likewise, <a href="http://www.ncbi.nlm.nih.gov/pubmed/19185083">many important medical questions</a> either can’t or shouldn’t be settled experimentally. A chasm separates the controlled conditions of the laboratory from the messy reality of life. Sometimes, studying participants in real conditions through observational studies is the best way to find answers.</p>
<h2>‘Only an observational study…’</h2>
<p>Epidemiology, <a href="https://en.wikipedia.org/wiki/Epidemiology">broadly defined</a>, seeks to understand the causes of disease. </p>
<figure class="align-left ">
<img alt="" src="https://images.theconversation.com/files/114769/original/image-20160311-11282-fqe8z0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/114769/original/image-20160311-11282-fqe8z0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=600&fit=crop&dpr=1 600w, https://images.theconversation.com/files/114769/original/image-20160311-11282-fqe8z0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=600&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/114769/original/image-20160311-11282-fqe8z0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=600&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/114769/original/image-20160311-11282-fqe8z0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=754&fit=crop&dpr=1 754w, https://images.theconversation.com/files/114769/original/image-20160311-11282-fqe8z0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=754&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/114769/original/image-20160311-11282-fqe8z0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=754&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">A chasm separates the controlled conditions of the laboratory from the messy reality of life.</span>
<span class="attribution"><span class="source">from shutterstock.com</span></span>
</figcaption>
</figure>
<p>An early example of observational epidemiology was <a href="https://en.wikipedia.org/wiki/John_Snow_(physician)">John Snow’s discovery</a> that cholera was spreading throughout Victorian-era London not through bad air, as was commonly thought, but through contaminated water from the Thames. He did this by mapping the location of affected households which revealed they clustered around specific water sources. </p>
<p>Almost a century later in the 1950s, Richard Doll and Austin Bradford Hill <a href="https://en.wikipedia.org/wiki/British_Doctors_Study">were the first to observe</a> the link between smoking and lung cancer by surveying doctors about their tobacco use and health. Smoking is now widely recognised as <a href="http://www.ncbi.nlm.nih.gov/pubmed/19509003">one of the most important modifiable</a> risk factors for early death.</p>
<p>These contributions are often unrecognised by science journalists and even by other researchers. Newspaper articles on the latest finding from observational research often include <a href="http://www.abc.net.au/worldtoday/content/2015/s4361079.htm">some variation on the phrase</a>: “only an observational study”, as if this type of scientific inquiry is not to be trusted. </p>
<p>But each study should be evaluated on its own merits – not just its broad design.</p>
<p>In randomised controlled trials, randomisation is used to break the connection between characteristics to identify the true cause of a disease or the most effective cure. For instance, people who exercise frequently may have other healthy habits. These might be the reason for their lower risk of heart attacks, rather than the exercise itself. </p>
<p>Randomisation helps ensure people receiving a particular health intervention are a mixed group and the only thing they definitely have in common is the intervention itself. </p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/114767/original/image-20160311-11302-zyc1he.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/114767/original/image-20160311-11302-zyc1he.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=973&fit=crop&dpr=1 600w, https://images.theconversation.com/files/114767/original/image-20160311-11302-zyc1he.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=973&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/114767/original/image-20160311-11302-zyc1he.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=973&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/114767/original/image-20160311-11302-zyc1he.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1222&fit=crop&dpr=1 754w, https://images.theconversation.com/files/114767/original/image-20160311-11302-zyc1he.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1222&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/114767/original/image-20160311-11302-zyc1he.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1222&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Physician John Snow found how cholera was spreading through London using observational epidemiology.</span>
<span class="attribution"><a class="source" href="https://upload.wikimedia.org/wikipedia/commons/c/cc/John_Snow.jpg">Rsabbatini at English Wikipedia [CC BY 4.0 (http://creativecommons.org/licenses/by/4.0)], via Wikimedia Commons</a></span>
</figcaption>
</figure>
<p>Observational researchers can often use statistical techniques to identify the true causes of disease, even when different relevant factors are clustering together. </p>
<p>For instance, if we are worried people who exercise are less likely to smoke and this might explain their lower risk of heart disease, we can restrict our analyses just to non-smokers. Then if we still see a difference between people who exercise and those who don’t, we can be sure it isn’t due to smoking.</p>
<p>Instead of randomising, observational studies investigate how people live in their natural circumstances – how they behave, their genetic profiles, what’s happened to them in the past, and so on. So many factors that have an impact on health can’t be randomly allocated.</p>
<h2>The value of observational research</h2>
<p>The repetition of the “only an observational study” mantra ignores the fact that randomised studies are often impossible - for example, if we want to study the impact of genes, long-term patterns in diet or physical activity, personal experiences like childhood trauma or incarceration, or natural disasters. </p>
<p>Obviously, researchers can’t randomly assign these traits or experiences to participants in a trial. </p>
<p>Observational studies have been used to identify the link between those who have <a href="http://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet#q1">the BRCA gene variants and their higher risk of breast cancer</a>. </p>
<p>Now women with these gene variants can take some measures to protect themselves from advanced breast cancer. This contribution joins a long list that began with controlling cholera in London, and continued with identifying the harms of smoking. </p>
<p>The complexity of human beings means that medical researchers can’t say with the perfect certainty of physicists that X causes Y, but the world can’t always wait for perfect certainty. </p>
<p>Observational epidemiologists design studies with the greatest degree of rigour possible given the messy reality of life, and we offer our findings up in the hope of protecting public health. Every so often, that can be the difference between life and death.</p><img src="https://counter.theconversation.com/content/49807/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Kathryn Snow does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The randomised controlled trial is touted as the gold standard in medical research. But its controlled laboratory conditions are far removed from the messy realities of life.Kathryn Snow, Epidemiologist, The University of MelbourneLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/525142016-01-06T10:16:21Z2016-01-06T10:16:21ZPsychodynamic therapy – there’s more to it than lying on a couch talking about your childhood<figure><img src="https://images.theconversation.com/files/107176/original/image-20160104-29000-79vble.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Tell me about your childhood</span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/cat.mhtml?lang=en&language=en&ref_site=photo&search_source=search_form&version=llv1&anyorall=all&safesearch=1&use_local_boost=1&autocomplete_id=&search_tracking_id=FBrMZflCqeECqdPh4rxP5Q&searchterm=therapists%20couch&show_color_wheel=1&orient=&commercial_ok=&media_type=images&search_cat=&searchtermx=&photographer_name=&people_gender=&people_age=&people_ethnicity=&people_number=&color=&page=1&inline=136749077">www.shutterstock.com</a></span></figcaption></figure><p>Some people think psychodynamic psychotherapy is mumbo jumbo. The therapy, which grew out of the Freudian school of psychoanalysis, is often portrayed as elitist, expensive, old-fashioned and ineffective. Cognitive behavioural therapy (CBT), by contrast, is portrayed as modern, evidence-based, quick and affordable. </p>
<p>Plenty of research shows that CBT can help people with mild or moderate depression or anxiety. As a result, CBT has become a bit like paracetamol for psychological problems. </p>
<p>However, when it comes to more deep-seated psychological problems, <a href="http://onlinelibrary.wiley.com/doi/10.1002/wps.20267/full">new research suggests</a> that psychodynamic psychotherapy – in which the therapist and patient form a therapeutic relationship where the patient can begin to think about and understand their past and present relationships with others and consider new ways to relate to people – can be effective. Mumbo jumbo it isn’t.</p>
<h2>Quick fix</h2>
<p>Since 2008, thousands of new cognitive behavioural therapists have been trained to provide treatment to hundreds of thousands of people. These <a href="http://www.iapt.nhs.uk/">services</a> are now usually the first port of call for anyone who goes to their doctor complaining of psychological problems. </p>
<p>There are said to be more than <a href="http://www.scientificamerican.com/article/are-all-psychotherapies-created-equal/">500 different types of talking therapy</a> which might suit different people at different times for different reasons. There is an argument that having put CBT on a pedestal, patient choice is much diminished.</p>
<p>CBT tends to be provided in six to 12 week doses and is offered either face-to-face, by telephone or through a computer program. This reminds me of “<a href="http://www.imdb.com/title/tt0578587/">gourmet night</a>” at Fawlty Towers when there were only three options on the menu: duck with orange, duck with cherries or “duck surprise”. Basil Fawlty famously pointed out: “If you don’t like duck, you’re rather stuck!”</p>
<p>Some services have now expanded their menu to include other quick-fix therapies. This includes a brief version of psychodynamic psychotherapy called <a href="http://www.d-i-t.org/">dynamic interpersonal therapy</a> which involves 16 one-to-one sessions to treat mood disorders, such as depression. But when people have very complex problems, they probably need a form of therapy which takes a lot longer. </p>
<h2>Not good enough for NICE</h2>
<p>Psychodynamic psychotherapy is available on the NHS at the <a href="http://tavistockandportman.uk/">Tavistock Clinic</a> in London where patients can be seen for a year or sometimes longer. In other areas, availability is relatively sparse and <a href="http://www.nhs.uk/Conditions/Psychotherapy/Pages/Introduction.aspx">waiting lists tend to be long</a>. </p>
<p>The reason why this and other types of talking therapy have not been considered to work as well as CBT is because, although there has been research, it has been the wrong type of research for NICE (the agency responsible for deciding whether new drugs and treatments should be funded by the NHS).</p>
<p>NICE prioritises research in the form of randomised controlled trials which compare how well one type of therapy works compared with a current standard treatment. However, research which compares therapies with each other or examines one type of therapy over time is not valued by NICE, even though this hierarchical approach to evaluating research has its <a href="http://onlinelibrary.wiley.com/doi/10.1002/cpp.1942/abstract">critics</a> both inside and outside the field of psychotherapy. </p>
<h2>A gold-standard study</h2>
<p>The new research is the first <a href="http://onlinelibrary.wiley.com/doi/10.1002/wps.20267/full">randomised controlled trial of psychodynamic psychotherapy</a> in the NHS (partly funded by the Tavistock Clinic Charitable Foundation) for adults with severe long-lasting depression. </p>
<p>The 129 patients who agreed to take part in the study had already found antidepressants – and in some cases CBT – unhelpful. This type of depression is sometimes called “treatment resistant”. </p>
<p>The patients were randomly assigned to receive psychodynamic psychotherapy or treatment-as-usual. The patients were treated for 18 months and then followed up for two years.</p>
<p>The results showed that when therapy ended after 18 months, patients were no more likely to have improved in the treatment group than the control group. Two years later, however, significantly more people had improved in the treatment group than in the control group. </p>
<p>Most psychotherapy research fails to follow patients for this long. A recent <a href="http://tinyurl.com/at8qpop">randomised controlled trial</a> of CBT for treatment resistant depression also found CBT to be helpful for this type of depression. However, the CBT in this trial was unusually long (18 sessions), the depression severity was slightly lower than in the psychodynamic psychotherapy study, and patients were followed up for one year only. </p>
<p>Because treatment resistant depression is a long-term – sometimes life-long – condition which is likely to return, longer term follow-up periods in trials are critical to understand what impact different therapies have, not just while the patient is in therapy but in the years that follow. </p>
<p>Psychodynamic psychotherapy is not a quick fix. It can take time after therapy finishes for the patient to put into practice what they have learned, so we might expect to see patients’ lives improving gradually, after therapy ends. If psychodynamic psychotherapy leads to improvements two years after the end of therapy instead of during therapy as the results of the new study suggest, then its potential as a therapy which might deliver long lasting as opposed to transient change should be of interest to patients seeking help. </p>
<h2>End the caricature</h2>
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<img alt="" src="https://images.theconversation.com/files/107212/original/image-20160104-28997-5ostc3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/107212/original/image-20160104-28997-5ostc3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=516&fit=crop&dpr=1 600w, https://images.theconversation.com/files/107212/original/image-20160104-28997-5ostc3.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=516&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/107212/original/image-20160104-28997-5ostc3.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=516&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/107212/original/image-20160104-28997-5ostc3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=648&fit=crop&dpr=1 754w, https://images.theconversation.com/files/107212/original/image-20160104-28997-5ostc3.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=648&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/107212/original/image-20160104-28997-5ostc3.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=648&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">The evidence is mounting.</span>
<span class="attribution"><a class="source" href="http://www.shutterstock.com/cat.mhtml?lang=en&language=en&ref_site=photo&search_source=search_form&version=llv1&anyorall=all&safesearch=1&use_local_boost=1&autocomplete_id=&search_tracking_id=VCxKbGMaYNDnYgGduDlUgg&searchterm=stack%20of%20documents&show_color_wheel=1&orient=&commercial_ok=&media_type=images&search_cat=&searchtermx=&photographer_name=&people_gender=&people_age=&people_ethnicity=&people_number=&color=&page=1&inline=133106732">www.shutterstock.com</a></span>
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<p>A <a href="http://onlinelibrary.wiley.com/doi/10.1002/wps.20235/full">recent review</a> which examined all relevant research on psychodynamic psychotherapy also supports the idea that this type of therapy could help people with a range of psychological difficulties including depression, anxiety and eating disorders.</p>
<p>This does not mean psychodynamic psychotherapy should now be offered to everyone. Because it’s a longer and more complex treatment, it may never fit into the mainstream NHS model which is based on providing brief therapies for the mass market which are delivered by therapists whose training and therefore time costs much less than a psychodynamic psychotherapist. But it does mean that some of the traditional caricatures of psychodynamic psychotherapy need to be reconsidered, especially the idea that it does not work. </p>
<p>It is important that patients are offered a real choice of therapy at the right time, particularly for people whose difficulties are long standing, complex and severe and where a quick fix approach is less likely to work and may even put people off seeking help.</p><img src="https://counter.theconversation.com/content/52514/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Susan McPherson has an honorary (unpaid) research affiliation with the Tavistock & Portman NHS Foundation Trust and is also employed by the University of Essex as a research tutor on the Essex-Tavistock Doctorate in Clinical Psychology which is a training programme run in partnership between the University of Essex and the Tavistock & Portman NHS Foundation Trust.</span></em></p>A new study has found that psychodynamic therapy is useful for treating depression, and the positive effects are longer lasting.Susan McPherson, Senior Lecturer in Clinical Psychology, University of EssexLicensed as Creative Commons – attribution, no derivatives.