tag:theconversation.com,2011:/uk/topics/evidence-based-medicine-40258/articlesEvidence-based medicine – The Conversation2023-06-27T21:21:32Ztag:theconversation.com,2011:article/2076792023-06-27T21:21:32Z2023-06-27T21:21:32ZLet evidence, not opinion, guide harm reduction policy and practice in Canada’s drug poisoning crisis<p>The poisoning of the unregulated drug supply, especially in Canada, is a public health crisis that deserves a high priority for the integration of evidence into policy and practice. </p>
<p>The <a href="https://www.cbc.ca/news/health/drug-poisoning-deaths-language-1.6457834">drug poisoning crisis</a> is often referred to as the opioid crisis, but it is all illicit substances, including stimulants, that are tainted with fentanyl, benzodiazepines and other dangerous ingredients, <a href="https://doi.org/10.1111/add.15844">increasing the risk of harm, especially overdose</a>. </p>
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Read more:
<a href="https://theconversation.com/benzo-dope-may-be-replacing-fentanyl-dangerous-substance-turning-up-in-unregulated-opioids-164286">‘Benzo-dope’ may be replacing fentanyl: Dangerous substance turning up in unregulated opioids</a>
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<p>It is still an ongoing battle for those in positions of power to submit to the rigorous evidence supporting harm reduction, despite strategies like <a href="https://doi.org/10.1186/s12954-017-0154-1">supervised consumption sites</a> and the distribution of drug equipment <a href="https://www.phs.ca/insite-an-anniversary-of-hope/">being more than two decades old</a>. </p>
<p>For example, North America’s first formal supervised consumption site, <a href="https://www.phs.ca/program/insite/">Insite</a>, has been in operation for 20 years showcasing what its founding organization, PHS Community Services, calls a “<a href="https://www.phs.ca/insite-an-anniversary-of-hope/">pragmatic and humane approach to the risks of drug use</a>.” </p>
<p>Thorough evaluation of harm reduction strategies has shown they can <a href="https://doi.org/10.1186/s12954-017-0154-1">save money, save lives and promote health</a> at an individual and population level. Furthermore, denial of access to supervised consumption is a <a href="https://scc-csc.lexum.com/scc-csc/scc-csc/en/item/7960/index.do">violation of Section 7 of the Canadian Charter of Rights and Freedoms</a>, which protects an individual’s right to life, liberty and security of the person.</p>
<h2>Stigma and ideology</h2>
<p>Recently, Canada’s leader of the Opposition Pierre Poilievre had his motion to defund safer supply voted down in Parliament. His reference to a “<a href="https://www.ourcommons.ca/DocumentViewer/en/44-1/house/sitting-200/hansard">tax-funded drug supply</a>” as fuelling addiction rather than recovery is not supported by evidence and follows the <a href="https://www.cbc.ca/news/politics/conservative-motion-safe-supply-fails-1.6858551">failed prejudicial ideology of the war on drugs era</a>. </p>
<p>Poilievre’s actions mirror the sentiments of former federal health minister Rona Ambrose, whose opinion also superseded evidence while in a position of influence. In 2013 she attempted to deny access to heroin assisted treatment (HAT) — an <a href="https://doi.org/10.1136/bmj.327.7410.310">opioid substitution treatment using diamorphine/diacetylmorphine (medical grade heroin</a>) — for persons with substance use disorder in Vancouver. </p>
<p><a href="https://www.providencehealthcare.org/sites/default/files/Supreme%20Court%20of%20British%20Columbia%20Decision.pdf">Ambrose publicly stated that</a> “Our policy is to take heroin out of the hands of addicts, not to put it into their arms.”</p>
<p>Ambrose made this public declaration <a href="https://doi.org/10.1016/j.jsat.2006.04.007">despite evidence</a> from both <a href="https://doi.org/10.1056/NEJMoa0810635">Canada</a> and <a href="https://doi.org/10.1136/bmj.317.7150.13">Europe</a> that <a href="https://doi.org/10.1192/bjp.bp.106.026112">showcased the efficacy</a> of HAT in six <a href="https://doi.org/10.1016/S0140-6736(10)60349-2">randomized controlled trials</a> with over 1,500 patients.</p>
<h2>What is evidence?</h2>
<p>What is considered evidence, especially regarding public health? From an epistemological (justified belief, as opposed to opinion) perspective, we may think evidence equals truth. However <a href="https://global.oup.com/academic/product/population-health-science-9780190459376?cc=ca&lang=en&">causation cannot be observed, only inferred</a>. While evidence may be viewed as more of a confirmation, truly <a href="https://doi.org/10.1046/j.1365-2753.2000.00244.x">definitive scientific evidence is rare due to its ever-changing and evolving nature</a>. </p>
<p>Evidence comes in many forms, and although it may not constitute absolute “proof,” it is reliable.</p>
<p>In harm reduction, best practices are grounded in evidence that comes from several facets including peer-reviewed literature, unpublished reports or grey literature, and the experiential knowledge of persons who use drugs themselves. </p>
<p>The way <a href="https://doi.org/10.1016/j.drugpo.2020.103015">harm reduction has progressed in Canada</a> tells us that <a href="https://doi.org/10.1186/s13011-021-00406-6">people who use drugs are key informants at the table</a> as they articulate their own experience of what it is like to use substances from an unregulated supply and to navigate the health and social services system. <a href="https://doi.org/10.1111/add.158441196COMMENTARIES">Their voice in the conversation</a> helps to reduce stigma, support client-centred essential services and policies, and prioritize the needs of people who use substances.</p>
<h2>Barriers to progress</h2>
<p>The question still remains as to why government policies across Canada, public stigma, and ignorance towards the use of substances and the people who use them, are still able to create barriers to the promotion of strategies that fight the current drug poisoning crisis. </p>
<p>During the COVID-19 pandemic, <a href="https://www.who.int/emergencies/diseases/novel-coronavirus-2019/interactive-timeline">public health strategies were implemented at a rapid pace</a>, but this same urgency is not translating to our community of people who use unregulated drugs. One would think that <a href="https://health-infobase.canada.ca/substance-related-harms/opioids-stimulants">the loss of nearly 40,000 Canadians to opioid overdoses since 2016</a> would be impetus for not just change, but bold action.</p>
<p>Has government not learned its lessons about taking all aspects of evidence into consideration while also considering the urgency of action required in crisis situations? After public health failures during the 2001 SARS crisis, <a href="https://doi.org/10.1098/rsfs.2021.0079">Justice Archie Campbell recommended in his report</a>: </p>
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<p>“Where there is reasonable evidence of an impending threat to public harm, it is inappropriate to require proof of causation beyond a reasonable doubt before taking steps to avert the threat…that reasonable efforts to reduce risk need not await scientific proof.” </p>
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<p>The ultimate question that needs to be asked to those who have the power to move harm reduction forward is: If they want to be a part of ending the drug toxicity crisis, then why and for whom? Is their primary objective more votes? Or is it to value all members of our community, and not just keep people who use drugs alive, but to help them thrive? </p>
<p>If the goal is wanting to be a part of ending this crisis for the betterment of the persons experiencing it, then the approach must include weighing evidence from a variety of sources and triumphing over public and political ideology and stigma. </p>
<p><a href="https://plato.stanford.edu/entries/egalitarianism/#Pri">Prioritarianism</a>, as a principle of justice, puts the focus on the population most in need, whether it be in terms of health, resources, opportunities or access. The moral and ethical values of this approach intend to maximize overall well-being for those who need it the most. </p>
<p>Movement forward requires collaboration that builds on existing strengths and capacities, with the guiding principle being to <a href="https://healthydebate.ca/2021/09/topic/encampments-pandemic-covid/">put the needs of the persons living this experience first</a>. Bioethicist Anita Ho describes epistemic humility — the ability to challenge one’s preconceived and biased assumptions — as “<a href="https://doi.org/10.2979/intjfemappbio.4.2.102">characterized by a commitment to mutual collaboration and trust with those they serve</a>.” </p>
<p>A healthy public includes us all.</p><img src="https://counter.theconversation.com/content/207679/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ross Upshur receives funding from Health Canada, CIHR, Atlas Institute for Veterans and Families</span></em></p><p class="fine-print"><em><span>Karla Ghartey 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>Harm reduction is grounded in evidence. But policies, stigma and ignorance about substance use still create barriers in battling Canada’s drug poisoning crisis.Karla Ghartey, Doctor of Public Health (DrPH) student, University of TorontoRoss Upshur, Professor, Dalla Lana School of Public Health, University of TorontoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2050142023-05-22T20:06:36Z2023-05-22T20:06:36ZDoes my treatment work? How major medical reviews can be ‘gold standard’ evidence, yet flawed<figure><img src="https://images.theconversation.com/files/525758/original/file-20230512-37784-bjz76q.jpg?ixlib=rb-1.1.0&rect=1%2C0%2C997%2C667&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/stack-paper-files-565403764">Shutterstock</a></span></figcaption></figure><p>Medical decision-making is complex. There are often hundreds, if not thousands, of published studies that may impact how to manage your medical condition.</p>
<p>Some studies look at which drug is best in a particular situation, or whether pain is better treated by, say, avoiding exercise or seeing a physio for therapeutic massage.</p>
<p>In this morass of difficult choices, <a href="https://community.cochrane.org">Cochrane reviews</a> stand out as internationally trusted and <a href="https://www.cochrane.org/about-us/our-funders-and-partners">independent</a>. They are considered the “gold standard” in evidence-based medicine.</p>
<p>They involve teams of researchers looking through all the published academic research on a topic to produce an overall answer on what the best evidence says about different treatments.</p>
<p>However, Cochrane has recently <a href="https://theconversation.com/yes-masks-reduce-the-risk-of-spreading-covid-despite-a-review-saying-they-dont-198992">come under fire</a> after a controversial review that looked at whether wearing masks in the community during COVID worked to reduce the spread of respiratory viruses.</p>
<p>Studies like this can <a href="https://www.mdlinx.com/article/cochrane-reviews-controversy-are-the-concerns-valid/7tjNVFB6sLR2l9VoaXqQDc">raise the question</a> of how useful Cochrane reviews are, particularly for the general public.</p>
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<h2>Issues with evidence-based medicine</h2>
<p>As with any research process, Cochrane reviews are not perfect. And they cannot answer all medical questions.</p>
<p>The entire process – from gathering data based primarily on randomised clinical trials, to reviewing that data and coming to some conclusion about the evidence – was mostly developed in the context of clinical interventions. <a href="https://theconversation.com/randomised-control-trials-what-makes-them-the-gold-standard-in-medical-research-78913">Randomised trials</a> are a type of medical study where people are given treatments in a controlled, random way, giving a robust estimate of whether the treatment works for the condition that’s being studied.</p>
<p>People regularly question whether this “gold standard” framework deals well with things other than surgery, drugs and the like. </p>
<p>For example, take the mask review mentioned above. <a href="https://theconversation.com/yes-masks-reduce-the-risk-of-spreading-covid-despite-a-review-saying-they-dont-198992">Much of the criticism</a> was focused not on the specifics of the included papers, but on the general idea of whether randomised clinical trials are an appropriate way to measure the impact of masks on respiratory disease. </p>
<p>What is the “gold standard” if randomised trials are impossible, unethical, or otherwise inappropriate? For example, if an intervention like vaccination is already proven effective, you can’t ethically randomise people into a group that doesn’t get the treatment.</p>
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Read more:
<a href="https://theconversation.com/yes-masks-reduce-the-risk-of-spreading-covid-despite-a-review-saying-they-dont-198992">Yes, masks reduce the risk of spreading COVID, despite a review saying they don't</a>
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<p>This gets at the underlying question of what a Cochrane review is actually there to do. The key aim of aggregating research this way is to filter out the noise and provide the most accurate data on a specific question.</p>
<p>Sometimes, the most honest answer is that we just don’t have enough evidence to make a conclusion.</p>
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<a href="https://images.theconversation.com/files/525571/original/file-20230511-15-c6zxpk.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C998%2C561&q=45&auto=format&w=1000&fit=clip"><img alt="Doctor in white coat, stethoscope around neck, taking notes from laptop" src="https://images.theconversation.com/files/525571/original/file-20230511-15-c6zxpk.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C998%2C561&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/525571/original/file-20230511-15-c6zxpk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=337&fit=crop&dpr=1 600w, https://images.theconversation.com/files/525571/original/file-20230511-15-c6zxpk.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=337&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/525571/original/file-20230511-15-c6zxpk.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=337&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/525571/original/file-20230511-15-c6zxpk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=424&fit=crop&dpr=1 754w, https://images.theconversation.com/files/525571/original/file-20230511-15-c6zxpk.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=424&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/525571/original/file-20230511-15-c6zxpk.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=424&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">Sometimes, there is evidence, but not from randomised clinical trials.</span>
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<p>In other cases, there is evidence, but not from randomised clinical trials. Then the debate becomes about how much weight to give this evidence, whether and how to include it, and how to draw conclusions based on this data. </p>
<p>This may seem arbitrary, but there are good reasons to be wary of findings based only on observational research. A systematic review of observational trials of hormone replacement therapy led to widespread use in the late 90s for preventative health, until randomised trials <a href="https://www.annualreviews.org/doi/abs/10.1146/annurev.publhealth.26.021304.144637">showed</a> the therapy had little to no benefit. </p>
<p>This isn’t actually a new problem. Indeed, it’s something Cochrane has been <a href="https://training.cochrane.org/handbook/current/chapter-24">grappling with for years</a>.</p>
<p>For example, <a href="https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD010216.pub7/full">a recent Cochrane review</a> into vaping to help people quit smoking included quite a few non-randomised trials. These were not given the same weight as randomised research, but did provide support for the central finding of the review.</p>
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Read more:
<a href="https://theconversation.com/controlled-experiments-wont-tell-us-which-indigenous-health-programs-are-working-74618">Controlled experiments won't tell us which Indigenous health programs are working</a>
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<h2>Cochrane is OK about being criticised …</h2>
<p>There have been many issues raised with Cochrane teams over the years. This includes <a href="https://www.sciencedirect.com/science/article/pii/S0895435621002778#!">problems</a> with how reviewers <a href="https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0096920">rate trials</a> included in the reviews.</p>
<p>However, the organisation is famously transparent. If you have an issue with a particular review, you can post your comments publicly. <a href="https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD015017.pub3/read-comments">I did this</a>, sharing my concerns about a review on using the drug ivermectin to treat COVID.</p>
<p>Cochrane is also good at incorporating criticism. It even has <a href="https://community.cochrane.org/news/prizes-and-awards/bill-silverman-prize">a prize</a> for the best criticism of its work.</p>
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Read more:
<a href="https://theconversation.com/the-government-says-ndis-supports-should-be-evidence-based-but-can-they-be-204763">The government says NDIS supports should be 'evidence-based' – but can they be?</a>
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<h2>… even if reviews take time</h2>
<p>There’s a reason so many experts trust Cochrane. The occasional controversy aside, Cochrane reviews are generally the most detailed and rigorous summary of the evidence on any question you can find. </p>
<p>This attention to detail comes at a cost. Cochrane reviews are often the final word on a subject, not just because they are so robust, but because they take a <a href="https://www.mdlinx.com/article/cochrane-reviews-controversy-are-the-concerns-valid/7tjNVFB6sLR2l9VoaXqQDc">very long time</a> to come out.</p>
<p>Cochrane aims to publish reviews within two years. But more than half take <a href="https://pubmed.ncbi.nlm.nih.gov/32413390/">longer</a> to complete. Cochrane reviews are also meant to be updated regularly, but many have not been updated for <a href="https://europepmc.org/article/med/34427395">more than five years</a>.</p>
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Read more:
<a href="https://theconversation.com/clinical-trials-are-useful-heres-how-we-can-ensure-they-stay-so-16113">Clinical trials are useful – here's how we can ensure they stay so</a>
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<h2>In a nutshell</h2>
<p>Cochrane reviews can be flawed, cannot answer all medical questions and, while comprehensive, can take long to complete.</p>
<p>But there’s a reason that these reviews are considered the gold standard in medical research. They are detailed, lengthy, and very impressive pieces of work. </p>
<p>With <a href="https://www.cochranelibrary.com/cdsr/reviews">more than 9,000</a> Cochrane reviews so far, these are still usually the best evidence we have to answer a range of medical questions.</p><img src="https://counter.theconversation.com/content/205014/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>I have previously worked with several members of Cochrane Australia on unaffiliated projects.</span></em></p>Major reviews of medical evidence, known as Cochrane reviews, have come under fire. But is that fair?Gideon Meyerowitz-Katz, PhD Student/Epidemiologist, University of WollongongLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1966512023-03-29T00:56:43Z2023-03-29T00:56:43ZObsessive compulsive disorder is more common than you think. But it can take 9 years for an OCD diagnosis<figure><img src="https://images.theconversation.com/files/511868/original/file-20230223-25-gc8koi.jpg?ixlib=rb-1.1.0&rect=1%2C5%2C997%2C770&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/man-obsessive-compulsive-disorder-placing-corn-1838649955">Shutterstock</a></span></figcaption></figure><p>Obsessive compulsive disorder, or OCD, is a <a href="https://www.sciencedirect.com/science/article/abs/pii/S2211364916301579">misunderstood</a>
mental illness despite affecting <a href="https://pubmed.ncbi.nlm.nih.gov/18725912">about one in 50 people</a> – that’s about half a million Australians.</p>
<p>Our <a href="https://www.tandfonline.com/doi/full/10.1080/00050067.2023.2189003">new research</a> shows how long and fraught the path to diagnosis and treatment can be. </p>
<p>This initial study showed it takes an average of almost nine years to receive a diagnosis of OCD and about four months to get some form of help.</p>
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Read more:
<a href="https://theconversation.com/no-ocd-in-a-pandemic-doesnt-necessarily-get-worse-with-all-that-extra-hand-washing-157961">No, OCD in a pandemic doesn't necessarily get worse with all that extra hand washing</a>
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<h2>What is OCD?</h2>
<p>OCD affects children, adolescents and adults. <a href="https://www.nature.com/articles/mp200894">About 60%</a> report symptoms before the age of 20.</p>
<p>One misconception is that OCD is mild: someone who is extra tidy or likes cleaning. You might have even heard someone say they are “<a href="https://theconversation.com/you-cant-be-a-little-bit-ocd-but-your-everyday-obsessions-can-help-end-the-conditions-stigma-49265">a little bit OCD</a>” while joking about having beautiful stationery.</p>
<p>But OCD is not enjoyable. Obsessions are highly distressing and there are repetitive, intrusive thoughts a person with OCD can’t control. They might believe, for instance, they or their loved ones are in grave danger. </p>
<p><a href="https://iocdf.org/about-ocd/">Compulsions</a> are actions that temporarily alleviate, but ultimately exacerbate, this distress, such as checking the door is locked. People with OCD spend hours each day consumed by this cycle, instead of their normal activities, such as school, work or having a social life. </p>
<p>It can also be very distressing for <a href="https://www.tandfonline.com/doi/abs/10.1586/ern.11.200">family members</a> who often end up completing rituals or providing excessive reassurance to the person with OCD.</p>
<p><div data-react-class="InstagramEmbed" data-react-props="{"url":"https://www.instagram.com/reel/Cl7ElJqBg4f","accessToken":"127105130696839|b4b75090c9688d81dfd245afe6052f20"}"></div></p>
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Read more:
<a href="https://theconversation.com/you-cant-be-a-little-bit-ocd-but-your-everyday-obsessions-can-help-end-the-conditions-stigma-49265">You can't be 'a little bit OCD' but your everyday obsessions can help end the condition's stigma</a>
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<h2>How is it diagnosed?</h2>
<p>People with OCD often don’t tell others about their disturbing thoughts or repetitive rituals. They often feel <a href="https://onlinelibrary.wiley.com/doi/abs/10.1002/%28SICI%291099-0879%28199905%296%3A2%3C80%3A%3AAID-CPP188%3E3.0.CO%3B2-C">ashamed or worried</a> that by telling someone their disturbing thoughts, they might become true.</p>
<p>Doctors <a href="https://www.ncbi.nlm.nih.gov/books/NBK56470/#ch2">don’t always ask about</a> OCD symptoms when people first seek treatment. </p>
<p>Both lead to delays getting correctly diagnosed.</p>
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<p>When people do feel comfortable talking about their OCD symptoms, a diagnosis might be made by a GP, psychologist or other health-care professional, such as a psychiatrist. </p>
<p>Sometimes OCD can be <a href="https://link.springer.com/article/10.1007/s10566-009-9092-8">tricky to differentiate</a> from other conditions, such as eating disorders, anxiety disorders or autism. </p>
<p>Having an additional mental health diagnosis <a href="https://www.nature.com/articles/s41572-019-0102-3">is common</a> in people with OCD. In those cases, a health-care provider experienced in OCD is helpful. </p>
<p>To diagnose OCD, the health professional asks people and/or their families questions about the presence of obsessions and/or compulsions, and how this impacts their life and family. </p>
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Read more:
<a href="https://theconversation.com/more-than-a-habit-when-to-worry-about-nail-biting-skin-picking-and-other-body-focused-repetitive-behaviours-102263">More than a habit? When to worry about nail biting, skin picking and other body-focused repetitive behaviours</a>
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<h2>How is it treated?</h2>
<p>After someone receives a diagnosis, it helps to learn more about OCD and what treatment involves. Great places to start are the <a href="https://iocdf.org">International OCD Foundation</a> and <a href="https://www.ocduk.org">OCD UK</a>. </p>
<p>Next, they will need to find a health-care provider, usually a psychologist, who offers a special type of psychological therapy called “exposure and response prevention” or ERP.</p>
<p>This is a type of
<a href="https://theconversation.com/explainer-what-is-cognitive-behaviour-therapy-37351">cognitive-behavioural therapy</a> that is a <a href="https://doi.org/10.1016/j.jocrd.2021.100684">powerful, effective treatment</a> for OCD. It’s recommended people with OCD try this first.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/511870/original/file-20230223-25-ge0aea.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Man with dreadlocks sitting on sofa talking to therapist" src="https://images.theconversation.com/files/511870/original/file-20230223-25-ge0aea.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/511870/original/file-20230223-25-ge0aea.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/511870/original/file-20230223-25-ge0aea.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/511870/original/file-20230223-25-ge0aea.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/511870/original/file-20230223-25-ge0aea.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=502&fit=crop&dpr=1 754w, https://images.theconversation.com/files/511870/original/file-20230223-25-ge0aea.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=502&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/511870/original/file-20230223-25-ge0aea.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=502&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">A type of psychological therapy known as ‘exposure and response prevention’ is recommended first.</span>
<span class="attribution"><a class="source" href="https://www.pexels.com/photo/positive-black-man-talking-to-female-therapist-5699421/">Alex Green/Pexels</a></span>
</figcaption>
</figure>
<p>It involves therapists helping people to understand the cycle of OCD and how to break that cycle. They support people to deliberately enter anxiety-provoking situations while resisting completing a compulsion. </p>
<p>Importantly, people and their ERP therapist <a href="https://pubmed.ncbi.nlm.nih.gov/18005936/">decide together</a> what steps to take to truly tackle their fears. </p>
<p>People with OCD learn new thoughts, for example, “germs don’t always lead to illness” rather than “germs are dangerous”.</p>
<p>There are a range of medications that also <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4967667/">effectively</a> <a href="https://pubmed.ncbi.nlm.nih.gov/27663940/">treat</a> OCD. But more research is needed to know more about when a medication should be added. For most people these are best considered a “boost” to help ERP.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/brain-scans-reveal-why-it-is-so-difficult-to-recover-from-ocd-and-hint-at-ways-forward-74092">Brain scans reveal why it is so difficult to recover from OCD – and hint at ways forward</a>
</strong>
</em>
</p>
<hr>
<h2>But not everything goes to plan</h2>
<p>Delays in being diagnosed is only the start:</p>
<ul>
<li><p>treatment is challenging to access. Only <a href="https://www.sciencedirect.com/science/article/abs/pii/S0887618518301038?via%3Dihub">30% of clinicians</a> in the United States offer ERP therapy. There is likely a similar situation in Australia</p></li>
<li><p>many people receive therapies that appear credible, <a href="https://onlinelibrary.wiley.com/doi/abs/10.1111/cpsp.12337?casa_token=Wn3bgnvINSsAAAAA%3A2sqam0BKtCzFA680_f6ln4scp1SKVpN_cOB6Tg8vQyEiNDZPwS-Z-NNveLelKYF6iz4PFqQSXyHKZYJS">but lack evidence</a>, such as general cognitive therapy that is not tailored to the mechanisms maintaining OCD. Inappropriate treatments waste valuable time and effort that the person could use to recover. Ineffective treatments can make OCD symptoms worse</p></li>
<li><p>even when someone receives first-line, evidence-based treatments, <a href="https://www.sciencedirect.com/science/article/pii/S0005796722001413?via%3Dihub">about 40-60%</a> of people don’t get better</p></li>
<li><p>there are no Australian clinical treatment guidelines, nor state or national clinical service plans for OCD. This makes it hard for health-care providers to know how to treat it</p></li>
<li><p>there has been <a href="https://journals.sagepub.com/doi/full/10.1177/00048674221125595">relatively little research funding</a> spent on OCD in the past ten years, compared with, for example, psychosis or dementia.</p></li>
</ul>
<h2>What can we do?</h2>
<p>Real change demands collaboration between health-care professionals, researchers, government, people with OCD and their families to advocate for proportionate funding for research and clinical services to:</p>
<ul>
<li><p>deliver public health messaging to improve general knowledge about OCD and reduce the stigma so people feel more comfortable disclosing their worries</p></li>
<li><p>upskill and support health professionals to speed up diagnosis so people can receive targeted early intervention</p></li>
<li><p>support health-care professionals to offer evidence-based treatment for OCD, so more people can access these treatments</p></li>
<li><p>develop state and national service plans and clinical guidelines. For example, the Australian government funds the <a href="https://nedc.com.au/">National Eating Disorders Collaboration</a> to develop and implement a nationally consistent approach to preventing and treating eating disorders</p></li>
<li><p>research to discover new, and enhance existing, treatments. These include ones for people who don’t get better after “exposure and response prevention” therapy.</p></li>
</ul>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/seeing-a-psychologist-on-medicare-soon-youll-be-back-to-10-sessions-but-we-know-thats-not-often-enough-194338">Seeing a psychologist on Medicare? Soon you'll be back to 10 sessions. But we know that's not often enough</a>
</strong>
</em>
</p>
<hr>
<h2>What if I think I have OCD?</h2>
<p>The most common barrier to getting help is not knowing who to see or where to go. Start with your GP: tell them you think you might have OCD and ask to discuss treatment options. These might include therapy and/or medication and a referral to a psychologist or psychiatrist.</p>
<p>If you choose therapy, it’s important to find a clinician that offers specific and effective treatment for OCD. To help, we’ve started <a href="https://ocd.org.au/directory">a directory</a> of clinicians with a special interest in treating OCD. </p>
<p>You <a href="https://iocdf.org/ocd-finding-help/how-to-find-the-right-therapist/#:%7E:text=Tips%20for%20Finding%20the%20Right%20Therapist&text=Also%2C%20remember%20that%20some%20therapists,the%20phone%20or%20in%20person">can ask</a> any potential health professional if they offer “exposure and response prevention”. If they don’t, it’s a sign this isn’t their area of expertise. But you still can ask them if they know of a colleague who does. You might need to call around, so hang in there. Good treatment can be life changing.</p>
<p><em>If this article has raised issues for you, or if you’re concerned about someone you know, call Lifeline on 13 11 14.</em></p><img src="https://counter.theconversation.com/content/196651/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Iain Perkes is employed by UNSW, Sydney and the Sydney Children's Hospitals Network. He receives funding from Rotary Mental Health, the Mindgardens Neuroscience Network, National Health and Medical Research, the Tourette's Association of America, and the New South Wales Higher Education and Training Institute.</span></em></p><p class="fine-print"><em><span>David Cooper was funded by the UNSW Scientia PhD scholarship for his time on this article. David is also a clinical psychologist in private practice.</span></em></p><p class="fine-print"><em><span>Jessica Grisham receives funding from the Australian Research Council and Rotary Mental Health. </span></em></p><p class="fine-print"><em><span>Katelyn Dyason receives funding from Rotary Mental Health, and was funded by Mindgardens Neuroscience Network for her time on this article. </span></em></p><p class="fine-print"><em><span>Lara Farrell receives funding from Rotary Mental Health, National Health and Medical Research Council (NHMRC), and Medical Research Future Fund (MRFF). </span></em></p><p class="fine-print"><em><span>Lizzie Manning receives funding from National Health and Medical Research Council (NHMRC), Australian Research Council (ARC) and Tourette Association of America (TAA). </span></em></p>People can be reluctant to discuss symptoms with their doctor. When they do, their symptoms can be mistaken for other illnesses. Even when people are diagnosed, they don’t always get the right treatment.Iain Perkes, Senior Lecturer, child and adolescent psychiatry, UNSW SydneyDavid Cooper, PhD Candidate, UNSW SydneyJessica Grisham, Professor in Psychology, UNSW SydneyKatelyn Dyason, Project manager and psychologist, School of Psychiatry, UNSW SydneyLara Farrell, Associate Professor and Clinical Psychologist, Griffith UniversityLizzie Manning, Lecturer in Physiology and Neuroscience, University of NewcastleLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1851672022-06-17T10:18:02Z2022-06-17T10:18:02ZWe don’t know whether most medical treatments work, and we know even less about whether they cause harm – new study<figure><img src="https://images.theconversation.com/files/469307/original/file-20220616-20-ye31mc.jpg?ixlib=rb-1.1.0&rect=0%2C16%2C5378%2C3558&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">'I have no idea if this will work.'</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/shot-female-dietician-prescribing-nutritional-supplement-1080163670">Josep Suria/Shutterstock</a></span></figcaption></figure><p>Only one in 20 medical treatments have high-quality evidence to support their benefits, according to a <a href="https://www.sciencedirect.com/science/article/abs/pii/S0895435622001007">recent study</a>. The study also found that harms of treatments are measured much more rarely (a third as much) as benefits.</p>
<p>Patients and doctors – and anyone who pays for them – need to know that medical treatments are safe and effective, but it’s an <a href="https://onlinelibrary.wiley.com/doi/book/10.1002/9781444342673">open secret</a> in the medical field that not all treatments, including ones that are commonly used, are safe and effective. For example, antiarrhythmic drugs were widely prescribed in the belief that they would reduce heart attack deaths until a clinical trial found that they <a href="https://www.nejm.org/doi/full/10.1056/nejm199103213241201">actually increased the risk of death</a>. </p>
<p>In another example, putting infants to sleep on their stomach was recommended based on expert opinion that babies would be less likely to choke on their vomit until large studies found that stomach sleeping increased the risk of <a href="https://iris.ucl.ac.uk/iris/publication/68455/1">sudden infant death syndrome</a>.</p>
<p>So how big is this problem? </p>
<p>In the early 2000s, researchers estimated that between <a href="https://pubmed.ncbi.nlm.nih.gov/11758290/">quarter</a> and a <a href="https://pubmed.ncbi.nlm.nih.gov/17683315/">half</a> of treatments are supported by high-quality evidence. But these estimates are now out of date and used old methods (such as researcher opinion) to determine whether the evidence was high quality or not. More recently, in 2020, a more rigorous estimate was published and found that only <a href="https://pubmed.ncbi.nlm.nih.gov/32890636/">10% of medical treatments</a> were based on high-quality evidence. However, this estimate was based on a small sample of 151 studies.</p>
<p>Meanwhile, some continue to insist that <a href="https://www.jstor.org/stable/10.1086/341855">most treatments must work</a>. How else can we explain that we live ten years <a href="https://archive.senseaboutscience.org/pages/ebm-matters.html">longer than our great-grandparents</a>? Yet the extension in lifespan is explicable at least partly by <a href="https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(08)60292-5.pdf">public health measures</a> such as clean water, better nutrition and <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1447499/">restrictions on smoking</a>.</p>
<figure class="align-center ">
<img alt="Two girls drinking water in a kitchen." src="https://images.theconversation.com/files/469468/original/file-20220617-26-haglol.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/469468/original/file-20220617-26-haglol.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=337&fit=crop&dpr=1 600w, https://images.theconversation.com/files/469468/original/file-20220617-26-haglol.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=337&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/469468/original/file-20220617-26-haglol.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=337&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/469468/original/file-20220617-26-haglol.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=424&fit=crop&dpr=1 754w, https://images.theconversation.com/files/469468/original/file-20220617-26-haglol.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=424&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/469468/original/file-20220617-26-haglol.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=424&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Having access to clean water partly explains our increased lifespan in the last century.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/happy-little-multiracial-sisters-sit-table-1707844096">fizkes/Shutterstock</a></span>
</figcaption>
</figure>
<h2>A more accurate picture</h2>
<p>To resolve the controversy about the proportion of treatments that are based on good evidence, an international team of researchers from the UK (University of Oxford), US, Switzerland and Greece conducted a large study of 1,567 healthcare treatments. The sample included all treatments tested in Cochrane Reviews between 2008 and 2021. <a href="https://training.cochrane.org/handbook">Cochrane Reviews are rigorous studies</a> that amalgamate all available relevant evidence about treatments. They are often referenced in national and international <a href="https://www.cochrane.org/news/use-cochrane-reviews-inform-who-guidelines">healthcare guidelines</a>. </p>
<p>The year 2008 was chosen as the cut-off because that was when Cochrane Reviews incorporated a system called <a href="https://bestpractice.bmj.com/info/toolkit/learn-ebm/what-is-grade/">grading quality of evidence and strength of recommendations (Grade)</a> to rate how trustworthy the evidence is. Unlike the earlier estimates that often relied on opinions, Grade is more widely accepted and is used by <a href="https://www.bjanaesthesia.org.uk/article/S0007-0912(19)30643-9/fulltext">over 100 organisations around the world</a>. Using Grade results in a quality rating of high, moderate, low or very low.</p>
<p>The study revealed that 95% of treatments do not have high-quality evidence to support their benefits. Worse, the harms are reported in only about 33% of Cochrane Reviews.</p>
<p>It is particularly worrying that the harms of healthcare interventions are rarely quantified. For a doctor or patient to <a href="https://pubmed.ncbi.nlm.nih.gov/23381520/">decide whether to use a treatment</a>, they need to know whether the benefits outweigh the harms. If the harms are inadequately measured, <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4603687/">an “informed choice” is not possible</a>.</p>
<p>A potential limitation of the study is that Grade might be too strict. Doctors and patients may be happy to use treatments whose benefits are not supported by high-quality evidence as long as they are supported by moderate-quality evidence. Even if this is right, the study found that less than half of treatments are supported by high or moderate-quality evidence. </p>
<p>Patients with ailments for which there are no effective treatments may be willing to try treatments that are not yet even supported by low-quality evidence. The study should not be used to constrain these patients’ choices. </p>
<p>Also, the sample may not have been representative. In theory, treatments tested in recent Cochrane Reviews may be less effective or based on lower-quality evidence than older treatments. However, given the rigour of Cochrane Reviews, this seems unlikely. </p>
<p>In practice, doctors can use <a href="https://effectivehealthcare.ahrq.gov/products/off-label-use-research-priorities/research">“off-label” treatments</a> which are less likely to have been studied in Cochrane Reviews and generally have <a href="https://www.uchicagomedicine.org/forefront/news/off-label-use-oft-not-evidence-based">lower-quality evidence to support them</a>. Despite these potential limitations, the study still showed that most treatments are not supported by high-quality evidence.</p>
<p>Doctors, patients and those who pay for them may wish to focus on treatments whose benefits and safety are established by high-quality evidence. Research funding should be allocated to generating high-quality evidence for treatments that are widely used but not yet supported by high-quality evidence about their benefits and harms. </p>
<p>Finally, potential harms should be measured with the same rigour as potential benefits. The evidence-based medicine community is <a href="https://www.bmj.com/content/308/6924/283">correct to continue calling for higher-quality research</a>, and also justified in their scepticism that high-quality evidence for medical treatments is <a href="https://pubmed.ncbi.nlm.nih.gov/26934549/">common or even improving</a>.</p><img src="https://counter.theconversation.com/content/185167/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jeremy Howick receives funding from the Medical Research Council (UK)</span></em></p>Around 95% of treatments do not have high-quality evidence to support their benefitsJeremy Howick, Professor and Director of the Stoneygate Centre for Excellence in Empathic Healthcare, University of LeicesterLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1556532021-03-17T13:51:43Z2021-03-17T13:51:43ZHow Canadians can use social media to help debunk COVID-19 misinformation<figure><img src="https://images.theconversation.com/files/386266/original/file-20210224-17-zix5lb.jpg?ixlib=rb-1.1.0&rect=83%2C11%2C1826%2C1413&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The #ScienceUpFirst campaign targets online misinformation about COVID-19 that can endanger public health.</span> <span class="attribution"><span class="source">(Canva)</span></span></figcaption></figure><p>You do not need statistics to know that health-related misinformation is rampant on social media, including with respect to COVID-19. But here are some jarring examples anyway: <a href="https://www150.statcan.gc.ca/n1/pub/45-28-0001/2021001/article/00003-eng.htm">Statistics Canada reported</a> that nearly all Canadians saw COVID-19 misinformation online; only one in five Canadians always check the accuracy of online COVID-19 information; and half of Canadians shared COVID-19 information they found online without knowing whether it was accurate. </p>
<p>These statistics are not trivial, as <a href="https://extranet.who.int/iris/restricted/handle/10665/330778">misinformation</a> can endanger public health. Many damaging myths about COVID-19 have circulated on social media, for example: </p>
<ul>
<li>COVID-19 can spread by 5G mobile networks (<a href="https://www.who.int/emergencies/diseases/novel-coronavirus-2019/advice-for-public/myth-busters#5g">viruses cannot travel through radio waves or mobile networks</a>); </li>
<li>mRNA COVID-19 vaccines can change your DNA (<a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html">nope, that’s seriously not how they work</a>); and </li>
<li>COVID-19 vaccines can negatively affect fertility in women or men (<a href="https://doi.org/10.1136/bmj.n509">there’s no evidence for this claim</a>). </li>
</ul>
<p>Health misinformation and conspiracy theories do real damage. They have been linked to a <a href="https://doi.org/10.1098/rsos.201199">decreased likelihood of following public health advice</a>, such as wearing masks, and can influence health decisions, such as the <a href="https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1835348">likelihood to get influenza vaccines</a> and <a href="https://www.nature.com/articles/s41562-021-01056-1">intent to get COVID-19 vaccines</a>. </p>
<p>In this vein, health misinformation can fuel vaccine hesitancy, which the <a href="https://journalistsresource.org/home/6-tips-for-covering-vaccine-hesitancy/">World Health Organization</a> has listed as one of the top 10 threats to global health. That threat becomes very clear and very immediate in the context of COVID-19. With vaccination programs underway, <a href="https://doi.org/10.1038/s41562-021-01056-1">vaccine hesitancy could threaten the goal of herd immunity</a>, which is key to ending the pandemic. </p>
<p>Organizations including the <a href="https://www.canada.ca/en/public-health/news/2021/02/government-of-canada-supports-projects-to-encourage-vaccine-uptake-in-canada.html">federal government</a> and the <a href="https://www.cbc.ca/news/canada/toronto/covid-19-vaccine-debunking-myths-1.5881177">Ontario Medical Association</a> are concerned enough about vaccine hesitancy to specifically address it through funding and advocacy, and the <a href="https://www.who.int/news-room/spotlight/let-s-flatten-the-infodemic-curve">World Health Organization</a> has dubbed the <a href="https://doi.org/10.1038/d41586-020-01266-z">extent of misinformation online an “infodemic</a>.” </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/389690/original/file-20210315-19-1ewbuhl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Infographic listing seven ways to spot misinformation" src="https://images.theconversation.com/files/389690/original/file-20210315-19-1ewbuhl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/389690/original/file-20210315-19-1ewbuhl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=340&fit=crop&dpr=1 600w, https://images.theconversation.com/files/389690/original/file-20210315-19-1ewbuhl.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=340&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/389690/original/file-20210315-19-1ewbuhl.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=340&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/389690/original/file-20210315-19-1ewbuhl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=427&fit=crop&dpr=1 754w, https://images.theconversation.com/files/389690/original/file-20210315-19-1ewbuhl.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=427&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/389690/original/file-20210315-19-1ewbuhl.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=427&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">The World Health Organization’s Infodemic campaign suggests seven ways to spot misinformation.</span>
<span class="attribution"><span class="source">(World Health Organization, 2020)</span>, <a class="license" href="http://creativecommons.org/licenses/by-nc/4.0/">CC BY-NC</a></span>
</figcaption>
</figure>
<p>There is a very real need to ensure that reliable, evidence-based information is as available, plentiful and accessible as misinformation, and that it travels as quickly online. That is precisely the goal of the <a href="https://www.scienceupfirst.com/">#ScienceUpFirst initiative</a>: to provide, support and boost accurate scientific information online to help people make informed health decisions. </p>
<h2>Championing evidence-based public health</h2>
<p>The #ScienceUpFirst project began when <a href="https://www.ualberta.ca/law/faculty-and-research/health-law-institute/people/timothycaulfield.html">public health scholar Timothy Caulfield</a>, Canada Research Chair in Health Law and Policy at the University of Alberta, and <a href="https://sencanada.ca/en/senators/kutcher-stan/">Senator Stanley Kutcher of Nova Scotia</a> recruited a national coalition of scientists, communicators and health experts to empower Canadians to work together against misinformation about COVID-19 and COVID-19 vaccines. </p>
<p>As a clinical psychologist with an interest in science communication and health-related misinformation, I was honoured to join the team in the service of those goals, along with other professionals who are independently represented from an array of Canadian universities and organizations. Operationally, the project is supported by the <a href="https://www.canadiansciencecentres.ca/">Canadian Association of Science Centres</a>, <a href="https://covid19resources.ca/">COVID-19 Resources Canada</a> and the <a href="https://www.ualberta.ca/law/faculty-and-research/health-law-institute/index.html">Health Law Institute at the University of Alberta</a>. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/385308/original/file-20210219-17-1gbpfgm.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="ScienceUpFirst logo reading 'Together against misinformation'" src="https://images.theconversation.com/files/385308/original/file-20210219-17-1gbpfgm.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/385308/original/file-20210219-17-1gbpfgm.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=300&fit=crop&dpr=1 600w, https://images.theconversation.com/files/385308/original/file-20210219-17-1gbpfgm.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=300&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/385308/original/file-20210219-17-1gbpfgm.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=300&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/385308/original/file-20210219-17-1gbpfgm.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=377&fit=crop&dpr=1 754w, https://images.theconversation.com/files/385308/original/file-20210219-17-1gbpfgm.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=377&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/385308/original/file-20210219-17-1gbpfgm.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=377&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">#ScienceUpFirst works to counter online misinformation and conspiracy theories.</span>
<span class="attribution"><span class="source">(ScienceUpFirst)</span>, <span class="license">Author provided</span></span>
</figcaption>
</figure>
<p>The bilingual campaign uses the online hashtags #ScienceUpFirst and #LaScienceDAbord on social media platforms including Twitter, Instagram and Facebook, and will eventually include TikTok. In essence, #ScienceUpFirst uses social media to promote and amplify the best available science-based content, in an effort to debunk misinformation. </p>
<p>The initial goal of the campaign is to follow <a href="https://www.ualberta.ca/law/media-library/faculty-research/hli/media/images/caulfield-debunking-works-vulnerable-caulfield.pdf">evidence-based guidelines</a> to target misinformation and conspiracy theories specifically related to COVID-19 vaccines, virus transmission and government response. Eventually, the framework can be applied beyond the COVID-19 pandemic to address other types of health- and science-related misinformation.</p>
<p>At the social media level, the campaign seeks out, evaluates and boosts existing, evidence-based content, with the intention of engaging Canadians to help to share and amplify that content on social media. Importantly, this involves efforts to adapt content and ensure that it reflects and speaks to the diverse socio-demographic that comprises the Canadian population.</p>
<p>The project will also track trending misinformation and respond swiftly with corrected content created as part of the #ScienceUpFirst initiative. </p>
<h2>Is it worth it?</h2>
<p>Addressing misinformation is definitely worth the effort. Research shows that <a href="https://www.ualberta.ca/law/media-library/faculty-research/hli/media/images/caulfield-debunking-works-vulnerable-caulfield.pdf">debunking works</a> and can be effective if it is done correctly. </p>
<p>This means using evidence-based tactics when crafting a message to counter misinformation. These include, but are not limited to: providing the science, using clear and shareable content, referencing trustworthy sources, noting the scientific consensus and its evolution, incorporating narrative and story, leading with facts, being nice and authentic and highlighting gaps in logic and rhetorical devices. </p>
<h2>How to participate</h2>
<p>The #ScienceUpFirst movement is not passive, but is an ongoing, interactive project designed to thrive on Canadians’ participation. </p>
<p>There are three ways people can help amplify evidence-based information, and debunk misinformation with #ScienceUpFirst: </p>
<ol>
<li><p>Follow @ScienceUpFirst on Twitter, Instagram and Facebook, and engage with and share content using the hashtag #ScienceUpFirst or #LaScienceDAbord.</p></li>
<li><p>Tag @ScienceUpFirst in COVID-19 science-based posts and misinformation posts on all social media channels.</p></li>
<li><p>Visit <a href="https://www.scienceupfirst.com/">www.ScienceUpFirst.com</a> to sign up for a weekly newsletter.</p></li>
</ol>
<p>The project launched at the end of January, and garnered over 8,500 posts and more than 42 million views across social media platforms in its first week.</p>
<p>Health professionals and scientists have an ethical responsibility to promote and practise evidence-based patient care and public health. Part of that mission includes calling out and correcting misinformation online via science communication on social media. </p>
<p>We welcome and encourage everyone to join us.</p><img src="https://counter.theconversation.com/content/155653/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jonathan N. Stea 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>A national coalition of scientists, communicators and health experts is empowering Canadians to work together against online misinformation about COVID-19 and COVID-19 vaccines with #ScienceUpFirst.Jonathan N. Stea, Clinical Psychologist and Adjunct Assistant Professor, University of CalgaryLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1462672020-09-21T12:16:14Z2020-09-21T12:16:14ZScientists don’t share their findings for fun – they want their research to make a difference<figure><img src="https://images.theconversation.com/files/358725/original/file-20200917-18-b3vrzz.jpg?ixlib=rb-1.1.0&rect=136%2C0%2C4210%2C3132&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Scientists talk about their research because they want their expertise to guide real-world decisions.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/caltech-seismologist-egill-hauksson-speaks-to-reporters-at-news-photo/1154154444">Frederic J. Brown/AFP via Getty Images</a></span></figcaption></figure><p><em>The <a href="https://theconversation.com/us/topics/research-brief-83231">Research Brief</a> is a short take about interesting academic work.</em></p>
<h2>The big idea</h2>
<p>Scientists don’t take time away from their research to share their expertise with journalists, policymakers and everyone else just to let us know about neat scientific facts.</p>
<p>They share findings from their research because they want leaders and the public to <a href="https://doi.org/10.1177/0963662520950671">use their hard-won insights to make evidence-based decisions</a> about policy and personal issues. That’s according to two surveys of Canadian and American researchers my colleagues <a href="https://scholar.google.com/citations?user=0ssM57wAAAAJ&hl=en&oi=ao">and I</a> conducted.</p>
<p>Scientists from both countries reported “ensuring that policymakers use scientific evidence” is at the top of their list of communication goals. Helping their fellow citizens make better personal decisions also scores high. Further, scientists say they’re not communicating just to burnish their own reputation.</p>
<p><iframe id="cXAyd" class="tc-infographic-datawrapper" src="https://datawrapper.dwcdn.net/cXAyd/6/" height="400px" width="100%" style="border: none" frameborder="0"></iframe></p>
<h2>Why it matters</h2>
<p>In just one recent week, American President Donald Trump said top health scientists were <a href="https://www.nytimes.com/2020/09/16/world/covid-coronavirus.html">making “a mistake” about the value of masks</a> in slowing COVID-19 transmission and that he doesn’t “<a href="https://www.nytimes.com/2020/09/14/us/politics/trump-biden-climate-change-fires.html">think science knows</a>” whether climate change is part of the reason the American West is beset by wildfires this summer.</p>
<p>The scientific community has come to expect this sort of historically unusual <a href="https://doi.org/10.1126/science.abe7391">disregard for scientific advice</a> from the current administration. But our new study underscores that scientists prioritize sharing their research so it can have an impact in the real world. They aren’t satisfied just producing knowledge for knowledge’s sake, but rather want it to inform such matters as pandemic response and wildfire management.</p>
<p>We know from other interviews and surveys that many scientists will often initially indicate that their communication “goal” is simply to increase knowledge or correct misinformation. However, if prodded by questions like “But why do you want to increase knowledge?” or “What do you hope will happen if you correct misinformation?” they will often identify their ultimate aim as helping people make better decisions.</p>
<p>Highly trained scientists <a href="https://doi.org/10.1177/1075547018786561">seem especially willing</a> to share what they’ve learned if they think it can help society make smarter choices. For example, forest scientists I’ve worked with in New England want to help land managers and policymakers find ways to <a href="https://harvardforest.fas.harvard.edu/other-tags/wildlands-woodlands">protect Northeastern forests from urban sprawl and other threats</a>. There also appears to be broad demand among scientists of all types <a href="https://www.aaas.org/programs/science-technology-policy-fellowships">to take part in</a> <a href="https://ritaallen.org/stories/report-calls-for-strengthening-science-engagement-fellowships-through-new-connections-and-inclusion/">policy fellowships</a> that help them connect with policymakers on issues like managing health and environmental risks.</p>
<p>Science isn’t infallible, but the premise of scientific research is that it’s among the best available ways of trying to understand a complicated world. Years of survey research also show that Americans have more <a href="https://ncses.nsf.gov/pubs/nsb20207/public-attitudes-about-s-t-in-general#figureCtr1095">confidence in scientists</a> than in most other groups in society and want scientists to be <a href="https://wayback.archive-it.org/5902/20170708080854/https://www.nsf.gov/statistics/seind12/c7/c7s3.htm#s4">involved in a range of different types of decision-making</a>.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/358726/original/file-20200917-24-1l2plgo.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Woman and child look at X-ray with pediatrician" src="https://images.theconversation.com/files/358726/original/file-20200917-24-1l2plgo.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/358726/original/file-20200917-24-1l2plgo.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/358726/original/file-20200917-24-1l2plgo.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/358726/original/file-20200917-24-1l2plgo.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/358726/original/file-20200917-24-1l2plgo.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/358726/original/file-20200917-24-1l2plgo.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/358726/original/file-20200917-24-1l2plgo.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"></a>
<figcaption>
<span class="caption">Scientists want their research to inform decisions like those made by families and health care providers.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/pediatrician-shows-x-ray-to-concerned-parent-royalty-free-image/807902904">SDI Productions/E+ via Getty Images</a></span>
</figcaption>
</figure>
<h2>What still isn’t known</h2>
<p>Our surveys didn’t ask about every possible goal. For example, we did not ask scientists about how much they aim to push policymakers to adopt specific laws or regulations. We also didn’t investigate how much effort scientists put into the goal of learning from those with whom they communicate, which might have implications for what they choose to research.</p>
<p>Another thing that’s missing from our research is direct information about what might lead scientists to prioritize specific goals.</p>
<p>However, we do know from past research that scientists are more likely to say they’re <a href="https://doi.org/10.1177/1075547018786561">willing to communicate</a>, as well as to prioritize <a href="https://doi.org/10.1177/0963662517728478">specific objectives</a> or <a href="https://doi.org/10.1371/journal.pone.0224039">tactics</a>, if they see a choice as ethical, able to make a difference and within their capacity.</p>
<h2>What’s next</h2>
<p>My colleagues and I continue to study scientists’ communication goals and overall views about communication. We’re especially interested in understanding how scientists identify their goals and how to encourage them to draw on evidence-based strategies that could help them achieve those goals. This increasingly includes efforts to encourage scientists to collaborate with communication experts <a href="https://doi.org/10.1108/JCOM-03-2020-0022">within their organizations</a>.</p><img src="https://counter.theconversation.com/content/146267/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>John C. Besley receives or has received funding from the National Science Foundation (AISL 1421214-1421723), the United States Department of Agriculture (MICL02468), the Albert and Mary Lasker Foundation, the John Templeton Foundation, the Rita Allen Foundation, the David & Lucile Packard Foundation, and the Kavli Foundation for research related to this article. Any opinions, findings, conclusions, or recommendations expressed in this material are those of the author and do not necessarily reflect the views of these organizations.</span></em></p>A survey of over a thousand scientists reveals that their goal when communicating about their work is to help the rest of us make evidence-based decisions that draw on scientific findings.John C. Besley, Ellis N. Brandt Professor of Public Relations, Michigan State UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1381972020-06-02T12:13:49Z2020-06-02T12:13:49ZFrom the research lab to your doctor’s office – here’s what happens in phase 1, 2, 3 drug trials<figure><img src="https://images.theconversation.com/files/334221/original/file-20200512-66644-10tznjn.jpg?ixlib=rb-1.1.0&rect=43%2C0%2C4800%2C3140&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Finding a cure for the coronavirus requires more than anecdotal evidence.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/doctor-wearing-ppe-or-isolation-grown-suite-for-royalty-free-image/1208754898?adppopup=true">Skaman306/Moment via Getty Images</a></span></figcaption></figure><p>For COVID-19, like all illnesses, the drugs and vaccines to treat or prevent the disease must be backed by rigorous evidence. <a href="https://www.nia.nih.gov/health/what-are-clinical-trials-and-studies">Clinical trials</a> are the source of this evidence. </p>
<p>With vaccines and drugs for the coronavirus already entering human testing, it is important to know what the different phases of clinical trials are testing for. <a href="https://keck.usc.edu/faculty-search/mindy-aisen/">I am a neurologist</a> with the <a href="https://keck.usc.edu/atri/">Alzheimer’s Therapeutic Research Institute</a> at the University of Southern California. Our team has been developing and overseeing all phases of clinical trials for decades. I am here to help you understand this complicated and important process. </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/l0ZBZ2Zy7Lw?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
</figure>
<h2>Preclinical trials</h2>
<p>The earliest indications about whether an intervention is effective and safe come from preclinical trials. This research is done in the laboratory using cells or animals.</p>
<p>Researchers can get some information about safety and efficacy of a treatment from preclinical trials, but the results do not say whether what they are testing is safe or works in people. </p>
<p>Once a treatment shows promise in preclinical trials, researchers begin the process of working through the phases that have been established by the <a href="https://www.fda.gov/patients/drug-development-process/step-3-clinical-research">U.S. Food and Drug Administration</a>. These phases are designed <a href="https://www.fda.gov/science-research/science-and-research-special-topics/clinical-trials-and-human-subject-protection">to do two things</a>: protect patients during the process and make sure that the drug or treatment works. </p>
<h2>Phase 1 trials</h2>
<p>Phase 1 trials are <a href="https://www.nia.nih.gov/health/what-are-clinical-trials-and-studies">focused on safety</a>. Researchers monitor kidney, liver, hormone and cardiac functions to look for adverse affects in human volunteers. They also look for biological signs of efficacy related to what they are hoping to treat. For example, if a trial was testing a vaccine, researchers might monitor immune activity to see if it increases.</p>
<p>Phase 1 clinical trials <a href="https://www.nia.nih.gov/health/what-are-clinical-trials-and-studiesand">typically take around two months</a> and involve small numbers of participants, usually 20 to 100 healthy volunteers or people with the condition that the intervention may treat. Researchers give the participants a range of medication dosages to help determine the lowest possible effective but safe dose. Some, but not all, phase 1 studies are randomized and placebo controlled, meaning that some portion of the subjects are given the real treatment and some <a href="https://www.nia.nih.gov/health/placebos-clinical-trials">get a placebo</a> that does nothing. Neither the subject nor clinician knows who is receiving which treatment. </p>
<p>Drugs that pass phase 1 trials can be considered likely safe, but whether they work or not still remains to be seen.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/334227/original/file-20200512-66681-pk6env.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/334227/original/file-20200512-66681-pk6env.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/334227/original/file-20200512-66681-pk6env.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=384&fit=crop&dpr=1 600w, https://images.theconversation.com/files/334227/original/file-20200512-66681-pk6env.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=384&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/334227/original/file-20200512-66681-pk6env.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=384&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/334227/original/file-20200512-66681-pk6env.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=483&fit=crop&dpr=1 754w, https://images.theconversation.com/files/334227/original/file-20200512-66681-pk6env.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=483&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/334227/original/file-20200512-66681-pk6env.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=483&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Once people are used in the testing process, the U.S. Food and Drug Administration gets involved.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/the-outside-of-the-food-and-drug-administration-news-photo/496532228?adppopup=true">Al Drago/CQ Roll Call via Getty Images</a></span>
</figcaption>
</figure>
<h2>Phase 2 trials</h2>
<p>In phase 2 trials, researchers focus on seeing if the treatment works, finding the safest effective dose and determining what symptoms, tests or outcomes are the best measures of efficacy of the treatment. Determining the best measures of success is important for designing the final stage of testing.</p>
<p>All phase 2 trials are randomized and placebo controlled.</p>
<p>This stage of research can take months to years, and only about <a href="https://www.fda.gov/patients/drug-development-process/step-3-clinical-research">one-third of drugs in phase 2 trials make it to the next phase</a>.</p>
<p>In phase 2 trials, researchers give the drug to hundreds of subjects and watch for safety through regular testing. To measure effectiveness, researchers look at clinical responses such as the length of illness, severity of the illness or survival rates. Direct measures of a disease – such as the amount of virus in a person’s cells – are also monitored, as well as <a href="https://dx.doi.org/10.1177%2F1535370217750088">biomarkers</a> – signals in the body that researchers <a href="https://www.clinicaltrials.gov/ct2/show/NCT04322513">know are changed by the targeted disease</a>.</p>
<p>At this point, the researchers will use all the information they have gained to design the phase 3 trial. They decide what measures to use, the doses to test and the type, or <a href="https://www.cancer.gov/publications/dictionaries/cancer-terms/def/cohort">cohort</a>, of people to test. </p>
<p>If there is evidence in either phase 1 or phase 2 that the drug or vaccine is unsafe or ineffective, the teams will stop the trial. </p>
<h2>Phase 3 trials</h2>
<p>Phase 3 trials are where researchers look to see if people that get the treatment are statistically better off than those don’t. The trials are randomized and placebo controlled, and use the measures of success chosen from the phase 2 trial. Phase 3 trials are also designed to find any rare side effects of a treatment. </p>
<p>In order to get statistically meaningful data, phase 3 trials are big, normally including a few hundred to 3,000 people. </p>
<p>This is the final step before a drug is approved for public use. After a phase 3 trial is finished, the FDA puts together a panel of independent scientists to review the data. The panel decides, based on evidence of success and prevalence of side effects, if the benefits of the drug outweigh the risks enough to approve it for widespread use.</p>
<p>According to the FDA, only <a href="https://www.fda.gov/patients/drug-development-process/step-3-clinical-research">25%-30% of drugs in phase 3 trials get approved</a>.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/338641/original/file-20200529-78867-1mjk2mt.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/338641/original/file-20200529-78867-1mjk2mt.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/338641/original/file-20200529-78867-1mjk2mt.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/338641/original/file-20200529-78867-1mjk2mt.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/338641/original/file-20200529-78867-1mjk2mt.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/338641/original/file-20200529-78867-1mjk2mt.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/338641/original/file-20200529-78867-1mjk2mt.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/338641/original/file-20200529-78867-1mjk2mt.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"></a>
<figcaption>
<span class="caption">Neither the researchers, physicians nor patients know whether they are handing real drugs or placebos for randomized placebo-controlled clinical trials.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/drug-research-doctor-working-in-hospital-writing-a-royalty-free-image/959237242?adppopup=true">krisanapong detraphiphat/Moment via Getty Images</a></span>
</figcaption>
</figure>
<h2>Phase 4 trials</h2>
<p>Phase 4 trials are used to test approved treatments for the same medical condition but in a different dose or time frame or group of people. For example, a phase 4 trial could be used to test if a drug that’s already approved for adults is safe and effective for children.</p>
<p>When a drug that’s been approved for one purpose is studied for a different medical condition – for example, testing the malaria drug hydroxychloroquine as a potential treatment for COVID-19 – this is not a phase 4 trial. This is a phase 2 or 3 trial because it is designed to answer those early questions about how well the treatment works for the new condition.</p>
<h2>A critical eye for medical news</h2>
<p>News headlines are full of <a href="https://www.msn.com/en-us/money/markets/coronavirus-live-updates-oxford-readying-a-phase-2-vaccine-trial-cases-surge-in-india/ar-BB14smVc">trial results concerning COVID-19 interventions</a>. It’s easy to get excited when reading about a new drug or vaccine. But early successes do not guarantee a treatment will work.</p>
<p>COVID-19, like <a href="https://www.actcinfo.org/projects/">Alzheimer’s</a>, is a complex disease, and clinical trials to test treatments are particularly challenging, with highly variable outcomes. The process for drug and treatment approval is long, but is designed to guarantee that what a physician gives you will do help, not hurt, you.</p>
<p>[<em>You need to understand the coronavirus pandemic, and we can help.</em> <a href="https://theconversation.com/us/newsletters?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=upper-coronavirus-help">Read The Conversation’s newsletter</a>.]</p><img src="https://counter.theconversation.com/content/138197/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Mindy Aisen does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Drugs and vaccines to fight the coronavirus are already in clinical trials. It is important to understand the difference between each step in this process as efforts to fight COVID-19 continue.Mindy Aisen, Clinical Professor of Neurology, University of Southern CaliforniaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1178362019-10-09T19:01:53Z2019-10-09T19:01:53ZIs this study legit? 5 questions to ask when reading news stories of medical research<figure><img src="https://images.theconversation.com/files/296114/original/file-20191009-3935-yjqvtr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">It can be difficult to work out whether you should believe a study's reported findings.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/cropped-image-male-freelancer-sitting-table-262335083">GaudiLab/Shutterstock</a></span></figcaption></figure><p>Who doesn’t want to know if drinking that second or third cup of coffee a day will improve your memory, or if sleeping too much increases your risk of a heart attack? </p>
<p>We’re invested in staying healthy and many of us are interested in reading about new research findings to help us make sense of our lifestyle choices. </p>
<p>But not all research is equal, and not every research finding should be interpreted in the same way. Nor do all media headlines reflect what was actually studied or found. </p>
<p>So how can you tell? Keep these five questions in mind when you’re reading media stories about new studies.</p>
<h2>1. Has the research been peer reviewed?</h2>
<p>Peer review is a process by which a study is checked by experts in the discipline to assess the study’s scientific validity.</p>
<p>This process involves the researcher writing up their study methods and results, and sending this to a journal. The manuscript is then usually sent to two to three experts for peer review.</p>
<p>If there are major flaws in a study, it’s either rejected for publication, or the researchers are made to address these flaws. </p>
<p>Although the peer-review process isn’t perfect, it shows a study has been subjected to scrutiny. </p>
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Read more:
<a href="https://theconversation.com/peer-review-has-some-problems-but-the-science-community-is-working-on-it-99596">Peer review has some problems – but the science community is working on it</a>
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<p>Any reported findings that haven’t been peer reviewed should be read with a degree of reservation.</p>
<h2>2. Was the study conducted in humans?</h2>
<p>Findings from studies conducted in animals such as mice or on cells in a lab (also called <em>in vitro</em> studies) represent the earliest stage of the scientific discovery process. </p>
<p>Regardless of how intriguing they may be, no confident claims about human health should ever be made based on these types of study alone. There is no guarantee that findings from animal or cell studies will ever be replicated in humans.</p>
<h2>3. Are findings likely to represent a causal relationship?</h2>
<p>For a study to have relevance to our day-to-day health, the findings need to reflect a <em>causal</em> relationship rather than just a <em>correlation</em>. </p>
<p>If a study showed that coffee drinking was associated with heart disease, for example, we want to know if this was because coffee actually <em>caused</em> heart disease or whether these to things happened to occur together.</p>
<p>In a number of studies that found this association, researchers <a href="https://www.ncbi.nlm.nih.gov/pubmed/18328848">subsequently found</a> that coffee drinkers were more likely to be smokers and therefore, these results were more likely to reflect a true causal relationship between smoking and heart disease. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/296132/original/file-20191009-3887-1odwcjl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/296132/original/file-20191009-3887-1odwcjl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/296132/original/file-20191009-3887-1odwcjl.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/296132/original/file-20191009-3887-1odwcjl.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/296132/original/file-20191009-3887-1odwcjl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/296132/original/file-20191009-3887-1odwcjl.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/296132/original/file-20191009-3887-1odwcjl.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">Just because something is common among coffee drinkers, doesn’t mean coffee caused it.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/female-hands-holding-cups-coffee-on-261247157?src=DYbOCy048cq5gPoe7MdxSA-1-20">Africa Studio/Shutterstock</a></span>
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<p>In observational studies, where researchers observe differences in groups of people, it can sometimes be difficult to disentangle the relationship between variables.</p>
<p>The highest level of evidence regarding causality comes from double-blind placebo controlled randomised controlled trials (RCTs). This experimental type of study, where people are separated into groups to randomly receive either an intervention or placebo (sham treatment), is the best way we can determine if a something causes disease. However it, too, is not perfect. </p>
<p>Although other types of studies in humans play an important role in our understanding of health and disease, they may only highlight associations that are not indicative of causal relationships.</p>
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Read more:
<a href="https://theconversation.com/clearing-up-confusion-between-correlation-and-causation-30761">Clearing up confusion between correlation and causation</a>
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<h2>4. What is the size of the effect?</h2>
<p>It’s not enough to know that an exposure (such a third cup of coffee or more than nine hours of sleep a night) causes an outcome, it’s also important to clearly understand the strength of this relationship. In other words, how much is your risk of disease going to increase if you are exposed?</p>
<p>If your risk of disease is reported to increase by 50% (which is a <em>relative</em> risk), this sounds quite frightening. However, if the original risk of disease is low, then a 50% increase in your risk may not represent a big actual increased risk of disease. A 50% increased risk of disease could mean going from a 0.1% risk of disease to your risk being 0.15%, which doesn’t sound quite so dramatic.</p>
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Read more:
<a href="https://theconversation.com/what-you-need-to-know-to-understand-risk-estimates-67643">What you need to know to understand risk estimates</a>
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<h2>5. Is the finding corroborated by other studies?</h2>
<p>A single study on its own, even if it’s a well-conducted randomised controlled trial, can never be considered definitive proof of a causal relationship between an exposure and disease.</p>
<p>As humans are complex and there are so many variables in any study, we can’t be confident we understand what is actually going on until findings are replicated in many different groups of people, using many different approaches. </p>
<p>Until we have a significant body of evidence that is in agreement, we have to be very careful about our interpretation of the findings from any one study.</p>
<h2>What if these questions aren’t answered?</h2>
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<img alt="" src="https://images.theconversation.com/files/296133/original/file-20191009-3880-153el8k.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/296133/original/file-20191009-3880-153el8k.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/296133/original/file-20191009-3880-153el8k.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/296133/original/file-20191009-3880-153el8k.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/296133/original/file-20191009-3880-153el8k.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/296133/original/file-20191009-3880-153el8k.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/296133/original/file-20191009-3880-153el8k.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">Switch news sites or try to see the original study.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/serious-woman-using-laptop-checking-email-1156208407?src=LnIBx_qkb1znqLKD0vsXKg-1-57">Fizkes/Shutterstock</a></span>
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<p>If the media report you’re reading doesn’t answer these questions, consider changing news sites or looking at the original paper. Ideally this would be linked in the news article you’re reading, or you can search <a href="https://www.ncbi.nlm.nih.gov/pubmed/">PubMed</a> for the article using a few keywords.</p>
<p>The journal article’s abstract should tell you the type of study, whether it was conducted on humans and the size of the effect. If you’re not blocked by a paywall, you may be able to view the full journal article which should answer all of the questions you have about the study.</p>
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Read more:
<a href="https://theconversation.com/wheres-the-proof-in-science-there-is-none-30570">Where's the proof in science? There is none</a>
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<img src="https://counter.theconversation.com/content/117836/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Hassan Vally 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>Wondering if that latest study finding is too good to be true, or whether it’s as bad as we’re told? Here are five questions to ask to help you assess the evidence.Hassan Vally, Associate Professor, La Trobe UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1237682019-09-24T05:02:47Z2019-09-24T05:02:47ZDo new cancer drugs work? Too often we don’t really know (and neither does your doctor)<figure><img src="https://images.theconversation.com/files/293510/original/file-20190923-23822-1kn8g6y.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C4294%2C3027&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The effectiveness of a drug may be evaluated based on its potential to shrink tumours – but this doesn't necessarily equate to improved survival rates.</span> <span class="attribution"><span class="source">From shutterstock.com</span></span></figcaption></figure><p>It’s hard to find anyone who hasn’t been touched by cancer. People who haven’t had cancer themselves will likely have a close friend or family member who has been diagnosed with the disease. </p>
<p>If the cancer has already spread, the diagnosis may feel like a death sentence. News that a new drug is available can be a big relief. </p>
<p>But imagine a cancer patient asks their doctor: “Can this drug help me stay alive longer?” And in all honesty the doctor answers: “I don’t know. There’s one study that says the drug works, but it didn’t show whether patients lived longer, or even if they felt any better.”</p>
<p>This might sound like an unlikely scenario, but it’s precisely what a team of <a href="https://www.bmj.com/content/366/bmj.l5221">UK researchers</a> found to be the case when it comes to many new cancer drugs. </p>
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Read more:
<a href="https://theconversation.com/we-dont-need-to-change-how-we-subsidise-breakthrough-cancer-treatments-87185">We don't need to change how we subsidise 'breakthrough' cancer treatments</a>
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<h2>A look at the research</h2>
<p>A study published last week in the <a href="https://www.bmj.com/content/366/bmj.l5221">British Medical Journal</a> reviewed 39 clinical trials supporting approval of all new cancer drugs in Europe from 2014 to 2016.</p>
<p>The researchers found more than half of these trials had serious flaws likely to exaggerate treatment benefits. Only one-quarter measured survival as a key outcome, and fewer than half reported on patients’ quality of life.</p>
<p>Of 32 new cancer drugs examined in the study, only nine had at least one study without seriously flawed methods. </p>
<p>The researchers evaluated methods in two ways. First, they used a standard “risk of bias” scale that measures shortcomings shown to lead to biased results, such as if doctors knew which drug patients were taking, or if too many people dropped out of the trial early. </p>
<p>Second, they looked at whether the European Medicines Agency (EMA) had identified serious flaws, such as a study being stopped early, or if the drug was compared to substandard treatment. The EMA identified serious flaws in trials for ten of the 32 drugs. These flaws were rarely mentioned in the trials’ published reports.</p>
<h2>From clinical trials to treatment – faster isn’t always better</h2>
<p>Before a medicine is approved for marketing, the manufacturer must carry out studies to show it’s effective. Regulators such as the EMA, the US Food and Drug Administration (FDA) or Australia’s Therapeutic Goods Administration (TGA) then judge whether to allow it to be marketed to doctors. </p>
<p>National regulators mainly examine the same clinical trials, so the findings from this research are relevant internationally, including in Australia.</p>
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Read more:
<a href="https://theconversation.com/spot-the-snake-oil-telling-good-cancer-research-from-bad-36344">Spot the snake oil: telling good cancer research from bad</a>
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<p>There’s strong public pressure on regulators to approve new cancer drugs more quickly, based on less evidence, especially for poorly treated cancers. The aim is to get treatments to patients more quickly by allowing medicines to be marketed <a href="https://ascpt.onlinelibrary.wiley.com/doi/full/10.1002/cpt.59">at an earlier stage</a>. The downside of faster approval, however, is more uncertainty about treatment effects. </p>
<p>One of the arguments for earlier approvals is the required studies can be carried out later on, and sick patients can be given an increased chance of survival before it’s too late. However, <a href="https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2733561">a US study</a> concluded that post-approval studies found a survival advantage for only 19 of 93 new cancer drugs approved from 1992 to 2017.</p>
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<img alt="" src="https://images.theconversation.com/files/293512/original/file-20190923-23822-zn3gbl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/293512/original/file-20190923-23822-zn3gbl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=399&fit=crop&dpr=1 600w, https://images.theconversation.com/files/293512/original/file-20190923-23822-zn3gbl.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=399&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/293512/original/file-20190923-23822-zn3gbl.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=399&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/293512/original/file-20190923-23822-zn3gbl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=502&fit=crop&dpr=1 754w, https://images.theconversation.com/files/293512/original/file-20190923-23822-zn3gbl.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=502&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/293512/original/file-20190923-23822-zn3gbl.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=502&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">If the evidence for a new cancer drug is flawed, this leaves patients vulnerable to false hope.</span>
<span class="attribution"><span class="source">From shutterstock.com</span></span>
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<h2>So how is effectiveness measured currently?</h2>
<p>Approval of new cancer drugs is often based on short-term health outcomes, referred to as “surrogate outcomes”, such as shrinking or slower growth of tumours. The hope is these surrogate outcomes predict longer-term benefits. For many cancers, however, they have been found to do a poor job of <a href="https://www.sciencedirect.com/science/article/pii/S095980491831476X?via%3Dihub">predicting improved survival</a>. </p>
<p><a href="https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2729389">A study of cancer trials</a> for more than 100 medicines found on average, clinical trials that measure whether patients stay alive for longer take an extra year to complete, compared to trials based on the most commonly used surrogate outcome, called “progression free survival”. This <a href="https://ascopubs.org/doi/10.1200/JCO.2011.38.7571">measure</a> describes the amount of time a person lives with a cancer without tumours getting larger or spreading further. It’s often poorly correlated with overall survival.</p>
<p>A year may seem like a long wait for someone with a grim diagnosis. But there are policies to help patients access experimental treatments, such as participating in clinical trials or compassionate access programmes. If that year means certainty about survival benefits, it’s worth waiting for. </p>
<h2>Approving drugs without enough evidence can cause harm</h2>
<p>In an <a href="https://www.bmj.com/content/366/bmj.l5399">editorial</a> accompanying this study, we argue that exaggeration and uncertainty about treatment benefits cause direct harm to patients, if they risk severe or life-threatening harm without likely benefit, or if they forgo more effective and safer treatments. </p>
<p>For example, the drug <a href="https://english.prescrire.org/en/81/168/57219/0/NewsDetails.aspx">panobinostat</a>, which is used for multiple myeloma patients who have not responded to other treatments, has not been shown to help patients live longer, and can lead to serious infections and bleeding.</p>
<p>Inaccurate information can also encourage false hope and create a distraction from needed palliative care. </p>
<p>And importantly, the ideal of shared informed decision-making based on patients’ values and preferences falls apart if neither the doctor nor the patient has accurate evidence to inform decisions.</p>
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Read more:
<a href="https://theconversation.com/if-we-dont-talk-about-value-cancer-drugs-will-become-terminal-for-health-systems-44072">If we don't talk about value, cancer drugs will become terminal for health systems</a>
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<p>In countries with public health insurance, such as Australia’s Pharmaceutical Benefits Scheme (PBS), patients’ access to new cancer drugs depends not just on market approval but also on payment decisions. The PBS often refuses the pay for new cancer drugs because of <a href="https://onlinelibrary.wiley.com/doi/full/10.1111/imj.13350">uncertain clinical evidence</a>. In the cases of the drugs in this research, some are available on the PBS, while others are not.</p>
<p>New cancer drugs are often very expensive. On average in the US, a course of treatment with a new cancer drug costs more than US$100,000 (A$148,000).</p>
<p>Cancer patients need treatments that help them to live longer, or at the very least to have a better quality of life during the time that they have left. In this light, we need stronger evidence standards, to be sure there are real health benefits when new cancer drugs are approved for use. </p>
<p><em>The article has been updated to reflect Agnes Vitry’s current role at the University of South Australia.</em></p><img src="https://counter.theconversation.com/content/123768/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Barbara Mintzes receives funding from the National Health and Medical Research Council (NHMRC) for a research project on post-market regulatory safety advisories on medicines. She is also a member of Health Action International (HAI-Europe), a network of health and consumer organisations that promotes access to essential medicines and quality use of medicines. </span></em></p><p class="fine-print"><em><span>Agnes Vitry is affiliated with Cancer Voices, SA.</span></em></p>National drug regulators use evidence from clinical trials to decide whether new cancer drugs will be approved for use. But these studies are often flawed.Barbara Mintzes, Senior Lecturer, Faculty of Pharmacy, University of SydneyAgnes Vitry, Senior lecturer, University of South AustraliaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1054942019-02-21T04:36:00Z2019-02-21T04:36:00ZAs pharmaceutical use continues to rise, side effects are becoming a costly health issue<figure><img src="https://images.theconversation.com/files/259862/original/file-20190219-136739-1nw6w7r.jpg?ixlib=rb-1.1.0&rect=67%2C158%2C4921%2C2645&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">If doctors questions evidence-based medicine guidelines, they are often viewed as incompetent practitioners.</span> <span class="attribution"><span class="source">from www.shutterstock.com</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span></figcaption></figure><p>The use of pharmaceuticals is on the rise and, globally, the expenses for drugs are <a href="https://www.contractpharma.com/issues/2018-01-01/view_features/pharma-industry-outlook">projected to reach US$1.5 trillion</a> by 2021. </p>
<p>The <a href="https://www.cdc.gov/nchs/data/databriefs/db42.htm">ageing of populations</a> is one of the drivers of this upward trend, but another important influence is our growing tendency to treat conditions and circumstances we didn’t use to medicalise.</p>
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Read more:
<a href="https://theconversation.com/medicines-to-treat-side-effects-of-other-medicines-sometimes-less-is-more-beneficial-62981">Medicines to treat side effects of other medicines? Sometimes less is more beneficial</a>
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<h2>Proto diseases</h2>
<p>One reason for this medicalisation is the creation of new conditions. The goal of preventing future disability and early death has fashioned new disorders – including high cholesterol and blood pressure. Such proto diseases are based on a person’s risk profile at a time when disease is not present and symptoms are not felt. </p>
<p><a href="https://onlinelibrary.wiley.com/doi/full/10.1111/1467-9566.12257">Proto diseases</a> can be identified in an ever growing proportion of the population. The belief that treating these conditions will lead to future cost savings drives up drug consumption, aimed at bringing cholesterol, blood pressure and glucose levels into line. </p>
<p>A simple shift towards lowering the threshold that determines when someone should be taking such drugs can lead to a substantial expansion in the number of people who are offered them by health professionals. While these medicines can indeed prevent future disease for individuals, if one takes a population health approach, it is not a given that cost savings will outweigh costs incurred.</p>
<h2>Evidence-based medicine</h2>
<p>Another driver is the dominance of evidence-based medicine (EBM). The idea of basing medicine on evidence would seem to be common sense. However, sitting at the top of the hierarchy of evidence-based medicine is the evaluation procedure of the <a href="https://ir.canterbury.ac.nz/bitstream/handle/10092/1782/12606228_why%20ebm%20may%20be%20bad%20for%20you.pdf?sequence=1&isAllowed=y">double-blind, placebo-controlled trial</a>. </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>This particular type of trial was designed to assess the efficacy of medications. The first such trial assessed the use of <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149409/">streptomycin in the treatment of pulmonary tuberculosis</a>. </p>
<p>Following the fallout from the <a href="https://helix.northwestern.edu/article/thalidomide-tragedy-lessons-drug-safety-and-regulation">thalidomide tragedy</a> in the 1950s and 1960s, there was an increased impetus to put in place rigorous procedures for the <a href="https://www.jstor.org/stable/10.7312/ligh14692?turn_away=true&refreqid=excelsior%3A9283af3f8ff663f0a5fce3f2dbf91714&seq=1#metadata_info_tab_contents">assessment of potentially toxic pharmaceuticals</a> by clinical trials. This effort to prevent lethal and dangerous drugs getting on to the market was transformed from a test for new drugs to a standard that all therapeutic interventions were expected to meet. </p>
<p>This remains the case even though many therapeutic interventions – surgery, counselling, public health advice – do not work like drugs and are not as easy to assess. As a consequence, medications are about the only form of therapeutic intervention that can successfully become evidence-based. </p>
<p>Since the development of the evidence-based medicine movement, there has been a trend where health professionals are required to follow evidence-based protocols and guidelines. These guidelines are an effective way of promoting the expansion of medication use. If health professionals do not follow standards and guidelines – for example don’t ask you to take a cholesterol test when you reach a certain age and recommend the cholesterol-lowering drug – they are in danger of being <a href="https://www.mdmag.com/physicians-money-digest/lifestyle/determining-whether-a-physician-is-competent-to-practice-medicine-is-complex-">viewed as incompetent practitioners</a>. </p>
<p>For many people their sense of identity is shaped by their <a href="https://www.ncbi.nlm.nih.gov/pubmed/24685105">relationship to medications</a>. At times they may be reliant on drugs for some quality of life, but they often have to <a href="https://www.taylorfrancis.com/books/9781315389677">trade off what is gained against at times debilitating side effects</a>. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/were-all-at-risk-from-scary-medicine-side-effects-but-we-have-to-weigh-the-risks-with-the-benefits-65029">We're all at risk from scary medicine side effects, but we have to weigh the risks with the benefits</a>
</strong>
</em>
</p>
<hr>
<h2>Remedies and poisons</h2>
<p>Some pharmaceuticals work very well. They can help prolong life and ameliorate symptoms. Many people will recall situations where they were glad a drug was readily available. </p>
<p>But the Greek term pharmakon refers to both remedy and poison. Pharmaceuticals are well known for their toxic effects, which is one reason why access to many drugs is carefully controlled, requiring a medical doctor’s prescription. But research shows that even with doctors overseeing these drugs, side effects occur on a large scale and we have <a href="https://www.tandfonline.com/doi/abs/10.1080/09581596.2017.1329520">woefully inadequate means of reporting side effects</a> and adverse reactions. </p>
<p>The costs of responding to adverse drug reactions and the disease and premature death they can cause makes side effects an important public health problem. Yet only around <a href="https://www.bmj.com/content/356/bmj.j337">10% of serious adverse drug reactions are reported</a> to agencies that monitor drug safety. </p>
<p>To deal with this issue, we need to consider trends in drug consumption, regulation and policy. We need to understand how decisions about drug use are made in clinical consultations and in homes, and how drug monitoring agencies, drug subsidising agencies and drug trial methodologies work.</p>
<p>There is little resistance to the ever expanding use of pharmaceuticals. Individuals, health professionals and health care institutions, nation states and international health agencies are increasingly governed by the dominance of pharmaceutical approaches to health care. </p>
<p>But there are interventions that we could be putting in place to ameliorate this expansion. We need to develop more rigorous vigilance procedures so that when drugs come on the market, they are carefully monitored for adverse reactions, and both patients and health practitioners are actively encouraged to report any concerns to drug monitoring agencies. </p>
<p>We also need to regulate the advertising of prescription medicines more tightly, particularly in New Zealand where drug companies can advertise their products and only have to make fleeting reference to possible side effects.</p><img src="https://counter.theconversation.com/content/105494/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Kevin Dew receives funding from the New Zealand Health Research Council. the Marsden Fund and the Faculty of Humanities and Social Sciences of Victoria University of Wellington.. </span></em></p>Ageing populations and efforts to medicate to prevent disease are both factors that have driven up the use of pharmaceuticals, but we have inadequate means of reporting side effects.Kevin Dew, Professor of Sociology, Te Herenga Waka — Victoria University of WellingtonLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1036552018-09-21T15:24:31Z2018-09-21T15:24:31ZCochrane Collaboration expels co-founder splitting board and prompting walkout<figure><img src="https://images.theconversation.com/files/237471/original/file-20180921-129865-av5xqn.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/image-photo/pharmaceuticals-antibiotics-pills-medicine-colorful-antibacterials-1061962868?src=hUJIwA63gpjyIayuaFJZrg-1-21">nokwalai/Shutterstock.com</a></span></figcaption></figure><p>The Cochrane Collaboration, a highly respected international medical research organisation that conducts systematic reviews and guides clinical practice, has been rocked by a scandal. Professor Peter Gøtzsche, a founding member, was recently <a href="https://www.nature.com/articles/d41586-018-06727-0">expelled from its board</a>, following a narrow vote. Gøtzsche was accused of bringing the organisation into disrepute, but four other experts on the board walked out in protest at the decision. </p>
<p>Gøtzsche, a Danish clinician, is a big name in medical research. Among other things, he is the co-author of several guidelines on the conduct and reporting of research, including CONSORT, PRISMA, STROBE and SPIRIT. And, until last week, Gøtzsche led the Nordic Cochrane Centre in Copenhagen. </p>
<p>Some people regard him as a maverick – he isn’t shy of speaking out. Others see him as a principled man whose commitment to the doctrine of evidence-based practice is displayed in his criticisms of flawed research, particularly when this is due to vested interests. Integrity is the bottom line for Gøtzsche. </p>
<p>Commenting <a href="https://blogs.bmj.com/bmj/2018/09/17/trish-greenhalgh-the-cochrane-collaboration-what-crisis/">on the BMJ website</a>, Trisha Greenhalgh, while not privy to the full details of the case, implied that Gøtzsche could be seen by some as a technical purist whose rigidity could rile more pragmatic members. </p>
<p>Greenhalgh, a leading research methodologist, has criticised the Cochrane “hierarchy of evidence”, which places experimental trials above any other study design, and affords limited value to qualitative research. She urges a more inclusive approach to evidence-based practice: “Facts are not self-interpreting; they are theory- and value-laden.”</p>
<p>Indeed. But if evidence is presented from a randomised controlled trial (RCT), it should be the result of a scientifically robust investigation. This is the best method for assessing effectiveness because it minimises bias through random sampling and blinded assignment to treatment or placebo. A clear logical process should be followed by the investigators. Yet sometimes, as Gøtzsche has documented, research is not done well. And if done properly, research is not always reported – arguably, because the result was undesirable. </p>
<h2>High profile</h2>
<p>In recent years, Gøtzsche has had a high public profile. His enquiring and sceptical mind led to his discovery that the placebo effect in research is negligible and that meta-analyses, a method of review that reanalyses original study data, was rife with data extraction errors. </p>
<p>He has taken a strong ethical stance against ghostwriting in medical research. Perhaps most controversially, he has argued that screening for breast cancer does more harm than good and that psychiatric drugs are damaging. </p>
<p>One in six adults in the UK takes antidepressant tablets daily, yet the effectiveness is doubtful for most patients. Indeed, instead of relieving depression, these drugs are taken for years, causing chemical dependence. An unholy alliance of biomedically orientated psychiatry and the pharmaceutical industry has created a vast and lucrative market. The evidence has been distorted by selective reporting. </p>
<p>Gøtzsche’s article in <a href="https://www.dailymail.co.uk/health/article-3234334/Prescription-pills-Britain-s-biggest-killer-effects-drugs-taken-insomnia-anxiety-kill-thousands-doctors-hand-like-Smarties.html">The Daily Mail</a> on the harms of psychiatric drugs (handed out “like Smarties”) attributed the shortened lives of people with severe mental illness to their prescribed treatments. This drew angry responses from psychiatrists, who are mostly in favour of pharmacological treatments (which they control) and less than enthusiastic towards the value of psychotherapies (which they don’t control). </p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/237469/original/file-20180921-129850-1jdvcig.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/237469/original/file-20180921-129850-1jdvcig.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=872&fit=crop&dpr=1 600w, https://images.theconversation.com/files/237469/original/file-20180921-129850-1jdvcig.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=872&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/237469/original/file-20180921-129850-1jdvcig.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=872&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/237469/original/file-20180921-129850-1jdvcig.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1096&fit=crop&dpr=1 754w, https://images.theconversation.com/files/237469/original/file-20180921-129850-1jdvcig.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1096&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/237469/original/file-20180921-129850-1jdvcig.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1096&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Peter Gøtzsche, an outspoken critic of big pharma.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/diethylstilbestrol/10097689405/in/photolist-goiigc-CVc9GE-nrCRSF-wR2MTN-DBEnG6-qedfFy-gDtCJa">DES Daughter/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-sa/4.0/">CC BY-NC-SA</a></span>
</figcaption>
</figure>
<p>David Nutt, best known for demanding that the government decriminalises illicit drugs, despite the obvious harm that they cause, <a href="https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(14)70232-9/abstract">accused critics</a> such as Gøtzsche of inciting headlines on antidepressants that “plumb a new nadir in irrational polemic”. In response, Gøtzsche repeated his list of charges against pharmaceutical companies and their supporters, arguing that the explosion in antidepressant dependence is a waste of money, while <a href="https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(14)70280-9/abstract">remarking</a> on the sweeteners given to some of his critics by drug companies: “There has been heavy marketing and widespread crime committed by drug companies, including fraud, illegal promotion, and corruption of psychiatrists.” </p>
<h2>Booted out</h2>
<p>Gøtzsche was upsetting the apple cart. After negative publicity and complaints, the Cochrane Collaboration issued a statement. As a research organisation, “Cochrane’s ability to take part in debate is damaged if we are falsely perceived to have taken a partisan position that we do not hold.” </p>
<p>But Gøtzsche caused further consternation with his allegations of bias in a Cochrane review of the human papillomavirus (HPV) vaccine, which apparently understated the side effects of this jab. Gøtzsche and fellow authors were accused of risking the lives of millions of women by <a href="https://www.medscape.com/viewarticle/902062">affecting vaccine uptake rates</a>. </p>
<p>This was the last straw. The dissident was booted out. </p>
<p>In a letter giving his side of the story, Gøtzsche argued that the Cochrane Collaboration is pursuing a business model to the detriment of scientific independence. Evidence-based medicine is at enormous risk of manipulation by commercial parties, unwittingly aided by practitioners, professional bodies and patient groups, although I suspect that some beneficiaries know what they’re doing. </p>
<p>Gøtzsche ended his letter thus: “This is not a personal question. It is a highly political, scientific and moral issue about the future of Cochrane.” </p>
<p>His persistent criticisms of the drug industry have resulted in a campaign to silence him, but patients might suffer if this hegemony is immune to challenge. Scientific integrity or commercial compromise; that is the choice faced by a hallowed institution.</p><img src="https://counter.theconversation.com/content/103655/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Niall McCrae receives funding from Contented Dementia Trust. </span></em></p>Evidence-based medicine is in turmoil after the much respected Cochrane Collaboration booted out one of its co-founders.Niall McCrae, Lecturer in Mental Health, King's College LondonLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/961142018-05-08T06:16:00Z2018-05-08T06:16:00ZGovernment decision not to ban homeopathy sales from pharmacies is a mistake<figure><img src="https://images.theconversation.com/files/218007/original/file-20180508-46356-1fu8iho.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Evidence homeopathy works is pretty clear: it doesn't. </span> <span class="attribution"><span class="source">from www.shutterstock.com</span></span></figcaption></figure><p>Last year <a href="http://www.health.gov.au/pharmacyreview#InterimReport">a review into pharmacy</a> in Australia recommended homeopathic products be banned from sale in chemist shops across the country. This was a sensible recommendation, given pharmacists are trusted scientists in the community and science tells us homeopathic products <a href="https://consultations.nhmrc.gov.au/public_consultations/homeopathy_health">simply don’t work</a>.</p>
<p>In the <a href="http://www.health.gov.au/internet/main/publishing.nsf/content/7E5846EB2D7BA299CA257F5C007C0E21/$File/Pharmacy-Review-Aus-Gov-Response-3-May-2018.pdf">government’s recent response</a> to this review they “noted” the concerns of the reviewer, and have chosen not to adopt it. Here’s why that is a mistake.</p>
<h2>What is homeopathy?</h2>
<p>Homeopathy involves extreme dilution of a compound that is claimed to be therapeutically effective, and uses the concept of “like cures like”. <a href="https://theconversation.com/no-evidence-homeopathy-is-effective-nhmrc-review-25368">For example</a> a fever might be treated with a compound used to induce fevers, in the belief the diluted active ingredient will have the opposite effect and cure the fever.</p>
<p>Products tend to contain the equivalent active ingredient to a single molecule within an Olympic-size swimming pool. Practitioners of fact-based medicine have understandably indicated that any effect of the product could only be attributable to the <a href="https://www.sciencedirect.com/science/article/pii/S0140673605671772">placebo</a> effect (it works because you believe it works) or because the product contains alcohol or a similar <a href="https://publications.parliament.uk/pa/cm200910/cmselect/cmsctech/45/45.pdf">base</a>.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/no-evidence-homeopathy-is-effective-nhmrc-review-25368">No evidence homeopathy is effective: NHMRC review</a>
</strong>
</em>
</p>
<hr>
<p>Most pharmacists probably abhor such treatments lacking evidence, given they go through years of rigorous university training, are heavily regulated and have a strong professional ethic. But it makes the cash registers clang.</p>
<p>These days pharmacies also sell jelly beans, lipstick, energy bars, vitamins, teddy bears and sunglasses – as well as prescription medications. This, unfortunately, is business practice. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/discount-chemists-are-cheapening-the-quality-of-pharmacy-along-with-the-price-68744">Discount chemists are cheapening the quality of pharmacy along with the price</a>
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<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/218009/original/file-20180508-46332-102fyyd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/218009/original/file-20180508-46332-102fyyd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/218009/original/file-20180508-46332-102fyyd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/218009/original/file-20180508-46332-102fyyd.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/218009/original/file-20180508-46332-102fyyd.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/218009/original/file-20180508-46332-102fyyd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/218009/original/file-20180508-46332-102fyyd.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/218009/original/file-20180508-46332-102fyyd.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"></a>
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<span class="caption">Pharmacists are trusted scientists.</span>
<span class="attribution"><span class="source">from www.shutterstock.com</span></span>
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</figure>
<h2>Business v health care</h2>
<p>Pharmacies have a special status as businesses, along with many actors in the health system. Successive governments have <a href="http://www.pc.gov.au/research/supporting/pharmacy-review">grappled</a> with tensions around service delivery, standards and <a href="https://www.pc.gov.au/inquiries/completed/productivity-review/report/productivity-review.pdf">competition</a>.</p>
<p>They’ve also had to grapple with a very strong industry body, the <a href="https://www.guild.org.au/">Pharmacy Guild</a> (stronger than the Pharmaceutical <a href="https://www.psa.org.au/">Society</a>). Much of the review reflects agreement between them. In responding to the review the government has flicked the homeopathic hot potato to pharmacy owners:</p>
<blockquote>
<p>Professional standards have been designed for use by individual pharmacists to assess their own professional practice. They are intended to serve as guidance for desired standards of practice. However, it is the sole responsibility of the individual pharmacist to determine, in all circumstances, whether a higher standard is required. It is equally their responsibility to meet that standard and ensure that consumers are provided with the best available information about the current evidence for, or lack-of efficacy in, offered treatments and therapies.</p>
</blockquote>
<p>So given the government has not banned homeopathic products from pharmacies, we could hope for restriction under Australian Consumer Law. They can, for example, <a href="https://www.accc.gov.au/publications/advertising-selling/advertising-and-selling-guide/avoid-misleading-or-deceptive-claims-or-conduct/misleading-or-deceptive-conduct">prohibit</a> sale of products that lack the purported constituents or qualities. But this has yet to happen with homeopathy, as it’s considered misleading but harmless.</p>
<p>The government is putting the onus on consumers to ask the pharmacist “does this work?”, and only the exceptional customer will ask. </p>
<p>If consumers wish to purchase therapies without a proven effect, they should be able to do so from venues that sell incense sticks and similar “wellness” paraphernalia. </p>
<p>They should not be available for sale in an industry necessarily regulated by government and trusted by the community. </p>
<p>It’s time for the Guild and Society to take a stand and reject sale by their members of products that by definition do not work. If pharmacies want status, they have to skip the junk products dollar. The government should help.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/pharmacists-are-trusted-medical-professionals-so-they-shouldnt-sell-remedies-that-lack-evidence-65148">Pharmacists are trusted medical professionals, so they shouldn't sell remedies that lack evidence</a>
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</em>
</p>
<hr>
<img src="https://counter.theconversation.com/content/96114/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Bruce Baer Arnold 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>A review into pharmacy practices last year recommended pharmacies stop selling ineffective remedies such as homeopathy. The government didn’t support the recommendation.Bruce Baer Arnold, Assistant Professor, School of Law, University of CanberraLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/876532017-12-08T10:50:09Z2017-12-08T10:50:09ZIs prescribing drugs ‘off label’ bad medicine?<figure><img src="https://images.theconversation.com/files/197842/original/file-20171205-22962-wkcb83.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/756231364?src=Qmk9ZacHMB_-wdQmXglVgQ-1-57&size=medium_jpg">i viewfinder/Shutterstock.com</a></span></figcaption></figure><p>A woman, let’s call her Sarah, is a young actor looking to make her debut at a major theatre. She is fit and healthy, but gets nervous on opening nights and can’t sleep. She’s tried zopiclone, but it didn’t work, so her GP prescribes a course of <a href="https://www.medicines.org.uk/emc/medicine/26582">quetiapine</a>. Quetiapine is usually used to treat bipolar disorder, but the doctor explains to Sarah that he is prescribing it “off label”. In other words, for a condition the drug wasn’t licensed to treat. </p>
<p>There are legitimate reason for prescribing off label – although, there are also legitimate criticisms of the practice. </p>
<p>In the UK, doctors, dentists, optometrists and other prescribers are <a href="https://www.gov.uk/drug-safety-update/off-label-or-unlicensed-use-of-medicines-prescribers-responsibilities">discouraged</a> from prescribing drugs off-label when a licensed alternative is available. But off-label prescribing is done, with caution, for several reasons. </p>
<p>First, each prescription drug has a product licence, that is, the company that makes it had to submit a mountain of evidence to the regulator proving not only that the drug is effective, but it is safe.</p>
<p>Second, the prescriber and the dispensing pharmacist are legally liable when things go wrong, so the patient can sue.</p>
<p>Finally, sometimes there are no alternative drugs for a given health problem. For example, in Sarah’s case, quetiapine is not licensed to treat insomnia. However, she has tried all available drugs licensed to treat insomnia, and none of them have worked. </p>
<h2>The right to say ‘no thanks’</h2>
<p>Drugs are prescribed off label based on limited evidence. Sometimes, doctors have to build the evidence as they use each medicine off label and learn from their experience – what works for a given condition and what doesn’t. Published case studies can also provide clues about what other uses a drug might be useful for. Case studies, though, are at the bottom of the hierarchy of medical evidence. </p>
<p>GPs and other prescribers have to make decisions based on the available evidence, which may not be very much. Sometimes it’s based on little more than an educated guess.</p>
<p>In Sarah’s case, the doctor feels that quetiapine might help. If the drug doesn’t work for her, she’ll have to come back to see him, and perhaps try a different drug – also off label.</p>
<p>This highlights another problem, though. Some patients – especially the elderly – take their doctor’s advice as gospel and follow it regardless of how a drug makes them feel. As a result, they can end up taking pills that aren’t effective and may even have unpleasant side effects. </p>
<p>In this example, Sarah should go back to her GP if she is concerned and she has the right not to take medicine that she doesn’t want to. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/198209/original/file-20171207-11299-ierg4s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/198209/original/file-20171207-11299-ierg4s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=401&fit=crop&dpr=1 600w, https://images.theconversation.com/files/198209/original/file-20171207-11299-ierg4s.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=401&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/198209/original/file-20171207-11299-ierg4s.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=401&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/198209/original/file-20171207-11299-ierg4s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=504&fit=crop&dpr=1 754w, https://images.theconversation.com/files/198209/original/file-20171207-11299-ierg4s.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=504&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/198209/original/file-20171207-11299-ierg4s.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">
<figcaption>
<span class="caption">It’s unethical to test drugs on pregnant women.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/645121957?src=jDPNI0WIZFQ_eTDOzp3dSQ-1-7&size=medium_jpg">YAKOBCHUK VIACHESLAV/Shutterstock</a></span>
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</figure>
<h2>Children and pregnant women</h2>
<p>Off-label prescribing also covers areas such as using a different formulation of the drug. For example, an antibiotic may have marketing authorisation from the drug regulator in pill form, but not as an eye drop medicine. Off-label prescribing can also describe when a drug is used for a population on which it hasn’t been tested. For example, some people, such as children and pregnant women, are excluded from clinical trials because it would be <a href="http://www.who.int/bulletin/archives/79%284%29373.pdf">unethical</a> to test drugs on them. So, when it comes to treating <a href="http://adc.bmj.com/content/83/6/498">children</a> and pregnant women, doctors have to make a best guess about which drug will work. </p>
<p>So off-label prescribing remains in the corner of medicine that isn’t based on robust evidence. Although we may know a drug’s safety profile, it’s not the same as proving it’s effective at treating a given condition. Still, it’s sometimes the only option we have – which may be better than nothing at all.</p><img src="https://counter.theconversation.com/content/87653/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ravina Barrett is affiliated with University of Portsmouth. </span></em></p>Prescribing a drug for a condition it hasn’t been tested for may sound reckless, but off-label prescribing has a useful function in medicine.Ravina Barrett, Senior Lecturer in Pharmacy Practice, University of PortsmouthLicensed 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">
<figcaption>
<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>
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<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/819042017-08-27T20:06:10Z2017-08-27T20:06:10ZCurious Kids: I heard that breathing through your mouth makes your IQ go down. Is that true?<figure><img src="https://images.theconversation.com/files/181905/original/file-20170814-28430-168nprt.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">What's better -- breathing through your nose or your mouth?</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/white_ribbons/6164625826/">Flickr/Lauren Rushing</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span></figcaption></figure><p><em>This is an article from <a href="https://theconversation.com/au/topics/curious-kids-36782">Curious Kids</a>, a series for children. The Conversation is asking kids to send in questions they’d like an expert to answer. All questions are welcome – serious, weird or wacky!</em> </p>
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<blockquote>
<p><strong>Hello. My name is Mannix and I am 10 years old. I want to know if it is better for your brain and body to breathe out of our nose than your mouth? I worry about this as I saw on YouTube that your IQ was less if you breathed through your mouth but how can I do this if I have a cold? My mum says I should not worry. – Mannix, aged 10, Sydney</strong></p>
</blockquote>
<p>Hi Mannix. Your mum is right; you shouldn’t worry. The way you breathe has no effect on your IQ. </p>
<p>However, breathing in through your nose has a number of benefits. </p>
<p>Firstly, it helps to warm and add moisture to dry air to make it less irritating to our lungs and trachea, which is the scientific word for your windpipe.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/curious-kids-are-zombies-real-79347">Curious Kids: Are zombies real?</a>
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</em>
</p>
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<p>The nose has a number of bony ridges, called turbinates, which increase its surface area and scatter the air flow. </p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/182027/original/file-20170815-5720-viqlex.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/182027/original/file-20170815-5720-viqlex.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/182027/original/file-20170815-5720-viqlex.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=902&fit=crop&dpr=1 600w, https://images.theconversation.com/files/182027/original/file-20170815-5720-viqlex.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=902&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/182027/original/file-20170815-5720-viqlex.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=902&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/182027/original/file-20170815-5720-viqlex.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1134&fit=crop&dpr=1 754w, https://images.theconversation.com/files/182027/original/file-20170815-5720-viqlex.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1134&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/182027/original/file-20170815-5720-viqlex.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1134&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">The nose has special features that help filter out dust and dirt.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/shelbychicago/4465772649/in/photolist-7NCfCa-eBGd2-ajE6K6-9snLPG-6efyfi-ashj89-bVfjJM-nqPVCg-9WbLwz-qNKjSK-9inwTt-7UJjk3-pANqS1-Xd1apA-9EL7BM-5D8ybQ-a19qwM-8sg46V-qzCNwz-qLn2hs-6bJHzx-8dgFTL-cu4dSy-oq3VnV-68JngN-cgL5M-7M9Ff-cseeMA-WEMcGh-Cutewt-qLHyZF-WbPmG8-oGhHr7-URtXxa-ggcL1u-qvQ382-aYUnqD-dJPnFs-699yem-52h1on-HYrwwQ-VVFZ2w-HsREd4-BYDQPx-7RKYT6-MWhBn-4aj8A4-7cvxfV-pbNSt8-aCz5wD">Flickr/Shelby H.</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<p>Unfortunately, the downside is when the skin over these ridges swells from colds or allergies they narrow the air passage and makes breathing through your mouth easier than via your nose. </p>
<p>Secondly, the microscopic hairs in your nose help to trap dust and other foreign particles, removing most of them before they get sucked into your lungs. </p>
<p>Fortunately, most of us live in relatively climate-controlled environments with fairly good air quality. This means we can do fine without the additional benefits that nose breathing provides over mouth breathing.</p>
<h2>Evidence-based medicine</h2>
<p>That’s a great question, though. It can be hard to find good information on the internet about health. There are many ways information on the internet can confuse us. It’s important to be careful about not trusting everything we read. </p>
<p>There is something called bias, which might cause us to believe something that’s not completely true. “Confirmation bias”, for instance, happens when you already have an opinion about something and then look for ways to confirm your opinion and ignore all the other information that suggests your opinion might be wrong.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/soy-products-do-not-increase-risk-of-breast-cancer-death-or-recurrence-696">Soy products do not increase risk of breast cancer death or recurrence</a>
</strong>
</em>
</p>
<hr>
<p>The practise of using good information for health is called “evidence-based medicine”. This might be something you want to look up on the internet.</p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/182028/original/file-20170815-12098-1tesoze.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/182028/original/file-20170815-12098-1tesoze.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/182028/original/file-20170815-12098-1tesoze.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/182028/original/file-20170815-12098-1tesoze.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/182028/original/file-20170815-12098-1tesoze.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/182028/original/file-20170815-12098-1tesoze.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=502&fit=crop&dpr=1 754w, https://images.theconversation.com/files/182028/original/file-20170815-12098-1tesoze.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=502&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/182028/original/file-20170815-12098-1tesoze.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=502&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">Noses are good for smelling as well as breathing.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/loimere/270506006/in/photolist-pUq1E-efvBtV-m3MNMF-4zSMZZ-fdQ1R2-at6AFZ-dMhUgB-Pcy5i-qasjrQ-4m15S7-9x3DU1-dMou6s-6HK6gG-9rDQxU-nBHAT5-6hoTjf-6DZdJ1-nRntVn-kDp6F-rQHKeH-5EXtyj-9EgxzD-8YmQm-8ysVLi-VfensM-83g8TL-TfYYje-eH7Nga-dhzZGb-qEiCoZ-gswzjK-5XB8LE-6YnvRs-6J1eCz-EbjfD-7jpwUG-ss8Z5q-VWvNBC-fU4Ey-bp2gnw-saHueo-4Sd7Y8-7YJCNq-7UDnVF-nVutes-6dGzM7-8eYfE5-H3yEtq-5qVqn9-Vn8pqE">Flickr/Derek Hatfield</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<p>Some good sites for health information include <a href="http://www.rch.org.au/kidsinfo/">this website</a> by The Royal Children’s Hospital which has a bunch of stories about different health conditions. The <a href="http://kidshealth.org/en/kids/center/htbw-main-page.html?WT.ac=classroom">KidsHealth</a> website also has some awesome videos about how the body works. The CSIRO is an Australian science institute who discovered a heap of great stuff like wi-fi. They have some videos on science and health you can find <a href="https://www.csiro.au/en/Education/Scope">here</a>.</p>
<p>Your curiosity in science and health is great. Keep asking questions, and good luck with your future endeavours! </p>
<hr>
<p><em>Hello, curious kids! Have you got a question you’d like an expert to answer? Ask an adult to send your question to us. They can:</em></p>
<p><em>* Email your question to curiouskids@theconversation.edu.au
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* Tell us on <a href="https://twitter.com/ConversationEDU">Twitter</a> by tagging <a href="https://twitter.com/ConversationEDU">@ConversationEDU</a> with the hashtag #curiouskids, or
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<figure class="align-left ">
<img alt="" src="https://images.theconversation.com/files/168011/original/file-20170505-21620-huq4lj.png?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/168011/original/file-20170505-21620-huq4lj.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=376&fit=crop&dpr=1 600w, https://images.theconversation.com/files/168011/original/file-20170505-21620-huq4lj.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=376&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/168011/original/file-20170505-21620-huq4lj.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=376&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/168011/original/file-20170505-21620-huq4lj.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=472&fit=crop&dpr=1 754w, https://images.theconversation.com/files/168011/original/file-20170505-21620-huq4lj.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=472&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/168011/original/file-20170505-21620-huq4lj.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=472&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="attribution"><a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
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<p><em>Please tell us your name, age, and which city you live in. You can send an audio recording of your question too, if you want. Send as many questions as you like! We won’t be able to answer every question but we will do our best.</em></p><img src="https://counter.theconversation.com/content/81904/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>David King 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>Breathing in through your nose has many medical benefits over mouth breathing. As usual, be wary of misinformation and bias when looking up health on the internet.David King, Senior Lecturer, The University of QueenslandLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/820072017-08-13T08:37:10Z2017-08-13T08:37:10ZMonitoring outcomes is key to improving mental health treatment in South Africa<figure><img src="https://images.theconversation.com/files/181430/original/file-20170808-13761-2396uy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Precision medicine matches patients with interventions, rather than just matching treatments to illnesses.</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>The traditional way of understanding medical treatment is that a doctor matches a particular treatment to a particular illness. The problem is that people with the same illness can respond differently to the same treatment. </p>
<p><a href="http://www.nejm.org/doi/full/10.1056/nejmp1500523#t=article">Precision medicine</a> – or personalised medicine – is a relatively new approach that takes account of individual differences when planning treatments. Here, doctors individualise interventions by matching patients with appropriate treatments. This entails using evidence to select the most effective intervention for a patient based on their genetic makeup, circumstances, lifestyle and collection of symptoms. </p>
<p>To do this doctors need to collect detailed information about how different patients respond to different treatments. </p>
<p>Many health related disciplines are moving towards the practice of precision medicine. For example, <a href="https://bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-017-1230-5">research</a> suggests that about 55% of people who are diagnosed with depression will respond well to antidepressant medication. In precision medicine, doctors try to understand what individual factors predict these different treatment responses. This enables doctors to make evidence based decisions about which patients with depression should be prescribed medication and which should receive other kinds of treatment. Using this approach could help patients recover quicker and can save time and resources</p>
<p>But this approach to collecting and using evidence to plan interventions is not being widely used when it comes to psychological treatments. This is particularly true in developing countries like South Africa where psychologists aren’t routinely monitoring their treatment outcomes and using evidence to improve their practice. </p>
<p>This is a serious problem. A precision approach would enable psychologists to use scarce mental health resources more efficiently, select the most appropriate treatments, and provide better care to the <a href="http://www.scielo.org.za/scielo.php?pid=S0256-95742009000500022&script=sci_arttext&tlng=pt">high number</a> of South Africans suffering from mental health problems. </p>
<p>It was in this context that we embarked on a <a href="http://journals.sagepub.com/doi/abs/10.1177/0081246317720853">project</a> to implement a routine outcome monitoring system in a community psychology clinic in the Western Cape Province of South Africa. Our results showed that it’s possible to monitor treatment outcomes as part of routine psychological care, although the tools used to achieve this need to be refined.</p>
<h2>Giving evidence-based approaches a chance</h2>
<p>So why has psychology been so slow to move towards precision medicine? </p>
<p><a href="http://journals.sagepub.com/doi/abs/10.1177/0081246317720853">Research</a> published recently in the South African Journal of Psychology highlights the fact that many psychologists are reluctant to use empirical evidence when treating individual patients. It seems that many psychologists also resist objectively monitoring how their patients respond to psychological interventions and measuring treatment outcomes. </p>
<p>Part of the problem is that many psychologists don’t believe that <a href="https://journals.co.za/content/sapsyc/42/1/EJC98673">psychological functioning</a> can be quantified. </p>
<p>It’s true that it can be difficult to measure psychological change and it’s impossible to use a single measure of treatment outcome for all patients. But there are a number of tools that have been developed that can provide useful information about how patients respond to psychotherapy. These tools are more widely used in developed countries and their use is <a href="http://psycnet.apa.org/record/2009-24214-002">advocated</a> by the American Psychiatric Association as a way of improving standards of care. But this isn’t the case in most developing countries.</p>
<p>We believe that it’s not enough for psychologists to <a href="https://journals.co.za/content/sapsyc/42/1/EJC98673">rely heavily</a> on theories which are unsupported by evidence or subjective accounts of recovery. Psychologists in South Africa have a duty to begin thinking about how they can adapt and apply tools that have been developed elsewhere to collect information about treatment outcomes. This will move the practice of psychology in South Africa closer to an evidence-based approach. </p>
<p>Based on this understanding, we implemented a treatment monitoring system at a community psychology clinic. We asked all patients at the clinic to give us regular feedback about their level of emotional and social functioning. Patients were asked to complete short questionnaires about changes in their symptoms, perceptions of their emotional well-being and changes in the quality of their relationships. We encouraged the clinicians working in the clinic to use this patient feedback to monitor patient responses and refine their treatments. </p>
<p>The goal was to see whether a system that has been used to monitor treatment outcomes in other countries, such as the US and Australia, could be usefully incorporated into routine care in a South African context. We found that it is possible to monitor treatment responses as part of routine psychological care and that the tools that currently exist could be used in South Africa. But we may still need to do some work to make sure that these tools are easily understood by patients and correctly used by psychologists. </p>
<h2>More work to be done</h2>
<p>Monitoring systems like the one we implemented normally rely on patients to self-report their symptoms and level of functioning. One of the challenges we experienced is that patients didn’t always understand what they were being asked. This meant that their responses could not always be accurately interpreted. </p>
<p>More work is clearly needed to refine the system to make it more user-friendly for patients. This will entail more than just directly translating the instruments into local languages. We need to make sure that the words and ideas used are culturally appropriate and meaningful in different South African contexts. </p>
<p>But even if the system is perfected, this will be of little value if psychologists don’t use it. In our research we found that some clinicians did not use the system consistently or correctly, even when they were trained to do so. </p>
<p>More work with practising psychologists is needed to understand their reluctance to monitor treatment outcomes as part of routine patient care. Maybe there are good reasons for their resistance. But it might also simply be that some psychologists need to make an ideological shift in the way they think about their work and the way they understand the importance of evidence-based practice.</p><img src="https://counter.theconversation.com/content/82007/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jason Bantjes receives funding from South African Medical Research Foundation.</span></em></p><p class="fine-print"><em><span>Mark Tomlinson and Xanthe Hunt do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>People with the same condition can respond differently to the same treatment. This is why personalised treatment is so important in all fields of medicine, including psychology.Jason Bantjes, Senior Lecturer in the Psychology Department, Stellenbosch UniversityMark Tomlinson, Professor in the Department of Psychology, Stellenbosch UniversityXanthe Hunt, Researcher in Psychology, Stellenbosch UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/788022017-07-11T23:05:15Z2017-07-11T23:05:15ZPublic health at risk when opinion trumps evidence<figure><img src="https://images.theconversation.com/files/176142/original/file-20170628-31335-1cpgagp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Dozens of studies and numerous reviews have demonstrated the safety of vaccines.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><p>In the Trump era, we have seen dramatic reductions in dialogue on important issues of the day. We have seen attacks on the legitimacy of science. We have seen attacks on trusted news sources, derided as fake. On social media, one person’s opinion, whether expert or not, often seems to outweigh all other forms of evidence. Belief in an opinion is treated as a legitimate form of evidence. For many people today, beliefs about vaccination or breastfeeding or marijuana inform everyday important decisions that affect their health and the public’s health.</p>
<p>This is dangerous.</p>
<p>Many historical examples show that beliefs can lead us astray. At one time, most people believed that the Earth was flat and if you sailed too far west, you would fall off. To counter such beliefs, we created processes like the scientific method and more recent approaches to evidence evaluation that help to ensure that the best evidence informs thinking and decisions.</p>
<p>Nurses, physicians and other health professionals learn about evaluating evidence in their basic education — it’s called <a href="https://dx.doi.org/10.1136/bmj.g3725">evidence-based medicine (EBM)</a>. In my role as Professor and Alberta Children’s Hospital Foundation Chair in Parent-Infant Mental Health at the University of Calgary in Alberta, I have taught countless students about EBM.</p>
<h2>Public policies based on evidence</h2>
<p>EBM draws upon systematic review and assessment of bias to help evaluators make judgements about the quality of evidence. Once judgements are made, recommendations can be designed to improve health. EBM also takes context into account. There is a recognition that recommendations from EBM may not be applicable to everyone. EBM is also open-minded, as new evidence should always be considered and add insight that can change recommendations.</p>
<p>Countless public health policies have derived from this approach. Recommendations on <a href="https://dx.doi.org/10.1542/peds.2007-1894">Vitamin D administration</a> to promote healthy bone growth in babies, <a href="https://dx.doi.org/10.1160/TH15-05-0383">aspirin intake for stroke prevention in adults</a>, and <a href="https://dx.doi.org/10.1503/cmaj.121505">pap screening</a> for cancer prevention in women are but a few examples. But today, EBM approaches are under threat. For most people, findings from one study or hearing an opinion of an expert on a topic are enough for beliefs to form.</p>
<h2>Name-calling and divisive tactics</h2>
<p>Breastfeeding, legalization of marijuana and vaccination are important public health issues that require EBM approaches. But instead, name-calling and divisive tactics rule the day. Often, “anti-vaxxers” accuse those who disagree of being in the pocket of “Big Pharma.” Public health officials who promote breastfeeding are accused of bullying. Camps form comprised of the “breast is best” advocates who are called “breastfeeding bullies” by the “fed is best” advocates. These tag lines or hashtags function as banners for proponents to get behind or oppose. Camp dwellers put down stakes and put up their tents and there seems to be no way to move either side.</p>
<p>An overwhelming majority of evidence, <a href="http://apps.who.int/iris/bitstream/10665/79198/1/9789241505307_eng.pdf?ua=1">reviewed by the World Health Organization</a>, generally shows that breastfeeding is good for babies and mothers’ health. Thus, health-care providers recommend and promote breastfeeding as a public good. EBM suggests that, of course, there are situations where mothers and babies cannot breastfeed and for whom we should show compassion. EBM is about what’s best for most people, not everyone. Recognizing that EBM allows exceptions would prevent camps from forming and encourage understanding of nuance and context. But the camps have dug in.</p>
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<img alt="" src="https://images.theconversation.com/files/176141/original/file-20170628-6546-clpigx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/176141/original/file-20170628-6546-clpigx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=399&fit=crop&dpr=1 600w, https://images.theconversation.com/files/176141/original/file-20170628-6546-clpigx.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=399&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/176141/original/file-20170628-6546-clpigx.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=399&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/176141/original/file-20170628-6546-clpigx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=502&fit=crop&dpr=1 754w, https://images.theconversation.com/files/176141/original/file-20170628-6546-clpigx.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=502&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/176141/original/file-20170628-6546-clpigx.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=502&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">Debate rages over public health issues like breastfeeding.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
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<p>Lots of evidence shows that <a href="https://dx.doi.org/10.1007/s40429-014-0019-6">marijuana is not good for people’s brains less than 25 years of age</a>, which are still forming and more sensitive than older brains. While sides of the debate are not encamped (yet), EBM is not leading the discussion. Rather, the focus is on the difficulty of policing the laws for teenagers and young adults. The conversation goes like this: Teens and young adults are smoking marijuana anyway while it’s illegal, so does it matter what the lower age limit is? Public health policy, led by EBM, would say yes, it does matter very much.</p>
<p>Dozens of studies and numerous reviews have demonstrated the <a href="https://dx.doi.org/10.1016/S0264-410X(03)00271-8">safety of vaccines</a>. Evidence shows the benefits far outweigh the risks. The dramatic decline in babies catching common childhood diseases that used to kill them is evidence enough to support the public good of vaccination. This is perhaps the most extreme example, because the evidence base is strong. Nonetheless, opponents will accuse the pharmaceutical companies of unethical gains from the use of vaccines, effectively shutting down the reasoned dialogue that we need, much less consider the special contexts when vaccination should not be used.</p>
<p>Each of these issues has evidence to support opposing camps. However, the use of EBM enables a more informed and nuanced understanding to inform healthy public policy and protect and promote health. The problem with the opposing arguments is that they ignore evidence and they ignore context – tenets of EBM. </p>
<h2>Protecting the public</h2>
<p>The confusion of the Trump era, fraught with division and distrust fostered by the avalanche of information on social media, could be reduced by giving members of the public the tools they need to evaluate evidence. </p>
<p>Understanding and using the tenets of EBM would reduce the likelihood that people would make dangerous decisions about their health practices. Thus, policy makers both federally and provincially should recommend investment in EBM education and marketing campaigns established to educate the population about EBM as a public good. Then EBM would cease to be endangered and the public would be protected from dangerous, poorly informed beliefs and lack of compassion for people’s individual contexts.</p><img src="https://counter.theconversation.com/content/78802/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Nicole Letourneau receives funding from CIHR, the Alberta Children's Hospital Foundation, NCE Allergen and anonymous donor. </span></em></p>In an era when opinion often trumps evidence in public health issues, it’s time to support and invest in evidence-based medicine to protect the public from dangerous, poorly informed beliefs.Nicole Letourneau, Professor (Nursing & Medicine) & ACHF Chair in Parent-Infant Mental Health, University of CalgaryLicensed as Creative Commons – attribution, no derivatives.