{"id":51839,"date":"2014-12-01T14:00:16","date_gmt":"2014-12-01T19:00:16","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=51839"},"modified":"2014-12-04T07:56:24","modified_gmt":"2014-12-04T12:56:24","slug":"deja-vu-6","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/12\/01\/deja-vu-6\/","title":{"rendered":"d\u00e9j\u00e0 vu&#8230;"},"content":{"rendered":"<br \/>\n<blockquote>\n<div align=\"center\" class=\"big\"><a target=\"_blank\" href=\"http:\/\/www.thelancet.com\/journals\/lanpsy\/article\/PIIS2215-0366%2814%2900003-0\/fulltext\">A level playing field<\/a><\/div>\n<div align=\"center\" class=\"middle\"><strong><font color=\"#200020\">The Lancet Psychiatry<\/font><\/strong>. 2014  1[6]:403.          <\/p>\n<p align=\"justify\">At <em>The Lancet Psychiatry<\/em>  we aim to publish research that illuminates and changes clinical  practice. Changing practice requires a high standard of evidence,  although existing practice does not always have a solid scientific base.  Management of mental health often seems intuitive, so many  interventions have been developed and rolled out on the basis of good  intentions rather than good science [eg, post-traumatic stress disorder  counselling after natural disasters]. We do not deny the role of  clinical expertise and the art of the individual psychiatrist, but we  believe that studies aimed at altering the status quo should be rigorous  in planning, execution, and communication.<\/p>\n<p align=\"justify\">The  acknowledged gold standard in terms of research is the randomised  controlled trial [RCT], a method that should be applied to all types of  intervention, wherever possible. In psychiatry, there are also good  pragmatic studies of intervention outcomes where RCTs are not feasible,  the most informative being those that combine cross-sectional and  longitudinal observations. Excellent work is done using registries,  particularly where health-based registries can be linked with others,  such as those held by the educational and justice systems. For each type  of study, there are recognised guidelines that list what should be  measured and reported [compiled by the EQUATOR network]. The best-known  is the Consolidated Standards of Reporting Trials [CONSORT] statement.  CONSORT is itself evidence-based, and for each item there is an  explanation of key methodological issues and the importance of reporting  that item. Many medical journals now include CONSORT in their  instructions to authors, but the slow rate of progress can be seen by  looking at the search results for any meta-analysis &mdash; too frequently,  studies have to be excluded because insufficient information is  available.<\/p>\n<p align=\"justify\">Some claim that psychiatry,  especially psychotherapy, is not suited to such rigorous approaches.  Psychotherapist and author Darian Leader has stated that &ldquo;the criteria  for the evaluation of therapies has moved to a very narrow view of  evidence, based on the medical model of randomised-controlled  trials &hellip; with a control group, and so on. You can&#8217;t do that with therapy,  because the whole point of therapy involves the beliefs the person has  initially about their treatment or therapeutic experience. So you can&#8217;t  randomly assign someone to a therapist.&rdquo;<\/p>\n<p align=\"justify\"><em>The Lancet Psychiatry<\/em>  admires this focus on the individual, but believes a strong evidence  base is both possible and necessary. In the interests of all those who  entrust their lives and well being to mental health professionals, it is  time to level the playing field. All interventions should be assessed to  the same standards of evidence, from psychopharmacology and  psychotherapies, to brain stimulation technologies and new approaches  such as video games and apps. Trials should be registered in a publicly  available database; the protocol should be available, and the methods  and results reported must match the protocol to avoid publication bias.  Most important, sufficient information should be provided to enable  replication of the study. The basis of scientific research is validation  and refutation. For compounds, this means chemical composition,  formulation, and dosing schedules. For psychological therapies, it means  details of how many sessions, the length of sessions, availability of a  manual where a specific therapy was given, details about the therapist,  and evaluation of differences between specific therapists and sites.  For training interventions, it means access to the training material,  and details of the trainers, sessions, etc. This approach also applies  to models of care: if something has the potential to be useful, it must  be replicable. Circumstances will differ and where people are involved  there will always be considerable variation, but providing relevant  detail will enable other researchers to test the data and perhaps to  explain different outcomes. Where trials are not possible, data on  outcomes &mdash; including those associated with general well being and function  rather than specific symptoms &mdash; are necessary. One essential set of  observations is that of adverse events. Again, there are people who  claim that the different nature of medicine and psychotherapy means  that, although it is relevant to collect adverse event data for the  latter, to do so in the same manner for the former is the equivalent of  comparing apples with oranges. However, <em>The Lancet Psychiatry<\/em> believes that if an intervention has the potential to confer benefit, it also has the potential to cause harm.<\/p>\n<div align=\"justify\">This  rigour is needed not just to satisfy journal editors but to convince  researchers, clinicians, patients, and ultimately governments. If we  want mental health services to be free at point of access, we must  demonstrate that they work.<\/div>\n<\/div>\n<\/blockquote>\n<div align=\"justify\">I haven&#8217;t run across this argument for some time. It was the constant rallying cry in the lead-in to the neoKraepelinian revolution and the DSM-III in the 1970s &#8211; directed primarily against the psychoanalysts and other psychiatrist psychotherapists who were billing medical insurance for their services. The outcome was a split in mental health care, at least in mental health care paid for by third party payers. Thereafter, psychiatrists stuck to the biological side of the street, primarily focused on psychopharmacology. <\/div>\n<p align=\"justify\">Carrier reimbursed psychotherapy didn&#8217;t disappear. It was taken over by other mental health specialties with controlled frequency, duration, and negotiated rates of payment. A psychiatrist colleague recently suggested to me that a physician [like me] shouldn&#8217;t be a psychotherapist based on a different argument &#8211; economics &#8211; saying that it costs too much to train a physician and the physician psychotherapist would therefore not be cost effective [the latter part implied].<\/p>\n<div align=\"justify\">I am a psychiatrist and psychotherapist, but I didn&#8217;t post this article to argue about psychotherapy. There is much about what it says that I agree with and I have no complaint about Lancet Psychiatry having high scientific standards for what they publish. Mostly, I just appreciated that the article doesn&#8217;t have the usual contempt, sarcasm, or ludicrous examples that often accompany pieces containing the word <em>psychotherapy<\/em>. My reason for posting it has to do with something else entirely &#8211; this statement:<\/div>\n<ul>\n<div align=\"justify\" class=\"small\"><em><font color=\"#200020\">The  acknowledged gold standard in terms of research is the randomised   controlled trial [RCT], a method that should be applied to all types of   intervention, wherever possible.<\/font><\/em><\/div>\n<\/ul>\n<div align=\"justify\">There was a time in my life when I would have automatically agreed with that statement. In a first career, I was a very <em>medical<\/em> physician involved in biological research. I was in love with any and every thing about the scientific method. That&#8217;s still true. But over the last six years as I&#8217;ve spent a lot of time looking at the domain of Randomized Controlled Trials [RCTs], my thoughts about that statement have changed dramatically &#8211; even though it seems like it ought to be correct.<\/div>\n<p align=\"justify\">The most obvious objection is the extent to which RCTs can be corrupted, manipulated, jury-rigged, etc. The scientific misbehavior in the RCTs of psychiatric drugs is staggering. I could never have imagined anything like it could even happen. So I spend my days involved in trying to insure that the kind of perverse science we&#8217;ve seen in psychiatric and other drug research never happens again. At the moment, access to the raw data from trials with independent analysis seems the best approach to what has gone before.<\/p>\n<p align=\"justify\">But even without the corruption, there&#8217;s more to be said about RCTs. I think they are essential as a beginning take on cataloging the adverse effects of drugs [psychiatric and otherwise], but only a beginning. Many adverse effects come with chronic use, so ongoing reporting is an essential ingredient in any accurate understanding of drug toxicity [for example, David Healy&#8217;s <a href=\"https:\/\/www.rxisk.org\/Default.aspx\" target=\"_blank\"><font color=\"#990000\">Rx<\/font><font color=\"#200020\">isk<\/font><\/a> site].<\/p>\n<p align=\"justify\">One might think that cleaning up&nbsp; the corruption, the distortion, the exaggeration might make RCTs the preferred standard in efficacy studies as well, but I&#8217;m not sure that&#8217;s totally right either. RCTs can be too sensitive &#8211; detecting small effects that are not clinically relevant even if they are statistically significant. They&#8217;re limited by their time frame, the outcome instruments, the subject recruitment and evaluation processes, and then there&#8217;s the placebo effect. The results are often hard to replicate, thus the increasing reliance on meta-analysis of multiple studies in evaluating overall efficacy. <\/p>\n<div align=\"justify\">The application of scientific principles in medicine is not like the strength of materials course in Civil Engineering training, no matter how much we&#8217;d like that to be true. There are too many parameters and inter-related forces at work for that kind of precision. That&#8217;s even more true in the region psychiatrists and psychotherapists haunt &#8211; the world of subjectivity. RCTs can sometimes add a degree of clarity, but sometimes not so much. In my specialty of psychiatry, the track record of RCTs is anything but exemplary. So I don&#8217;t think any single methodology is made out of gold or achieves <em>level<\/em>. That&#8217;s what makes things so confusing and leads to so much contention. It&#8217;s also what makes it all so incredibly interesting&#8230;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>A level playing field The Lancet Psychiatry. 2014 1[6]:403. At The Lancet Psychiatry we aim to publish research that illuminates and changes clinical practice. Changing practice requires a high standard of evidence, although existing practice does not always have a solid scientific base. Management of mental health often seems intuitive, so many interventions have been [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[5],"tags":[],"class_list":["post-51839","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/51839","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=51839"}],"version-history":[{"count":29,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/51839\/revisions"}],"predecessor-version":[{"id":51928,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/51839\/revisions\/51928"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=51839"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=51839"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=51839"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}