{"id":16829,"date":"2011-12-04T13:33:52","date_gmt":"2011-12-04T18:33:52","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=16829"},"modified":"2011-12-04T13:50:13","modified_gmt":"2011-12-04T18:50:13","slug":"hypothetical-diagnoses","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2011\/12\/04\/hypothetical-diagnoses\/","title":{"rendered":"hypothetical diagnoses&#8230;"},"content":{"rendered":"<div align=\"justify\">In the last post, I spoke of the blurring of boundaries between research and clinical medicine in psychiatry over the last twenty-five years in reference to Dr. Darrel Regier&#8217;s bizarre comment, &quot;<strong><em><font color=\"#200020\">&hellip;<\/font><\/em><em><font color=\"#200020\">   that&rsquo;s what the DSM is &ndash; a  set of scientific hypotheses that are    intended to be tested and  disproved if the evidence isn&rsquo;t found to    support them<\/font><\/em><\/strong>.&quot; As I approach my 50th year in medicine, I&#8217;ll have to say that is the single most ridiculous statement I&#8217;ve encountered during my tour of duty.<\/div>\n<p align=\"justify\">I suppose I can make up a way to hear that without foaming at the mouth. Since we don&#8217;t know the etiology of most of the conditions we treat, everything is a hypothesis in a way. Shizophrenia is a well defined clinical entity, but at some level, our grouping such patients under a unifying nosology hypothesizes a unitary cause &#8211; something we don&#8217;t know to be true. But that&#8217;s not what Dr. Regier means. He is proposing that we include hypothetical groupings in the DSM-5 diagnostic Manual and see how they pan out &#8211; that we use the DSM-5 as a clinical trial [I&#8217;m having trouble not putting statements like that in bold, colored, underlined text, followed with exclamation points &#8211; &quot;<u><strong><font color=\"#990000\">use the DSM-5 as a clinical trial!!!!!<\/font><\/strong><\/u>&quot;].                 <\/p>\n<div align=\"justify\">I now recognize that the background idea of the DSM-III was a good one &#8211; define the mental illnesses as syndromes, leaving out hypothesized etiologies. As Dr. Carroll says in a <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2011\/12\/03\/the-grand-prize\/#comment-217701\"><u><strong><font color=\"#200020\">comment<\/font><\/strong><\/u><\/a> more eloquently than I, the DSM-III died in its implementation. It was a list of symptoms rather than a full syndromatic description. Worse, it didn&#8217;t iterate scientifically in subsequent editions [DSM-IIIR, DSM-IV, DSM-IVTR]. It was too flattened to collect data that would refine its categories &#8211; define pathognomonic findings or useful ancillary information. But at least the former versions were attempts to create a nosology that approximated the state of our knowledge. Regier&#8217;s idea is that we create diagnoses to test diagnostic hypotheses. Who is it that thinks like that?<\/div>\n<ul>\n<div align=\"justify\"><u><strong><a target=\"_blank\" href=\"http:\/\/www.psych.org\/MainMenu\/Research\/DSMIV\/DSMV\/MeettheTaskForce\/DarrelARegierMDMPH.aspx\"><font color=\"#000000\">Darrel A. Regier, M.D., M.P.H.<\/font><\/a><\/strong><\/u><br \/>            <sup><img decoding=\"async\" hspace=\"4\" width=\"84\" vspace=\"2\" border=\"1\" align=\"right\" src=\"http:\/\/img.medscape.com\/news\/2011\/ht_111109_darrel_regier_120x156.png\" \/>Dr.  Regier has served for the past seven years as Executive Director of the  American Psychiatric Institute for Research and Education (APIRE), as  well as Director, Division of Research at the American Psychiatric  Association (APA).&nbsp; APIRE is an independent 501(c)(3) Research Institute  component of the APA, with its own Board of Directors and research  mission in mental health services, health policy, epidemiology, and  nosology\/psychopathology research and research training.&nbsp; It also  supports psychiatric education and other career development programs.&nbsp; A  principle responsibility has been to coordinate the maintenance and  revision plans for the APA&rsquo;s Diagnostic and Statistical Manual. This has  involved coordinating a series of Research Agenda white papers and  serving as Principal Investigator for an NIH Conference grant to review  the research basis for mental disorder diagnoses.&nbsp; In 2006, he was named  Vice-Chair of the DSM-V Task Force to work jointly with the Task Force  Chair, Dr. David Kupfer.<\/p>\n<p>            Prior  to taking this position, Dr. Regier completed 25 years at the National  Institute of Mental Health (NIMH), during which time he directed three  research divisions in the areas of epidemiology, prevention, clinical  research, and health services research.&nbsp; He initiated the development of  several areas of research including national surveys of prevalence of  mental disorders, mental health service use in primary care and  specialty settings, the organization and financing of such services, and  international programs on the classification of mental disorders with  the World Health Organization.&nbsp; He served as the Scientific  Coordinator\/Director for four National Advisory Mental Health Council  reports to Congress on mental health insurance parity, and was a section  editor of the Surgeon&rsquo;s General&rsquo;s Report on Mental Health.&nbsp; In the  international arena, Dr. Regier served as the mental health coordinator  for the Health Committee of the U.S.\/Russian Commission on Science and  Technology and remains as a consultant to the World Health  Organization&rsquo;s mental health initiatives.<\/sup><\/div>\n<\/ul>\n<div align=\"justify\">Well, there&#8217;s not much in there that says &quot;clinician&quot; &#8211; as in a doctor who sees patients, makes diagnoses, and prescribes treatment. It more says &quot;policy wonk&quot; to me. Here&#8217;s a window into why I have to suppress impulses to say everything in highlighted text:<\/div>\n<blockquote>\n<div align=\"center\"><strong><u><a target=\"_blank\" href=\"http:\/\/www.cnsspectrums.com\/aspx\/articledetail.aspx?articleid=1444\"><font color=\"#200020\">An Interview with Darrel A. Regier, MD, MPH<\/font><\/a><\/u>:<\/strong><br \/>                         <strong><font color=\"#200020\"><sup>The Developmental  Process for the Diagnostic and Statistical Manual of Mental Disorders,  Fifth Edition<\/sup><\/font><\/strong><br \/>                          <strong><font color=\"#200020\">CNS Spectrums<\/font><\/strong>. 2007;13(2):120-124.<\/div>\n<p>                         <\/p>\n<div align=\"justify\"><sup>One of the most important advances in the field since the publication of the <em>DSM-IV<\/em>  has been the emergence of greater attention to what has been referred  to as measurement-based care, particularly brought out in the recent <strong><font color=\"#660033\"> Sequenced Treatment Alternatives to Relieve Depression<\/font><\/strong> [<strong><font color=\"#660033\">STAR*D<\/font><\/strong>] clinical  trial, which emphasized the need to be able to measure both the  thresholds for disorders on some kind of continuous scale as well as be  able to look at the response to treatment on such a scale.<\/sup><\/div>\n<p align=\"justify\"><sup>For years, researchers have known that to conduct clinical trials, it is  necessary to have dimensional measures of severity and to establish  adequate thresholds. Instruments such as the Quick Inventory for  Depression Scale are being used more often, such as in the <strong><font color=\"#660033\">STAR*D<\/font><\/strong> study.  In routine primary care settings, there has been an increasing reliance  on instruments like the nine-item Patient Health Questionnaire to  assess what is a severe illness and what is an adequate treatment  response.<\/sup><\/p>\n<div align=\"justify\"><sup>Throughout the full range of mental disorders, measures like these have  been used in research studies. Researchers are now very interested in  looking at dimensional measures for assessing thresholds for disorders  and providing some guidance for clinicians to be able to look at a way  of monitoring treatment response&#8230;<\/sup><\/div>\n<\/blockquote>\n<div align=\"justify\">Bringing up <strong><font color=\"#660033\">STAR*D<\/font><\/strong> as a guiding paradigm is really a bad move [<u><strong><a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/04\/03\/a-thirty-five-million-dollar-misunderstanding\" target=\"_blank\"><font color=\"#200020\">a thirty-five million dollar misunderstanding&hellip;<\/font><\/a><\/strong><\/u>]. That was the very large study of sequenced treatment in Major Depressive Disorder that generated over a hundred papers but never published any results that included the primary efficacy parameters &#8211; a dud of galactic proportions. And as it turns out, what they did publish was probably wrong [<u><strong><a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/04\/06\/recalculating\"><font color=\"#200020\">recalculating&hellip;<\/font><\/a><\/strong><\/u>]. STAR*D was the outgrowth of a line of thinking by Drs. John Rush and Madhukar Trivedi that had been going on for years:<\/div>\n<div align=\"center\"><img loading=\"lazy\" decoding=\"async\" height=\"261\" width=\"368\" vspace=\"5\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/prefer-1.gif\" \/><\/div>\n<div align=\"justify\">It involved treating patients using fixed algorithms and following their progress with standard measures [measurement-based care], as in the QIDS-SR [property of Dr. Rush himself]. The outcomes of their studies?:<\/div>\n<ul>\n<li>\n<div align=\"justify\"><strong><font color=\"#200020\">TMAP<\/font><\/strong>: Defunct. Coming soon &#8211; the trial of a suit against J&amp;J alleging [convincingly] that TMAP was a scam to sell drugs to public health systems.<\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong><font color=\"#200020\">STAR*D<\/font><\/strong>: A failed $35 M study with no results other than endless articles.<\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong><font color=\"#200020\">IMPACTS<\/font><\/strong>: A computerized algorithm study that was never done.<\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong><font color=\"#200020\">COMED<\/font><\/strong>: Another failed study &#8211; combination treatment.<\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong><font color=\"#200020\">EMBARC<\/font><\/strong>: Dr. Trivedi&#8217;s study to predict responses using biosignatures &#8211; already doomed in my opinion.<\/div>\n<\/li>\n<\/ul>\n<div align=\"justify\">Lest you doubt my assertion the Dr. Regier [and Dr. Kupfer, his DSM-5 co-creator] are part of this line of thinking, how about this?       <\/div>\n<blockquote>\n<div align=\"center\"><a target=\"_blank\" href=\"http:\/\/www.nature.com\/npp\/journal\/v31\/n9\/full\/1301131a.html\"><u><strong><font color=\"#200020\">Report by the ACNP Task Force on response and remission in major depressive disorder.<\/font><\/strong><\/u><\/a><br \/>                     <sup>by <strong><font color=\"#990000\">Rush AJ<\/font><\/strong>, Kraemer HC, Sackeim HA, Fava M, <strong><font color=\"#990000\">Trivedi MH<\/font><\/strong>, Frank E, Ninan PT, Thase ME, Gelenberg AJ, <strong><font color=\"#990000\">Kupfer DJ<\/font><\/strong>, <strong><font color=\"#990000\">Regier DA<\/font><\/strong>, Rosenbaum JF, Ray O, and <strong><font color=\"#990000\">Schatzberg AF<\/font><\/strong>; ACNP Task Force.<\/sup><br \/>                     <strong><font color=\"#200020\">Neuropsychopharmacology<\/font><\/strong>. 2006 Sep;31(9):1841-53.<br \/>                     [<strong><font color=\"#200020\">full text on-line<\/font><\/strong>]<\/div>\n<p>                     <\/p>\n<div align=\"justify\"><sup>This  report summarizes recommendations from the ACNP Task Force on the  conceptualization of remission and its implications for defining  recovery, relapse, recurrence, and response for clinical investigators  and practicing clinicians. Given the strong implications of remission  for better function and a better prognosis, remission is a valid,  clinically relevant end point for both practitioners and investigators.  Not all depressed patients, however, will reach remission. Response is a  less desirable primary outcome in trials because it depends highly on  the initial (often single) baseline measure of symptom severity. It is  recommended that remission be ascribed after 3 consecutive weeks during  which minimal symptom status (absence of both sadness and reduced  interest\/pleasure along with the presence of fewer than three of the  remaining seven DSM-IV-TR diagnostic criterion symptoms) is maintained.  Once achieved, remission can only be lost if followed by a relapse.  Recovery is ascribed after at least 4 months following the onset of  remission, during which a relapse has not occurred. Recovery, once  achieved, can only be lost if followed by a recurrence. Day-to-day  functioning and quality of life are important secondary end points, but  they were not included in the proposed definitions of response,  remission, recovery, relapse, or recurrence. These recommendations  suggest that symptom ratings that measure all nine criterion symptom  domains to define a major depressive episode are preferred as they  provide a more certain ascertainment of remission. These recommendations  were based largely on logic, the need for internal consistency, and  clinical experience owing to the lack of empirical evidence to test  these concepts. Research to evaluate these recommendations empirically  is needed.<\/sup><\/div>\n<\/blockquote>\n<div>In the full article, they end with:<\/div>\n<ul><sup><\/p>\n<div align=\"justify\">If these recommendations were adopted for daily practice, clinicians  would need to:<\/div>\n<ol>\n<li>\n<div align=\"justify\">specifically and repeatedly measure core criterion  depressive symptom severity to guide the implementation and timely  modification of treatment,<\/div>\n<\/li>\n<li>\n<div align=\"justify\">conduct sufficient visits or measurements  to establish that 3 consecutive weeks of minimal to no symptoms [ie,  remission] has or has not been achieved, <\/div>\n<\/li>\n<li>\n<div align=\"justify\">systematically inquire  about the magnitude and types of side effects and overall side-effect  burden, so as to accurately gauge whether the dose or type of treatment  needs modification in order to achieve remission in a time-efficient  fashion, and <\/div>\n<\/li>\n<li>\n<div align=\"justify\">follow the trajectory of symptom change [or lack of  change] such that treatments [dose, type] can be modified in a timely  fashion, hopefully informed by empirically defined triage points. <\/div>\n<\/li>\n<\/ol>\n<div align=\"justify\">The  use of a depressive symptom measure to assess the nine criterion symptom  domains that define an MDE by DSM-IV-TR would become routine.<\/div>\n<p><\/sup><\/ul>\n<div align=\"justify\">In essence, they are proposing that the model of the Clinical Research Trial become the way we treat patients that come to us for care. The whole model looks like this:<\/div>\n<div align=\"center\"><img decoding=\"async\" width=\"350\" vspace=\"5\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/evidence-3.gif\" \/>&nbsp;<\/div>\n<div align=\"justify\">Let&#8217;s call it &quot;robotic care&quot; [I&#8217;m stifling impulses again to drift into a rant, but I&#8217;ll control myself]. Make a diagnosis using a structured interview and the DSM categories. Treat with algorithms based on Clinical Trials. Follow treatment with a questionnaire, adjusting the treatment with the algorithm. Dr. Regeir is essentially proposing that we extend this Clinical Trial methodology even further into clinical practice by introducing new diagnoses into our practices as a way of seeing how they play out. Essentially our patients become subjects in a universal Clinical Trial via the DSM-5. I wish I were exaggerating here, but I don&#8217;t think I am.<\/div>\n<p><\/p>\n<div align=\"right\"> [I can&#8217;t seem to think about this further without ranting so I&#8217;ll stop for a while] <\/div>\n","protected":false},"excerpt":{"rendered":"<p>In the last post, I spoke of the blurring of boundaries between research and clinical medicine in psychiatry over the last twenty-five years in reference to Dr. Darrel Regier&#8217;s bizarre comment, &quot;&hellip; that&rsquo;s what the DSM is &ndash; a set of scientific hypotheses that are intended to be tested and disproved if the evidence isn&rsquo;t [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","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":[2],"tags":[],"class_list":["post-16829","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/16829","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=16829"}],"version-history":[{"count":42,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/16829\/revisions"}],"predecessor-version":[{"id":16871,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/16829\/revisions\/16871"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=16829"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=16829"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=16829"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}