{"id":46146,"date":"2014-05-12T13:43:47","date_gmt":"2014-05-12T17:43:47","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=46146"},"modified":"2014-05-12T13:48:36","modified_gmt":"2014-05-12T17:48:36","slug":"a-fabrication","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/05\/12\/a-fabrication\/","title":{"rendered":"a fabrication?&#8230;"},"content":{"rendered":"<br \/>\n<blockquote>\n<div align=\"center\" class=\"big\"><a target=\"_blank\" href=\"http:\/\/www.nimh.nih.gov\/about\/director\/2014\/from-research-to-practice.shtml\">Director&rsquo;s Blog: From Research to Practice<\/a><\/div>\n<div align=\"center\" class=\"big\"><strong><font color=\"#0033ff\">N.I.M.H.<\/font><\/strong><\/div>\n<div align=\"center\" class=\"middle\">By  Thomas Insel and Pamela Hyde, SAMHSA Administrator<\/div>\n<div align=\"center\" class=\"small\">May 1, 2014<\/div>\n<p align=\"justify\">Conventional wisdom says that there is a long delay between a  research finding and putting that finding into practice. Based on  treatments for hypertension, that delay is usually described as 17  years. So it is especially worth noting an announcement last week from  the Substance Abuse and Mental Health Services Administration [SAMHSA]  that 5 percent of the Mental Health Block Grant allocation would be used  to implement evidence-based treatments for first episode psychosis  [FEP]. The overall approach &ndash; team-based, youth-oriented specialty care  &ndash; was developed in consultation with the National Institute of Mental  Health [NIMH], and is based on similar programs operating in Australia  and Europe, as well as lessons learned in the Recovery After an Initial  Schizophrenia Episode [<a target=\"_blank\" href=\"http:\/\/www.nimh.nih.gov\/health\/topics\/schizophrenia\/raise\/index.shtml\">RAISE<\/a>]  project. While part of the RAISE study is ongoing, <strong><font color=\"#200020\">completed studies in  New York and Maryland have already demonstrated the feasibility of  implementing this complex approach in community settings in the United  States<\/font><\/strong>. Rather than a 17-year delay, the feasibility component of the  RAISE project was completed in December, 2013, and is now being  implemented by SAMHSA about 17 weeks later &ndash; a vast improvement in the  timeline for moving research into real-world settings where it can truly  have the broadest impact.<\/p>\n<p align=\"justify\">How did this happen so quickly? SAMHSA provides states funding via the <a target=\"_blank\" href=\"http:\/\/beta.samhsa.gov\/grants\/block-grants\">Mental Health Block Grant <\/a>  to support local mental health programs. In this year&rsquo;s budget,  Congress directed SAMHSA to require that states set aside 5 percent of  the Block Grant funds to support &ldquo;evidence-based programs that address  the needs of individuals with early serious mental illness, including  psychotic disorders.&rdquo; With recent experience demonstrating the  feasibility of creating FEP treatment programs in U.S. community  treatment settings NIMH staff developed an <a target=\"_blank\" href=\"http:\/\/www.nimh.nih.gov\/health\/topics\/schizophrenia\/raise\/summary-of-fep-treament-components-d9-11apr-2014-final-edits-for-briefin.pdf\">overview document<\/a>  for state planners and providers, Evidence-Based Treatments for First  Episode Psychosis: Components of Coordinated Specialty Care [CSC], as  well as a <a target=\"_blank\" href=\"http:\/\/www.nimh.nih.gov\/health\/topics\/schizophrenia\/raise\/coordinated-specialty-care-for-first-episode-psychosis-resources.shtml\">resources page<\/a>  that includes a variety of CSC program development materials, such as  treatment manuals, videos, educational handouts, and worksheets. Like  the interventions tested in the RAISE studies, CSC is based on  collaborative treatment planning, a respectful and effective means for  establishing a positive therapeutic alliance, and maintaining engagement  with individuals and their family members over time.<\/p>\n<p align=\"justify\">To prepare states for the implementation of the set-aside,  SAMHSA and NIMH are co-hosting national webinars to inform states of the  evidence-based components of coordinated specialty care for FEP. In  addition, SAMHSA will be providing technical assistance and resources to  states as they develop and implement their plan. Some states already  have significant investments to help individuals experiencing FEP. We  encourage these states to coordinate existing programs with programs  supported by the new 5 percent set-aside. We hope that, with this new  Block Grant investment, leveraged by services reimbursed by Medicaid or  private insurance, every state should be able to begin to develop or  enhance early intervention services for FEP.<\/p>\n<div align=\"justify\">While SAMHSA&rsquo;s mission is service and NIMH&rsquo;s is research, we  share the same goal of recovery for those experiencing a first episode  of psychosis. Rather than a 17-year delay, this new announcement from  SAMHSA uses the latest evidence to implement a much-needed innovation  over the next few months across the country. This is a great example of  what can happen when two agencies work together, moving research into  practice to ensure the best outcomes.<\/div>\n<\/blockquote>\n<div align=\"justify\">The RAISE Project [Recovery After an Initial  Schizophrenia Episode] has two studies. The one in New York and Maryland is <em>RAISE Connection<\/em>, Clinical Trial <a href=\"http:\/\/clinicaltrials.gov\/show\/NCT01216891\" title=\"Current version of study NCT01216891 on ClinicalTrials.gov\" target=\"_blank\">NCT01216891<\/a>. Looking at the          <a title=\"Historical versions of study NCT01216891 on ClinicalTrials.gov Archive Site\" href=\"http:\/\/clinicaltrials.gov\/ct2\/archive\/NCT01216891\">History of Changes<\/a>, it started in <a href=\"http:\/\/clinicaltrials.gov\/archive\/NCT01216891\/2010_10_18\/changes\" target=\"_blank\">October 2010<\/a> and was described as:<\/div>\n<blockquote>\n<div align=\"justify\">This study, the RAISE Connection Program, is one of the two independent  research studies that NIMH has funded to conduct the NIMH RAISE Project.  The Connection Program is being supported in whole or in part with  Federal funds from the American Recovery and Reinvestment Act of 2009  and the NIMH, National Institutes of Health, Department of Health and  Human Services. <strong><font color=\"#200020\">The Connection Program aims to compare two early  treatment interventions for adolescents and adults experiencing a first  episode of psychosis.<\/font><\/strong> The study will also examine the costs associated  with the treatment interventions&#8230;<\/div>\n<p>   <\/p>\n<div align=\"justify\">This study will <strong><font color=\"#200020\">compare two different approaches to helping people get these treatments  and services<\/font><\/strong>: a team-based approach versus a facilitated community-based approach. The study will determine if one of  the approaches is better than the other in helping individuals go             to work or       to school, live independently,          and have enjoyable relationships with others.     <\/div>\n<\/blockquote>\n<div align=\"justify\">with the responsible party being Jeffrey Lieberman MD. in <a href=\"http:\/\/clinicaltrials.gov\/archive\/NCT01216891\/2011_02_18\/changes\" target=\"_blank\">February 2011<\/a>, it was no longer recruiting. In <a href=\"http:\/\/clinicaltrials.gov\/archive\/NCT01216891\/2011_06_22\/changes\" target=\"_blank\">June 2011<\/a>, there were multiple changes. Dr. Lieberman was replaced as the responsible party by Susan Ellis PhD and it looks as if the target enrollment was dropped from 370 to 80, and shortened. The parts quoted above were changed to:<\/div>\n<blockquote>\n<div align=\"justify\"> The  Connection  Program  aims  to       to assess the effectiveness of a Team-based intervention for      individuals with a  first      psychotic episode, observing outcomes over time for our study     participants. <strong><font color=\"#200020\">When tracking outcomes, the    Connection Program will make comparisons with  what is known about the    natural history of untreated first episode of psychosis as well as usual care outcomes from other experimental studies<\/font><\/strong>&#8230;<\/div>\n<p>   <\/p>\n<div align=\"justify\">  This  study  will            adapt and                  evaluate the            impact of a comprehensive and integrated treatment intervention for first episode psychosis to    be delivered in real-world practice settings to     promote symptomatic recovery, minimize disability, and maximize social, academic, and       vocational functioning&#8230;<\/div>\n<\/blockquote>\n<div align=\"justify\">along with several other changes:<\/div>\n<div align=\"center\"><img decoding=\"async\" width=\"400\" vspace=\"5\" border=\"1\" src=\"http:\/\/1boringoldman.com\/images\/raise-1.jpg\" \/>&nbsp;<\/div>\n<div align=\"justify\">It&#8217;s listed as<em> recruiting<\/em> up through the last update in <a href=\"http:\/\/clinicaltrials.gov\/archive\/NCT01216891\/2013_06_27\/changes\" target=\"_blank\">June 2013<\/a>. <\/div>\n<p align=\"justify\">I read Dr. Insel&#8217;s blog post as something as a <em>rah-rah-aren&#8217;t-we-swift-in-going-from-the-bench-to-the-bedside<\/em> piece. But I was unclear about what it was that was being moved, so I looked it up on clinicaltrials.gov and looked at the history of changes almost out of habit. <em>RAISE Connection<\/em> started life as an uncontrolled comparative study, comparing two different intervention approaches in first break schizophrenic patients. Something happened [?], and it became a one-armed study with neither control or comparator, with a new recruitment period and a pared down enrollment. Dr. Insel presents it as a <em>feasibility study<\/em>.<\/p>\n<div align=\"justify\">So I thought I&#8217;d take a look at the other RAISE study, <em>RAISE ETP<\/em> [Early Treatment Program][<a href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/NCT01321177?term=Recovery+After+an+Initial+Schizophrenia+Episode&#038;rank=2\" target=\"_blank\">NCT01321177<\/a>]. It was registered in January 2011, around the time <em>RAISE Connection<\/em> was changed. So maybe <em>RAISE Connection<\/em> morphed into a feasibility study? <\/div>\n<blockquote>\n<div align=\"justify\">The ETP study aims to compare two early treatment interventions for  adolescents and adults experiencing a first episode of psychosis.  The  clinical centers have been randomly allocated to offer one of the two  treatment programs. Both treatment interventions are designed to provide  a person with treatment soon after he or she experiences the early  signs of schizophrenia. Participants will be offered mental health  services such as medication and psychosocial therapy. These strategies  are all aimed at promoting symptom reduction and improving life  functioning. Participation in this study will last between 2 and 3 years.<\/div>\n<\/blockquote>\n<div align=\"justify\">It was a more ambitious undertaking with 33 sites, a target enrollment of 400, and two treatment arms:<\/div>\n<div align=\"center\"><img loading=\"lazy\" decoding=\"async\" width=\"500\" vspace=\"5\" height=\"321\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/raise-2.jpg\" \/><\/div>\n<div align=\"justify\">Insofar as I can tell, this second study isn&#8217;t completed [&quot;<em>While part of the RAISE study is ongoing&#8230;<\/em>&quot;] and it is listed as <a href=\"http:\/\/clinicaltrials.gov\/archive\/NCT01321177\/2012_01_04\/changes\" target=\"_blank\"><em>Single Blind [Outcomes Assessor]<\/em><\/a>. The point being that the results aren&#8217;t known.<\/div>\n<p align=\"justify\">To rehash: The two &quot;independent&quot; RAISE studies were funded by the ARRA of 2009. The<em> RAISE Connection<\/em> study was at two sites [New York and Maryland] and was going to compare two different intervention programs in First Episode Schizophrenia. After a little over a year, the study was radically amended with a change in P.I., duration, enrollment target, and one intervention program dropped &#8211; meaning that there was neither control nor comparator. The outcome was to compare results with <strong><font color=\"#200020\">&quot;<\/font><\/strong><strong><font color=\"#200020\">&#8230;what is known about the    natural history of  untreated first episode of psychosis as well as usual care outcomes from  other experimental studies.&quot;<\/font><\/strong> The study ended in December 2013 and I can find no published results. The <em>RAISE ETP study <\/em>was of similar design at 33 sites with a Mental Health Center treatment <em>as usual <\/em>arm and a Behavioral Integrative Treatment arm [see above].<\/p>\n<p align=\"justify\">In Dr. Insel&#8217;s version on his blog, the first study [<em>RAISE Connection<\/em>] is referred to as a <em>feasibility<\/em> study. The second study [<em>RAISE ETP<\/em>] is still continuing. So I&#8217;m having a difficult time understanding how this is an example of a &quot;<em>research finding and putting that finding into practice.<\/em>&quot; Whatever happened to <em>RAISE Connection<\/em> removed any research from the field by eliminating any comparator. Even Dr. Insel referred to it as a <em>feasibility<\/em> exercise. The research study is <em>RAISE ETP<\/em> which has yet to be completed. They mention no preliminary results. So I just don&#8217;t get it. <\/p>\n<div align=\"justify\">It seems more like the ARRA money became available and they financed <em>RAISE<\/em>. Then when the SAMHSA budget allocated funding to &quot;<em>implement evidence-based treatments for first episode psychosis,<\/em>&quot; they wrote up what the <em>RAISE<\/em> protocols proposed. If it&#8217;s &quot;<em>evidence-based<\/em>,&quot; it didn&#8217;t get its evidence from <em>RAISE<\/em>. And whatever the case, the phrase &quot;<em>a  research finding and putting that finding into practice<\/em>&quot; is stretching the facts beyond too thin. An uncontrolled study that misfired? A second uncompleted study? Where&#8217;s the research in that? Maybe I misread something, because by my reading, Dr. Insel&#8217;s blog is a fabrication. I&#8217;d appreciate someone else looking it over&#8230;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Director&rsquo;s Blog: From Research to Practice N.I.M.H. By Thomas Insel and Pamela Hyde, SAMHSA Administrator May 1, 2014 Conventional wisdom says that there is a long delay between a research finding and putting that finding into practice. Based on treatments for hypertension, that delay is usually described as 17 years. So it is especially worth [&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-46146","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/46146","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=46146"}],"version-history":[{"count":28,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/46146\/revisions"}],"predecessor-version":[{"id":46174,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/46146\/revisions\/46174"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=46146"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=46146"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=46146"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}