{"id":63771,"date":"2016-03-01T16:18:57","date_gmt":"2016-03-01T21:18:57","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=63771"},"modified":"2016-03-01T16:50:06","modified_gmt":"2016-03-01T21:50:06","slug":"words-and-music","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2016\/03\/01\/words-and-music\/","title":{"rendered":"words and music&#8230;"},"content":{"rendered":"\n<div align=\"justify\" class=\"small\">It is either fashionable or required to end articles with a few comments about the limitations of the study. In this case, I&#8217;m going to start with the limitations; then summarize my previous musings on the topic; then say what the topic actually is that has these limitations and musings:<\/div>\n<blockquote>\n<div align=\"justify\"><u><strong><font color=\"#200020\">Limitations<\/font><\/strong><\/u><br \/>               <font color=\"#660033\">Several  limitations of this study require comment. First, the conditions of a  randomized trial like RAISE-ETP may not be generalizable to real-world  practice since all sites that volunteered for RAISE-ETP were capable and  motivated to successfully implement a comprehensive, integrated care  FEP program with existing non-research sources of funding.<\/font> As a result,  CC sites most likely offered a level of FEP care that was superior to  usual FEP treatment in the US, thus minimizing observed differences  between NAV and usual treatment. In several other RCTs of FEP programs,  rates of hospitalization among control groups were 37% to 71% over 12  months, 1.5 to 3.5 times greater than the 20% seen in the first 12  months for CC in this study. This difference suggests that the lack of  more favorable NAV-CC differences in inpatient care and costs may  reflect an exceptionally good performance at keeping hospital  utilization low at CC sites in this study. If CC subjects in the present  study had performed similarly to  control groups in previous trials  cited above, the differentially greater costs associated with NAV  might have been reduced to zero or might even have been reversed to as  much as $7000 in savings. Generalizability of these results is thus  uncertain as RAISE-ETC may have artificially increased CC effectiveness  and reduced CC costs&#8230;.<\/div>\n<\/blockquote>\n<hr size=\"1\" \/>\n<div align=\"justify\"><sup><em><strong><font color=\"#200020\">Translation?<\/font><\/strong><\/em> My first encounter with the NIMH RAISE [Recovery After Initial Schizophrenic Episode] study was Dr. Insel&#8217;s blog touting the fact that SAMHSA had announced the availability of Block Grants to States for setting up early intervention programs in Schizophrenia, and was using the methodology of the ongoing NIMH RAISE study as a template for that effort. Dr. Insel saw that as moving research from the bench to the bedside &#8211; an oft quoted motto for Translational Medicine [<\/sup><sup><a href=\"http:\/\/www.nimh.nih.gov\/about\/director\/2014\/from-research-to-practice.shtml\" target=\"_blank\">Director&rsquo;s Blog: From Research to Practice<\/a>].<\/sup><\/div>\n<ul><sup>           <\/p>\n<li><a href=\"http:\/\/1boringoldman.com\/index.php\/2014\/05\/12\/a-fabrication\/\" target=\"_blank\">a fabrication?&hellip;<\/a><\/li>\n<li><a href=\"http:\/\/1boringoldman.com\/index.php\/2014\/05\/14\/where-did-it-go-2\/\" target=\"_blank\">where&rsquo;s the beef?&hellip;<\/a><\/li>\n<li><a href=\"http:\/\/1boringoldman.com\/index.php\/2014\/05\/16\/out-of-the-loop\/\" target=\"_blank\">out of the loop&hellip;<\/a><\/li>\n<p>            <\/sup><\/ul>\n<div align=\"justify\"><sup><em><strong><font color=\"#200020\">Opportunity knocks:<\/font><\/strong><\/em> What I concluded after that exploring around was that Dr. Insel&#8217;s version was more spin than not. When the Funds became available with ARA, he jumped on the opportunity to fund a study on the treatment of First Episode Psychosis [and good for him!]. It had a rocky start with two different programs &#8211; John Kane and Jeffrey Lieberman. Kane&#8217;s study survived &#8211; a community based program that was controlled by matched treatment-as-usual controls. The along came another program &#8211; Block Grants for the States for FEP, and the NIMH again jumped and passed along their Protocol [again, good for them!]. I say Protocol because the study wasn&#8217;t completed and there weren&#8217;t yet any results. So this wasn&#8217;t exactly a story about the wonders of Translational Medicine so much as a story about taking advantage of the breaks that come your way. I suspected that there was a back story, but sometimes the back story isn&#8217;t something bad.<\/sup><sup> In the course of things, I got interested in the actual RAISE program itself, focusing on one arm &#8211; the <\/sup><sup><em><a target=\"_blank\" href=\"https:\/\/raiseetp.org\/studymanuals\/IRT%20Complete%20Manual.pdf\">Individual Resiliency Training<\/a><\/em>. <\/sup>                <\/div>\n<ul><sup>           <\/p>\n<li><a href=\"http:\/\/1boringoldman.com\/index.php\/2014\/05\/23\/its-effectiveness\/\" target=\"_blank\">its effectiveness&hellip; <\/a><\/li>\n<li><a href=\"http:\/\/1boringoldman.com\/index.php\/2014\/05\/25\/another-irt-prequel\/\" target=\"_blank\">another IRT prequel&hellip;<\/a><\/li>\n<li><a href=\"http:\/\/1boringoldman.com\/index.php\/2014\/05\/26\/on-irt-some-comments\/\" target=\"_blank\">on IRT, some comments&hellip;<\/a><\/li>\n<li><a href=\"http:\/\/1boringoldman.com\/index.php\/2014\/07\/11\/the-maual\/\" target=\"_blank\">the manual&hellip; <\/a><\/li>\n<p>            <\/sup><\/ul>\n<div align=\"justify\"><sup><em><strong><font color=\"#200020\">Resiliency? Training?<\/font><\/strong><\/em> I won&#8217;t reiterate my complaints about the<\/sup><sup> <em><a target=\"_blank\" href=\"https:\/\/raiseetp.org\/studymanuals\/IRT%20Complete%20Manual.pdf\">Individual Resiliency Training<\/a><\/em> here. I am indebted to Dr. Sandra Steingard who was connected with the study through her center, and reassured me that it was only meant as a guide. We so need an effort for these patients that anything that gets a funded program going can evolve into something good. So I sat quietly and awaited the results [which were slow in coming]. Then they published something:<\/sup><\/div>\n<ul><sup>           <\/p>\n<li><a href=\"http:\/\/1boringoldman.com\/index.php\/2015\/10\/22\/raising-a-dilemma\/\" target=\"_blank\">raising a dilemma&hellip;<\/a><\/li>\n<li><a href=\"http:\/\/1boringoldman.com\/index.php\/2015\/10\/28\/spin-is-for-politicians\/\" target=\"_blank\">spin is for politicians&hellip;<\/a><\/li>\n<p>               <\/sup><\/ul>\n<div align=\"justify\"><sup><em><strong><font color=\"#200020\">More Confusion:<\/font><\/strong><\/em> The paper finally came out [<a href=\"http:\/\/ajp.psychiatryonline.org\/doi\/full\/10.1176\/appi.ajp.2015.15050632\" target=\"_blank\">Comprehensive Versus Usual Community Care for First-Episode  Psychosis: 2-Year Outcomes From the NIMH RAISE Early Treatment Program<\/a>], and it was confusing at best. The <font color=\"#200020\">New York Times<\/font> reported that this study showed that their program worked [<a href=\"http:\/\/1boringoldman.com\/wp-admin\/\" target=\"_blank\">New Approach Advised to Treat Schizophrenia<\/a>] &#8211; the patients were treated with &quot;talk therapy,&quot; required less antipsychotic medication [which is exactly what we all wanted to hear]. But that&#8217;s not what the paper itself said. I weould summarize what it said as &quot;We did it! We got a program going for First Episode Psychotic illness!&quot; and not much else. It took Discovery Magazine&#8217;s best-ever-blogger, Neuroskeptic, to clear things up [sort of] [<a target=\"_blank\" href=\"http:\/\/blogs.discovermagazine.com\/neuroskeptic\/2015\/10\/27\/medication-for-schizophrenia-less-is-more\/\">Medication for Schizophrenia: Less is More?<\/a>]. His finding was that <em><font color=\"#200020\">we don&#8217;t <\/font><\/em><\/sup><sup><em><font color=\"#200020\"> know the outcome just yet<\/font><\/em>. So again I sat patiently and awaited the results, thinking once more that there was a buried back story that would surely come out in time..<\/sup><\/div>\n<hr size=\"1\" \/>\n<div align=\"justify\" class=\"small\">I have a little text file of things I keep up with that I check each month. It&#8217;s something of a pet peeve of mine that the news cycle is so rapid that many things that matter just get lost in the whirrs and buzzes of life. This is on that list as &quot;<font color=\"#200020\">RAISE RESULTS?<\/font>&quot; So yesterday [the end of a month list check], I saw that annotation and went looking. I got a hit!    <\/div>\n<blockquote>\n<div align=\"center\" class=\"big\"><a href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/26834024\" target=\"_blank\">Cost-Effectiveness of Comprehensive, Integrated Care for First Episode Psychosis in the NIMH RAISE Early Treatment Program<\/a><\/div>\n<div align=\"center\" class=\"middle\">by Robert Rosenheck, Douglas Leslie, Kyaw Sint, Haiqun Lin, Delbert C. Robinson, Nina R. Schooler, Kim T. Mueser, David L. Penn,, Jean Addington, Mary F. Brunette, Christoph U Correll, Sue E. Estroff, Patricia Marcy, James Robinson, Joanne Severe, Agnes Rupp, Michael Schoenbaum, and John M. Kane.<\/div>\n<div align=\"center\" class=\"middle\"><strong><font color=\"#0033ff\">Schizophrenia Bulletin<\/font><\/strong>. Advance Access 01\/31\/2016.<\/div>\n<p>                    <\/p>\n<div align=\"justify\">This study compares the cost-effectiveness of Navigate [NAV], a comprehensive, multidisciplinary, team-based treatment approach for first episode psychosis [FEP] and usual Community Care [CC] in a cluster randomization trial. Patients at 34 community treatment clinics were randomly assigned to either NAV [N = 223] or CC [N = 181] for 2 years. Effectiveness was measured as a one standard deviation change on the Quality of Life Scale [QLS-SD]. Incremental cost effectiveness ratios were evaluated with bootstrap distributions. The Net Health Benefits Approach was used to evaluate the probability that the value of NAV benefits exceeded its costs relative to CC from the perspective of the health care system. The NAV group improved significantly more on the QLS and had higher outpatient mental health and antipsychotic medication costs. The incremental cost-effectiveness ratio was $12 081\/QLS-SD, with a .94 probability that NAV was more cost-effective than CC at $40 000\/QLS-SD. When converted to monetized Quality Adjusted Life Years, NAV benefits exceeded costs, especially at future generic drug prices.<\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">It&#8217;s the abstract of the study that had those <em><strong><font color=\"#200020\">limitations<\/font><\/strong><\/em> I started with at the end of the full paper. And this press release from the NIMH goes with it [it&#8217;s on-line and deserves a full reading if this is a topic of interest]:<\/div>\n<blockquote>\n<div align=\"center\" class=\"big\"><a target=\"_blank\" href=\"http:\/\/www.nimh.nih.gov\/news\/science-news\/2016\/team-based-treatment-for-first-episode-psychosis-found-to-be-high-value.shtml\">Team-based Treatment for First Episode Psychosis Found to be High Value<\/a>       <\/div>\n<div align=\"center\" class=\"middle\"><strong><font color=\"#200020\">NIH-funded study shows early intervention is more cost-effective than typical care<\/font><\/strong><\/div>\n<div align=\"center\" class=\"big\"><strong><font color=\"#0000cc\">NIMH: <em>Press Release<\/em> <\/font><\/strong><\/div>\n<div align=\"center\" class=\"middle\">February 1, 2016<\/div>\n<p align=\"justify\">New analysis from a mental health care study shows that &ldquo;<a href=\"http:\/\/www.nimh.nih.gov\/health\/topics\/schizophrenia\/raise\/what-is-coordinated-specialty-care-csc.shtml\">coordinated specialty care<\/a>&rdquo; [CSC] for young people with <a href=\"http:\/\/www.nimh.nih.gov\/health\/topics\/schizophrenia\/raise\/fact-sheet-first-episode-psychosis.shtml\">first episode psychosis<\/a>  is more cost-effective than typical community care. Cost-effectiveness  analysis in health care is a way to compare the costs and benefits of  two or more treatment options.&nbsp; While the team-based CSC approach  has modestly higher costs than typical care, it produces better clinical  and quality of life outcomes, making the CSC treatment program a better  value. These findings of this study, funded by the National  Institute of Mental Health, part of the National Institutes of  Health, will help guide mental health professionals in their  treatment for first episode psychosis.<\/p>\n<p align=\"justify\">This new analysis, published online today by <em>Schizophrenia Bulletin<\/em>, was led <a href=\"https:\/\/medicine.yale.edu\/psychiatry\/people\/robert_rosenheck-2.profile\" title=\"\">by Robert Rosenheck, M.D.&nbsp;<\/a>, professor of psychiatry and public health at Yale University. It is part of the <a href=\"http:\/\/www.nimh.nih.gov\/health\/topics\/schizophrenia\/raise\/index.shtml\">Recovery After an Initial Schizophrenia Episode<\/a>&nbsp; initiative also funded by the National Institute of Mental  Health. This paper reported on the cost-effectiveness of CSC treatment  in the <a href=\"https:\/\/raiseetp.org\" title=\"\">RAISE Early Treatment Program&nbsp;<\/a> , a randomized controlled trial headed by <a href=\"https:\/\/www.northwell.edu\/find-care\/find-a-doctor\/psychiatry\/dr-john-kane-md-11315975\" title=\"\">John M. Kane, M.D&nbsp;<\/a>.,  professor and chairman, Department of Psychiatry at The Hofstra North  Shore-LIJ School of Medicine and The Zucker Hillside Hospital.<\/p>\n<p align=\"justify\">Coordinated specialty care for first episode psychosis is a  team-based treatment program tailored to each individual that involves  more specialty care from mental health providers than typical care. Dr.  Rosenheck and colleagues focused on a specific CSC program, called  NAVIGATE, which featured a team of specialists offering  recovery-oriented psychotherapy, low-dose antipsychotic medications,  family education and support, case management, and work or education  support&#8230;<\/p>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">I wondered why I hadn&#8217;t seen this. Looking back, it was <em>sort of<\/em> all over the Internet, but not in the places I usually follow. And it didn&#8217;t make it to the big news outlets. As far as I can tell, it didn&#8217;t even make it to <font color=\"#200020\">Psychiatric News<\/font> or to <font color=\"#200020\">Mad in America<\/font>. Anyway, for whatever reason, I missed it.  <\/div>\n<p align=\"justify\" class=\"small\">Well, those are all the words, at least the ones I know about. Here&#8217;s the music. Anybody reading this knows that we badly need stable programs for people with psychotic illness, particularly First Episode Psychosis. I expect that most people reading this feel that the skillful use of antipsychotic medication is part of that treatment for many. I expect most would agree that there needs to be a place in those programs for people who won&#8217;t or don&#8217;t need to take medication. Many would agree that there needs to be a provision for actively psychotic people who are out of control or dangerous other than prison. And most accept that the care needed is a humanitarian responsibility of society. I expect that people who think it&#8217;s all a medication issue or all a psychotherapy issue aren&#8217;t reading this.  <\/p>\n<div align=\"justify\" class=\"small\">So as much as I am a critic of Dr. Insel and his reign at the NIMH, of the particular <em><a target=\"_blank\" href=\"https:\/\/raiseetp.org\/studymanuals\/IRT%20Complete%20Manual.pdf\">Individual Resiliency Training<\/a><\/em> protocol in RAISE, of Dr. Kane&#8217;s PHARMA connections, of their unwillingness to publish the RAISE results directly, of spinning seredipity as Translational Medicine, I&#8217;ve got to admit that they &quot;<em><font color=\"#200020\">did it! [they] got a program going for First Episode Psychotic illness!<\/font><\/em>&quot; They saw some opportunities and did something with them. <font color=\"#660033\">I&#8217;ll bet that the program cost more than they wanted it to and that the medication use was more than they hoped and that the results weren&#8217;t as robust as they&#8217;d hoped [how often have you heard &quot;<em>with a .94 probability<\/em>&quot; instead of p=0.06?], so they published their cost-effectiveness data and slid the study results in the spaces and the press release rather than publishing a separate straight-shooting paper.<\/font> In spite of all of that,  if this statement turns out to be even slightly true, this may turn out to be the NIMH&#8217;s best outing of the Insel Era [but I still want them to just tell us outright what they found]:<\/div>\n<blockquote>\n<div align=\"justify\">&ldquo;This scientific work is having an immediate impact on clinical practice  in the United States and is setting a new standard of care,&rdquo; added  Heinssen. &ldquo;We&rsquo;re seeing more states adopt coordinated specialty care  programs for first episode psychosis, offering hope to thousands of  clients and family members who deserve the best care that science can  deliver.&rdquo; <\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">So, I guess on rare occasion, I can go for &quot;<em><font color=\"#200020\">the ends justify the means&#8230;<\/font><\/em>&quot; And, by the way, I buy that <strong><font color=\"#200020\">limitations<\/font><\/strong> comment. They picked their initial cohort from among the ones that are working well. There are many, many more that aren&#8217;t&#8230; <\/div>\n","protected":false},"excerpt":{"rendered":"<p>It is either fashionable or required to end articles with a few comments about the limitations of the study. In this case, I&#8217;m going to start with the limitations; then summarize my previous musings on the topic; then say what the topic actually is that has these limitations and musings: Limitations Several limitations of this [&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_forum_subforum_count":0,"footnotes":""},"categories":[5],"tags":[],"class_list":["post-63771","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/63771","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=63771"}],"version-history":[{"count":34,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/63771\/revisions"}],"predecessor-version":[{"id":64318,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/63771\/revisions\/64318"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=63771"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=63771"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=63771"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}