The American Psychiatric Association publishes Guidelines for treating various psychiatric conditions. I’ve never actually looked at them, but this evening, I ran across a reference that lead me to the November 2010 Guidelines for the treatment of Major Depressive Disorder. It’s >100,000 words long, some 35% of which are taken up listing 1171 references. In addition, they reference 18 additional documents as Clinical Tools in MDD. It ends with that familiar refrain:
In time, brain imaging, genomics, proteomics, and other recent advances in neuroscience should help us "carve nature along its joints," allowing major depressive disorder to be broken into discrete diseases with defined and personalized treatments. In the meantime, clinical investigation focused on existing and novel treatment strategies remains essential.
Scanning down the main document, one finds:
8. Integrate measurements into psychiatric management
The integration of measurement tools into psychiatric management, which has been referred to as measurement-based care, may enhance the quality of care and improve clinical outcomes. Clinician-rated and/or self-rated scales can help determine the trajectory of disease course and effects of treatment…
Although the use of rating scales is not yet common practice in clinical settings, in part due to pragmatic concerns, the use of such scales can be valuable in monitoring symptoms and treatment progress. In addition, electronic monitoring is becoming more feasible, as electronic health records are more commonly utilized and patients and psychiatrists have increased access to technological tools that can help monitor and record symptoms. Baseline data and information about treatment-emergent changes can be collected systematically from the patient and electronically transmitted via telephone or the Internet. In addition to providing secure electronic capture of patient data, computerized decision support systems can be useful in implementing evidence-based treatment for major depressive disorder.
And where there are guidelines, algorithms, or a mention of measurement-based care, there’s one name likely to be on the list:
Work Group on Major Depressive Disorder
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Madhukar H. Trivedi, M.D.
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Madhukar H. Trivedi, M.D.
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I rather doubt that anyone has actually read this whole document. It’s written in that mildly insulting way characteristic of government-esque guidelines – sort of school-marmish, assuming that the reader knows nothing and needs to be told everything from the ground up [usually meaning written by a medical writer]. I’m always reminded in these circumstances of my favorite childhood books [the Miss Minerva series] with a spinster Aunt raising her orphaned Nephew [awkwardly]. At some point, Nephew Billy is leaving to visit relatives on the family farm, and Miss Minerva is instructing him before he leaves, saying, "Don’t put clean clothes on top of dirty clothes." That’s how the Guidelines are written. But just in case you didn’t read them, Dr. Trivedi has authored many other articles this year so far emphasizing the wonders of evidence-based, measurement-based, algorithmic care.
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Crisis of confidence: antidepressant risk versus benefit
by Nierenberg AA, Leon AC, Price LH, Shelton RC, and Trivedi MH Journal of Clinical Psychiatry. 2011 Mar;72(3):e11. Andrew A. Nierenberg, MD, assembled a group of experts to discuss recent research and lay media reports about the safety and efficacy of antidepressants for treating mild-to-moderate depression, including recent controversy surrounding antidepressant-related suicidality. The panel agreed that the data regarding the efficacy of antidepressants are complex, making it easy to misinterpret meta-analysis results. Additionally, the issue of suicidality is quite complicated, but the risk is not great enough to abandon the use of antidepressants, although patients should be monitored carefully. The panel discussed that patients who have mild or moderate depression may benefit from receiving evidence-based psychotherapy first, instead of antidepressants. The panel stressed that additional research and novel treatments are needed to improve outcomes for patients with depression. However, measurement-based pharmacotherapy is an effective tool for helping many patients with depression achieve remission and recovery. Clear communication with the public, the media, and nonpsychiatric clinicians about the safety and efficacy of antidepressants will encourage those who need treatment to seek it.
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Challenges and algorithm-guided treatment in major depressive disorder
by Shelton RC and Trivedi MH Journal of Clinical Psychiatry. 2011 Apr;72(4):e14. Major depressive disorder is complicated and difficult to treat, primarily because of its chronic and recurrent nature and the poor efficacy of most pharmacologic treatment options. Until more effective treatments become available, clinicians must focus on optimizing patient outcomes through patient care. Implementing measurement-based care and using treatment algorithms can reduce symptoms of depression and help patients achieve and maintain remission.
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Measurement-based care for unipolar depression
by Morris DW and, Trivedi MH Current Psychiatry Report. 2011 13(6):446-58. This article outlines the role of measurement-based care in the management of antidepressant treatment for patients with unipolar depression. Using measurement-based care, clinicians and researchers have the opportunity to optimize individual treatment and obtain maximum antidepressant treatment response. Measurement-based care breaks down to several simple components: antidepressant dosage, depressive symptom severity, medication tolerability, adherence to treatment, and safety. Quick and easy-to-use, empirically validated assessments are available to monitor these areas of treatment. Utilizing measurement-based care has several steps-screening and antidepressant selection based upon treatment history, followed by assessment-based medication management and ongoing care. Electronic measurement-based care systems have been developed and implemented, further reducing the burden on patients and clinicians. As more treatment providers adopt electronic health care management systems, compatible measurement-based care antidepressant treatment delivery and monitoring systems may become increasingly utilized.
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Using moderator-based algorithms and electronic medical records to achieve optimal outcomes in depression
by Shelton RC and Trivedi MH Journal of Clinical Psychiatry. 2011 Jul;72(7):e24. Moderator-based treatment algorithms for depression are available to assist clinicians by providing a highly structured approach for the monitoring and assessment of medication efficacy and risks. Algorithm-based treatment strategies provide consistent care and improve outcomes, and patients treated with measurement-based care experience greater reduction of symptoms, faster remission rates, and better overall efficacy than care as usual. Additionally, electronic medical records have the potential to provide interactive guidance on optimal treatment choices during patient follow-up visits. This Webcast focuses on evaluating predictors of treatment response within the context of using algorithms and integrating this information into clinical practice via electronic medical records.
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Measurement-based care in psychiatric practice: a policy framework for implementation
by Harding KJ, Rush AJ, Arbuckle M, Trivedi MH, and Pincus HA Journal of Clinical Psychiatry. 2011 Aug;72(8):1136-43. This article describes the need for measurement-based care (MBC) in psychiatric practice and defines a policy framework for implementation. Although measurement in psychiatric treatment is not new, it is not standard clinical practice. Thus a gap exists between research and practice outcomes. The current standards of psychiatric clinical care are reviewed and illustrated by a case example, along with MBC improvements. Measurement-based care is defined for clinical practice along with limitations and recommendations. This article provides a policy top 10 list for implementing MBC into standard practice, including establishing clear expectations and guidelines, fostering practice-based implementation capacities, altering financial incentives, helping practicing doctors adapt to MBC, developing and expanding the MBC science base, and engaging consumers and their families. Measurement-based care as the standard of care could transform psychiatric practice, move psychiatry into the mainstream of medicine, and improve the quality of care for patients with psychiatric illness.
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Wait! What’s this? An actual study instead of a polemic? And with Dr. Regeir the DSM-5 Guru signed on too. Imagine that…
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Depression outcomes in psychiatric clinical practice: using a self-rated measure of depression severity.
by Katzelnick DJ, Duffy FF, Chung H, Regier DA, Rae DS, and Trivedi MH Psychiatric Services. 2011 Aug;62(8):929-35. OBJECTIVES: This study determined rates of response and remission at 12 and 24 weeks among patients being treated by psychiatrists for depression on the basis of Patient Health Questionnaire-9 [PHQ-9] scores and identified factors associated with response and remission.
METHODS: Adult patients at 17 psychiatric practices participating in the National Depression Management Leadership Initiative completed the PHQ-9 at every office visit for one year irrespective of severity or chronicity of symptoms or adherence to treatment. Treating psychiatrists recorded the date when formal self-management goals were documented. Patients with a diagnosis of depression and a PHQ-9 score ≥10 were included in the response and remission analysis. Results are based on "last observation carried forward" analysis. RESULTS: Of the 1,763 patients with a depressive disorder, 960 had PHQ-9 scores ≥10 (mean±SD of 16.4±4.6) on their first study visit, indicating moderate to severe depression. At 12 weeks, 41% of the 792 who returned for follow-up had responded to treatment, and by 24 weeks 45% had responded. Response was defined as a PHQ-9 score <10. Symptoms were in remission for 13% and 18% of patients at 12 and 24 weeks, respectively. Severity of initial PHQ-9 score, weeks to first follow-up, and documented self-management were the three factors that predicted remission. CONCLUSIONS: Administering the PHQ-9 at each visit allowed psychiatrists to determine rates of response and remission among patients, but as anticipated, the rates were lower than those reported in trials of efficacy and effectiveness of psychiatric treatment of depression. |
This was an APIRE funded study involving 17 practices. Depressed patients were followed using the PHQ-9 self-rating questionnaire. This table summarizes the results [more comment below]:
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Performance improvement CME: algorithms and EMRs in depression
by Shelton RC and Trivedi MH Journal of Clinical Psychiatry. 2011 72(9):e29. Major depressive disorder is difficult to treat due to its chronic and recurrent nature and the poor performance of most pharmacologic treatment options. To improve patient outcomes, clinicians should become familiar with moderators of antidepressant response, implement measurement-based care, and follow treatment algorithms. The use of electronic medical records and computerized decision support systems may improve documentation and facilitate clinicians’ adherence to current standards of care. This Performance Improvement activity focuses on improving treatment outcomes for antidepressant therapy through familiarity with moderators of antidepressant response and the use of treatment algorithms, measurement-based care, and electronic medical records.
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Moderators of antidepressant response in major depression.
by Shelton RC, and Trivedi MH Journal of Clinical Psychiatry. 2011 Oct;72(10):e32. Moderators are baseline variables that predict response to a treatment. Prognostic moderators predict response to all treatments, whereas prescriptive moderators predict differential response to particular treatments. In patients with major depressive disorder, prognostic variables include having anxious or chronic depression, living alone, and having psychiatric comorbidities. Prescriptive variables include gender, menopausal status, age and age at onset, depressive subtype, severity, and chronicity. Recognizing these variables can help clinicians better predict patients’ response to treatment, select effective treatments for individual patients, and move patients to the next treatment step when response is inadequate.
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There are others, C.M.E. presentations on the same topic [but a fellow only has so much libido for cataloging the works of Madhukar Trivedi]. As I said earlier in a magnificent obsession…, Dr. Trivedi is running a campaign [a heavily financed campaign], now in its second decade, for evidence-based, measurement-based, algorithmic care. His track record is abysmal [TMAP, STAR*D, IMPACTS, CO-MED], and yet his studies keep getting funded and his papers keep getting published. His studies follow a predictable Modus Operandi. They often have a prequel that describes how they’re going to be conducted – and as in the full text of #6 above, there’s a lot of emphasis on trying to mimic real practice [what’s called "naturalistic" these days]. While this study was in psychiatric practices, he usually mixes psychiatry and primary care sites. There are two ways to take the naturalistic bent, the way he wants us to take it, or as just plain scientific sloppiness.
In this study, they gave the PHQ-9 [coming in a later post] and collected 960 patients who scored >10. They looked at the PHQ-9 scores at 12 weeks and 24 weeks. This is another piece of Trivedi’s M.O., the results are based on who stuck to treatment. So their reported Response Rate of ~40% and Remission Rate of ~20% leaves out the drop-outs which were about a third of the patients. There’s absolutely nothing in the study that has anything to do with Trivedi’s assertion that measurement-based care was helpful in treatment. In fact, they didn’t even keep up with treatment – at all. So the Response Rates and Remission Rates measure going to the doctor only. Here’s what they say about that:
A limitation of the regression analysis is the lack of information about current treatments patients were receiving. This is a potentially important factor to account for since treatment approaches are targeted to achieve response and remission. However, previous findings suggest that nearly 95% of patients with major depression (that is not in remission) treated by psychiatrists receive at least psychopharmacologic treatment and that the remainder receive psychotherapy. Therefore, it is safe to assume that close to 100% of patients in this study, all of whom were being treated by psychiatrists, received some form of treatment for depression.
At the end of the study, they conclude:
Administering the PHQ-9 at every visit allowed participating psychiatrists to determine rates of response and remission in their practices. Because most sites had not routinely monitored depression severity before this project, use of the PHQ-9 provided new information and led to discussions about ways to improve outcomes, including the feasibility of implementing other elements of measurement-based care that were described in the STAR*D study. This is the first large study to assess depression response and remission rates in typical psychiatric practices and can act as a source of comparison for future studies. Its findings need to be confirmed in future naturalistic studies of depression treatment that can assess outcomes routinely. Studies that randomly assign patients to psychiatric care with self-management or to usual psychiatric care are also needed to determine whether the improved odds of response and remission seen in the regression analyses are valid. Prospective research on the impact of time to psychiatric follow-up on depression response and remission is also indicated. Finally, research is needed to compare the impact of routine measurement of depression severity versus usual care or to examine whether practice patterns differ for acute or chronic episodes of depression when measurement is used.
Notice that the conclusion states what they fantasized about the study and is unconnected to anything that actually happened in the study itself [M.O. again]. There’s no evidence that it helped or hurt. All they can conclude legitimately is that they did the study which, incidentally, hardly lived up to their grandiose plans of treating to Remission. It was just another Clinical Trial without a Placebo Group or even a specified treatment that came out with some lackluster results [there was a thread of something about "self management" that I couldn’t follow without reading even other Trivedi papers, and I’ve about reached my 2011 quota]. It’s reasonable to ask why Trivedi perseverates on this measurement-based care meme in the face of such a bleak track record, but it’s even more interesting to ask why anyone funds these studies – over and over. This one was funded by APIRE:
…the American Psychiatric Institute for Research and Education [APIRE]. APIRE is a division of the American Psychiatric Foundation, a 501[c][3] subsidiary of the American Psychiatric Association. APIRE was established in 1998 to fulfill the leadership role of the APA in contributing to the scientific base of psychiatric practice and policy…
The acknowledgements to #6 add:
This study benefited from generous support by the American Psychiatric Foundation [APF] and an unrestricted educational grant to APF for this research by a consortium of industry supporters, including AstraZeneca International, Eli Lilly and Company, Lilly Foundation, Forest Laboratories, Pfizer, Sanofi Aventis, and Wyeth.
I haven’t previously understood clearly why they keep hammering away at the silly, trivial idea that it’s so important to add measurement-based, evidence-based algorithmic care to the treatment of depression. None of their studies have ever shown it to be helpful. The "call-in" system for the QIDS-SR phone evaluations in STAR*D was a monumental failure. This study adds nothing to recommend it. And yet they pour out article after article, year after year, that talk about it like it’s vital. They’re even trying to tag it onto the DSM-5 diagnostic system [a depressometer?…, a magnificent obsession…]. Article #5 offers a plan to insist on doctors using such a system. What’s the point? Nobody either wants or needs it. Well Drs. Rush and Trivedi are both company men [the company being PHARMA]. If TMAP and Grassley weren’t enough, just look at the acknowledgements in any paper eg #6:
Dr. Trivedi has received research support from the Agency for Healthcare Research and Quality (AHRQ), Corcept Therapeutics, Inc., Cyberonics, Inc., Merck, Naurex, Novartis, Pharmacia & Upjohn, Predix Pharmaceuticals (Epix), Solvay Pharmaceuticals, Inc., Targacept, and Valient. He has received consulting and speaker fees from Abbott Laboratories, Inc., Abdi Ibrahim, Akzo (Organon Pharmaceuticals Inc.), Alkermes, AstraZeneca, Bristol-Myers Squibb Company, Cephalon, Inc., Evotec, Fabre Kramer Pharmaceuticals, Inc., Forest Pharmaceuticals, GlaxoSmithKline, Janssen Pharmaceutica Products, Libby, LP, Johnson & Johnson PRD, Eli Lilly & Company, Meade Johnson, Medtronic, Neuronetics, Otsuka Pharmaceuticals, Parke-Davis Pharmaceuticals, Inc., Pfizer Inc., Sepracor, SHIRE Development, Sierra, Tal Medical/Puretech, Transcept, VantagePoint, and Wyeth-Ayerst Laboratories.
And, as a matter of fact, APIRE is part of the American Psychiatric Foundation, part of the American Psychiatric Association, but the study is ultimately financed by PHARMA. So in spite of the fact that this study is being funded by the American Psychiatric Association [APA] and the measurement-based care is being incorporated into the APA’s DSM-5, it looks to me that the end goal is to move the treatment of depressed people out of the domain of psychiatrists and into the domain of primary care physicians by automation [and simplification]. Further, that this move is being funded indirectly by PHARMA. Even further, this move is being supported by the American Psychiatric Association. Smells something like PHARMA wants psychiatrists out of the loop [for obvious reasons] and is using Madhukar Trivedi and others including the American Psychiatric Association to achieve that goal. Remarkable…
Like I said a couple days ago, it’s McLuhanesque. And the longer this goes on the more it descends from obsessoid ritual into poverty of content. This version of clinical psychiatry is to the real thing as reality TV shows are to reality. What’s truly stupefying is that the APA, APIRE, NIMH, journal editors, and thought leaders who should know better have bought into it. And now DSM-5 seems to want to buy into it!
My suspicions about this are as follows: a lot of patients stop taking antidepressants on their own. I would guess (don’t know for sure) that the number increases for those who get the prescription from a primary care physician, since people who get prescriptions from psychiatrists seem to check in at pretty regular intervals but those who get them from PCPs can go months/years with the same prescription.
The business about management and tools is really about electronic tracking to see who’s taking their meds. It’s a way to address “noncompliance.” Note who they’re looking at–those with mild / moderate depression. Presumably, that would be the group most likely to drop their meds, especially if there were side effects.
Well, Dr. Carroll, your comment sent me straight to Google and Wikipedia! McLuhanesque? Wow. But I like “poverty of content”.
I wonder if the drop-outs were not only people who felt the side effects of medication weren’t worth it, but also people who decided their doctors were idiots?
also remarkable
Director’s Blog
December 06, 2011
Antidepressants: A complicated picture
Thomas Insel
http://www.nimh.nih.gov/about/director/2011/antidepressants-a-complicated-picture.shtml
” As we engage ourselves in efforts to gain a deeper understanding of the biology of depression, it is important to remember that optimal treatment for depression does not begin or end with medication. Treating depression is an art that requires many tools. We will not save lives by dismissing any of the tools we currently have available, even as we endeavor to develop better ones. A quality treatment plan for depression includes a thorough assessment, a comprehensive treatment plan that includes choices tailored to and guided by the individual—whether that be medication, psychotherapy or both—and careful, frequent follow-up.”