Success Rates In Psychiatry

 

Today's comment is on a brief editorial in JAMA Psychiatry about the evidence of success of psychiatric treatments (1). The authors present an even handed argument for establishing systems that would allow for the determination of success rates of psychiatric care. They point out the obvious limitations of developing these systems in the United States but may not have gone far enough. In the US - our healthcare data is considered proprietary by the health care company who owns the electronic medical record that the data is recorded in. Patients often find themselves in varying negotiations in order to get access to their own records. They may find some data is not accessible at all. If they venture into another system of care that uses the same electronic health record (EHR) – they may have to repeat significant portions of their record (current medication list, allergy list, immunization record, test results) that should have easily transitioned. Within a typical metropolitan area in the US – there may be many EHRs that cannot communicate with one another at a level that would allow determination of success rates. As a result, the authors conclude most of the success rate data in psychiatry comes from clinical trials.  That data is limited by selection biases and brief periods of treatment.

The authors also look at Specific Success Rates (SSR) and Aggregate Success Rates (ASR) as population-based quality measures. To the best of my knowledge there are no corporations currently using these measures. That lack of usage is based more on medical tradition than usefulness of quality measures. Current hospital and clinical measures typically sample worst possible outcomes or so-called sentinel events. This is the business approach to mortality and morbidity conferences in medicine and surgery that were detailed discussions of deaths and complications. The thinking has typically been to learn from worst case scenarios or your colleagues’ obvious mistakes. The problem with those conferences is that they provide little guidance about the best treatment for most other patients.  For many years Medicare used the same system.  I was a Medicare Quality reviewer for 2 states and their focus was on process rather than outcomes and success rates were never discussed.  Major quality events like a death on a psychiatric unit would trigger a detailed quality review.

As a long time follower of the work of Tiihonen, the first flaw that I noticed was that none of his work was referenced.  Tiihonen has a long track record of looking at outcomes using observational studies (2-12) and has commented on both the limitations and advantages of these studies (17). One of the critical advantages of doing research in Scandinavian countries is access to nationwide databases or registries that include the usual demographic patient information but also diagnoses, treatments, medications and outcome data.  Those data include hard outcomes (suicide, all cause mortality, disability) and soft outcomes (drug discontinuation, rehospitalization, symptom checklists, side effects checklists, psychosocial outcomes).  Similar data is available in other studies such as long acting injectable (LAIs) antipsychotic medications back to the 1980s, treatment cohort studies (Schou, Winokur, Guze, Angst) from similar periods and various sampling studies that look at surveys of medical clinics.  There are also the statistics from the 19^th century protopsychiatry era.  My favorite one is from Luther Bell (15) describing the outcomes of delirious mania:

“A subsequent case series published by Luther Bell in 1849 described 40 patients with the condition among 1700 admissions to McLean Hospital (Bell, 1849). He reported a mortality rate of 75% in these patients."

Today - nobody dies from delirious mania or the more common forms of mania that frequently led to deaths from congestive heart failure during the protopsychiatry era.  That is an improvement in mortality on par with any other medical specialty and it is due to improvements in psychiatric care.

But nothing can replace the rigor and data of registry studies from Scandinavia. By rigor I mean the results of treatment of unselected real-world patients in real world systems of care, very large data sets, and no missing data. Clinical trials can't compare when as many as 80% of real-world patients are omitted from consideration (16) and those patients may be at higher risk for morbidity and mortality outcomes.

Psychiatric treatment success rates are available if you look for them.  I am not as negative about observational or registry studies when I consider the advantages about knowing real world outcomes and how they diverge from relatively brief randomized controlled trials that do not choose real world patients and are biased at times to the point of being irrelevant by drop outs over time. Additional considerations in terms of the goals of this post include experienced psychiatrists themselves are the typically the best critics of the field. Critics who maintain a specific obvious viewpoint will generally continue to repeat the same criticisms they have been repeating for decades and cannot be considered reliable.  All psychiatrists have varying experiences clinically, in research, and in the literature of the field. An extensive review of psychiatric outcomes over time would seem to be indicated – but there is a lot of applicable research out there right now.  In terms of generating more thorough success rates several biases described above need to be overcome including viewing the necessary data as proprietary or the disingenuous application HIPPA regulations that seem to allow mass marketing of patient data but not allow adequate population-wide quality measures.  I would go as far as establishing a nationwide pharmacosurveillance/pharmacovigilance system to get adequate real world pharmacology data. 

In ending this note I will say that the editorial generated predictable rhetoric.  I typically find myself responding to rhetoric on this blog – but in this case another blogger stepped in and did the heavy lifting.  For anyone interested in the rhetorical side I refer you to the commentary by Awais Aftab, MD who provides excellent responses. Psychiatrists are trained in critiquing their own literature and provide the best legitimate criticism.  A lot of critics outside the field basically repeat what they have been saying for decades.  Those responses tend to be impervious to criticism reflect a general lack of knowledge about the field.  The original editorial by Freedland and Zorumski has merit. It was not intended as a blanket condemnation of the field.  I hope to have fleshed it out a bit in this post and suggested both sources of current data and next steps.

 

George Dawson, MD, DFAPA

 

Supplementary 1:  I am very interested in a large review of psychiatric outcomes.  If you have similar interests and expertise – send me your favorite references or suggestions on how we can collaborate.

 

References:

1:  Freedland KE, Zorumski CF. Success Rates in Psychiatry. JAMA Psychiatry. 2023 Mar 22. doi: 10.1001/jamapsychiatry.2023.0056. Epub ahead of print. PMID: 36947055.

2:  Taipale H, Tanskanen A, Mehtälä J, Vattulainen P, Correll CU, Tiihonen J. 20-year follow-up study of physical morbidity and mortality in relationship to antipsychotic treatment in a nationwide cohort of 62,250 patients with schizophrenia (FIN20). World Psychiatry. 2020 Feb;19(1):61-68. doi: 10.1002/wps.20699. PMID: 31922669; PMCID: PMC6953552.

“These data suggest that long-term antipsychotic use does not increase severe physical morbidity leading to hospitalization, and is associated with substantially decreased mortality, especially among patients treated with clozapine.”

3:  Tiihonen J, Tanskanen A, Taipale H. 20-Year Nationwide Follow-Up Study on Discontinuation of Antipsychotic Treatment in First-Episode Schizophrenia. Am J Psychiatry. 2018 Aug 1;175(8):765-773. doi: 10.1176/appi.ajp.2018.17091001. Epub 2018 Apr 6. PMID: 29621900.

“Whatever the underlying mechanisms, these results provide evidence that, contrary to general belief, the risk of treatment failure or relapse after discontinuation of antipsychotic use does not decrease as a function of time during the first 8 years of illness, and that long-term antipsychotic treatment is associated with increased survival.”

4:  Tiihonen J, Wahlbeck K, Lönnqvist J, Klaukka T, Ioannidis JP, Volavka J, Haukka J. Effectiveness of antipsychotic treatments in a nationwide cohort of patients in community care after first hospitalisation due to schizophrenia and schizoaffective disorder: observational follow-up study. BMJ. 2006 Jul 29;333(7561):224. doi: 10.1136/bmj.38881.382755.2F. Epub 2006 Jul 6. PMID: 16825203; PMCID: PMC1523484.

16 yr study

“The effectiveness of first and second generation antipsychotics varies greatly in the community. Patients treated with perphenazine depot, clozapine, or olanzapine have a substantially lower risk of rehospitalisation or discontinuation (for any reason) of their initial treatment than do patients treated with haloperidol. Excess mortality is seen mostly in patients not using antipsychotic drugs.”

5:  Taipale H, Lähteenvuo M, Tanskanen A, Mittendorfer-Rutz E, Tiihonen J. Comparative Effectiveness of Antipsychotics for Risk of Attempted or Completed Suicide Among Persons With Schizophrenia. Schizophr Bull. 2021 Jan 23;47(1):23-30. doi: 10.1093/schbul/sbaa111. PMID: 33428766; PMCID: PMC7824993.

6:  Tiihonen J, Mittendorfer-Rutz E, Majak M, Mehtälä J, Hoti F, Jedenius E, Enkusson D, Leval A, Sermon J, Tanskanen A, Taipale H. Real-World Effectiveness of Antipsychotic Treatments in a Nationwide Cohort of 29 823 Patients With Schizophrenia. JAMA Psychiatry. 2017 Jul 1;74(7):686-693. doi: 10.1001/jamapsychiatry.2017.1322. PMID: 28593216; PMCID: PMC5710250.

7:  Heikkinen M, Taipale H, Tanskanen A, Mittendorfer-Rutz E, Lähteenvuo M, Tiihonen J. Real-world effectiveness of pharmacological treatments of alcohol use disorders in a Swedish nation-wide cohort of 125 556 patients. Addiction. 2021 Aug;116(8):1990-1998. doi: 10.1111/add.15384. Epub 2021 Jan 14. PMID: 33394527; PMCID: PMC8359433.

8:  Lähteenvuo M, Tanskanen A, Taipale H, Hoti F, Vattulainen P, Vieta E, Tiihonen J. Real-world Effectiveness of Pharmacologic Treatments for the Prevention of Rehospitalization in a Finnish Nationwide Cohort of Patients With Bipolar Disorder. JAMA Psychiatry. 2018 Apr 1;75(4):347-355. doi: 10.1001/jamapsychiatry.2017.4711. Erratum in: JAMA Psychiatry. 2022 May 1;79(5):516. PMID: 29490359; PMCID: PMC5875349.

9:  Puranen A, Koponen M, Lähteenvuo M, Tanskanen A, Tiihonen J, Taipale H. Real-world effectiveness of mood stabilizer use in schizophrenia. Acta Psychiatr Scand. 2023 Mar;147(3):257-266. doi: 10.1111/acps.13498. Epub 2022 Sep 14. PMID: 36065482.

10:  Tiihonen J, Haukka J, Taylor M, Haddad PM, Patel MX, Korhonen P. A nationwide cohort study of oral and depot antipsychotics after first hospitalization for schizophrenia. Am J Psychiatry. 2011 Jun;168(6):603-9. doi: 10.1176/appi.ajp.2011.10081224. Epub 2011 Mar 1. Erratum in: Am J Psychiatry. 2012 Feb;169(2):223. PMID: 21362741.

11:  Tiihonen J, Tanskanen A, Hoti F, Vattulainen P, Taipale H, Mehtälä J, Lähteenvuo M. Pharmacological treatments and risk of readmission to hospital for unipolar depression in Finland: a nationwide cohort study. Lancet Psychiatry. 2017 Jul;4(7):547-553. doi: 10.1016/S2215-0366(17)30134-7. Epub 2017 Jun 1. PMID: 28578901.

12:  Tiihonen J, Lönnqvist J, Wahlbeck K, Klaukka T, Tanskanen A, Haukka J. Antidepressants and the risk of suicide, attempted suicide, and overall mortality in a nationwide cohort. Arch Gen Psychiatry. 2006 Dec;63(12):1358-67. doi: 10.1001/archpsyc.63.12.1358. PMID: 17146010.

13:  Kisely S, Preston N, Xiao J, Lawrence D, Louise S, Crowe E. Reducing all-cause mortality among patients with psychiatric disorders: a population-based study. CMAJ. 2013 Jan 8;185(1):E50-6. doi: 10.1503/cmaj.121077. Epub 2012 Nov 12. PMID: 23148054; PMCID: PMC3537812.

14: McMahon FJ. Prediction of treatment outcomes in psychiatry--where do we stand ? Dialogues Clin Neurosci. 2014 Dec;16(4):455-64. doi: 10.31887/DCNS.2014.16.4/fmcmahon. PMID: 25733951; PMCID: PMC4336916.

15: Bell, L., 1849. On a form of disease resembling some advanced stageof mania and fever. Am. J. Insanity 6, 97–127. 

16:  Taipale H, Schneider-Thoma J, Pinzón-Espinosa J, Radua J, Efthimiou O, Vinkers CH, Mittendorfer-Rutz E, Cardoner N, Pintor L, Tanskanen A, Tomlinson A, Fusar-Poli P, Cipriani A, Vieta E, Leucht S, Tiihonen J, Luykx JJ. Representation and Outcomes of Individuals With Schizophrenia Seen in Everyday Practice Who Are Ineligible for Randomized Clinical Trials. JAMA Psychiatry. 2022 Mar 1;79(3):210-218. doi: 10.1001/jamapsychiatry.2021.3990. PMID: 35080618; PMCID: PMC8792792.

17: Taipale, H. and Tiihonen, J. (2021) “Registry-Based Studies: What They Can Tell Us, and What They Cannot,” European Neuropsychopharmacology, 45, pp. 35–37. doi: 10.1016/j.euroneuro.2021.03.005. 

18:  Lähteenvuo M, Paljärvi T, Tanskanen A, Taipale H, Tiihonen J. Real-world effectiveness of pharmacological treatments for bipolar disorder: register-based national cohort study. Br J Psychiatry. 2023 Oct;223(4):456-464. doi: 10.1192/bjp.2023.75. PMID: 37395140.

The Problem With Making Medical Information More Like Financial Information

I have been an interested reader of financial information for the the past 40 years.  My uncle was an avid stock market investor when I was a kid and he got me interested in reading the Value Line investment  survey.  I still read it and base some of my decisions on it.  Over the years I have had some degree of success in investing, but it hasn't all been good.  One of my greatest successes was a defensive maneuver that resulted in me not losing anything during the stock market crash of 2008.  I have been a subscriber at one time or another to most of the significant investment magazines and newspapers in the United States.

It has been interesting to observe what has happened to what has come to be known as the financial services industry over my investing career because it has implications for the increasing business control over medicine.  I have already alluded to many on these implications on this blog including treating knowledge workers like production workers and creating an unhealthy work environment that results in a lack of empathy for the patients being treated.  But there are even larger implications.  Financial services industry friendly legislation has probably been the single largest contributor to the idea that the privacy of individuals is relative to the advantages gained by establishing credit reporting.  Credit reporting agencies were born out of the idea that data could be collected under a Social Security Number and released to any financial institution without the consent of the person behind that SSN.  That single idea violated a previous promise by Congress that SSNs would not be used as any type of national identifier and was single handedly responsible for creating a multi-billion dollar industry that basically buys and sells credit information and the identity theft industry - both the criminal side and the services to protect people from the criminals.  It is much harder to be an identity thief in a world that does not have credit information centralized on a SSN.

The driving force behind businesses everywhere is to create leverage that results in people needing to buy a product or service and make it so they can't get it anywhere else.  We hear a lot about competition and its importance in capitalism, but there is plenty of evidence that capitalism is not only lacking but that measures are often in place to severely restrict it.    It results in an industry that is set up to optimize gain from consumers while keeping them all at risk.  As an example, one of the "low risk" strategies for investing with some of these companies is to investment in index funds.  As retirement nears, the recommendation can be to put funds into an annuity or with an advisor who can determine withdrawal rates, reallocation, and future investment decisions.  In many cases the retiree is charged up to 1% for that service on top of whatever service charges and transaction fees are associated with the funds that are invested in.  There is always the disclaimer that there is no guarantee of income from the account and this is compounded by the fact that interest on cash and money market funds is at an all time low.  Very few investors can fund their retirement by interest on so-called safe investments and in the last decade we have witnessed the first losses on money market funds.  All things considered, regulation at all levels seems like it is clearly set up to favor the financial services industry.  They have a license to warn you that you can lose money even though you may be paying them to protect it - and that's OK.  In some extreme examples, investment banks have recommended purchases to customer that they were actively betting against.

I don't know how many people can see the trend, but it is pretty obvious to me.  As medical information gets more like financial information - it moves farther away from any reality basis and it becomes a vehicle for manipulation.  The whole point of collecting data from a medical and scientific standpoint is to look at underlying meaning specifically implications for health care.  The best example is lab data.  If I look at a patient's CBC with differential count and chemistry profile,  I have about 40 data points, any one of which could have significant health implications for the care of that individual.  If I look at various quality markers and screening scores that are being collected for business purposes that data varies from questionable to clearly invalid and yet physicians are being held "accountable" for what is essentially business quality data.  In other words, data that has no scientific basis and can be manipulated for a specific result.  The usual intent is to maximize business profits and make it seem like the business is much more critical to the provision of health care than the health professionals it hires.  As absurd as that last sentence looks, it is without a doubt one of the goals of most health care businesses.

Business information collected and manipulated for the sake of furthering business interests in the health care industry is no more valid than  what happens in the financial services industry.  Both types of information have evolved to place the consumer at risk all of the time and give them no clear reason for a making a decision in their own interest.  And in both cases, consumers have no choice but to participate.  We have a government mandated retirement industry that provides a windfall to financial services.  We now have a government mandated health care industry that is set to provide a windfall the large health care and pharmaceutical companies.  In both cases it is underwritten by the American consumer who is placed at financial risk all of the time in an economy of stagnant wages and significant unemployment.

George Dawson, MD, DFAPA

National Behavioral Health Quality Framework - Ultimate Oxymoron?

As I pointed out in a previous post, the Substance Abuse and Mental Health Services Administration (SAMHSA) a branch of the U.S. Department of Health and Human Services is currently working with the managed care industry.  They are also the object of criticism by E. Fuller Torrey in his recent editorial and upcoming book for promoting non evidence based care of people with severe mental illnesses and in fact at many levels dismantling existing care.   With that kind of a backdrop, their e-mail to me this morning suggesting that I should review the National Behavioral Health Quality Framework (NBHQF) and provide comments as an interested member of the public should not have been very surprising.  I thought I would put that commentary here rather than letting it be buried on a government website that nobody would read.

To set the appropriate tone for my comments, the introduction section of this document identifies the major entity that the government is working with here as the managed care industry.  I consider the NCQA (or NQF) to be a proxy for the managed care industry.  That is their history as I recall it and I am not aware of any physician professional group that says otherwise.  In fact, I cannot find the American Psychiatric Association as a member of the NQF, but I am fairly certain that they used to be a member of NCQA..

Getting back to the document - six goals are identified with a page each dedicated to currently available measures and a second page that is described as "future targeted measures that are deemed important to advancing the behavioral health quality measurement."  An example of what that involves is illustrated in "NBHQF Goal 1: Effective - Promote the most effective prevention, treatment, and recovery practices for behavioral health disorders."  Not to be too much of a stickler here, but I don't really know what a "behavioral health disorder" is.  The most precise definition would be "whatever mental or psychiatric disorder that a managed care company has decided that they will pay for".  Behavioral health is basically a business term with no medical or psychological meaning.  As far as I can tell, it was designed to disenfranchise psychiatrists and other mental health providers and yet the rationale for denying treatment was always proprietary "medical necessity" criteria.   Moving beyond that we basically see a number of screening interventions for "Provider/Practitioners", a number of completely unproven interventions and quality markers, and at least 30% of the cells in the matrix are left "intentionally blank".  What exactly is there to comment on?  In the second page "payers using payment incentives to increase the use of EBP (evidence based practices)" is actually considered a quality marker.  That is a conflict of interest much greater than any pharmaceutical company scandal.  To translate, that means that managed care companies nation wide have another way to deny payment and save money based on what they consider to be an "evidence based practice." but they are rationalizing it as a quality marker.

Let me suggest how the depression assessment and screening should be done in this matrix.  First of all the screening test in this case the PHQ-9 does need to be validated as a diagnostic and outcome measure in populations.  The  current literature is extremely limited and there is no evidence that population screening for depression accomplished anything other than exposing a lot of people to antidepressants that the FDA has identified as potentially arrhythmogenic.  The cost of prescribing SSRIs to a large population as well as the electrocardiogram abnormalities is unknown.

I will briefly comment on the additional goals.  "Goal 2: Person-Centered Care".  As previously explained, this is the goal of every physician who has ever been trained in medical school.  It appears here basically as rhetoric that is designed to disenfranchise professionals and make it seem like managed care companies invented individualized care.  "Goal 3: Encourage effective coordination within behavioral health".  What jumps out of the page at me under this sparsely populated matrix is "Ratio of detox to outpatient admissions".  It is well known that managed care tactics have essentially destroyed the availability of medical detox in most communities.  I can recall being told that medical detox was not "medically necessary" by managed care reviewers.  I guess the hope was that the cost of detox could be transferred from managed care companies to non-medical county facilities.  Quality care for addictions means that there needs to be a spectrum of care.  I don't know what ratio is implied by this quality marker but I can assure you that it will favor managed care companies.

"Goal 5: SAFE - make behavioral health care safer."  Suicide, injury and death, treatment for overdoses after hospitalization, and discharges on multiple antipsychotic drugs are suggested as quality markers.  There is no evidence of what it takes to make the assessment and treatment.  To capture any problems in these areas you need a quality process, not a piecemeal check box that can be gamed so that it appears that you are providing quality care.  Measuring these variables in the absence of defining a quality process is meaningless.

"Goal 6: Affordable/Accessible: Foster affordable high quality behavioral health care...".  This continues to be an absurd priority of the partnership between the government and the managed care system. There is no more "cost effective" approach than what passes for behavioral health care.  Mental health treatment in the US has been decimated by 20 years of managed care to the point it is practically non-existent.  During that same time there has been an addition of trillions of dollars in Cardiology, Intensive Care, and Oncology infrastructure.  Even if that were not true, what is the evidence that cost effectiveness has to do with quality?  It is certainly not reflected in the previous specialties that I just listed.

Are there problems with this approach?  It turns out there are major problems and here are just a couple:

1.  Administrative data - administrators have significant biases that seem to impact on so called quality markers across the board.  They don't seem to understand their biases and the major biases include not really knowing anything about medical quality,  thinking that medical quality can be derived from what is basically administrative data (length of stay, readmissions, etc.) and at this point in time having so much political leverage from government backing that they don't really have to pay attention to the considerable number of people out there who know a lot more about quality.  As I have documented on this blog this is a thirty year trend and all of that is captured in the NBHQF.  Any who has followed quality markers over the last two decades will probably have made the observation that business heavy entities like managed care systems are information averse.  By that - I mean that they collect a large amount of data  but it is really not enough data or the right data.  Great examples are HEDIS data and PHQ-9 scores.  Is it really possible to collapse medical quality in to what are really simplified demographic parameters?  No more than knowing that 50% of 85 year old men have coronary artery disease.

2.  Business practices trumping medical practice -  on this blog I have also reviewed these practices and will focus on one this glares in this report - "person-centered care".  For years HMOs and their administrators were focused on "population based care".  They scoffed at the notion that people or patients needed to be treated on an individual basis.  This was at the peak time when they were deciding that everyone with a certain condition should be hospitalized for a the same number of days and it was a "quality problem" if the length of stay in the hospital was too long.  Nobody ever complained if the length of stay was too short.  Many of the thought leaders in managed care go to that position by basically promoting these ideas.  Why is the managed care industry suddenly behind "person centered care".  You won't see the history recorded anywhere but a lot of it goes back to the primary care physician as gatekeeper.  If you assume that you can managed populations of people with the same interventions, you can tell your subscribers that they have to get "referrals" from their primary care physician for any tests or consultations that are viewed outside of the population norm.  This was happening on a large scale in the 1980s and 1990s but subscribers rebelled against it.  After all they were paying good money for insurance coverage and not seeing it back in what they were interested in for health care.  The gatekeeper function disappeared and suddenly even managed care subscribers could directly seek consultations and referrals that they were interested in.  Patient centered care from the managed care industry was basically determined by the market and the failed theory of their thought leaders about managing populations rather than treating individual people.

Physicians have always been taught that patient care is highly individualized.  The question is will they continue to let the government, business entities, and non-evidence based practices masquerade as quality.  Looking at the quality of physician commentary in the media, in journals, and on blogs is not very hopeful.  It is clear that physicians would prefer to blame themselves or one up one another rather than look at the true problems with the health care system and what bureaucrats and businessmen are calling quality.

George Dawson, MD, DFAPA

SAMHSA.  National Behavioral Health Quality Framework (NBHQF)