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tag:blogger.com,1999:blog-40537708664542961902016-09-18T10:49:51.198-04:00Psych PracticePsychpracticehttp://firstname.lastname@example.com:blogger.com,1999:blog-4053770866454296190.post-17308049918858623172016-08-05T00:01:00.000-04:002016-08-05T00:01:02.466-04:00Laziness

I'm very curious about the idea of laziness. "Lazy" is one of those words we throw around as though everyone understands what it means and agrees on its definition. Kind of like, "Love". But I don't think anyone honestly knows what lazy means. I'm not sure it even has a meaning. I think what is really meant by, "He's so lazy," is, "I don't understand why he's not doing the things I think he should be motivated to do, or that I would be doing in his position."

I'm hard pressed to think of an instance in which the word lazy is used in a non-pejorative way. At least in reference to a person or an animal. Rivers and summer days are exempt from this criticism.

I searched Pep-Web to see if the concept is addressed in the analytic literature, and there were a lot of hits for "laziness" (343) and "lazy" (806), but none in a title, and while I didn't go through every one, the ones I did look at all seemed to be either quoting someone speaking about himself or someone else, or describing someone, and all with the assumption that no elaboration was needed as to what was meant by "laziness" or "lazy".

I'll share a multilayered thought I just had. I generally make an effort to write correctly, which means that there's a comma before quotes, and the first word of a quote is capitalized, and the ending punctuation is within the quotes, even though that's weird. Or, "That's weird." Not, "that's weird". But it's not always clear to me what to do when I'm referring to an individual term. Do I place a comma before, "Lazy?" Do I always need to put quotes around, "Lazy?" Do I capitalize , "Lazy," if I use it over and over again? Do I place the punctuation within the quotes if it's just a word I'm defining, like, "Lazy"?

I assume I should do the same thing with "lazy" that I do with longer quotes, but I don't always do so. And my thought was, I'm just too lazy to bother.

Then I thought about Frank McCourt in Angela's Ashes, where he doesn't bother to use quotes, but he manages to write in such a way that you're never confused about who's saying what. Presumably, he's mimicking Joyce. So who cares whether I get the punctuation right or not? The whole purpose of punctuation is to make yourself understood, and if readers know what I mean, what difference does it make?

I'm impressed by how easily I fell into using the catchall term, "Lazy," to explain why I don't always punctuate correctly. But I'll get back to this.

I Googled, "What is Laziness?" and after the definition: the quality of being unwilling to work or use energy; idleness, I linked to an article by Neel Burton, MD, in Psychology Today, The Causes of Laziness.

It's not a bad article, but the explanations are a bit simplistic: We haven't evolved enough past our ancestral need to conserve energy and to assume life will be short so why plan for the future; We prefer immediate gratification to long-term goals; We can't see the purpose of our work; We're afraid of success; We're afraid of failure so we don't try.

Now back to my previous point. I don't think anyone knows much about why she does what she does. Even less about why someone else does what he does. You can get at some unconscious content in analysis, but there will always be mysterious actions and thoughts.

What I do notice is that when I have to make a decision about how to punctuate, it causes a slight twinge of anxiety. Am I doing this right? Is my meaning clear if I don't do it right? Why do I care? Do I care?

Clearly, I do.

I'm reminded of Otto Fenichel's paper, On the Psychology of Boredom. Fenichel describes a particular kind of boredom, a sort of ennui, in which the bored person can never settle into any particular activity. Fenichel's understanding of this is that it reflects a warded off, unacceptable wish. So the bored person wants something, but is unable to allow himself to know what it is he wants, because he's conflicted about it, and it makes him anxious. So instead, he searches for something to satisfy the wish, but of course, nothing does, because he doesn't consciously know what he's wishing for.

Laziness is not directly related to boredom, though obviously it can be, in some instances. The common thread here is anxiety generated by unconscious content-likely conflict. And it's hard to assess motivation when there's all sorts of unconscious fermentation going on.

My final association: I read a story when I was a kid, and I still don't quite understand it. It was a Chinese fable about a lazy boy who never did anything his mother asked. He never helped out at home. He never did any kind of work. He was just a lazy good-for-nothing. Then one day, there was some kind of threat to his family, and the boy got up and deftly handled the situation, and saved the day.

The End.

PsychPracticehttp://email@example.com:blogger.com,1999:blog-4053770866454296190.post-78725637135769501202016-07-27T22:59:00.001-04:002016-07-27T22:59:08.638-04:00Good and Bad IdeasToday, NY State sent a letter to insurance companies, telling them they better comply with parity laws, and that they'll be checking up to make sure the insurers are keeping in line. Specifically, the letter was written to "remind" insurers that

MHPAEA (Mental Health Parity and Addiction Equity Act) prohibits issuers whose
policies or contracts provide medical and surgical benefits and MH/SUD benefits from applying
financial requirements, quantitative treatment limitations ("QTLs"), and NQTLs to MH/SUD
benefits that are more restrictive than the predominant financial requirements or treatment
limitations that are applied to substantially all medical and surgical benefits covered by the plan...

...state regulators [will] further review the processes, strategies, evidentiary standards, or other factors used inapplying the NQTL to both MH/SUD and medical and surgical benefits to determine parity compliance:

• preauthorization and pre-service notice requirements;
• fail-first protocols;
• probability of improvement requirements;
• written treatment plan requirement; and
• other requirements, such as patient non-compliance rules, residential treatment limits,
geographical limitations, and licensure requirements.

Accordingly, issuers are advised that the Department of Financial Services will be reviewing
issuers' NQTLs and QTLs to ensure that issuers fully comply with MHPAEA and will take
necessary action in the event of any non-compliance.

Some additional NQTLs are:

"...treatment limitations based on geography, facility type, provider specialty, and the criteria limiting the scope or duration of benefits or services."

This is a good idea, enforcing rules for insurance companies. But I worry about certain bad ideas. In fact, I have a sneaking suspicion that insurance companies pay lawyers or others so inclined large sums of money to sit around all day and come up with new bad ideas by finding ways to comply with parity laws, but still hinder or delay reimbursement.

I've written previously about one of these bad ideas, namely, an insurance company's demand that I provide proof that my patient requires out of network services. I almost fell for this and started researching articles on continuity of treatment, etc., until Dinah from Shrink Rap pointed out that the insurance company doesn't need to cover out of network services, but if they do cover out of network, the patient doesn't need to justify not using in-network care.

Other egregious examples are stalling and finally informing the patient that the claims were never submitted, or that they were lost, and then sometimes even more egregiously, when the claims are resubmitted, the insurance company comes back and says it's too late to submit.

Or prior authorization. I tried to get Brintellix, now Trintellix (because Brintellix sounds too much like some other drug) approved, got rejected, appealed by filling out a long form that met every criterion for approval, got rejected again, and finally decided it's a crappy drug anyway, and not worth the effort.

A recent gem involved asking the patient's spouse, who is the primary insured, to call the insurance company to verify or "prove" that the patient has no other insurance (Doesn't, never did).

And I'm quite convinced that these stalling tactics are effective overall, because some percentage of them will not be pursued by patients. That percentage is a gold mine for insurance companies. And mental health patients are perhaps more susceptible than most to this hindrance, since things like depression, psychosis, and anxiety can get in the way of accomplishing tiresome, long, and frustrating tasks like talking to insurance companies.

Anyone else have insurance horror stories?PsychPracticehttp://email@example.com:blogger.com,1999:blog-4053770866454296190.post-20181529038417164522016-07-21T17:10:00.003-04:002016-07-21T17:10:58.989-04:00The Gene GenieIn response to my recent post, In the Genes?, I got the following email message:

Dear PsychPractice,
I am a genetic counselor for Assurex Health, the company behind GeneSight. We read your recent blog post comparing Genesight, the Genecept Assay, and Genelex with interest, and I wanted to reach out to you concerning a couple items that you may not have run across in your search of GeneSight. While much of what you wrote about GeneSight is accurate, some of it is outdated. For example, GeneSight Psychotropic now includes 12 genes, not 5. Based on the images of the report in your blog, I wonder if perhaps you pulled the images from our Pine Rest (Winner et al, 2013) study? This study was published in 2013, at a time when GeneSight had 5 genes. GeneSight has since been updated and currently includes 12 genes. Additionally, 4 other studies on GeneSight have been published, as well as 2 meta-analyses of these data, all of which were statistically significant.

If you are interested in receiving any of these studies, please let me know and I will send them to you. You may also be interested in white papers on GeneSight genes that outline all current research in the context of psychiatric pharmacogenomics. We have also created white papers on genes we choose not to add to GeneSight due to lack of clinical utility.

Somehow, I thought I had gotten the image I used, with the list of genes, from the Genesight site. So I went there to look for it again, and I couldn't find it. So then I tracked down where I found the image, by scrolling through my browser history, and it was here:

Winner, Joel G; A prospective, Randomized, Double-Blind Study Assessing the Clinical Impact of Integrated Pharmacogenomic Testing for Major Depressive Disorder; Discovery Medicine; ISSN: 1539-6509; Discov Med 16(89):219-227, November 2013.

I guess it was from the Pine Rest study, and yes, I suppose it is outdated. And I'm pretty sure I looked up the paper because I couldn't find much information about which genes Genesight uses on their site.

I checked again just now, and it took a while for me to find it, but they do have a description of all the genes they're testing, including four new ones.

Pharmacokinetic:

UGT2B15
CYP2D6
CYP2C19
CYP2C9
UGT1A4
CYP3A4
CYP2B6
CYP1A2

Pharmacodynamic:

HLA-A*3101
HLA-B*1502
HTR2A
SLC6A4

The UGTs and HLAs are the new ones.

So now we've got that straightened out. My apologies to Genesight for propagating outdated information.

That said, since publishing that last post, I have used Genesight. Yes, I have. I chose it partially for reasons having to do with insurance coverage.

I had to meet with a rep. I tried to tell him, via email, that all I needed was a test kit. He insisted that we had to meet in person, and that it would only take 15 minutes. We scheduled and rescheduled, mostly because I was annoyed about the waste of my time so I didn't prioritize the time slot. Maybe that sounds obnoxious, but I felt I was giving up my time, and therefore money, so he and his company could make more money. I was paying to make him money.

He asked if he should just bring along a lunch. I flat out said no. When he got to my office, he had a bag with lunch, from Panera. I refused it, and I'm really proud of this fact because I was super hungry.

The meeting took closer to 40 minutes, with most of my time spent sitting quietly and waiting while the rep talked on the phone to his IT people, to figure out the new tablet system they were using. When the rep did talk to me, there was emphasis on the fact that the tests are covered by medicare. Maybe that makes them more respectable. I don't know. I was also told I'd be receiving 10 more kits in the mail shortly. I was encouraged to use them on new patients, and asked about when I do my chart review, in the mornings or evenings. I tried to explain that I don't have a high volume practice, and it doesn't work that way. He also mentioned something about my EMR, and looked a bit nonplussed when I nodded towards my file cabinet and said, "I don't use one."

I did the test on a Monday. You do two buccal swabs-1 per cheek, 10 seconds each. Then you put the swabs in an envelope and seal it. You add a consent form and the swab envelope to a larger envelope, seal that, and send it out via Fedex-it's already labeled and paid for overnight shipment. This sounded easy, but I wanted it sent off that day, my doorman wasn't sure when or whether Fedex would be in the building, and the closest Fedex drop box had been shut down some time ago. So I wandered around a bit til I found a place. More lost time and money. I had tried to contact Fedex to come pick it up, but their site didn't work properly, so I had to wander.

Also, it was a little confusing, because you don't include an order form. Instead, you login to your Genesight account and order the test there (You can print out and use an order form, but only if you don't use the online system). They give you an order number, but there's nowhere to record it on anything you mail in. I wrote it on the swab envelope, anyway.

The results came in at 10pm on Wednesday night, which is probably within the 36 hour turnover time. I can't get into the clinical details, but the test results were about as helpful as I expected. The pharmacokinetic stuff was fair. They suggested some dose adjustments that might be helpful. They also yellow-boxed, meaning use, but with caution, a couple meds that have caused serious side effects in this patient, in the past.

The pharmacodynamic stuff was not particularly good. Meds were recommended that have been of little or no use in the past, or have actually had deleterious effects. I didn't expect much of this aspect, so I wasn't too disappointed. I already knew that genetic testing that's supposed to predict which drugs will be helpful is not ready for prime time, yet.

The best I can say for Genesight, so far, is that it made one potentially useful suggestion, and it seems to be covered by insurance, or if it isn't, it has a decent financial assistance plan, with patients who make less than $50K per year paying $20 for testing. Will I use it again? Hard to say.

David Bowie: The Jean Genie

PsychPracticehttp://email@example.com:blogger.com,1999:blog-4053770866454296190.post-27834103242698239092016-07-06T16:41:00.001-04:002016-07-06T16:41:32.277-04:00Keeping Mum

Hippocrates

This post was prompted by an article written by Ben Goldacre in The Guardian, Care.Data is in Chaos. It Breaks My Heart. The article is about the Health and Social Care Information Centre (HSCIC, in the UK), which, "admitted giving the insurance industry the coded hospital records of millions of patients." These records, according to Goldacre, were line for line, and could be decoded by anyone with an inclination to do so. The purpose of this "gift", by the way, was for the insurance companies' actuaries to figure out premiums, based on likelihood of death (or illness, I assume).

Useless Fun Fact: Years ago, in another professional trajectory, I passed the first of the however many actuarial exams.

Anyway, then the HSCIC said it couldn't share documentation on this release of information, presumably because it's more important to protect insurance company privacy than patient privacy.

Summarily, in Goldacre's words, "...a government body handed over parts of my medical records to people I've never met, outside the NHS and medical research community, but it is refusing to tell me what it handed over, or who it gave it to, and the minister is now incorrectly claiming that it never happened anyway."

So I started to think about patient privacy, including a long-ago post, What, Exactly, Is HIPAA?, where I wrote that I would follow-up with more information about privacy, and I never did. Incidentally, I've looked, and I still haven't found any contradictory information about what constitutes a HIPAA covered entity, and I'm still convinced that I'm not one, because I don't bill patients electronically.

So I was wondering, what is the difference between privacy and confidentiality, as they relate to patients? And I found this article (Prater), which was helpful.

Basically, confidentiality is the, "...obligation of professionals who have access to patient records or communication to hold that information in confidence," while privacy is the, "...right of the individual client or patient to be let alone and to make decisions about how personal information is shared."

In other words, confidentiality is my professional, or at least ethical obligation to my patients, while privacy is a patient right I need to respect. From this I infer that technically, my patients do not have a right to confidentiality, and I don't have an obligation to protect patient privacy.

Here are some more details.

Confidentiality

Confidentiality goes back, at least, to the Hippocratic Oath:

And whatsoever I shall see or hear in the course of my profession, as well as outside my profession in my intercourse with men, if it be what should not be published abroad, I will never divulge, holding such things to be holy secrets.

It is a cornerstone of professional association codes of ethics. The AMA's code of Ethics, Opinion 5.05, states:

The information disclosed to a physician by a patient should be held in confidence. The patient should feel free to make a full disclosure of information to the physician in order that the physician may most effectively provide needed services. The patient should be able to make this disclosure with the knowledge that the physician will respect the confidential nature of the communication. The physician should not reveal confidential information without the express consent of the patient, subject to certain exceptions which are ethically justified because of overriding considerations.

And don't forget about postmortem confidentiality:

All medically related confidences disclosed by a patient to a physician and information contained within a deceased patient's medical record, including information entered postmortem, should be kept confidential to the greatest possible degree...At their strongest, confidentiality protections after death would be equal to those in force during a patient's life. Thus, if information about a patient may be ethically disclosed during life, it likewise may be disclosed after the patient has died.

In reading this stuff, I also found that the AMA has a slightly different slant on the definitions of privacy and confidentiality:

In the context of health care, emphasis has been given to confidentiality, which is defined as information told in confidence or imparted in secret. However, physicians also should be mindful of patient privacy, which encompasses information that is concealed from others outside of the patient-physician relationship.

An example of support for the legal status of confidentiality, as the privileged communication between patient and doctor, can be found in Jaffee v. Redmond, where the, "...U.S. Supreme Court upheld a therapist's refusal to disclose sensitive client information during trial." (Prater)

Effective psychotherapy...depends upon an atmosphere of confidence and trust in which the patient is willing to make a frank and complete disclosure of facts, emotions, memories, and fears. Because of the sensitive nature of the problems for which individuals consult psychotherapists, disclosure of confidential communications made during counseling sessions may cause embarrassment or disgrace. For this reason, the mere possibility of disclosure may impede development of the confidential relationship necessary for successful treatment. (p.10, Jaffee v. Redmond)

Privacy

There is no constitutional right to medical privacy. Rather, healthcare privacy rights, "...have been outlined in court decisions, in federal and state statutes, accrediting organization guidelines and professional codes of ethics." (Prater)

The big example is HIPAA. Subject to HIPAA, "Individuals are provided some elements of control, such as the right to access their own health information in most cases and the right to request amendment of inaccurate health information...However, in [the] attempt to strike a balance, the Rule provides numerous exceptions to use and disclosure of protected health information without patient authorization, including for treatment, payment, health organization operations and for certain public health activities..."(Prater)

I've been trying to read through the relevant parts of this ponderous document about HIPAA, and on pages 757 and following, in part Squiggle164.512, Uses or Disclosures for which an Authorization or Opportunity to Agree or Object is not Required, I found what appear to be a number of these exceptions to the "privacy" provided by HIPAA. I think. I'm not a lawyer. Such as:

a) required by law
b) public health activities
c) victims of abuse, neglect, or domestic violence
d) health oversight activities
e) judicial and administrative proceedings
f) law enforcement purposes
g) about decedents, i.e. coroners, ME's, funeral directors
h) cadaveric organ, eye, or tissue donation purposes
i) research purposes
j) aversion to serious threat to health or safety
k) specialized government functions
j) worker's compensation

There are many specifics, including disclosing information to a patient's employer, but I'll leave those as an exercise for the reader.

Point being, HIPAA does little to protect patient privacy. I think the value of HIPAA is that it attempts to delineate what patient privacy rights are, and that it has succeeded in making people aware that the privacy of their medical information is vulnerable. It does not solve this difficulty, which becomes hugely magnified by the use of electronic health records. This leads to consideration of one more important term, security, or the means by which patient information is protected, such as a locked filing cabinet, or encrypted data.

What I glean from all this is that there is at least a notion of a patient's right to privacy, which I should try to respect. But that my standards for protecting patient information are much higher than anything HIPAA has to say.

PsychPracticehttp://email@example.com:blogger.com,1999:blog-4053770866454296190.post-77572984361904236902016-06-29T15:40:00.000-04:002016-06-29T15:40:19.192-04:00In the genes?

I'm starting to look into genetic testing to help my work with patients who have not responded well to multiple psychotropic medications. It feels like a desperate bid, but I'm not sure what other help I can offer.

There are three main testing products, that I could find:

Genesight

Genecept Assay

and

Genelex

I have three main questions about these products:

1. What do they tell me?

2. How accurate/helpful are they?

3. How easy are they to use?

Genesight

Genesight seems to be the one mentioned most by people I asked. Practically speaking, it involves a buccal swab sent to Genesight via prepaid FedEx, with access to results online 36 hours after the sample is received. They are covered by some insurance plans, and have a financial assistance program. And it looks like, in order to try out the test, you need to speak with one of their representatives-there's no way to order online.

In terms of how well it works, their claim is, "Patients with uncontrolled symptoms who switch off of genetically discordant medications show the greatest reduction in depressive symptoms."

They also claim that, "70% of patients who have failed at least one medication are currently taking a genetically sub-optimal medication," and that, "GeneSight testing may help avoid drug-drug interactions and compounding side effects."

Finally, for patients younger than 18, Genesight can help in decisions about efficacy, tolerability, and dosing.

They site a paper, A prospective, randomized, double-blind study assessing the clinical impact of integrated pharmacogenomic testing for major depressive disorder, the results of which were:

Between-group trends were observed with greater than double the likelihood of response and remission in the GeneSight group measured by HAMD-17 at week 10. Mean percent improvement in depressive symptoms on HAMD-17 was higher for the GeneSight group over TAU (30.8% vs 20.7%; p=0.28). TAU subjects who had been prescribed medications at baseline that were contraindicated based on the individual subject's genotype (i.e., red bin) had almost no improvement (0.8%) in depressive symptoms measured by HAMD-17 at week 10, which was far less than the 33.1% improvement (p=0.06) in the pharmacogenomic guided subjects who started on a red bin medication and the 26.4% improvement in GeneSight subjects overall (p=0.08).

You'll notice that they talk about "trends" without any statistics, and mean percent improvement showed no significant difference (p=0.28), even though they point out that improvement in the Genesight group was higher. Recall that p=0.28 means there is a 28% chance that the differences they found were due to chance alone.

The "red bin" is a reference to the way Genesight presents its results, which I find easy to understand, if not entirely illuminating. This is an example:

I don't get the impression that the results give me information about which drugs will be helpful, as much as which drugs won't be harmful.

How does the test work? Genesight measures polymorphisms among 5 genes, CYP2D6; CYP2C19; CYP1A2; the serotonin transporter gene, SLC6A4; and the serotonin 2A receptor gene, HTR2A.

The CYP genes are clearly measures of rates of metabolism. A repeat length polymorphism in the promoter of SLC6A4 has been shown to affect the rate of serotonin uptake. The implications of this fact are not clear to me, but according to Wikipedia, genetic variations in the SLC6A4 gene have resulted in phenotypic changes in mice, including increased anxiety. HTR2A influences serotonin transporter binding potential, and variations in the gene have been associated with variations in outcome in treatment with citalopram.

So the answers to my three questions, for Genesight, are:

1. It tells me which drugs are more and less safe and tolerable to use. And if I accept their conclusion that patients switched off red bin drugs improved significantly, then perhaps it tells me which drugs will be effective, but I'm skeptical about this part.

2. The results are less impressive than they'd like me to think.

3. Results are clear and easy to read. Turnover time is good. Getting hold of a test is not that easy.

Genecept Assay

The genecept FAQ page is much more informative than the Genesight pages. The test can be ordered online or by phone. It's covered by most insurance and they have a patient assistance program. Turnaround time is 3-5 business days from receipt of the sample, also a buccal swab, and they provide expert staff to help interpret results.

The online order form also gives you the option of becoming a "Preferred Provider", which means they'll send patients who are looking for genetic testing to you.

As for function:

The Genecept Assay® report is intended to aid clinicians in making personalized treatment decisions tailored to a patient's genetic background and helps to inform psychiatric treatments that:

Are more likely to be effective
Have lower risk for side effects and adverse events
Are dosed appropriately

The report consists of two pages, and looks like this:

So they look at more genes than Genesight, and they provide one report about what's safe to use, and another about what's potentially helpful. And in all honesty, I don't have the energy right now to look up how believable their first page markers are in terms of efficacy, and I think I would need their help to interpret these results, but they do provide more information than Genesight.

Answers:

1. Safety, tolerability, and efficacy

2. I'm too tired to check

3. Easy to get the test, harder to interpret results

Genelex

Genelex allows you to order tests online, too. They claim there is some insurance coverage (See *, below), they have some fancy software that's supposed to be helpful, in addition to their report, and they have a 3-5 day turnaround time.

Genelex restricts itself to CYP450 genes, but it includes three that Genesight doesn't, 3A4, 3A5, and 2C9, but doesn't include 1A2. This is a link to a sample result, which is too long to include as an image. And like Genesight, it's mainly about what is and isn't safe or tolerable to take.*

*Actually, I just learned on the FAQ page that Genelex also includes CYP1A2; NAT2;DPD Enzyme; UGT1A1; 5HTT; and HLA-B*5701, but that these are generally not covered by insurance. I also couldn't figure out what data these additional tests provide.

Answers:

1. Safety, tolerability, maybe efficacy?

2. For the CYP tests, same as above, for others, I don't know

3. The software seems like overkill. The report is clear and moderately informative. You can order the test online.

That's it for this topic, for now, for me. I have yet to decide whether I'm going to use any testing.

PsychPracticehttp://email@example.com:blogger.com,1999:blog-4053770866454296190.post-57576308567002573382016-06-23T13:25:00.000-04:002016-06-23T13:25:24.494-04:00Virtually CertifiedA while back, I wrote about HealthTap, a platform that allows people to ask doctors questions in almost real time. The company was also developing a system for virtual care, and I recently received an email suggesting I take an online course, worth 2 CME credits, to be certified in said virtual care.

I was curious about the progress in this field, so I did take the course, and am now officially certified. I also accidentally clicked an "okay" button, thinking it would allow me to print out my certificates. But it was the wrong button. The button I wanted said, "certificate only", but I didn't see it in time. The "okay" button indicated that I was allowing myself to be part of the HealthTap network of physicians. I didn't really want that, but I suppose it doesn't matter since I'm not going to do anything with it. So watch out for this if you decide to try it.

What I was mainly interested in, in the course, were the legal and regulatory issues related to virtual care. And I did learn a couple things. For instance, you do need to be licensed in your patient's state in order to provide virtual care. I don't know if that means the state where the patient resides, or just the state the patient is in when seeing you. I would guess the latter, since I can treat patients, in person, who live in neighboring New Jersey or Connecticut for example, where I'm not licensed, as long as they see me in my New York office.

Incidentally, you don't need to be licensed in any particular state to virtually treat patients outside the US.

The course referenced the Interstate Medical Licensure Compact, which, "Creates a new pathway to expedite the licensing of physicians seeking to practice medicine in multiple states. States participating in the Compact agree to share information with each other and work together in new ways to significantly streamline the licensing process."

A number of states have already enacted legislature that will allow this expedited pathway to proceed, and other states have introduced such legislation. Still others, such as New York, have done neither. One interesting point I noted is that in order to use this expedited system, you need to be primarily licensed in a state that has already enacted the legislature. So if I want to virtually care for patients in Montana, which has enacted this legislature, I can't, because I'm licensed in New York, which hasn't.

That point is irrelevant, though, since there is currently no administrative process for applying for this pathway, although they state that there, "...will be soon."

The video mentioned that there are CPT codes for virtual care, ranging from 99441 for a 5-10 minute telephone Eval/Management consultation, to a 99444 for an online E/M, to a 99446 inter-professional 5-10 minute consult, to a 99490 > 20 minutes of chronic care management. But most virtual care billing is done using the same CPT codes that would be used for a regular office visit, with a GT modifier, e.g. 99213 GT.

Most importantly, 25 states with parity laws, plus Washington DC, have enacted "...legislation requiring private insurers to pay for Virtual Care at the same level as equivalent in-person services, provided the care is deemed medically necessary."

According to this document, in New York, "The law requires telehealth parity under private insurance, Medicaid, and state employee health plans. The law does restrict the patient setting as a condition of payment."

This image depicts which states make it easy to provide virtual care (A is best), and which make it difficult (I'm not sure what the * means):

Aside from that, the course touts the virtues of virtual care, claiming that in some ways, it's superior to in-person care, and giving examples, such as the fact that patients have quicker access to virtual care. They also claim that many, if not most, common complaints can be treated virtually, and a lot of monitoring can be done at a distance, e.g. glucose. In addition, they mention the use of wearable devices for tracking activity, etc., and the up and coming virtual examination tools, like stethoscopes.

The video is careful to note situations which require in-person treatment, such as a wheezing infant, or chest and jaw pain in a 68 year old man.

A bit comical were the presentations. For a company that's promoting care via video-conferencing, they should probably have gotten better people to present in their video. One guy had shifty eyes, another had drooping eyelids and looked like he was falling asleep and forgetting what he needed to say, yet another guy looked like his shoulders were hiked up to the point of having no neck.

While I definitely prefer in-person work, I can see where psychiatry, and especially psychotherapy, are amenable to virtual care, probably more-so than specialties that require a physical examination. But given the regulatory and legal limitations, I'm not ready to go there, yet.

PsychPracticehttp://email@example.com:blogger.com,1999:blog-4053770866454296190.post-55239491223611468932016-06-13T11:49:00.001-04:002016-06-13T11:49:52.549-04:00OrlandoThe mass shooting in Florida has left me nearly speechless. But I want to post something because silence is the wrong response.

Maybe I could write something useful about hate crimes or terrorism or psychotic enactments, but that would imply I have some understanding of this tragedy, and I don't.

All I have is sadness, and my heart goes out to the victims and their loved ones.
PsychPracticehttp://firstname.lastname@example.com:blogger.com,1999:blog-4053770866454296190.post-23327299657476730072016-06-07T16:42:00.001-04:002016-06-07T18:21:37.089-04:00Film Review-In A Town This SizeI recently learned about a documentary, In a Town this Size, by photographer and filmmaker Patrick V Brown. It tells the story of the wealthy, Oklahoma oil town, Bartlesville, in which the pediatrician sexually abused many children over the course of many years. Brown, himself, was one of the victims.

I'm not really going to make this a review, as in, what did I like, what didn't I like, whether it's worth seeing. It is worth seeing, so please do. (That I know of, In a Town this Size is available on iTunes, on DVD from Netflix, and on Amazon Prime.) It addresses very important issues, aside from the obvious one of pedophilia. It addresses what it means to move from being a victim to being a survivor, to finding support, both within oneself and externally. It's also extremely well made, although quite simple-just interviews with a few interspersed pieces of footage and photographs. Mainly, I'm going to relate what it made me think about.

Dr. Bill Dougherty was a pediatrician and a prominent citizen in Bartlesville. He was friendly with the families of many of his patients, and was welcomed into their homes, and joined them on family vacations. Many of the adults considered him an "odd duck", because he had never married. Some assumed he was gay, but in that time and place, this was not a topic for discussion.

In the film, Brown interviews people who, as children, were abused by "Dr. Bill". He also interviews their family members, including his own parents, as well as a few lawyers and therapists. Everyone who was interviewed was articulate and thoughtful. In part, this is a product of Brown's skillful interviewing-sensitive but appropriately direct. But I suspect it's also a product of the innate selection bias in who volunteers to be interviewed for a film like this, and what parts of the interviews made the final cut.

But the interviews did hit home the point for me that Bartlesville is a wealthy, educated town. There is footage of the Price Tower, the only skyscraper designed by Frank Lloyd Wright, and commissioned by Harold C. Price, of the H. C. Price oil company. There is also footage of the home of Harold Price, Jr., which looks like a Lloyd Wright structure to me. And Harold Price, Jr. is one of the interviewed parents.

The status of the town is what, perhaps, informed the title of the film. I couldn't tell if the idea was, "Who would believe something like this could happen in such a small town with so much money and power?" or, "Who would believe everyone didn't know about what was happening?" I suspect the ambiguity is intentional.

Which brings me to the topic of denial. Brown, himself, told his parents about the abuse after it had happened several times, starting when he was around 6 years old. But a child that young has neither the language nor the emotional wherewithal to describe sexual abuse, and the most he could come up with was, "He leaves his hands down there too long."

In their interviews, Brown's parents comment on their reactions. His father seemed to think he was talking about a normal genital exam, which is uncomfortable and embarrassing for everyone. His mother said that strange as it sounds now, maybe she'd heard of the word, "pedophile", but she couldn't imagine it applied to her family.

I was a bit outraged by their responses. I realize this is anachronistic of me, and their reactions to Brown's revelation were typical for the time, but even if you don't believe your child, don't you wonder? Aren't you at least a little suspicious? Don't you watch to see what your child's reaction is after the next pediatrician visit, or don't you insist on being present for the exam?

In fact, all but one of the parents interviewed say something along the lines of, "This sounds stupid now, but..."

Upon hearing that Dougherty had been accused of sexually abusing children, several of the parents went and comforted him. One ex-marine said he thought, "He's my friend. He'd never do that to me or my children. Besides, he knows I'd kill him."

Years later, after this man's sons revealed the abuse, his wife spent countless hours looking at photographs of her children from that period. The younger son's eyes are haunted. In retrospect, she says, she knew.

By all appearances in the film, Brown has a good relationship with his parents, and is working with his father, who is a lawyer, on changing the laws about the statute of limitations for reporting this kind of abuse. But I found myself outraged once more when he asked his father, "What made you finally believe me?"

The father's answer was that, as an attorney, he had gotten letters from other survivors of Dr. Bill's abuse, asking for legal help. He had to hear it from someone else in order to believe it.

Several of the survivors note that they don't feel angry at Dougherty. Some posit that this is because they don't have the self esteem to generate the anger. I wondered if their anger is threatening to them because it's not just towards Dougherty, it's towards their families, for not protecting them.

Based on the families interviewed, it seems like once it became clear, years after the fact, that the accusations of sexual abuse by Dr. Bill were true, the families did become very supportive of their children and of each other. The film, itself, is a testament to that.

My own reaction to Dougherty was interesting. Generally, after I get over the initial horror of a story like this, my mind goes to, "What could possibly have happened to this man to have turned him into such a monster?" There's some sympathy involved, even if the crimes are inexcusable.

But I really don't have that much sympathy for Dougherty. There's something terribly opportunistic and psychopathic about him. Some of the survivors suggested that there was premeditation in his choice of pediatrics. My first thought about that was skeptical. I thought he probably felt an irresistible pull towards pediatrics, even though he knew this was a problem for him, and then rationalized the choice by convincing himself that he understood children, and that that would make him a good doctor. Apparently, when he wasn't abusing his patients, he was a good pediatrician.

As the film proceeded, I was less convinced by my argument. Atypically for a pedophile, he abused both boys and girls, although it seemed like there was a predilection for boys. His patterns of abuse also varied, and the choice of behavior seemed to vary with what he thought he could get away with. Several men report having been masturbated by him on the examining table. One woman reports having him take her on his lap and try to get her to masturbate him, while on vacation. On that same vacation he paraded in front of her and her sister in his underwear, showing his penis. It also seems that he sodomized a boy he knew to have psychiatric problems, and to me, that sounds like he thought the boy's story wouldn't be credible.

When Harold Price, who I mentioned above, visited him to offer support after he had been accused of the sodomy, Dougherty said something like, "That's absurd. I would never do that. Besides, he was ugly."

Such was Dougherty's power over these children that Brown seems to be in a minority in telling his parents about the abuse. Most of the kids didn't say anything to anyone. They didn't feel threatened, and they weren't told not to say anything, they just didn't.

Incidentally, after the truth about his abuse had come out, while the statute of limitations for criminal charges had run out, he did lose his medical license. However, he is still alive and living in Bartlesville, leaving his home only in disguise. He recently got married, for the first time, to a woman, at age 81.

The final point that struck me was about forgiveness, and its different meanings. The ex-marine father, who is a religious Christian, was torn for a long time between killing Dougherty and forgiving him. After reading a lot of scripture, and a lot of soul searching, he decided to forgive him. He says it is easier said than done. What puzzled me was the man's description of seeing Dougherty at a church with a woman and her sons, and thinking, There go those kids down the tubes. Does his forgiveness preclude speaking out against Dougherty to protect those children?

Brown's mother says she can't forgive him because he's shown no remorse. She and other's have written him many letters, and he has never responded. And Brown, himself, says he's not interested in forgiving Dougherty. It made me think about whether forgiveness is more for the one being forgiven, or the one forgiving.

In a Town this Size tells a horrifying story in a sensitive way. I think this approach has a further reach than a film that was more graphic and less forward-looking would have. The real strength of the film lies in the question Brown asks all the survivors, "How has the abuse impacted your life?" This simple question places the emphasis on where the survivors are now, and where they're headed, which is why this is a film about survivors, not victims.

One of the most powerful scenes takes place towards the end, where Brown goes to Bill Dougherty's house to confront him. He knocks on the door -forcefully, not timidly-, we hear a dog bark, but no one answers. Brown paces back and forth with his hands on his hips and knocks again. Still, no answer.

There is tremendous pathos in witnessing the courage it must have taken Brown to try to confront his abuser, only to be disappointed. But even if Brown didn't succeed in confronting the external version of Dougherty, I hope that In a Town this Size did succeed in helping him confront the internal version of the monster that is Dr. Bill.

PsychPracticehttp://firstname.lastname@example.com:blogger.com,1999:blog-4053770866454296190.post-8178359758628836682016-06-01T11:58:00.002-04:002016-06-01T11:58:38.729-04:00A Tale of Two HospitalsThis is the story of two New York city hospitals, Mount Sinai, and Beth Israel.

According to Wikipedia. Mount Sinai was founded in 1852 as the Jews' Hospital, in response to discrimination against Jews by other hospitals, which would not treat or hire them. It is one of the oldest teaching hospitals in the US.

Also according to Wikipedia:

Beth Israel was incorporated in 1890 by a group of 40 Orthodox Jews on theLower East Side each of whom paid 25 cents to set up a hospital serving New York's Jewish immigrants, particularly newcomers. At the time New York's hospitals would not treat patients who had been in the city less than a year. It initially opened a dispensary on the Lower East Side. In 1891 it opened a 20-bed hospital and in 1892 expanded again and moved into a 115-bed hospital in 1902.[2] In 1929 it moved into a 13-story, 500-bed building at its current location at the corner of Stuyvesant Square. It purchased its neighbor the Manhattan General Hospital in 1964 and renamed the complex Beth Israel Medical Center, located at First Avenue and 16th Street in Manhattan.

According to other verbal sources I've encountered, Beth Israel Hospital was founded in response to discrimination by Mount Sinai against poor Jewish immigrants on the lower east side. Mount Sinai would not treat them, but restricted its Jewish patients to middle- and higher-class Jewish immigrants from Germany.

I like to believe that this is the reason for the inscription on the entrance to the original Stuyvesant Square building:

It's a little hard to see, and it's in Hebrew, but roughly translated (by me) it reads:

Welcome! Welcome! From far and near. So says the Lord and his Healers. (Isaiah 57:19)

Hospitals in NYC are like 7th graders. They merge, split up, merge again with a different hospital, move around. For a while, Beth Israel belonged to a group of hospitals known as "Continuum," which included Albert Einstein Hospital, from which Beth Israel got its medical school affiliation. A few years back, Columbia Presbyterian joined up with New York Hospital Cornell, and became New York Presbyterian. These two hospitals are in very different parts of Manhattan, so the merger gave them access to a huge group of patients from diverse neighborhoods. My guess is that this was done for financial reasons. Then Mount Sinai decided to be even bigger, and subsumed Beth Israel, as well as St. Luke's/ Roosevelt (these two had merged years previously, and were formerly affiliated with Columbia).

For a little orientation, this is a map:

This gives you an idea of the current relationship statuses, which I've color coded. Mt. Sinai is the white star. Beth Israel, now called Mt. Sinai Beth Israel, is all the way downtown in red. It is the southern-most hospital in Manhattan.

Well, in case you didn't read it in the NY Times, Mt. Sinai Beth Israel Hospital in Manhattan Will Close to Rebuild Smaller.

The 825-bed Beth Israel will be closed over the next four years, to be replaced by a 70-bed hospital somewhere nearby, with an ER a few blocks away. Residents will be dispersed to other Mt. Sinai hospitals, union employees will be found new jobs. And according to an email I got from Mt. Sinai, where I'm affiliated, everyone else will be assisted in finding new employment. I suspect that's not precisely what will happen.

Ken Davis, President and CEO of the Mt. Sinai Health System (and former chair of psychiatry) explained that health care is too expensive, that Beth Israel lost $115 million last year and stood to lose $2 billion in the next 10 years, that hospitals are no longer the most efficient vehicles for delivering care, etc.

They plan to have 16 outpatient practice locations and 35 stand alone operating and procedure rooms.

Interestingly, from what I can tell, they plan to keep the psychiatry building, and expand its services. I assume the department actually makes some money, although I thought that was because of the rapid turnover on the Dual Diagnosis unit.

I worry about the impact on the community. There used to be 3 hospitals in Beth Israel's area, Beth Israel, itself, Cabrini, and St. Vincent's. Cabrini closed in 2008. St. Vincent's, much larger, and beloved by the community, closed in 2010. It's been replaced by some pretty fancy condos. Beth Israel is also situated in an extremely desirable neighborhood.

Going from 825 beds to 70? It may look like, what's the big deal, there are dozens of hospitals throughout NYC. But there are 8.5 million people living in NYC, plus people come in for treatment regularly from neighboring New Jersey and Connecticut.

Dr. Davis may be correct in stating that hospitals are not the future of medicine. But I don't believe 70 inpatient beds are adequate to the needs of all of lower Manhattan. We seem to have come full circle since 1890.

The word I translated above as "Welcome!" is Shalom, and the Hebrew word has multiple meanings. It can mean welcome, peace, and hello. It can also mean, "Goodbye."

PsychPracticehttp://email@example.com:blogger.com,1999:blog-4053770866454296190.post-33950494445285827452016-05-24T18:01:00.001-04:002016-05-24T18:01:45.948-04:00ODD Clinical TrialThis post is a sort of advertisement, except that no one's getting paid anything. A colleague of mine and his group just got a 2 year grant to conduct a trial of Regulation Focused Psychotherapy (RFP) for the treatment of Oppositional Defiant Disorder in children ages 5-12. This is the flyer:

That's the advertisement part. I think it's a great idea. But just to be clear, not only am I not being paid, I'm not involved in the study in any way except feeling pleased about it, and writing this post.

Why do I think it's a great idea? The American Academy of Child and Adolescent Psychiatry has a brochure about ODD. It describes treatment for ODD, which includes a combination of Parent-Management Training Programs and Family Therapy, Cognitive Problem-Solving Skills Training, Social-Skills Programs and School-Based Programs, plus or minus medication.

These are all useful tools, but none of them addresses the underlying affects, and difficulty in regulating these affects, that children with ODD experience. That's where RFP comes in.

The group conducting the study recently published the Manual of Regulation-Focused Psychotherapy for Children (RFP-C) with Externalizing Behaviors: A Psychodynamic Approach.

In it, they describe the way, "RFP-C enables clinicians to help by addressing and detailing how the child's externalizing behaviors have meaning which they can convey to the child," and more specifically, that RFP-C can:

Achieve symptomatic improvement and developmental maturation as a result of gains in the ability to tolerate and metabolize painful emotions, by addressing the crucial underlying emotional component.

Diminish the child's use of aggression as the main coping device by allowing painful emotions to be mastered more effectively.

Help to systematically address avoidance mechanisms, talking to the child about how their disruptive behavior helps them avoid painful emotions.

Facilitate development of an awareness that painful emotions do not have to be so vigorously warded off, allowing the child to reach this implicit awareness within the relationship with the clinician, which can then be expanded to life situations at home and at school.

That's my pitch. So if you know anyone in the New York City area who could benefit from this trial, whether child, parent, educator or clinician, please get this information to them.

Thanks.

PsychPracticehttp://firstname.lastname@example.com:blogger.com,1999:blog-4053770866454296190.post-51057625608008259912016-05-08T20:47:00.002-04:002016-05-08T20:47:37.944-04:00Outside InIn the context of my working on building my own practice website, I found a NY Times article, Inner Peace? The Dalai Lama Made a Website for That, compelling to read.

The website is, Atlas of Emotions, and it's not really about inner peace. It's more about the Dalai Lama's notion of emotions as reactive internal events that prevent inner peace, combined with information about the five emotions considered universal by the 149 experts surveyed for this purpose.

The emotions are:

Anger
Fear
Disgust
Sadness
Enjoyment

The site was conceived by the Dalai Lama as a "map of the mind", and developed by Dr. Paul Ekman (for $750,000), who conducted the survey, and has done pioneering work in nonverbal behaviors, especially facial expressions. He now has a company called the Paul Ekman Group, or PEG, which will teach you, for a fee, to read people's expressions and determine if, for example, they are lying. He was a major consultant for Inside Out, the Pixar movie that illustrates the emotional life of a girl named, Riley (I assume based on the expression, "Living the life of Riley," meaning the good life). He was also consultant and inspiration for the main character on the TV series, "Lie to Me", which I know nothing about.

The site is primarily visual, with the imagery designed by a company called, Stamen, that creates data visualizations. It's interesting that the colors used to depict the five emotions on the site:

match the colors of the corresponding characters in Inside Out:

I probably shouldn't be including either of these images without permission, but the Disney-fication was just so striking. Then again, we do associate colors with feelings, like red with anger, blue with sadness, and green with disgust, and red and green, at least, are related to changes in skin color that occur with their associated emotions. I don't know about purple with fear or yellow/orange with enjoyment.

The way the site works is you land on the home page, with those five circles of emotion, which are called, "continents". Remember, this is supposed to be a map. If you click on a continent, you get a brief description. For example, Sadness brings up, "We're saddened by loss."

You also get a menu to the right which lists, Continents, States, Actions, Triggers, Moods, and Calm. If you go to States, after you've clicked on Sadness, you get a graph of various states related to sadness, with overlaps, from least intense to most. The least intense for Sadness is Disappointment, "A feeling that expectations are not being met." The most intense is Anguish, "Intense agitated sadness."

There are left and right arrows to switch to other basic emotions, but also a down arrow, corresponding to the menu on the right, with more about the emotion you're looking at. The next one down is Actions, with another visual including a range of possible actions for each given state. For anguish, you can seek comfort, which is considered a constructive action. You can mourn, which is ambiguous. And you can withdraw, which is destructive.

This is a good illustration of one of the main limitations of the site-that it oversimplifies, but that probably makes it more widely accessible.

The next down is Triggers, which are either universal, like losing a loved one, or learned, like perceiving a loss of status.

And next down is Moods, the "longer lasting cousins" of emotions. For Sadness, the corresponding mood is Dysphoria.

That's as deep as the graphics go. The only thing left is calm, which you access from the right hand menu. It has nothing but a short description:

Experiencing Calm

A calm, balanced frame of mind is necessary to evaluate and understand our changing emotions. Calmness ideally is a baseline state, unlike emotions, which arise when triggered and then recede.

The only other feature of the site is a link to the "Annex", where you can find the scientific basis for the work, some more complicated definitions, the signals of emotional display, and a page of "Psychopathology", which lists various DSM diagnoses related to each emotion.

I wasn't thrilled with this page. For one thing, I disagreed with some of the categorization. For example, as an anxiety disorder, OCD was listed under Fear. But etiologically, at least from an analytic standpoint, OCD is more about a way of dealing with aggression, so I would have listed it under Anger. It also lists Mania under enjoyment, with a qualification about it being pathological enjoyment. But I don't think this is what's actually meant by the term, Enjoyment.

And this page doesn't mention the DSM, even though it includes diagnoses like Disruptive Mood Dysregulation Disorder (DMDD).

Overall, I have mixed feelings about the Atlas of Emotions. On the one hand, it recognizes that we usually don't know why we feel what we feel, or do what we do, and that's useful to know. To quote the NY Times quoting the Dalai Lama:

"We have, by nature or biologically, this destructive emotion, also constructive emotion," the Dalai Lama said. "This innerness, people should pay more attention to, from kindergarten level up to university level. This is not just for knowledge, but in order to create a happy human being. Happy family, happy community and, finally, happy humanity."

On the other hand, the goal is a calm state:

"When we wanted to get to the New World, we needed a map. So make a map of emotions so we can get to a calm state."

I think this calm state is supposed to be an absence of emotion, either good-feeling or bad-feeling, a Buddhist ideal, so emotion is viewed as the enemy:

"Ultimately, our emotion is the real troublemaker," he said. "We have to know the nature of that enemy."

When I read this, I was reminded of the talk I attended, that I wrote about in Laughing Rats, where Jaak Panksepp noted that, "Most learning takes place through affective shifts." So if we contain our emotions, do we prevent ourselves from learning new things?

And in that same talk, Jean Roiphe noted that, "Ego functioning often involves "taming" certain affects, especially through thought and language, but it also involves intensifying some affects, so that people can feel truly alive. A full human life can't be reduced to an all or nothing switch of feeling in response to external events."

Also, I'm not sure "calm" isn't an emotion.

Maybe I just have trouble with this because I'm so steeped in a culture of neurotically exaggerated emotions, so the ideal of inner peace isn't just unattainable, it's laughably unapproachable, which, for me, quickly turns into undesirable.

PsychPracticehttp://firstname.lastname@example.com:blogger.com,1999:blog-4053770866454296190.post-50791434189796184382016-05-06T17:00:00.000-04:002016-05-06T17:00:19.747-04:00NACI've been hearing a lot about N-Acetylcysteine (NAC) in the treatment of psychiatric disorders, so I thought it would be worth looking into.

A 2015 systematic review in Neuroscience and Biobehavioral Reviews has the following abstract:

N-acetylcysteine (NAC) is recognized for its role in acetaminophen overdose and as a mucolytic. Over the past decade, there has been growing evidence for the use of NAC in treating psychiatric and neurological disorders, considering its role in attenuating pathophysiological processes associated with these disorders, including oxidative stress, apoptosis, mitochondrial dysfunction, neuroinflammation and glutamate and dopamine dysregulation. In this systematic review we find favorable evidence for the use of NAC in several psychiatric and neurological disorders, particularly autism, Alzheimer's disease, cocaine and cannabis addiction, bipolar disorder, depression, trichotillomania, nail biting, skin picking, obsessive-compulsive disorder, schizophrenia, drug-induced neuropathy and progressive myoclonic epilepsy. Disorders such as anxiety, attention deficit hyperactivity disorder and mild traumatic brain injury have preliminary evidence and require larger confirmatory studies while current evidence does not support the use of NAC in gambling, methamphetamine and nicotine addictions and amyotrophic lateral sclerosis. Overall, NAC treatment appears to be safe and tolerable. Further well designed, larger controlled trials are needed for specific psychiatric and neurological disorders where the evidence is favorable.

I'm not sure how they drew their conclusions. They have a rating system called, Grade of Recommendation (GOR), from A-best, to D-worst, and N-no studies identified. They also state, at least for some disorders, whether they recommend NAC for treatment, from Yes to No, with Mixed in between.

They found only 1 GOR of A, for Bipolar disorder, and even that they recommended as Mixed.

The B/Mixed were:

Addiction-Cannabis
Addiction-Cocaine
Autism
Depressive Disorder
Impulse Control-Trichotillomania
Schizophrenia.

Specifically:

-In one study of NAC in treating and preventing symptoms during the maintenance phase of Bipolar Disorder, when compared to placebo, the NAC group demonstrated a significant improvement on the Montgomery–Asberg Depression Scale (MADRS), Bipolar Depression Rating Scale (BDRS).

-Cannabis-dependent adolescents and young adults given NAC and counseling had significantly fewer positive urine cannabinoid tests than those given placebo and counseling.

-There may or may not have been a reduction in cravings for Cocaine.

-Children with Autism had less irritability.

-A large randomized controlled trial in individuals with major depressive disorder (MDD) and MADRS score ≥ 18 showed improvement in multiple outcome measures – in the NAC group when compared to placebo add on treatment to usual treatment for 12 weeks.

-In a medium sized trial, significant improvements were found on the Massachusetts General Hospital Hair Pulling Scale, the Psychiatric Institute Trichotillomania Scale and the CGI in participants who received NAC as compared to the placebo group.

- I can't figure out from the paper what NAC did for patients with Schizophrenia.

Everything else was worse.

However, NAC was pretty well-tolerated, with no serious side effects, so it's probably worth a try in conditions not responding well to other treatments. At least, I think that's their conclusion. Also, other than the IV form used in acetaminophen overdose, and the Sub-Q form used in ALS studies, NAC is sold over the counter as an oral medication, with doses ranging from 2-2.4g/day.

Posited mechanisms of action for NAC include effects on:

Oxidative Stress
Mitochondrial Dysfunction
Inflammatory Mediators
Glutamate Neurotransmission
Long Term Neuroadaptation
Dopamine Neurotransmission
Serotonergic Neurotransmission

Check out this visual:

http://www.cell.com/trends/pharmacological-sciences/fulltext/S0165-6147(13)00002-3

To get into a little more clinical nitty-gritty, there are a number of trials posted on clinicaltrials.gov, most without results.

One that did have results looked at NAC in alcohol dependence, with the primary outcome measure Alcohol consumption in percentage of heavy drinking days:

No statistical analysis was provided.

Another was NAC in pediatric trichotillomania:

Again, no statistical analysis.

However, when I plug the raw data into 1 Boring Old Man's table, (see also DIY Study Evaluation) I get:

The trichotillomania study had a p value of 0.185, a Cohen's D effect size of 0.433, and a 95% CI of -0.202 to 1.068 (In case it's too hard to read). So there's no statistically significant difference.

The Alcohol study's data was weird, with no calculable p value, and negative Cohen's D's, so then I tried change in means, which was negative, and that got p=0.533; Cohen's D=0.190; CI (-0.403-0.782). I'm not sure if that's a legitimate calculation on my part.

Basically, the numbers are bad, and I only decided to include the spreadsheet as practice at evaluating a study.

So now I ask myself, "Would I prescribe or recommend NAC?" Based on this post, I'd have to say maybe. I'd probably stick to the conditions I listed above. Maybe I'd use it as an add-on for depressive symptoms in between bipolar episodes, or in unipolar depressed patients stable on medication but with some residual symptoms. I might suggest it to patients trying to stop using cannabis or cocaine. I don't treat children, but I think if I did, I'd feel more comfortable prescribing NAC for irritability than risperdal. If I ever had a patient with trichotillomania, I'd be willing to try it. And maybe as an adjunct for anxiety or something in schizophrenia.

The bottom line is probably that it won't hurt, and it might help.

PsychPracticehttp://email@example.com:blogger.com,1999:blog-4053770866454296190.post-42715538484788971422016-04-29T14:00:00.000-04:002016-05-05T22:40:32.974-04:00Building a Website-The PricingFirst, I want to thank people who read my first website post and made suggestions about using Blogger, Wordpress, and Google for my website. I'll incorporate those into my research.

I'm continuing to figure out which company I'm going to use to build my practice website. As part of my research, I found a wonderfully helpful site called, The Site Wizard, that contains all kinds of information like the definition of a domain name, and html tutorials. The author does not allow his material to be reproduced all or in part, so I'll just have to paraphrase, and you have the link.

The question of pricing is more complicated than I expected, because different website builders or platforms have different features, with different charges. So I've tried to narrow things down to basic costs-the site itself, and the domain name.

But let's discuss basics.

What is a Web Host?
A Web Host is a home for your website. The companies I've been looking at, Weebly, Duda, Squarespace, and Web.com, are all web hosts. They have lots of computers, or access to cloud space, where your website will live. Duda, for example, claims to offer hosting on Amazon Cloud.

What is a Domain Name?
If I want my own site, that I name myself, that doesn't belong to some larger thing like this blog does to blogger, I need a domain name, which is like a business name. As long as I register it and pay the annual fee, it's mine whether or not I choose to have a website associated with it. That makes me the owner of the domain name, and allows me to take it with me if I switch web hosts.

You register your domain name, for an annual fee, with an organization called, ICANN, which has a list of domain name registrar companies that you need to register through. GoDaddy, the website builder I rejected in my last post, is also a domain name registrar, so I may need to reconsider using it. Google is also a registrar.

Some web hosts provide a domain name free for the first year, and then charge the annual fee. Many let you import a domain name you already own for less money than they would charge for getting you the domain name. And reputedly, some dubious web hosts will register your domain under their name, making them the owner. But apparently, those companies are largely gone.

Domains also come in different suffixes, like .com, .org, .company, .biz, .education, and respective costs depend on something called, "TLD", or Top Level Demand.

So let's look at the cost of a website at the various companies, including a domain name, and let's assume I want to call my website, "MyPsychiatry.com," provided that name is available.

Let's also assume I'm not going to use the free sites available via the web hosts I'm considering. They exist, but they have ads, and I can't use my own domain name.

And finally, I'm just considering price in this post. I'm ignoring various features, for now, because it just gets too complicated to look at all at once.

Google would charge me $12/year for that name. Google would also need me to use blogger or squarespace or something as my web host, so that would be additional.

Squarespace charges $20/year for the domain name, including the first year, but that $20 fee doesn't increase in subsequent years, something I haven't seen clearly indicated on other sites. It also includes something called, "WHOIS Privacy" which I don't really understand but seems to protect some information about you, as the domain name owner.

Then there's the website fee. The personal site costs $16/month or $12/month billed annually, and if you get the annual plan, they waive the first year's domain fee. The Business site's corresponding prices are $26 and $18 per month.

Wordpress:

This is Wordpress' price chart for website plans. It doesn't say anything about an annual fee for a domain name.

Duda does not sell custom domain names. The'll set up a subdomain on their free plan, which would be mypsychiatry.dudaone.com. But if I want a custom domain name, I have to go elsewhere. They have lists of compatible registrars, including Hover and GoDaddy, but they have a partnership with Hover which allows you to purchase a domain name from Hover while you're setting up your Duda site. Hover's .com pricing is $12.99 the first year, then $14.99 for annual renewals.

This is Duda's pricing:

Duda does have that excellent one-time payment of $299 site for life deal. I checked, and you can switch from a monthly or annual plan to a site for life plan, but they do say they may not have that deal forever.

Blogger is probably the best deal, financially. The web hosting is free, and you can get a custom domain name through them for $10/year. Blogger allows up to 20 standalone pages, so I could include things like the Surprise Act form and my office policies. The main problem with blogger is that sites tend to look like blogs, not websites. Some people have done amazing things with customization, check out this article and this one to see some impressive sites. But these were customized with html code, so if I knew html, this would be great, but since I don't I'd probably consult someone professional to help me at least get started, adding to the cost.

Weebly has a pretty good deal:

The domain is free for the first year, and $19.95 each additional year, with discounts for extended terms.

I really find GoDaddy unnerving. They have a domain name auction site, where you can purchase a domain name that someone else swept up. For example, mypsychiatry.com isn't available. But mypsychiatrist.com is available for $14.99/year, plus an initial $5700.00 purchase fee. I used the 2 decimal places so you wouldn't think it was $57. On the other hand, mypsychiatry.net and .org are each $11.99/year. As I mentioned in my last post, they also have web hosting, but I find interacting with their site very unpleasant.

Finally, I couldn't find domain name prices on Web.com. Mypsychiatry.xyz was available, as well as .net, but all the "pricing" said was, "Add to cart." So I added .xyz to the cart so I could see the price, and pressed "continue". It was $1.95/month (not year), with a "*" I couldn't find the text to, and an option to keep my information private or not. Then it asked for my information before giving me a real price, and that's where I stopped.

And now for the spreadsheet:

From a strictly monetary perspective, Blogger is the best deal. I'm now quite sure I'm not interested in GoDaddy and Web.com, so I'm ruling those out. Everything else is somewhere in between, and will depend on specific features.

I'm also wondering if the most useful thing I learned in researching this topic is that I should buy up a bunch of domain names and charge exorbitantly for people to purchase them from me.

PsychPracticehttp://email@example.com:blogger.com,1999:blog-4053770866454296190.post-76110018521287056382016-04-26T16:15:00.001-04:002016-04-26T16:16:33.892-04:00Building A Website-The TemplateI've been blogging for a little over three years now, which is hard to believe. I feel like I'm about average on the tech-y scale, and I certainly feel like a web presence is an important thing for any business to have. But I'm just starting to consider setting up a website for my private practice.

The main reason I've delayed this long is that since I don't use email to communicate with patients due to privacy/confidentiality and delay-in-treatment concerns, there didn't seem to be a point to a website where the contact information consists of a phone number.

Also, I knew I'd want an attractive, professional-looking site, but I didn't want to pay a lot of money to a designer for a site, the function of which is to get people to call me. There are some nice mixes of low and high tech, like a wooden iPhone case, or 3D printing a yarn winder, but a website with a phone number didn't seem to qualify as such a mix.

I finally decided to cave when I was researching my Analytic Evidence post, and I checked out the website of John Thor Cornelius, whose YouTube presentation I referenced in the post. I'm not sure how he'd feel about my linking to his site, which is why I haven't done so.

It's a thoughtful site, not glitzy, not overwhelming, but with all the information prospective and current patients might need about his practice, in addition to the ability to pay bills via PayPal, and I thought, yeah, this can be done well.

There are companies out there that design websites just for doctors, but they're expensive, and I don't need or want all the EMR integration stuff. So I've pretty much decided that, at least initially, I'll design my own site, for free, or for as little money as possible, and then see how it goes.

A few things I need to figure out before creating my site:

I need to decide what information to include on it. I'll need a decent headshot, contact info with a map feature, and a brief paragraph describing myself and my practice philosophy, which means I need to figure out what my practice philosophy is. I'm pretty sure I have one, I've just never articulated it. And I need to articulate it in a way that feels confident and inviting, but not exhibitionistic.

I need to decide how much information to provide about myself. Is a CV a good idea? Will that much information interfere with therapy?

I need some kind of description of what patients can expect from treatment.

I need to include my practice policies, which I already have written up. And I want to include the Surprise Act forms indicating that I don't accept insurance, and what my fees are, because that way I don't need to hand the stupid forms to my patients.

And I'd like patients to be able to pay through the site, but I need to understand how that impacts privacy.

I also need to pick a free or cheap website builder. I did several online searches including "build your own website free", "website builder for physicians,", and "best website builder for doctors". After googling around, I found a few I want to look into:

Weebly
Wix
Sitebuilder
Duda
Squarespace
GoDaddy
Web.com

Web.com seems to have the highest rating when I looked up reviews, but my first concern was the template. Specifically, I wanted to find a template that looks like it's professional for a doctor, not professional for a lawyer, or a restaurant, or a dog-walker. My theory is that if such a template exists, then the company has probably had a number of doctors design sites through it, which feels like a "safer" bet to me. I don't want my site to look amateurish, but I also don't want it to look like I'm a graphic designer or the APA.

Note that contrary to my inclination, I'm not including images because I assume these sites are pretty proprietary with their stuff. Or maybe I'm wrong and they want the advertising.

Sitebuilder has a template category specifically for professional services, and it includes a physician page which is a little slick for my taste, but usable. What I didn't like about it was that it was the only site for which I had to register before I was allowed to see the available templates.

Weebly's closest business theme was for a law firm, and the next closest theme was a personal one that was basically a large business card.

Similarly, Wix's closest templates were Dentist and Doula.

Squarespace had nothing specifically medical, but I thought it had the most aesthetically pleasing themes.

GoDaddy has what I think of as a "jittery" site, where there's too much information thrown at you at once, and you just want to close the page. I don't think that bodes well for my own site. I did briefly look at their templates though, and I didn't much care for them.

The same was true for web.com-too busy, with only a small sampling of templates, all fairly ugly.

My favorite was Duda, which allowed access to templates, and had a specific medical template that looks about right to me. Also, their templates are responsive, which means they adjust themselves to whatever device the user is on, and can be customized for specific devices, i.e. you can make your smartphone page a bit different from your laptop page.

Well, okay, just this one image, since I'm saying it's my favorite:

Here's a spreadsheet summary of the templates:

Based on this information, I'm going to rule out GoDaddy, Sitebuilder, and Wix. I'm not crazy about Web.com but I'm going to keep it in the running because it gets consistently high ratings, so maybe there's more to it than I've seen thus far.

PsychPracticehttp://firstname.lastname@example.com:blogger.com,1999:blog-4053770866454296190.post-37571764901371579832016-04-15T20:08:00.000-04:002016-04-15T20:08:11.830-04:00OOOOOOKLAHOMA!Good news for doctors in Oklahoma, also known as the "Sooner State", "...in reference to the non-Native settlers who staked their claims on the choicest pieces of land prior to the official opening date."

I learned from an email from the National Board of Physicians and Surgeons (NBPAS, See, "Another Board", and "Summing Up 2015"), that in response to pressure from physician groups like NBPAS, the Oklahoma state legislature has passed a bill stating that Maintenance of Certification (MOC) cannot be required as a condition of licensure, reimbursement, employment or admitting privileges. The bill was approved by the governor on April 11, 2016.

The link to the bill is here. You need to click on "SB1148" in the upper left-hand corner to view the actual bill. The relevant language is the following, with an otherwise identical clause included further on for osteopathic doctors:

G. Nothing in the Oklahoma Allopathic Medical and Surgical Licensure and Supervision Act shall be construed as to require a physician to secure a Maintenance of Certification (MOC) as a condition of licensure, reimbursement, employment or admitting privileges at a hospital in this state. For the purposes of this subsection, "Maintenance of Certification (MOC)" shall mean a continuing education program measuring core competencies in the practice of medicine and surgery and approved by a nationally-recognized accrediting organization.

Go, Oklahoma! And because I'm a little giddy about this small but important victory, I'm including this Sesame Street clip:

PsychPracticehttp://firstname.lastname@example.com:blogger.com,1999:blog-4053770866454296190.post-7592442267772252722016-04-13T23:32:00.001-04:002016-04-13T23:32:22.970-04:00Investing in Mental HealthAccording to the NY Times, which does not lie, while mental health care is scarce in parts of the US, it's virtually non-existent in most of the world, with one mental health professional per 1 million people in developing countries.

This is the push behind the World Health Organization's (WHO's) goal to, "...move mental health to the forefront of the international development agenda," and the focus of a conference in Washington this week.

In support of this goal is a paper published yesterday in the Lancet Psychiatry, Scaling-up treatment of depression and anxiety: a global return on investment analysis, by Chisholm, et al. The study was funded by Grand Challenges Canada, which supports, "Bold Ideas with Big Impact in global health," and is, itself, funded by the Canadian government.

I was curious about the study, in particular, how they went about assessing something huge like economic impact of mental illness, and what interventions they think would be helpful. They used the OneHealth tool, which you can download here, to estimate the number of people with depression and anxiety disorders living in 36 large countries, constituting 80% of the world's population, and 80% of the global burden of depression and anxiety disorders. The countries were a mix of low-, middle-, and high-income. Incidentally, I didn't download the OneHealth tool even though it looks really interesting because it's designed for Windows, feh, and I would have to do funny things to my precious Mac to use it. But there's an introductory tutorial on YouTube, and boy does OneHealth have a lot of fascinating data for countries, and powerful functionality.

Quite reasonably, in my opinion, they excluded prevention as a type of treatment, because the evidence for it is weak, and not easily generalizable. Interventions included, "...basic psychosocial treatment for mild cases, and either basic or more intensive psychosocial treatment plus antidepressant drug for moderate to severe cases." The choice of intervention is based on WHO's Mental Health Gap Action Programme (mhGAP), where the recommended treatment for moderate to severe depression is:

Anxiety and mild depression are considered, "Other Significant Emotional or Medically Unexplained Complaints." In those cases, the recommended treatment is:

INT are advanced psychosocial interventions which take, "...more than a few hours of a health-care provider's time to learn and typically more than a few hours to implement." They include Behavioral Activation, CBT, Contingency Management Therapy, Family Counseling or Therapy, Interpersonal Psychotherapy, Motivational Enhancement Therapy, Parent Skills Training, Problem-Solving Counseling or Therapy, Relaxation Training, and Social Skills Therapy.

I have to say I'm a little skeptical about how effective these interventions will be. However, their computations were based on the assumption that there would be only a 5% improvement in the ability to work, and productivity at work, as a result of treatment. So their expectations were modest-if someone would normally miss 20 days of work per year, how much money would it cost or save if that person only missed 19 days per year. At least, that's how I understand it.

They were looking for the total cost of scaling-up treatment, as well as effects on three categories:

Health Return = increased healthy life years gained as a result of treatment
Value of Health Returns = I don't really understand this
Economic Return = enhanced levels of productivity

One table I initially skimmed over but now realize is quite important is:

Current and target levels of scaled-up treatment coverage for depression and anxiety disorders (all interventions combined), by country income level

It reflects the idea I pointed out above that their expectations are modest. Currently, 7% of people who need it get treatment in low-income countries. With the scaled-up program, that number will rise to 34%, which means that 2/3 of people who need treatment won't get it.

The article notes that, "...very few studies have assessed the extent to which effective depression treatments get people back into work." So that's an important question to try to answer. They looked at absenteeism, meaning days lost to work, and "presenteeism", meaning partial days of impaired activity while at work. I guess that includes things like staring off into space.

Let's review. They used this powerful, OneHealth tool to see how many people in the world suffer from depression and anxiety. And they also used the tool to determine the economic impact of these illnesses when they're treated, and when they're not treated. Then they figured out how many more people would need treatment in order to get a 5% increase in productivity. They estimated the cost of the additional treatment, and they estimated how much money would be saved (or made, depending on your perspective) by having that many more people back at work.

And this is what they found:

Costs and benefits of scaled up treatment of depression and anxiety disorders, 2016–30

The total investment is $91.5 billion for depression, plus $55.7 billion for anxiety, equals approximately $147 billion.

They claim that, "...scaled-up treatment leads to 43 million extra years of healthy life over the scale-up period [2016-30]." I don't understand how they determined this, but they placed an economic value on these healthy life-years, the "Value of Health Returns". For depression, it's $258 billion, and for anxiety, $52 billion, for a total of $310 billion.

In terms of economics, they got $230 billion for depression, and $170 billion for anxiety. That's a total of $400 billion.

To summarize, just looking at pure dollar amounts, over a 15 year period, you put in $147 billion, you get out $400 billion, yielding a total benefit to cost ratio of 2.3-3 : 1.

The discussion describes some limitations. For example, it notes that is a modest return on investment. By comparison, in another OneHealth model, the benefit to cost ratio for malaria was 28-40 : 1. But they also mention that they didn't include things like reduction in unemployment- and welfare-benefits in their analysis, so that could change the ratio.

Another limitation is that unlike the prevalence of of depression and anxiety, the prevalence of treated depression and anxiety is unknown. Meaning that even if you invest in and set up programs, they may not be implemented well. Also, treating more people, for example in remote locations, may drive up the cost of treatment.

Plus, the study didn't consider the negative effect of maternal depression on early child development, the health, social, and economic benefits of effective treatment of maternal depression on the cognitive and physical development of newborns, the monetary and non-monetary impact of effective treatment on family and other caregivers, and the effect of depression and its treatment on physical health outcomes.

To these considerations I would add my own concerns about the particular interventions the WHO recommends. However, I will concede that while the whole endeavor is about the bottom line, and may not make that much emotional difference to that many people, some people will be helped, and that's more than are helped now. And, more importantly, if things work out like they want them to, they will have demonstrated that helping more people actually saves money. I hope they're right.

PsychPracticehttp://firstname.lastname@example.com:blogger.com,1999:blog-4053770866454296190.post-69378223875016023682016-04-07T13:33:00.002-04:002016-04-07T13:33:19.470-04:00Making My ComebackI am very sorry for my long absence. I can come up with excuses, like I was out of the country, then sick, and the whole time working on what is turning out to be a very challenging article for The Carlat Report. All true, but still excuses.

I'm gonna show you some photos from Thailand, anyway:

6 foot shadow puppet

Street Market

Tuk Tuk

Detail from Wall Mural, Temple of the Emerald Buddha

I'm not gonna get into the part where I was sick, except to convey the one important lesson I learned, although it was too late to be of use to me: There are home IV services. You can google them, if you like. They're mainly for hangovers, and they come to your home and hang some lactated ringers, but they also cover the occasional flu and GI bug. Good to know.

Now for some real content.

You may recall that a few months ago, I went into this rabbit hole about statistics and flu vaccination. I looked at an article by Talbot et al, that the CDC is using to support its recommendation for universal influenza vaccination. First I finagled around for a while trying to figure out how the article obtained its statistics. When I had finally done that, I considered the conclusions from those statistics, and decided they were erroneous-meaning that even if the statistics are accurate, they don't prove what the authors claim they prove, namely, that there is a 71% reduction in flu-related hospitalizations in patients who have been vaccinated against flu, vs. those who haven't. Instead, I believe what they demonstrate is that flu vaccination resulted in a 71% reduction in flu INFECTION, in their study population, which consisted exclusively of patients who were already hospitalized for something that resembled flu. These are very different conclusions, and if you check my post, you can see where I demonstrated that with the study's data, it's possible flu vaccination reduced flu-related hospitalization, but it's also possible it increased it. They don't have the right data to know.

Since I'm not a statistician, I asked a few people who I thought knew more statistics than I if my conclusion was correct, but I couldn't seem to get a clear answer. I even wrote to the Cochrane Review about it, then promptly forgot I had done so.

Well, they responded, and this is en excerpt (most) of their reply:

Our opinion on the Talbot, et al observational study is as follows:

The public health significance of the study is limited for multiple reasons including the inability to estimate absolute treatment effects and number needed to vaccinate. Without this vital information it is difficult to determine the value of the intervention for public health use. Furthermore there is no information on harms reported therefore we have no idea of the balance between positive and negative outcomes. It is well known that observational studies tend to be associated with higher risk of bias compared to randomised clinical trials. Bias introduced by the design usually has the effect of exaggerating the effects of the intervention, in this case influenza vaccines. Coupled with absence of any mention of harms is well within the narrative findings of our reviews.

The assumptions required for validity of the case-positive, control-negative study design are not stated in the paper and no information is provided on whether they have been met. For example, a critical assumption is that the risk of non-influenza ILI needs to be the same in vaccinated and non-vaccinated individuals1. This may not be the case as shown by Cowling et al who reported an increased risk of non-influenza respiratory virus infections associated with receipt of inactivated influenza vaccine2. Stratification by disease severity (apparently not measured in this study) is needed because this is likely to be associated with a person's probability to seek medical care as well as vaccination status3. If the vaccine modifies the conditional probability of developing symptoms after infection with influenza then the odds ratio may be biased3.

The case-positive, control-negative study design is not recommended for study of patients hospitalised for influenza-related illnesses because hospitalisations may occur due to complications that become manifest after the virus is no longer detectable3. It is notable that only 10% had positive RT-PCR tests; surprisingly low given the participants were selected and recruited during the influenza season.

Further weaknesses of the study include selection bias as only 169 of 413 eligible participants were included in the analysis. Only 17 had a positive RT-PCR test making estimates from statistical modelling unreliable.

Given these multiple methodological concerns we consider the study to be at high risk of bias; providing very low quality evidence.

References
1Broome, C., Facklam, R., Fraser, D. Pneumococcal Disease after Pneumococcal Vaccination — An Alternative Method to Estimate the Efficacy of Pneumococcal Vaccine. N Engl J Med 1980; 303: 549-552.
2Cowling, B., Fang, V., Nishiura, H., et al. Increased Risk of Noninfluenza Respiratory Virus Infections Associated With Receipt of Inactivated Influenza Vaccine. Clin Infect Dis. 2012 Jun 15; 54(12): 1778–1783.
3Foppaa, I., Haberc, M., Ferdinandsa, J., Shaya, D. The case test-negative design for studies of the effectiveness of influenza vaccine. Vaccine 31 (2013) 3104– 3109.

Cochrane replied to my inquiry! I feel so important! Sure, they didn't really answer my vanity question of, "Did I catch the CDC in a big statistical boo boo?" But that's probably for the best. What they do seem to be saying is that the the study is poor enough that it's not even worth considering the validity of its conclusions, which still supports my contention that this is a terrible study to use as part of the recommendation for universal flu vaccination.

The Cochrane people also suggested that I post our exchange in PubMed Commons as comments to the Talbot et al study, which I told them I would like to do, but haven't gotten around to yet.

That's my bit for today. I will try to be less neglectful of the blog, going forward.

PsychPracticehttp://email@example.com:blogger.com,1999:blog-4053770866454296190.post-44470753390946471952016-03-01T16:22:00.002-05:002016-03-01T16:22:54.142-05:00Benzodiazepines are ConfusingFor about a year now, I've been trying to figure out what to make of data coming in about the association between Benzodiazepine (BZD) use and dementia.

To start from the very beginning, I recognize that BZDs are potentially addictive, can cause gait and memory impairment, and precipitate withdrawal seizures with continued use, and don't mix well with other drugs like EtOH and Opioids, for instance. They're not ideal drugs.

But for a certain subpopulation, they're helpful. Anxious people who are on other meds that don't quite hold them, and who don't escalate their doses, for instance. Patients who are scared of flying, and who need a Xanax to get them there, and another to get them back. And sure, everyone knows BZDs have, at best, a short duration of helping with insomnia, and still, some patients do well with them long-term.

I'm definitely more liberal with BZDs than I was taught to be as a resident, where they were viewed as the evil purview of manipulative drug seekers. I consider that perspective a bit extreme. On the other hand, I try to encourage other methods for coping with anxiety, and taper patients off them, when I can.

Lately, though, I've been worrying about the connection between BZDs and dementia. In a 2012, French study by Billioti de Gage, et al, 1063 men and women, (mean age 78.2) who were dementia free were followed for up to 15 years. Those who used BZDs prior to the onset of the study were excluded, so only those who used BZDs three or more years into the study were included. They found that new use of BZDs was associated with an increased risk of dementia (multivariable adjusted hazard ratio 1.60, 95% confidence interval 1.08 to 2.38). They also found that:

"Results of a complementary nested case-control study showed that ever use of benzodiazepines was associated with an approximately 50% increase in the risk of dementia (adjusted odds ratio 1.55, 1.24 to 1.95) compared with never users. The results were similar in past users (odds ratio 1.56, 1.23 to 1.98) and recent users (1.48, 0.83 to 2.63) but reached significance only for past users."

This was the part I found particularly perplexing. I didn't understand this separate, complementary study, or what to make of "ever use" vs. "never use". For instance, what are the implications for someone who gets a versed fentanyl drip for a colonoscopy? Does that constitute "ever use"?

Other studies cited by this one demonstrate increased risk of dementia in chronic use, former use, and ever use (please see study for citations). The "ever use" particularly bothered me, because why should I encourage patients to stop taking BZDs if their risk is already well-established.

Another study, (same author, 2014) looked at people already diagnosed with Alzheimers, and considered a dose response relationship to BZDs. They found an association with "ever use", but not with cumulative dose. Also, the strength of association was greater for long half-lifed BZDs than for short half-lived. There were a whole bunch of confusing points and confounders.

Finally, there's this study:
Benzodiazepine use and risk of incident dementia or cognitive decline: prospective population based study, by Gray, et al, published in the BMJ last month. It's a prospective, population-based study done in Seattle, "To determine whether higher cumulative use of benzodiazepines is associated with a higher risk of dementia or more rapid cognitive decline."

They had 3434 participants age > 65, dementia-free at study entry. They screened for dementia every 2 years over the course of 10, with the CASI (Cognitive Abilities Screening Instrument), and got data about BZD use via computerized pharmacy records.

They concluded:

The risk of dementia is slightly higher in people with minimal exposure to benzodiazepines but not with the highest level of exposure. These results do not support a causal association between benzodiazepine use and dementia.

There's so much inconsistency here that I don't know what to think. At least all three of the articles are open access.

I'm off to the Far East for several weeks, see you when I get back.

PsychPracticehttp://firstname.lastname@example.com:blogger.com,1999:blog-4053770866454296190.post-81538252638219301232016-02-19T10:40:00.000-05:002016-02-19T10:40:52.170-05:00Tequila MOC-kingbirdFirst, sorry about my prolonged absence. I've been writing an article for Carlat, and it's taking up all my time.

Second, sorry about the title. I'm pretty sure I saw a cocktail called, "Tequila Mockingbird" on some restaurant menu, but I can't remember where. And then an MOC topic came up, so.*

Got this email today:

AMERICAN BOARD OF PSYCHIATRY AND NEUROLOGY EXPANDS
IMPROVEMENT IN MEDICAL PRACTICE (PIP) OPTIONS FOR DIPLOMATES

February 18, 2016, Buffalo Grove, Illinois --- The American Board of Psychiatry and Neurology, Inc. (ABPN) has expanded the options for diplomates for their one required Improvement in Medical Practice (PIP) activity every three years to include any Clinical Module OR Feedback Module activity listed on the ABPN website.

Effective immediately, this development now gives diplomates more flexibility with the Part IV requirement for their maintenance of board certification.

The ABPN Improvement in Medical Practice Unit is a quality improvement exercise designed to identify and implement areas for improvement based on the review of one's own patient charts (Clinical Module), involvement in personal or institutional quality improvement activities, or feedback from peers or patients via a questionnaire/survey (Feedback Module).

"These additional options for fulfilling the requirements of MOC Part IV recognize the importance of patient and/or peer feedback to the process of physician quality improvement, and it should also make it easier for many ABPN diplomates to document their quality improvement activities," said Larry R. Faulkner, MD, ABPN President and CEO.

More details, including full option lists for both the Clinical and Feedback Module activities, are available on the ABPN website.

Reading this evoked a kind of comical fury in me. The ABPN is stooping pretty low, but it just won't bow to the pressure to remove Part IV. In case you've forgotten, and who wouldn't want to, there's lots of controversy about the Part IV Performance in Practice (PIP) modules, which you often need to pay for, and which have not been demonstrated to do anything but raise blood pressure. The American Board of Internal Medicine (ABIM) caved to its protesting diplomates, suspending Part IV until 2018. But the ABPN did not.

If the Board thinks PIP is so valuable, why agree to make it an either/or with a form that any diplomate can fill out five times by herself, asking her friends for their approval and signatures, in exchange for her own?

I checked out the ABPN products list page, and after a click or two, I got this:

The bottom part scrolls to more options, and it's almost this difficult to read. The important column here is, "PIP F", the feedback modules. It took me a little while to find the right one. There were a couple "page not available" dead ends, as well as ones that didn't apply, like the adolescent feedback and patient forms. I've discussed my thoughts about patient feedback forms elsewhere.

The main form you need, if you're willing to be the ABPN's bitch and do this, is the ABPN's Peer Feedback Form (NOT the AACAP's form, which gets you a description of MOC). It gives you a 1-6 Likert scale in six areas:

Patient Care
Medical Knowledge
Interpersonal and Communication Skills
Practice-Based Learning and Improvement
Professionalism
Systems-Based Practice

'Nuff said.

I had already decided to wait to see if the ABPN makes any concessions about Part IV and the meaningless, expensive recertification exam that exists to pay ABPN salaries, to decide if I want to bother re-certifying again, or to fulfill any of the requirements other than CME. I'm taking this concession as a sign that I should keep waiting.

* I just Googled "Tequila Mockingbird", and I got a link to this book:

Maybe I saw it in a bookstore? The drinks have names like, "Last of the Mojitos", "One Hundred Beers of Solitude", and, "The Rye in the Catcher". It looks like fun.

PsychPracticehttp://firstname.lastname@example.com:blogger.com,1999:blog-4053770866454296190.post-68124099412345694062016-02-02T18:35:00.000-05:002016-02-02T18:35:28.465-05:00Laughing RatsI attended a talk a couple weeks ago at The New York Psychoanalytic Society and Institute (NYPSI), given by Jaak Panksepp, and entitled, Cross Species Affective Neuroscience. It was a really good talk that I'll try to summarize here. Panksepp spoke using a power point that didn't quite work right, through no fault of his own, and gave a talk similar to his TEDx talk about affect in non-human animals, and the way humans can be understood by studying these animals, particularly with respect to depression. His part was followed by the discussant, Jean Roiphe, who presented a corresponding analytic perspective, and highlighted points of overlap and divergence.

First, the speakers. This is from Wikipedia:

And Jean Roiphe's description from the NYPSI site is:

Clinical Associate Professor of Psychiatry, Weill-Cornell Medical College
Associate Attending Psychiatrist, New York-Presbyterian Hospital
Training and Supervising Analyst, New York Psychoanalytic Institute

One of Panksepp's main points is that affect is the foundation for all consciousness, and that most learning takes place through affective shifts. This reminded me of a guy from my medical school class who decided he should memorize everything by singing, because while the Complement pathways eluded him, he could still remember every TV commercial jingle he learned as a kid.

Panksepp briefly addressed the question of why one would choose to study emotional feelings in animals, which is to say, whether animals have minds at all, and pointed out that animal lovers' beliefs that this is the case is an argument from empathy, and that LeDoux is skeptical about whether animals have feelings.

Panksepp, himself, believes that animals have feelings and that all their experiences are labeled "good" or "bad"; that animals can tell us if something is rewarding or punishing. And here, the definition of "good" = leads to survival, while the definition of "bad" = leads to destruction.

He noted, quite emphatically, that in his opinion, all feelings are based in the subcortical system, and pointed out that while Damasio initially believed feelings are generated in the neocortex, he later switched to Panksepp's position, and acknowledged so, which earned him Panksepp's label of, "mensch". Panksepp does not feel similarly about LeDoux.

Panksepp described the seven emotional systems in the brain. This is one of the places where his slides malfunctioned, so I'm taking this from the slide in his TEDx talk:

SEEKING----Enthusiastic
RAGE---------Pissed Off
FEAR---------Anxious
LUST---------Horny
CARE--------Tender and Loving
PANIC-------Lonely and Sad
PLAY--------Joyous

He mentioned that dopamine and the nucleus accumbens are the foundation for all positive emotions, and that this probably represents a general purpose learning system. He also mentioned the association between the Hypothalamus/PAG/Amygdala and the ANGER system.

He returned to his discussion about the subcortical system as the foundation of feelings and consciousness, and pointed out that rats with no neocortex behave "normally", and that raters were not able to differentiate these from rats with neocortices. In fact, the neocortex-less rats showed more interest in their environment than the normal rats. No inhibition, I suppose.

He focused particularly on the SEEKING, PLAY, and PANIC systems, because these were areas of exploration that have shown promise for the treatment of depression.

SEEKING is associated with the Medial Forebrain Bundle. Bilateral lesions in this region yield profound depression, while bilateral deep brain stimulation in this region yields an antidepressant effect.

One medication that usefully impacts the SEEKING system and acts as an antidepressant is very low dose buprenorphine, which makes juvenile animals play more. He claimed that drug withdrawal shows similarities to the experience of separation distress, which is a model for depression via the PANIC system.

Opioids mediate every good feeling ever studied, and in fact, contact comfort, known to be effective at soothing panic, doesn't work as well if opioid receptors are blocked.

Oxytocin is just as powerful as opioids with respect to depression, in its re-creation of mothering attachment. This has implications for placebo effect, since handing someone a placebo is an act of caring.

Panksepp cited a very small study he did with Yovell using buprenorphine to treat depression and suicidality. The suicidality results are what he included in his slides:

He also spoke about a study using bilateral Deep Brain Stimulation (DBS) to act on the SEEKING system in 7 subjects with treatment resistant depression. 6/7 responded well, with a marked improvement in planning for their futures. It turned out that in the one non-responder, the DBS had missed on one side.

Finally, and to me this was the most important part, he talked about an antidepressant he has been researching, a tetrapeptide called, GLYX-13, that acts on the PLAY system. The results have been promising, with decreases in depression thought to be mediated by promoting positive social feelings, including laughter. Panksepp is big on laughter, and is known for tickling rats to get them to laugh. Unfortunately, he seemed to indicate that GLYX-13 was bought up by a company with a competing antidepressant, so it may not make it to market.

His slides really gave out at this point, so he handed the stage over to Jean Roiphe for her discussion. Spoiler alert: It's quite brilliant, and if you don't think so after reading my summary, it's only because I didn't do it justice.

Roiphe described being on safari a decade ago, watching animals spending their days grazing on the veldt, except when they sensed a predator, at which point they would take evasive action. This was pretty much all they did, and it correlates well with the SEEKING and FEAR systems. It made her wonder, now that our survival is so much more assured, at least in some parts of the world, what has happened to our emotional meanings? We now fill our free time with things like art and science and architecture and literature and blogging, but we also fill it with neuroses, anxiety, eating disorders, perversions, and all the many clinical presentations we see in our work.

She noted that while the seven emotional systems are preserved in our brains, it's important to remember that, paraphrasing Kandel, humans now change more by cultural than by biological evolution. At the same time, it's also important to establish a line of communication between those who study the subjective aspects of the mental apparatus, such as psychoanalysts, and those who study its objective aspects, such as neuroscientists. And that the mind is simultaneously and always both a psychological and a biological entity.

She spoke about the value of linking the two approaches, in both directions. For psychoanalysis, the value is having neurological correlates to analytically abstract concepts of the mind, because the former are technologically easier to study, with the proviso that this may not simplify matters all that much, since different neuroscientists can interpret "brain data" differently, as in the above example of Panksepp vs. LeDoux.

And for neuroscience, the value is in learning about the complexity of subjective experience, and recognizing that the human condition is impossible to understand or even study without taking the subjective into account.

In some respects, the emotional systems described by Panksepp correlate with Freud's affect theory, in which affect is a way for a person to tell if his or her drives are being satisfied. Or not. I feel good or I feel bad. This experience is pleasant, that one is unpleasant. However, the seven emotional systems are instinctual, do not need to be learned, and involve behavioral responses, whereas Freud's affect theory involves only a pressured sense that something needs to be fulfilled, and this may or may not lead to a behavioral response, but always leads to mental activity, to thought as trial action. This is a good example of why it's important to avoid the trap of trying to create one to one correspondences between approaches.

Freud's ideas about affect evolved over time, along with his changing theory of anxiety, and his shift from the topographic model (unconscious vs. conscious) to the structural model (id, ego, superego), but ultimately, affect became tied to ego function, as a way for the ego (which acts as a combination of party coordinator and chaperone) to mark the need for some kind of response to something, whether that something is internal or external.

This is similar to the concept of the seven emotional systems as survival mechanisms-X happened, I feel Y in response, and now I need to do Z. The difference lies in the connections between affect, ego function, and object relationships. Human emotions such as guilt, shame, and envy, are generated by the development of the ego in a complicated social context. Uniquely human affects and moods and their corresponding pathologies arise from the interactions of cortical regulatory effects on subcortical systems, and these are mediated by the ego, which becomes itself under the influence of the people around it.

Ego functioning often involves "taming" certain affects, especially through thought and language, but it also involves intensifying some affects, so that people can feel truly alive. A full human life can't be reduced to an all or nothing switch of feeling in response to external events.

We can illustrate the role of the ego in human experience by examining Panksepp's model for depression, which involves the malfunction of the PANIC, SEEKING, and/or PLAY systems. This model corresponds well with anaclitic depression, in which babies separated from their mothers for extended periods became despondent, emotionally withdrawn, and frequently died. Strikingly, Spitz, who studied the syndrome, noted that a way to prevent this deterioration was to find a suitable substitute caregiver, and to allow the babies to move around outside their cribs (see this post). This meshes well with the involvement of both the PANIC/separation distress and SEEKING systems.

Spitz attributed the need for the babies to move around not to an innate SEEKING system, but to a need for discharge of aggression. The absence of aggression is where Panksepp's model for depression diverges from psychoanalytic models, in which aggression is central. Freud's, Mourning and Melancholia, reflects the idea that sadness is not the same as depression, which results when a loss, usually of an ambivalently loved object, precipitates rage, which is then directed towards the self.

There are other types of depression, as well. In an ego depression, the actual self falls short of the wished-for self, as in the loss of a job, or the limitations that come with aging. Depression results when there is an aggressive attack on the self for these losses, "I have failed." In a superego depression, the actual self falls short of the wished for self in moral or ethical values, which results in an aggressive attack on the self: "I'm bad, I should be punished."

Panksepp also considered the evolutionary advantage of depression as a shut down mechanism in PANIC situations. But a psychoanalytic perspective includes not only the concept of depressive pathology, which is a source of immense suffering and need for treatment, but also depressive capacity.

Depressive capacity includes the ability to tame or appropriately redirect aggression, and to tolerate the inevitable disappointments and losses of life. It involves the willingness to accept responsibility for our moral failings by not hiding behind depression-inducing guilt, or other defenses such as blame or projection. And it requires the ability to relinquish ones unattainable dreams, to accept the lack of fulfillment of ones impossible wishes, and to bear the limitations in ones self.

That was pretty heavy. Now this. I mentioned the problem with Panksepp's power point for a reason. He didn't get to show the video of himself tickling rats. So here it is:

PsychPracticehttp://email@example.com:blogger.com,1999:blog-4053770866454296190.post-6603176350813302882016-01-22T00:39:00.001-05:002016-01-22T10:03:10.914-05:00Minding Our P'sI've been reluctant to write this post, even though I've referenced it previously. It's just that I've been trying to gain a better grasp of statistics, and reading 1boringoldman's posts has really helped me, and based on them, I finally managed to explain to myself what p-values actually are, but I just figured that must be completely obvious to everyone but me, so why should I bother writing about it.

What finally convinced me was thinking about how so many studies include p-values as a way of proving one drug is "significantly" better than another or placebo, and don't bother to include effect sizes. This is a great obfuscating tactic, so whoever's conducting these studies must think that people misunderstand p-values. And that makes it worth writing this post.

This is the story of how I clarified p-values to myself.

Let's say we're doing a study comparing two compounds,

Hubba Bubba

and Bubble Yum

to determine which is better at curing the common cold.

We start out with the null hypothesis, which states that we assume there is no difference between the two compounds, or what they can do. If the p-value turns out to be less than 0.05, then we can reject the null hypothesis. I don't like thinking about the null hypothesis because it confuses me. It's like trying to decipher a triple negative. So we're gonna put it aside for now.

We randomize 100 patients to each arm, and follow up the next day, and the day after, with a rating scale, the CQ-7. And this is what we find:

Let's assume we've done all our work honestly and accurately, and we get a p-value less than 0.05. Does this mean that Bubble Yum is significantly better at curing the common cold than Hubba Bubba? It does not. It means we can reject the null hypothesis. But what does THAT mean?

Think of it this way.

Suppose that on the night before the study begins, I sneak into the lab and change the wrappers so that there is no Bubble Yum, only Hubba Bubba. And then suppose we do the study, and we get exactly the same results as above. Can it be? Is it possible that all 100 subjects taking Hubba Bubba wrapped as Bubble Yum got better, and all 100 subjects taking Hubba Bubba wrapped as Hubba Bubba didn't? Yes, it is possible. It's just extremely unlikely. Extremely improbable. How improbable? Well, there's less than a 5% chance that the two compounds could be exactly the same, and yet yield such freakishly different results. That's why the "p" in p-value stands for probability.

In other words, we've rejected the null hypothesis.

Let me repeat. If the p-value is less than 0.05, then there is less than a 5% chance that the null hypothesis is true, i.e. less than a 5% chance that the compounds could be the same and yet yield such disparate results. Which means they're probably not the same. And we choose the significance level to be 0.05, but we could just as easily choose 0.10, or 0.01.

So a very small p-value does not mean that Bubble Yum is significantly better than Hubba Bubba at curing the common cold. It just means that it is extremely unlikely that Bubble Yum could be no better than Hubba Bubba at curing the common cold, with these very different results.

In order to determine how much better Bubble Yum is than Hubba Bubba, you need to look at effect size, and as we have seen any number of times, a small p-value does not imply a large effect size. For example, in the CBT study I recently looked at, p was <0.001, but the effect size was 0.45, only moderate.

This is why many studies leave the effect size out of their publications.

PsychPracticehttp://firstname.lastname@example.com:blogger.com,1999:blog-4053770866454296190.post-80164566703746360532016-01-17T01:35:00.001-05:002016-01-17T01:35:29.158-05:00Long Term Efficacy of CBT?I get email updates from several places I consider reasonably reputable, like NEJM, that have lists of new and interesting articles. I consider those kinds of updates helpful ways of staying current. I also get other kinds of email updates that feel more like ads, or infomercials, like this one, from Psychiatric News Alert:

Study Finds Long-Term Benefits of CBT for Patients With Treatment-Resistant Depression

Patients with treatment-resistant depression who receive cognitive-behavioral therapy (CBT) in addition to antidepressants over several months may continue to benefit from the therapy years later, according to a study in Lancet Psychiatry...

"Our findings provide robust evidence for the effectiveness of CBT given as an adjunct to usual care that includes medication in reducing depressive symptoms and improving quality of life over the long term," the study authors wrote. "As most of the CoBalT participants had severe and chronic depression, with physical or psychological comorbidity, or both, these results should offer hope for this population of difficult-to-treat patients."

You can link to the Lancet Study, Long-term effectiveness and cost-effectiveness of cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment-resistant depression in primary care: follow-up of the CoBalT randomised controlled trial, by Wiles et al, here. It's full text.

In brief:

Background
Cognitive behavioural therapy (CBT) is an effective treatment for people whose depression has not responded to antidepressants. However, the long-term outcome is unknown. In a long-term follow-up of the CoBalT trial, we examined the clinical and cost-effectiveness of cognitive behavioural therapy as an adjunct to usual care that included medication over 3–5 years in primary care patients with treatment-resistant depression.

Methods
CoBalT was a randomised controlled trial done across 73 general practices in three UK centres. CoBalT recruited patients aged 18–75 years who had adhered to antidepressants for at least 6 weeks and had substantial depressive symptoms (Beck Depression Inventory [BDI-II] score ≥14 and met ICD-10 depression criteria). Participants were randomly assigned using a computer generated code, to receive either usual care or CBT in addition to usual care. Patients eligible for the long-term follow-up were those who had not withdrawn by the 12 month follow-up and had given their consent to being re-contacted. Those willing to participate were asked to return the postal questionnaire to the research team. One postal reminder was sent and non-responders were contacted by telephone to complete a brief questionnaire. Data were also collected from general practitioner notes. Follow-up took place at a variable interval after randomisation (3–5 years). The primary outcome was self-report of depressive symptoms assessed by BDI-II score (range 0–63), analysed by intention to treat. Cost-utility analysis compared health and social care costs with quality-adjusted life-years (QALYs)...

They took an old study, with subjects who had taken antidepressants for at least 6 weeks and had substantial depression symptoms characterized by a BDI-II score of at least 14, and followed up with a questionnaire and GP notes. Primary outcome was self-report of depressive symptoms assessed by BDI-II score. They also did a cost analysis.

Findings
Between Nov 4, 2008, and Sept 30, 2010, 469 eligible participants were randomised into the CoBalT study. Of these, 248 individuals completed a long-term follow-up questionnaire and provided data for the primary outcome (136 in the intervention group vs 112 in the usual care group). At follow-up (median 45·5 months [IQR 42·5–51·1]), the intervention group had a mean BDI-II score of 19·2 (SD 13·8) compared with a mean BDI-II score of 23·4 (SD 13·2) for the usual care group (repeated measures analysis over the 46 months: difference in means −4·7 [95% CI −6·4 to −3·0, p<0·001]). Follow-up was, on average, 40 months after therapy ended. The average annual cost of trial CBT per participant was £343 (SD 129). The incremental cost-effectiveness ratio was £5374 per QALY gain. This represented a 92% probability of being cost effective at the National Institute for Health and Care Excellence QALY threshold of £20 000.

Follow-up was a median of 45.5 months, at which point, the CBT group had a mean BDI-II of 19.2, and the control group a mean BDI-II of 23.4

Interpretation
CBT as an adjunct to usual care that includes antidepressants is clinically effective and cost effective over the long-term for individuals whose depression has not responded to pharmacotherapy. In view of this robust evidence of long-term effectiveness and the fact that the intervention represented good value-for-money, clinicians should discuss referral for CBT with all those for whom antidepressants are not effective.

Note that "individuals whose depression has not responded to pharmacotherapy," were taking antidepressants for 6 weeks. The study states later that, "This definition of treatment-resistant depression was inclusive and directly relevant to primary care."

Let's look at the details. I'll start by stating that I'm not going to consider the cost effectiveness, because I don't know how. And it may be that even if the clinical effects turn out to not be impressive (spoiler!), the treatment may be worthwhile from a financial standpoint.

At the start of the current study, all patients were taking antidepressants, and were randomized to 12-18 sessions of CBT, or usual care from their GPs. I find this confusing. It seems like medication ought to be a confounder, since depression is cyclic to begin with and people respond to medications at variable rates. Also, if you consider these patients to be treatment resistant, why continue them on antidepressants?

I also find what they did with the outcome measures confusing:

The primary outcome was self-report of depressive symptoms assessed by BDI-II score (range 0–63). Secondary outcomes were response (≥50% reduction in depressive symptoms relative to baseline); remission (BDI-II score <10); quality of life (Short-Form health survey 12 [SF-12]); and measures of depression (PHQ-9) and anxiety (Generalised Anxiety Disorder assessment 7 [GAD-7])...

The primary outcome for the main trial was a binary response variable; for this follow-up, the primary outcome was specified as a continuous outcome (BDI-II score) to maximise power. The change in the specification of the primary outcome for the long-term follow-up was made at the time the request for additional funding was submitted to the funder (Nov 6, 2012).

Does this mean they changed the primary outcome? In the original CoBalT trial, "The primary outcome was response, defined as at least 50% reduction in depressive symptoms (BDI score) at 6 months compared with baseline." Did the present study start out using response, and then switch to change in BDI-II score after the fact, which we all know is a no-no? They're claiming they changed it when they requested funding for the current study, but is that before or after they had established their primary outcome measure?

Or did the current study start with change in BDI-II score as the primary outcome measure, and is that okay? In other words, if you're basing your current study on a previous study, is it valid to establish your protocol with a different outcome measure than the original study? I don't know.

Moving on. The study makes a lot of claims about secondary outcomes, and whether or not subjects were still taking antidepressants, but I'm restricting myself to thinking about the primary outcome, and the BDI-II measures are as follows:

The effect size, according to this chart, is 0.45, which is on the low side of moderate. I don't know how they did their computation, but when I used 1BoringOldman's spreadsheet (see this post), I got a Cohen's d effect size of 0.31, which is low.

I'm not sure how this constitutes "Robust evidence." I'm also not sure what's robust about a mean BDI-II of 19.2, when by their definition, a BDI-II score of more than 14 is considered "Substantial depressive symptoms."

Look. I'm not a big fan of CBT, but I'm willing to consider it as a useful treatment if you show me good data. Just don't go hyping your at-best-mediocre data like it's amazing. But of course, Psychiatric News is a product of the APA.

PsychPracticehttp://email@example.com:blogger.com,1999:blog-4053770866454296190.post-80366640425877054902016-01-14T23:30:00.000-05:002016-01-14T23:30:20.001-05:00DIY Study EvaluationIf you have any interest at all in being able to evaluate the results of clinical trials on your own, say because you don't trust what the pharmaceutical companies are telling you, then I HIGHLY recommend you head on over to 1 Boring Old Man and read through his posts from the last few weeks. Basically, he's writing a statistics manual for clinicians, complete with downloadable spreadsheets of his own devising.

His explanations are clear, but I wanted to make sure I could do this on my own, so I tried it out. Here's how it worked.

I would categorize myself as a fairly conservative prescriber, by which I mean that I'm not eager to jump on the new drug bandwagon, and I like to wait a year or two, until we know a little about the effects and side effects of a new drug, before I write for it. I also wait a few weeks before upgrading my iOS for the same reason, so there ya go. But I recently had occasion to prescribe the antidepressant, Brintellix, or vortioxetine. I can't get into the clinical details, but suffice it to say there were reasons. So with Brintellix on my mind, I decided to try out the 1 Boring Old Man spreadsheet on one of their studies that I found on clinicaltrials.gov, specifically, Efficacy Study of Vortioxetine (LuAA 21004) in Adults with Major Depressive Disorder, the results of which were submitted to clinicaltrials.gov in October 2013.

From the get-go, it's looks like a poor study. There were 50 study sites scattered all over Asia, Europe, Australia, and Africa, and it looks like they did something to the outcome measures midstream. But I'm just trying out the spreadsheet, so I'm ignoring all that for now.

The primary outcome measure was change in HAM-D score, which means that I needed to use the spreadsheet for continuous variables, because mean change could have been any number. If the measure was, "Achieved remission," however they define, "remission," then the results would be tabulated in Yes/No form, and I would have had to use a different spreadsheet designed for categorical variables.

But let me pause here and ask a question: Just what am I looking for? Well, I'm looking for effect size, which generally isn't given in results. Usually, we just get to see p-values, but I'll get to why that's not sufficient in a later post.

As a reminder, effect size is the difference between treatment groups, expressed in standard deviations. Roughly speaking, a large effect size is 0.8, medium is 0.5, and small is 0.2. So, for example, if the effect size of A v. B is 0.8, then A did 0.8 of a standard deviation better than B, and this is considered a large effect. So if I know the effect size, then I can tell how much better one group did than another. I can quantify the difference between groups. Cohen's d is often used as a measure of effect size.

It turns out that you only need three pieces of information to determine effect size, all generally available in typical papers. For each arm of the study, you need the number of subjects in that arm, the mean, and the standard error of measure (SEM) or standard deviation, which are interchangeable via the formula (sorry, I don't have Greek letters in my font):

That's it: n, mean, SEM.

Here is that information from the study report. Note that there were four arms: Placebo; Vortioxetine 1mg, 5mg, and 10mg.

Let's plug 'em all in to the 1BOM spreadsheet, while noting that I'm not including the ANOVA, which you really need to do first, to make sure the four groups aren't all the same in comparison to each other, because if they are, then any result you get when you compare 1 group directly with 1 other group is invalid. Just so you know, I computed the ANOVA using this calculator, also recommended by 1BOM, which requires exactly the same information as you need to compute effect sizes, and it turns out that the groups are NOT all the same (this is another thing related to p value, which I plan to discuss in a later post).

The top three rows show the effect sizes for the three active arms, compared with placebo. Note that the effect sizes are in the moderate range, 0.423 to 0.591.

In the next three rows, I also checked to see how the active arms compared with each other in a pairwise fashion, and the 10mg really doesn't do much better than the 5mg or even the 1mg, with 0.170 the largest effect size.

Just considering effect sizes in this one study, Brintellix looks okay.

So you can see that there are powerful things you can do in the privacy of your home, to understand what a study is really telling you, using only minimal information. That feels pretty good. At the same time, you have to take into account other elements, like the fact that they seem to have changed outcome measures after the protocol was already established. That should invalidate the whole kit and kaboodle, but sometimes you need to try out a new drug, and the studies aren't great, but it's the best you can do.

PsychPracticehttp://email@example.com:blogger.com,1999:blog-4053770866454296190.post-9414674216539379412016-01-12T17:20:00.000-05:002016-01-12T17:20:27.012-05:00Shrinks, Once More, AgainYes, I thought I was done with Jeffery Liebermans's, Shrinks: The Untold Story of Psychiatry, but it was not to be.

Clinical Psychiatry News asked me to write a shorter review than the one on my blog, from the angle of whether it would be a good book for a psychiatrist to recommend to patients.

So how could I resist? This one is much shorter, and less of a rant.

So please surf over there and check it out. It feels good to have my opinion expressed beyond these confines. I think the site is free but you may have to register. Also, the print version will be out in a few weeks.

Enjoy, and come back here to comment, if you like.

PsychPracticehttp://email@example.com:blogger.com,1999:blog-4053770866454296190.post-64127524336497052962015-12-31T01:47:00.001-05:002015-12-31T10:30:26.657-05:00Mourning and Falconry-A Book Review

I recently finished reading, H is for Hawk, by Helen Macdonald. I stumbled across it in a bookstore in Berkeley called, Books Inc. A real bookstore. The small kind that has a mini-review or commentary by the staff every few books on the shelf. It was refreshing to be there. I didn't realize it was a NY Times Bestseller. It just drew my eye and looked interesting.

According to her page at The Marsh Agency, Ms. Macdonald is a, "writer, poet, illustrator, historian, and naturalist, and an affiliated research scholar at the Department of History and Philosophy of Science at the University of Cambridge. Over the years she's also worked as a Research Fellow at Jesus College, Cambridge, as a professional falconer, assisted with the management of raptor research and conservation projects across Eurasia, and bred hunting falcons for Arab royalty. She's also sold paintings, worked as an antiquarian bookseller, organised academic conferences, shepherded a flock of fifty ewes and once attended an arms fair by mistake."

H is for Hawk is moving and fascinating, but I'm also very happy to report that even if the subject didn't interest me, I would have enjoyed the book because the woman can write. Sometimes I'll read a book, particularly fiction, and while I may be enjoying the story, I find myself editing the writing- this passage was awkwardly phrased, that sentence would have been better at the end of the paragraph, etc. Not so for Macdonald's writing. It's both beautiful and accessible.

Here's a sample (p. 181):

But then the pheasant is flushed, a pale and burring chunk of muscle and feathers, and the hawk crashes from the hedge towards it. And all the lines that connect heart and head and future possibilities, those lines that also connect me with the hawk and the pheasant and with life and death, suddenly become safe, become tied together in a small muddle of feathers and gripping talons that stand in mud in the middle of a small field in the middle of a small county in a small country on the edge of winter.

Shortly after her father's sudden death, Macdonald decided to train a goshawk. She'd been fascinated by hawks all her life, and had extensive experience training them. But this was her first attempt at training the notoriously challenging goshawk.

There are a number of reasons she made this decision. One early-Spring morning, she felt restless, got up at dawn, and for no discernible reason, drove to the Brecklands to see goshawks, which are rarely visible in the open except at that time of year. The experience reminded her of watching for sparrowhawks with her father, when she was a child. She brought home a piece of reindeer moss she'd been gripping while watching the goshawks that day, and three weeks later, she was staring at the moss when her mother called to tell her her father had died.

That's the first connection. One of the brilliant things about the book, and there are many, is that Macdonald clearly recognizes the complex interactions between her thoughts and feelings, and her behavior. But she does not dwell on them, as one would in a typical psychoanalytic case report. She simply describes them, and leaves the reader to draw conclusions, although she does, occasionally, mention Melanie Klein, Freud, and other analytic thinkers.

The next connection is closer to the heart of her mourning. She describes a summer experience she set up for herself when she was 12, and went to spend several weeks with some gentlemen who flew goshawks:

I was terrified. Not of the hawks: of the falconers. I'd never met men like these. They wore tweed and offered me snuff. They were clubbable men with battered Range Rovers and vowels that bespoke Eton and Oxford, and I was having the first uncomfortable inklings that while I wanted to be a falconer more than anything, it was possible I might not be entirely like these men...

On the first day of that trip, she watched a goshawk kill a pheasant, her first sight of death. She also watched as later that same day, the goshawks seemed to lose interest in their handlers and flew off into the trees. Some took hours before returning:

The disposition of their hawks was peculiar. But it wasn't unsociable. It was something much stranger. It seemed that the hawks couldn't see us at all, that they'd slipped out of our world entirely and moved into another, wilder world from which humans had been utterly erased.

After that summer, she chose to stay away from goshawks:

I never forgot those silent, wayward goshawks. But when I became a falconer I never wanted to fly one. They unnerved me. The were things of death and difficulty: spooky, pale-eyed psychopaths that lived and killed in woodland thickets. Falcons were the raptors I loved...

Yet another connection has to do with T. H. White, best known as the author of, The Once and Future King. He also wrote a book entitled, The Goshawk, his firsthand account of training his own goshawk, who he named, Gos. It was a disaster. It's like an instruction manual for how NOT to train a goshawk, or any other animal, for that matter. As a child, Macdonald reviled White for his inconsistent, and ultimately cruel treatment of Gos. But in H is for Hawk, she comes to view, The Goshawk, differently, as White's account of his conflicts surrounding sadism and love, and his struggle to become himself through his identification with Gos.

Macdonald is a much better trainer than White, although she doubts herself constantly. Is she feeding Mabel (her goshawk) too much, or too little, or the wrong kind of food? The feeding of a goshawk is not a trivial, Jewish mother issue. Goshawks weigh around two pounds, and a couple ounces either way can throw off their flying completely. But the level of Macdonald's worry is indicative of her mourning, which, by her own acknowledgement, is mixed with depression to a degree that would bewilder the most hardcore DSM-5 enthusiast.

Certainly, Mabel is a comfort to Macdonald. She turns out to be not that difficult to train, and is even playful-there's a lovely description of a game involving some rolled up paper, with Macdonald commenting that she hadn't realized goshawks DID play. She attributes at least some of their affinity to their shared gender, and notes that all the falconers and austringers (solitary goshawk trainers) who have described the bird as difficult and sulky have been men.

Incidentally, I attempted to contact Macdonald through her agent to get permission to use a photo of Mabel that I found online, in this post, but I never heard back from either of them-I suspect my message didn't get through-so I'm not comfortable using the picture here. But if you google "Mabel the goshawk" you will see that she was very beautiful.

Macdonald traces her bonding with Mabel, as well as her use of Mabel to isolate herself while she's mourning. We sense the appeal of the hawk's ability to "slip out of this world". By identifying with Mabel, she can distance herself from her pain, or access her father, who has "moved into another, wilder world from which humans had been utterly erased."

And we see the painful, drawn out process of letting go that Freud wrote about in Mourning and Melancholia (Freud, S. (1917). Mourning and Melancholia. The Standard Edition of the Complete Psychological Works of Sigmund Freud, Volume XIV, Pp. 244-5):

In what, now, does the work which mourning performs consist? I do not think there is anything far-fetched in presenting it in the following way. Reality-testing has shown that the loved object no longer exists, and it proceeds to demand that all libido shall be withdrawn from its attachments to that object. This demand arouses understandable opposition—it is a matter of general observation that people never willingly abandon a libidinal position, not even, indeed, when a substitute is already beckoning to them. This opposition can be so intense that a turning away from reality takes place and a clinging to the object through the medium of a hallucinatory wishful psychosis. Normally, respect for reality gains the day. Nevertheless its orders cannot be obeyed at once. They are carried out bit by bit, at great expense of time and cathectic energy, and in the meantime the existence of the lost object is psychically prolonged. Each single one of the memories and expectations in which the libido is bound to the object is brought up and hyper-cathected, and detachment of the libido is accomplished in respect of it.

At some point, Macdonald has to literally let go of Mabel's jesses and allow her to fly free, to have faith that she'll return.

I learned a lot of fun terminology from the book, too. Jesses are the leather straps that fit through the anklets on a hawk's legs. Bating is a, "Headlong dive of rage and terror, by which a leashed hawk leaps from the fist in a wild bid for freedom." That was me quoting Macdonald quoting White.

She describes making jesses as a child. Then she comments, " I have a suspicion that all those hours making jesses and leashes weren't just preparation games...It reminds me of a paper by the psychoanalyst D. W. Winnicott, the one about the child obsessed with string; a boy who tied together chairs and tables, tied cushions to the fireplace, even...Winnicott saw this behaviour as a way of dealing with fears of abandonment by the boy's mother, who'd suffered bouts of depression. For the boy, the string was a kind of wordless communication, a symbolic means of joining. It was a denial of separation. Holding tight. Perhaps those jesses might have been unspoken attempts to hold on to something that had already flown away."

Macdonald had a twin brother who died shortly after birth. She wasn't told about him until years later, but she wasn't that surprised by the news. She wonders if a detailed drawing of a kestrel's jesses, that she drew when she was six, was, "...a way of holding tight to something I didn't know I'd lost, but knew had gone..." And she imagines that the jesses she makes for Mabel are a way of similarly holding on to her father. But I wondered if her father's death hit her as hard as it did, in part, because of the unremembered but somehow perceived loss of her twin, now being re-experienced. And I wondered further what it means to her that she survived, and her brother didn't.

Because we also see the connection between death and aggression. Mabel is beautiful and playful, but she is a powerful killer. That's what she does. That's why Macdonald got her in the first place. So they could hunt together.

Mabel, as she kills her prey, becomes the actualization of Macdonald's rage against her father's death, and against her father, for dying. When she and the bird are one, she becomes the master of death, able to decide who lives and who dies. A powerful wish fulfilled, only too late for her father.

Ultimately, with Mabel's assistance, but also of her own accord, Macdonald gets through her mourning period and is able to resume her life with some joy. To begin again.

Happy New Year!

Addendum:

I really don't get twitter. I couldn't figure out how to send a private message to Helen Macdonald to ask permission to use a photo of Mabel, which is why I contacted her agent. But when I tweeted this post, I added her twitter handle, and she read the tweet, and apparently the post, and gave me permission to use a photo. So, this is Mabel. Wasn't she beautiful? (Disclosure: I grew up with parakeets, and I have a soft spot for birds):

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