Using F1000 “peer review” to promote politics over evidence about delivering psychosocial care to cancer patients

The F 1000 platform allowed authors and the reviewers whom they nominated to collaborate in crafting more of their special interest advocacy that they have widely disseminated elsewhere. Nothing original in this article and certainly not best evidence!

 

mind the brain logo

A newly posted article on the F1000 website raises questions about what the website claims is a “peer-reviewed” open research platform.

Infomercial? The F1000 platform allowed authors and the reviewers whom they nominated to collaborate in crafting more of their special interest advocacy that they have widely disseminated elsewhere. Nothing original in this article and certainly not best evidence!

I challenge the authors and the reviewers they picked to identify something said in the F1000 article that they have not said numerous times before either alone or in papers co-authored by some combination of authors and the reviewers they picked for this paper.

F1000 makes the attractive and misleading claim that versions of articles that are posted on its website reflect the response to reviewers.

Readers should be aware of uncritically accepting articles on the F 1000 website as having been peer-reviewed in any conventional sense of the term.

Will other special interests groups exploit this opportunity to brand their claims as “peer-reviewed” without the risk of having to tone down their claims in peer review? Is this already happening?

In the case of this article, reviewers were all chosen by the authors and have a history of co-authoring papers with the authors of the target paper in active advocacy of a shared political perspective, one that is contrary to available evidence.

Cynically, future authors might be motivated to divide their team, with some remaining authors and others dropping off to become nominated as reviewers. They could then suggest content that had already been agreed would be included, but was left off for the purposes being suggested in the review process

F1000

F1000Research bills itself as

An Open Research publishing platform for life scientists, offering immediate publication of articles and other research outputs without editorial bias. All articles benefit from transparent refereeing and the inclusion of all source data.

Material posted on this website is labeled as having received rapid peer-review:

Articles are published rapidly as soon as they are accepted, after passing an in-house quality check. Peer review by invited experts, suggested by the authors, takes place openly after publication.

My recent Google Scholar alert call attention to an article posted on F1000

Advancing psychosocial care in cancer patients [version 1; referees: 3 approved]

 Who were the reviewers?

open peer review of Advancing psychosocial care

Google the names of authors and reviewers. You will discover a pattern of co-authorship; leadership positions in international Psycho-Oncology society, a group promoting the mandating of specially mental health services for cancer patients, and lots of jointly and separately authored articles making a pitch for increased involvement of mental health professionals in routine cancer care. This article adds almost nothing to what is multiply available elsewhere in highly redundant publications

Given a choice of reviewers, these authors would be unlikely to nominate me. Nonetheless, here is my review of the article.

 As I might do in a review of a manuscript, I’m not providing citations for these comments, but support can readily be found by a search of blog posts at my website @CoyneoftheRealm.com and Google Scholar search of my publications. I welcome queries from anybody seeking documentation of these points below.

 Fighting Spirit

The notion that cancer patients having a fighting spirit improves survival is popular in the lay press and in promoting the power of the mind over cancer, but it has thoroughly been discredited.

Early on, the article identifies fighting spirit as an adaptive coping style. In actuality, fighting spirit was initially thought to predict mortality in a small methodologically flawed study. But that is no longer claimed.

Even one of the authors of the original study, Maggie Watson,  expressed relief when her own larger, better designed study failed to confirm the impression that a fighting spirit extended life after diagnosis  of cancer. Why? Dr. Watson was concerned that the concept was being abused in blaming cancer patients who were dying there was to their personal deficiency of not having enough fighting spirit.

Fighting spirit is rather useless as a measure of psychological adaptation. It confounds severity of cancer enrolled dysfunction with efforts to cope with cancer.

Distress as the sixth vital sign for cancer patients

distress thermometerBeware of a marketing slogan posing as an empirical statement. Its emptiness is similar to that of to “Pepsi is the one.” Can you imagine anyone conducting a serious study in which they conclude “Pepsi is not the one”?

Once again in this article, a vacuous marketing slogan is presented in impressive, but pseudo-medical terms. Distress cannot be a vital sign in the conventional sense. Thr  vital signs are objective measurements that do not depend on patient self-report: body temperature, pulse rate, and respiration rate (rate of breathing) (Blood pressure is not considered a vital sign, but is often measured along with the vital signs.).

Pain was declared a fifth vital sign, with physicians mandated  by guidelines to provide routine self-report screening of patients, regardless of their reasons for visit. Pain being the fifth vital sign seems to have been the inspiration for declaring distress as the sixth vital sign for cancer patients. However policy makers declaring pain  as the fifth vital sign did not result in improved patient levels of pain. Their subsequent making intervention mandatory for any reports of pain led to a rise in unnecessary back and knee surgery, with a substantial rise in associated morbidity and loss of function. The next shift to prescription of opioids that were claimed not to be addictive was the beginning of the current epidemic of addiction to prescription opioids. Making pain the fifth vital sign is killed a lot of patients and  turned others into addicts craving drugs on the street because they have lost their prescriptions for the opioids that addicted them.

pain as 5th vital signCDC launches

 Cancer as a mental health issue

There is a lack of evidence that cancer carries a risk of psychiatric disorder more than other chronic and catastrophic illnesses. However, the myth that there is something unique or unusual about cancer’s threat to mental health is commonly cited by mental health professional advocacy groups is commonly used to justify increased resources to them for specialized services.

The article provides an inflated estimate of psychiatric morbidity by counting adjustment disorders as psychiatric disorders. Essentially, a cancer patient who seeks mental health interventions for distress qualifies by virtue of help seeking being defined as impairment.

The conceptual and empirical muddle of “distress” in cancer patients

The article repeats the standard sloganeering definition of distress that the authors and reviewers have circulated elsewhere.

It has been very broadly defined as “a multifactorial, unpleasant, emotional experienceof a psychological (cognitive, behavioural, emotional), social and/or spiritual nature that may interfere with the ability to cope effectively with cancer, its physical symptoms and its treatment and that extends along a continuum, ranging from common normalfeelings of vulnerability, sadness and fears to problems that can become disabling, such as depression, anxiety, panic, social isolation and existential and spiritual crisis”5

[You might try googling this. I’m sure you’ll discover an amazing number of repetitions in similar articles advocating increasing psychosocial services for cancer patients organized around this broad definition.]

Distress is so broadly defined and all-encompassing, that there can be no meaningful independent validation of distress measures except for by other measures of distress, not conventional measures of adaptation or mental health. I have discussed that in a recent blog post.

If we restrict “distress” to the more conventional meaning of stress or negative affect, we find that any elevation in distress (usually 35% or so) associated with onset diagnosis of cancer tends to follow a natural trajectory of decline without formal intervention. Elevations in distress for most cancer patients, are resolved within 3 to 6 months without intervention. A residual 9 to 11% of cancer patients having elevated distress is likely attributed to pre-existing psychiatric disorder.

Routine screening for distress

The slogan “distress is the sixth vital sign” is used to justify mandatory routine screening of cancer patients for distress. In the United States, surgeons cannot close their electronic medical records for a patient and go on to the next patient without recording whether they had screened patients for distress, and if the patient reports distress, what intervention has been provided. Clinicians simply informally asking patients if they are distressed and responding to a “yes” by providing the patient with an antidepressant without further follow up allows surgeons to close the medical records.

As I have done so before, I challenge advocates of routine screening of cancer patients for distress to produce evidence that simply introducing routine screening without additional resources leads to better patient outcomes.

Routine screening for distress as uncovering unmet needs among cancer patients

 Studies in the Netherlands suggest that there is not a significant increase in need for services from mental health or allied health professionals associated with diagnosis of cancer. There is some disruption of such services that patients were receiving before diagnosis. It doesn’t take screening and discussion to suggest that patients that they at some point resume those services if they wish. There is also some increased need for physical therapy and nutritional counseling

If patients are simply asked a question whether they want a discussion of the services (in Dutch: Zou u met een deskundige willen praten over uw problemen?)  that are available, many patients will decline.

Much of demand for supportive services like counseling and support groups, especially among breast cancer patients is not from among the most distressed patients. One of the problems with clinical trials of psychosocial interventions is that most of the patients who seek enrollment are not distressed, and less they are prescreened. This poses dilemma: if you require elevated distress on a screening instrument, we end up rationing services and excluding many of the patients who would otherwise be receiving them.

I welcome clarification from F 1000 just what they offer over other preprint repositories. When one downloads a preprint from some other repositories, it clearly displays “not yet peer-reviewed.” F 1000 carries the advantage of the label of “peer-reviewed, but does not seem to be hard earned.

Notes

Slides are from two recent talks at Dutch International Congress on Insurance Medicine Thursday, November 9, 2017, Almere, Netherlands   :

Will primary care be automated screening and procedures or talking to patients and problem-solving? Invited presentation

and

Why you should not routinely screen your patients for depression and what you should do instead. Plenary Presentation

        

                                  

 

 

 

Why PhD students should not evaluate a psychotherapy for their dissertation project

  • Things some clinical and health psychology students wish they had known before they committed themselves to evaluating a psychotherapy for their dissertation study.
  • A well designed pilot study addressing feasibility and acceptability issues in conducting and evaluating psychotherapies is preferable to an underpowered study which won’t provide a valid estimate of the efficacy of the intervention.
  • PhD students would often be better off as research parasites – making use of existing published data – rather than attempting to organize their own original psychotherapy study, if their goal is to contribute meaningfully to the literature and patient care.
  • Reading this blog, you will encounter a link to free, downloadable software that allows you to make quick determinations of the number of patients needed for an adequately powered psychotherapy trial.

I so relish the extra boost of enthusiasm that many clinical and health psychology students bring to their PhD projects. They not only want to complete a thesis of which they can be proud, they want their results to be directly applicable to improving the lives of their patients.

Many students are particularly excited about a new psychotherapy about which extravagant claims are being made that it’s better than its rivals.

I have seen lots of fad and fashions come and go, third wave, new wave, and no wave therapies. When I was a PhD student, progressive relaxation was in. Then it died, mainly because it was so boring for therapists who had to mechanically provide it. Client centered therapy was fading with doubts that anyone else could achieve the results of Carl Rogers or that his three facilitative conditions of unconditional positive regard, genuineness,  and congruence were actually distinguishable enough to study.  Gestalt therapy was supercool because of the charisma of Fritz Perls, who distracted us with his showmanship from the utter lack of evidence for its efficacy.

I hate to see PhD students demoralized when their grand plans prove unrealistic.  Inevitably, circumstances force them to compromise in ways that limit any usefulness to their project, and maybe even threaten their getting done within a reasonable time period. Overly ambitious plans are the formidable enemy of the completed dissertation.

The numbers are stacked against a PhD student conducting an adequately powered evaluation of a new psychotherapy.

This blog post argues against PhD students taking on the evaluation of a new therapy in comparison to an existing one, if they expect to complete their projects and make meaningful contribution to the literature and to patient care.

I’ll be drawing on some straightforward analysis done by Pim Cuijpers to identify what PhD students are up against when trying to demonstrate that any therapy is better than treatments that are already available.

Pim has literally done dozens of meta-analyses, mostly of treatments for depression and anxiety. He commands a particular credibility, given the quality of this work. The way Pim and his colleagues present a meta-analysis is so straightforward and transparent that you can readily examine the basis of what he says.

Disclosure: I collaborated with Pim and a group of other authors in conducting a meta-analysis as to whether psychotherapy was better than a pill placebo. We drew on all the trials allowing a head-to-head comparison, even though nobody ever really set out to pit the two conditions against each other as their first agenda.

Pim tells me that the brief and relatively obscure letter, New Psychotherapies for Mood and Anxiety Disorders: Necessary Innovation or Waste of Resources? on which I will draw is among his most unpopular pieces of work. Lots of people don’t like its inescapable message. But I think that if PhD students should pay attention, they might avoid a lot of pain and disappointment.

But first…

Note how many psychotherapies have been claimed to be effective for depression and anxiety. Anyone trying to make sense of this literature has to contend with claims being based on a lot of underpowered trials– too small in sample size to be expected reasonably to detect the effects that investigators claim – and that are otherwise compromised by methodological limitations.

Some investigators were simply naïve about clinical trial methodology and the difficulties doing research with clinical populations. They may have not understand statistical power.

But many psychotherapy studies end up in bad shape because the investigators were unrealistic about the feasibility of what they were undertaken and the low likelihood that they could recruit the patients in the numbers that they had planned in the time that they had allotted. After launching the trial, they had to change strategies for recruitment, maybe relax their selection criteria, or even change the treatment so it was less demanding of patients’ time. And they had to make difficult judgments about what features of the trial to drop when resources ran out.

Declaring a psychotherapy trial to be a “preliminary” or a “pilot study” after things go awry

The titles of more than a few articles reporting psychotherapy trials contain the apologetic qualifier after a colon: “a preliminary study” or “a pilot study”. But the studies weren’t intended at the outset to be preliminary or pilot studies. The investigators are making excuses post-hoc – after the fact – for not having been able to recruit sufficient numbers of patients and for having had to compromise their design from what they had originally planned. The best they can hope is that the paper will somehow be useful in promoting further research.

Too many studies from which effect sizes are entered into meta-analyses should have been left as pilot studies and not considered tests of the efficacy of treatments. The rampant problem in the psychotherapy literature is that almost no one treats small scale trials as mere pilot studies. In a recent blog post, I provided readers with some simple screening rules to identify meta-analyses of psychotherapy studies that they could dismiss from further consideration. One was whether there were sufficient numbers of adequately powered studies,  Often there are not.

Readers take their inflated claims of results of small studies seriously, when these estimates should be seen as unrealistic and unlikely to be replicated, given a study’s sample size. The large effect sizes that are claimed are likely the product of p-hacking and the confirmation bias required to get published. With enough alternative outcome variables to choose from and enough flexibility in analyzing and interpreting data, almost any intervention can be made to look good.

The problem is is readily seen in the extravagant claims about acceptance and commitment therapy (ACT), which are so heavily dependent on small, under-resourced studies supervised by promoters of ACT that should not have been used to generate effect sizes.

Back to Pim Cuijpers’ brief letter. He argues, based on his numerous meta-analyses, that it is unlikely that a new treatment will be substantially more effective than an existing credible, active treatment.  There are some exceptions like relaxation training versus cognitive behavior therapy for some anxiety disorders, but mostly only small differences of no more than d= .20 are found between two active, credible treatments. If you search the broader literature, you can find occasional exceptions like CBT versus psychoanalysis for bulimia, but most you find prove to be false positives, usually based on investigator bias in conducting and interpreting a small, underpowered study.

You can see this yourself using the freely downloadable G*power program and plug in d= 0.20 for calculating the number of patients needed for a study. To be safe, add more patients to allow for the expectable 25% dropout rate that has occurred across trials. The number you get would require a larger study than has ever been done in the past, including the well-financed NIMH Collaborative trial.

G power analyses

Even more patients would be needed for the ideal situation in which a third comparison group allowed  the investigator to show the active comparison treatment had actually performed better than a nonspecific treatment that was delivered with the same effectiveness that the other had shown in earlier trials. Otherwise, a defender of the established therapy might argue that the older treatment had not been properly implemented.

So, unless warned off, the PhD student plans a study to show not only that now hypothesis can be rejected that the new treatment is no better than the existing one, but that in the same study the existing treatment had been shown to be better than wait list. Oh my, just try to find an adequately powered, properly analyzed example of a comparison of two active treatments plus a control comparison group in the existing published literature. The few examples of three group designs in which a new psychotherapy had come out better than an effectively implemented existing treatment are grossly underpowered.

These calculations so far have all been based on what would be needed to reject the null hypothesis of no difference between the active treatment and a more established one. But if the claim is that the new treatment is superior to the existing treatment, our PhD student now needs to conduct a superiority trial in which some criteria is pre-set (such as greater than a moderate difference, d= .30) and the null hypothesis is that the advantage of the new treatment is less. We are now way out into the fantasyland of breakthrough, but uncompleted dissertation studies.

Two take away messages

 The first take away message is that we should be skeptical of claims of the new treatment is better than past ones except when the claim occurs in a well-designed study with some assurance that it is free of investigator bias. But the claim also has to arise in a trial that is larger than almost any psychotherapy study is ever been done. Yup, most comparative psychotherapy studies are underpowered and we cannot expect robust claims are robust that one treatment is superior to another.

But for PhD students been doing a dissertation project, the second take away message is that they should not attempt to show that one treatment is superior to another in the absence of resources they probably don’t have.

The psychotherapy literature does not need another study with too few patients to support its likely exaggerated claims.

An argument can be made that it is unfair and even unethical to enroll patients in a psychotherapy RCT with insufficient sample size. Some of the patients will be randomized to the control condition that is not what attracted them to the trial. All of the patients will be denied having been in a trial makes a meaningful contribution to the literature and to better care for patients like themselves.

What should the clinical or health psychology PhD student do, besides maybe curb their enthusiasm? One opportunity to make meaningful contributions to literature by is by conducting small studies testing hypotheses that can lead to improvement in the feasibility or acceptability of treatments to be tested in studies with more resources.

Think of what would’ve been accomplished if PhD students had determined in modest studies that it is tough to recruit and retain patients in an Internet therapy study without some communication to the patients that they are involved in a human relationship – without them having what Pim Cuijpers calls supportive accountability. Patients may stay involved with the Internet treatment when it proves frustrating only because they have the support and accountability to someone beyond their encounter with an impersonal computer. Somewhere out there, there is a human being who supports them and sticking it out with the Internet psychotherapy and will be disappointed if they don’t.

A lot of resources have been wasted in Internet therapy studies in which patients have not been convinced that what they’re doing is meaningful and if they have the support of a human being. They drop out or fail to do diligently any homework expected of them.

Similarly, mindfulness studies are routinely being conducted without anyone establishing that patients actually practice mindfulness in everyday life or what they would need to do so more consistently. The assumption is that patients assigned to the mindfulness diligently practice mindfulness daily. A PhD student could make a valuable contribution to the literature by examining the rates of patients actually practicing mindfulness when the been assigned to it in a psychotherapy study, along with barriers and facilitators of them doing so. A discovery that the patients are not consistently practicing mindfulness might explain weaker findings than anticipated. One could even suggest that any apparent effects of practicing mindfulness were actually nonspecific, getting all caught up in the enthusiasm of being offered a treatment that has been sought, but not actually practicing mindfulness.

An unintended example: How not to recruit cancer patients for a psychological intervention trial

Randomized-controlled-trials-designsSometimes PhD students just can’t be dissuaded from undertaking an evaluation of a psychotherapy. I was a member of a PhD committee of a student who at least produced a valuable paper concerning how not to recruit cancer patients for a trial evaluating problem-solving therapy, even though the project fell far short of conducting an adequately powered study.

The PhD student was aware that  claims of effectiveness of problem-solving therapy reported in in the prestigious Journal of Consulting and Clinical Psychology were exaggerated. The developer of problem-solving therapy for cancer patients (and current JCCP Editor) claimed  a huge effect size – 3.8 if only the patient were involved in treatment and an even better 4.4 if the patient had an opportunity to involve a relative or friend as well. Effect sizes for this trial has subsequently had to be excluded from at least meta-analyses as an extreme outlier (1,2,3,4).

The student adopted the much more conservative assumption that a moderate effect size of .6 would be obtained in comparison with a waitlist control. You can use G*Power to see that 50 patients would be needed per group, 60 if allowance is made for dropouts.

Such a basically inert control group, of course, has a greater likelihood of seeming to demonstrate a treatment is effective than when the comparison is another active treatment. Of course, such a control group also has the problem of not allowing a determination if it was the active ingredient of the treatment that made the difference, or just the attention, positive expectations, and support that were not available in the waitlist control group.

But PhD students should have the same option as their advisors to contribute another comparison between an active treatment and a waitlist control to the literature, even if it does not advance our knowledge of psychotherapy. They can take the same low road to a successful career that so many others have traveled.

This particular student was determined to make a different contribution to the literature. Notoriously, studies of psychotherapy with cancer patients often fail to recruit samples that are distressed enough to register any effect. The typical breast cancer patient, for instance, who seeks to enroll in a psychotherapy or support group trial does not have clinically significant distress. The prevalence of positive effects claimed in the literature for interventions with cancer patients in published studies likely represents a confirmation bias.

The student wanted to address this issue by limiting patients whom she enrolled in the study to those with clinically significant distress. Enlisting colleagues, she set up screening of consecutive cancer patients in oncology units of local hospitals. Patients were first screened for self-reported distress, and, if they were distressed, whether they were interested in services. Those who met both criteria were then re-contacted to see if that be willing to participate in a psychological intervention study, without the intervention being identified. As I reported in the previous blog post:

  • Combining results of  the two screenings, 423 of 970 patients reported distress, of whom 215 patients indicated need for services.
  • Only 36 (4% of 970) patients consented to trial participation.
  • We calculated that 27 patients needed to be screened to recruit a single patient, with 17 hours of time required for each patient recruited.
  • 41% (n= 87) of 215 distressed patients with a need for services indicated that they had no need for psychosocial services, mainly because they felt better or thought that their problems would disappear naturally.
  • Finally, 36 patients were eligible and willing to be randomized, representing 17% of 215 distressed patients with a need for services.
  • This represents 8% of all 423 distressed patients, and 4% of 970 screened patients.

So, the PhD student’s heroic effort did not yield the sample size that she anticipated. But she ended up making a valuable contribution to the literature that challenges some of the basic assumptions that were being made about how cancer patients in psychotherapy research- that all or most were distressed. She also ended up producing some valuable evidence that the minority of cancer patients who report psychological distress are not necessarily interested in psychological interventions.

Fortunately, she had been prepared to collect systematic data about these research questions, not just scramble within a collapsing effort at a clinical trial.

Becoming a research parasite as an alternative to PhD students attempting an under-resourced study of their own

research parasite awardPsychotherapy trials represent an enormous investment of resources, not only the public funding that is often provided for them,be a research parasite but in the time, inconvenience, and exposure to ineffective treatments experienced by patients who participate in the trials. Increasingly, funding agencies require that investigators who get money to do a psychotherapy study some point make their data available for others to use.  The 14 prestigious medical journals whose editors make up the International Committee of Medical Journal Editors (ICMJE) each published in earlier in 2016 a declaration that:

there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk.

These statements proposed that as a condition for publishing a clinical trial, investigators would be required to share with others appropriately de-identified data not later than six months after publication. Further, the statements proposed that investigators describe their plans for sharing data in the registration of trials.

Of course, a proposal is only exactly that, a proposal, and these requirements were intended to take effect only after the document is circulated and ratified. The incomplete and inconsistent adoption of previous proposals for registering of  trials in advance and investigators making declarations of conflicts of interest do not encourage a lot of enthusiasm that we will see uniform implementation of this bold proposal anytime soon.

Some editors of medical journals are already expressing alarmover the prospect of data sharing becoming required. The editors of New England Journal of Medicine were lambasted in social media for their raising worries about “research parasites”  exploiting the availability of data:

a new class of research person will emerge — people who had nothing to do with the design and execution of the study but use another group’s data for their own ends, possibly stealing from the research productivity planned by the data gatherers, or even use the data to try to disprove what the original investigators had posited. There is concern among some front-line researchers that the system will be taken over by what some researchers have characterized as “research parasites.”

 Richard Lehman’s  Journal Review at the BMJ ‘s blog delivered a brilliant sarcastic response to these concerns that concludes:

I think we need all the data parasites we can get, as well as symbionts and all sorts of other creatures which this ill-chosen metaphor can’t encompass. What this piece really shows, in my opinion, is how far the authors are from understanding and supporting the true opportunities of clinical data sharing.

However, lost in all the outrage that The New England Journal of Medicine editorial generated was a more conciliatory proposal at the end:

How would data sharing work best? We think it should happen symbiotically, not parasitically. Start with a novel idea, one that is not an obvious extension of the reported work. Second, identify potential collaborators whose collected data may be useful in assessing the hypothesis and propose a collaboration. Third, work together to test the new hypothesis. Fourth, report the new findings with relevant coauthorship to acknowledge both the group that proposed the new idea and the investigative group that accrued the data that allowed it to be tested. What is learned may be beautiful even when seen from close up.

The PLOS family of journals has gone on record as requiring that all data for papers published in their journals be publicly available without restriction.A February 24, 2014 PLOS’ New Data Policy: Public Access to Data  declared:

In an effort to increase access to this data, we are now revising our data-sharing policy for all PLOS journals: authors must make all data publicly available, without restriction, immediately upon publication of the article. Beginning March 3rd, 2014, all authors who submit to a PLOS journal will be asked to provide a Data Availability Statement, describing where and how others can access each dataset that underlies the findings. This Data Availability Statement will be published on the first page of each article.

Many of us are aware of the difficulties in achieving this lofty goal. I am holding my breath and turning blue, waiting for some specific data.

The BMJ has expanded their previous requirements for data being available:

Loder E, Groves T. The BMJ requires data sharing on request for all trials. BMJ. 2015 May 7;350:h2373.

The movement to make data from clinical trials widely accessible has achieved enormous success, and it is now time for medical journals to play their part. From 1 July The BMJ will extend its requirements for data sharing to apply to all submitted clinical trials, not just those that test drugs or devices. The data transparency revolution is gathering pace.

I am no longer heading dissertation committees after one that I am currently supervising is completed. But if any PhD students asked my advice about a dissertation project concerning psychotherapy, I would strongly encourage them to enlist their advisor to identify and help them negotiate access to a data set appropriate to the research questions they want to investigate.

Most well-resourced psychotherapy trials have unpublished data concerning how they were implemented, with what bias and with which patient groups ending up underrepresented or inadequately exposed to the intensity of treatment presumed to be needed for benefit. A story awaits to be told. The data available from a published trial are usually much more adequate than then any graduate student could collect with the limited resources available for a dissertation project.

I look forward to the day when such data is put into a repository where anyone can access it.

until youre done In this blog post I have argued that PhD students should not take on responsibility for developing and testing a new psychotherapy for their dissertation project. I think that using data from existing published trials is a much better alternative. However, PhD students may currently find it difficult, but certainly not impossible to get appropriate data sets. I certainly am not recruiting them to be front-line infantry in advancing the cause of routine data sharing. But they can make an effort to obtain such data and they deserve all support they can get from their dissertation committees in obtaining data sets and in recognizing when realistically that data are not being made available, even when the data have been promised to be available as a condition for publishing. Advisors, please request the data from published trials for your PhD students and protect them from the heartache of trying to collect such data themselves.

 

Trusted source? The Conversation tells migraine sufferers that child abuse may be at the root of their problems

Patients and family members face a challenge obtaining credible, evidence-based information about health conditions from the web.

Migraine sufferers have a particularly acute need because their condition is often inadequately self-managed without access to best available treatment approaches. Demoralized by the failure of past efforts to get relief, some sufferers may give up consulting professionals and desperately seek solutions on Internet.

A lot of both naïve and exploitative quackery that awaits them.

Even well-educated patients cannot always distinguish the credible from the ridiculous.

One search strategy is to rely on websites that have proven themselves as trusted sources.

The Conversation has promoted itself as such a trusted source, but its brand is tarnished by recent nonsense we will review concerning the role of child abuse in migraines.

Despite some excellent material that has appeared in other articles in The Conversation, I’m issuing a reader’s advisory:

exclamation pointThe Conversation cannot be trusted because this article shamelessly misinforms migraine sufferers that child abuse could be at the root of their problems.

The Conversation article concludes with a non sequitur that shifts sufferers and their primary care physicians away from getting consultation with the medical specialists who are most able to improve management of a complex condition.

 

The Conversation article tells us:

Within a migraine clinic population, clinicians should pay special attention to those who have been subjected to maltreatment in childhood, as they are at increased risk of being victims of domestic abuse and intimate partner violence as adults.

That’s why clinicians should screen migraine patients, and particularly women, for current abuse.

This blog post identifies clickbait, manipulation, misapplied buzz terms, and  misinformation – in the The Conversation article.

Perhaps the larger message of this blog post is that persons with complex medical conditions and those who provide formal and informal care for them should not rely solely on what they find on the Internet. This exercise specifically focusing on The Conversation article serves to demonstrate this.

Hopefully, The Conversation will issue a correction, as they promise to do at the website when errors are found.

We are committed to responsible and ethical journalism, with a strict Editorial Charter and codes of conduct. Errors are corrected promptly.

The Conversation article –

Why emotional abuse in childhood may lead to migraines in adulthood

clickbaitA clickbait title offered a seductive  integration of a trending emotionally laden social issue – child abuse – with a serious medical condition – migraines – for which management is often not optimal. A widely circulating estimate is that 60% of migraine sufferers do not get appropriate medical attention in large part because they do not understand the treatment options available and may actually stop consulting physicians.

Some quick background about migraine from another, more credible source:

Migraines are different from other headaches. People who suffer migraines other debilitating symptoms.

  • visual disturbances (flashing lights, blind spots in the vision, zig zag patterns etc).
  • nausea and / or vomiting.
  • sensitivity to light (photophobia).
  • sensitivity to noise (phonophobia).
  • sensitivity to smells (osmophobia).
  • tingling / pins and needles / weakness / numbness in the limbs.

Persons with migraines differ greatly among themselves in terms of the frequency, intensity, and chronicity of their symptoms, as well as their triggers for attacks.

Migraine is triggered by an enormous variety of factors – not just cheese, chocolate and red wine! For most people there is not just one trigger but a combination of factors which individually can be tolerated. When these triggers occur altogether, a threshold is passed and a migraine is triggered. The best way to find your triggers is to keep a migraine diary. Download your free diary now!

Into The Conversation article: What is the link between emotional abuse and migraines?

Without immediately providing a clicklink so that  readers can check sources themselves, The Conversation authors say they are drawing on “previous research, including our own…” to declare there is indeed an association between past abuse and migraines.

Previous research, including our own, has found a link between experiencing migraine headaches in adulthood and experiencing emotional abuse in childhood. So how strong is the link? What is it about childhood emotional abuse that could lead to a physical problem, like migraines, in adulthood?

In invoking the horror of childhood emotional abuse, the authors imply that they are talking about something infrequent – outside the realm of most people’s experience.  If “childhood emotional abuse” is commonplace, how could  it be horrible and devastating?

In their pursuit of click bait sensationalism, the authors have only succeeded in trivializing a serious issue.

A minority of people endorsing items concerning past childhood emotional abuse actually currently meet criteria for a diagnosis of posttraumatic stress disorder. Their needs are not met by throwing them into a larger pool of people who do not meet these criteria and making recommendations based on evidence derived from the combined group.

Spiky_Puffer_Fish_Royalty_Free_Clipart_Picture_090530-025255-184042The Conversation authors employ a manipulative puffer fish strategy [1 and  2 ] They take what is a presumably infrequent condition and  attach horror to it. But they then wildly increase the presumed prevalence by switching to a definition that arises in a very different context:

Any act or series of acts of commission or omission by a parent or other caregiver that results in harm, potential for harm, or threat of harm to a child.

So we are now talking about ‘Any act or series of acts? ‘.. That results in ‘harm, potential for harm or threat’? The authors then assert that yes, whatever they are talking about is indeed that common. But the clicklink to support for this claim takes the reader behind a pay wall where a consumer can’t venture without access to a university library account.

Most readers are left with the authors’ assertion as an authority they can’t check. I have access to a med school library and I checked. The link is  to a secondary source. It is not a systematic review of the full range of available evidence. Instead, it is a  selective search for evidence favoring particular speculations. Disconfirming evidence is mostly ignored. Yet, this article actually contradicts other assertions of The Conversation authors. For instance, the paywalled article says that there is actually little evidence that cognitive behavior therapy is effective for people whose need for therapy is only because they  reported abuse in early childhood.

Even if you can’t check The Conversation authors’ claims, know that adults’ retrospective of childhood adversity are not particularly reliable or valid, especially studies relying on checklist responses of adults to broad categories, as this research does.

When we are dealing with claims that depend on adult retrospective reports of childhood adversity, we are dealing with a literature with seriously deficiencies. This literature grossly overinterprets common endorsement of particular childhood experiences as strong evidence of exposure to horrific conditions. This literature has a strong confirmation bias. Positive findings are highlighted. Negative findings do not get cited much. Serious limitations in methodology and inconsistency and findings generally ignored.

[This condemnation is worthy of a blog post or two itself. But ahead I will provide some documentation.]

The Conversation authors explain the discrepancy between estimates based on administrative data of one in eight children suffering abuse or neglect before age 18 versus much higher estimates from retrospective adult reports on the basis of so much abuse going unreported.

The discrepancy may be because so many cases of childhood abuse, particularly cases of emotional or psychological abuse, are unreported. This specific type of abuse may occur within a family over the course of years without recognition or detection.

This could certainly be true, but let’s see the evidence. A lack of reporting could also indicate a lack of many experiences reaching a threshold prompting reporting. I’m willing to be convinced otherwise, but let’s see the evidence.

The link between emotional abuse and migraines

The Conversation authors provide links only to their own research for their claim:

While all forms of childhood maltreatment have been shown to be linked to migraines, the strongest and most significant link is with emotional abuse. Two studies using nationally representative samples of older Americans (the mean ages were 50 and 56 years old, respectively) have found a link.

The first link is to an article that is paywalled except for its abstract. The abstract shows  the study does not involve a nationally representative sample of adults. The study compared patients with tension headaches to patients with migraines, without a no-headache control group. There is thus no opportunity to examine whether persons with migraines recall more emotional abuse than persons who do not suffer headaches.  Any significant associations in a huge sample disappeared after controlling for self-reported depression and anxiety.

My interpretation: There is nothing robust here. Results could be due to crude measurement, confounding of retrospective self-report by current self-report anxious or depressive symptoms. We can’t say much without a no-headache control group.

The second of the authors’ studies is also paywalled, but we can see from the abstract:

We used data from the Adverse Childhood Experiences (ACE) study, which included 17,337 adult members of the Kaiser Health Plan in San Diego, CA who were undergoing a comprehensive preventive medical evaluation. The study assessed 8 ACEs including abuse (emotional, physical, sexual), witnessing domestic violence, growing up with mentally ill, substance abusing, or criminal household members, and parental separation or divorce. Our measure of headaches came from the medical review of systems using the question: “Are you troubled by frequent headaches?” We used the number of ACEs (ACE score) as a measure of cumulative childhood stress and hypothesized a “dose–response” relationship of the ACE score to the prevalence and risk of frequent headaches.

Results — Each of the ACEs was associated with an increased prevalence and risk of frequent headaches. As the ACE score increased the prevalence and risk of frequent headaches increased in a “dose–response” fashion. The risk of frequent headaches increased more than 2-fold (odds ratio 2.1, 95% confidence interval 1.8-2.4) in persons with an ACE score ≥5, compared to persons with and ACE score of 0. The dose–response relationship of the ACE score to frequent headaches was seen for both men and women.

The Conversation authors misrepresent this study. It is about self-reported headaches, not the subgroup of these patients reporting migraines. But in the first of their own studies they just cited, the authors contrast tension headaches with migraine headaches, with no controls.

So the data did not allow examination of the association between adult retrospective reports of childhood emotional abuse and migraines. There is no mention of self-reported depression and anxiety, which wiped out any relationship with childhood adversity in headaches in the first study. I would expect that a survey of ACES would include such self-report. And the ACEs equate either parental divorce and separation (the same common situation likely occur together and so are counted twice) with sexual abuse in calculating an overall score.

The authors make a big deal of the “dose-response” they found. But this dose-response could just represent uncontrolled confounding  – the more ACEs indicates the more confounding, greater likelihood that respondents faced other social, person, economic, and neighborhood deprivations.  The higher the ACE score, the greater likelihood that other background characteristic s are coming into play.

The only other evidence the authors cite is again another one of their papers, available only as a conference abstract. But the abstract states:

Results: About 14.2% (n = 2,061) of the sample reported a migraine diagnosis. Childhood abuse was recalled by 60.5% (n =1,246) of the migraine sample and 49% (n = 6,088) of the non-migraine sample. Childhood abuse increased the chances of a migraine diagnosis by 55% (OR: 1.55; 95% CI 1.35 – 1.77). Of the three types of abuse, emotional abuse had a stronger effect on migraine (OR: 1.52; 95% CI 1.34 – 1.73) when compared to physical and sexual abuse. When controlled for depression and anxiety, the effect of childhood abuse on migraine (OR: 1.32; 95% CI 1.15 – 1.51) attenuated but remained significant. Similarly, the effect of emotional abuse on migraine decreased but remained significant (OR: 1.33; 95% CI 1.16 – 1.52), when controlled for depression and anxiety.

The rates of childhood abuse seem curiously high for both the migraine and non-migraine samples. If you dig a bit on the web for details of the National Longitudinal Study of Adolescent Health, you can find how crude the measurement is.  The broad question assessing emotional abuse covers the full range of normal to abnormal situations without distinguishing among them.

How often did a parent or other adult caregiver say things that really hurt your feelings or made you feel like you were not wanted or loved? How old were you the first time this happened? (Emotional abuse).

An odds ratio of 1.33 is not going to attract much attention from an epidemiologist, particularly when it is obtained from such messy data.

I conclude that the authors have made only a weak case for the following statement: While all forms of childhood maltreatment have been shown to be linked to migraines, the strongest and most significant link is with emotional abuse.

Oddly, if we jump ahead to the closing section of The Conversation article, the authors concede:

Childhood maltreatment probably contributes to only a small portion of the number of people with migraine.

But, as we will  see, they make recommendations that assume a strong link has been established.

Why would emotional abuse in childhood lead to migraines in adulthood?

This section throws out a number of trending buzz terms, strings them together in a way that should impress and intimidate consumers, rather than allow them independent evaluation of what is being said.

got everything

The section also comes below a stock blue picture of the brain.  In web searches, the picture  is associated with social media where the brain is superficially brought into  in discussions where neuroscience is  not relevant.

An Australian neuroscientist commented on Facebook:

Deborah on blowing brains

The section starts out:

The fact that the risk goes up in response to increased exposure is what indicates that abuse may cause biological changes that can lead to migraine later in life. While the exact mechanism between migraine and childhood maltreatment is not yet established, research has deepened our understanding of what might be going on in the body and brain.

We could lost in a quagmire trying to figuring out the evidence for the loose associations that are packed into a five paragraph section.  Instead,  I’ll make some observations that can be followed up by interested readers.

The authors acknowledge that no mechanism has been established linking migraines and child maltreatment. The link for this statement takes the reader to the authors own pay walled article that is explicitly labeled “Opinion Statement ”.

The authors ignore a huge literature that acknowledges great heterogeneity among sufferers of migraines, but points to some rather strong evidence for treatments based on particular mechanisms identified among carefully selected patients. For instance, a paper published in The New England Journal of Medicine with well over 1500 citations:

Goadsby PJ, Lipton RB, Ferrari MD. Migraine—current understanding and treatment. New England Journal of Medicine. 2002 Jan 24;346(4):257-70.

Speculations concerning the connections between childhood adversity, migraines and the HPA axis are loose. The Conversation authors their obviousness needs to be better document with evidence.

For instance, if we try to link “childhood adversity” to the HPA axis, we need to consider the lack of specificity of” childhood adversity’ as defined by retrospective endorsement of Adverse Childhood Experiences (ACEs). Suppose we rely on individual checklist items or cumulative scores based on number of endorsements. We can’t be sure that we are dealing with actual rather than assumed exposure to traumatic events or that there be any consistent correlates in current measures derived from the HPA axis.

Any non-biological factor defined so vaguely is not going to be a candidate for mapping into causal processes or biological measurements.

An excellent recent Mind the Brain article by my colleague blogger Shaili Jain interviews Dr. Rachel Yehuda, who had a key role in researching HPA axis in stress. Dr. Yehuda says endocrinologists would cringe at the kind of misrepresentations that are being made in The Conversation article.

A recent systematic review concludes the evidence for specific links between child treatment and inflammatory markers is of limited and poor quality.

Coelho R, Viola TW, Walss‐Bass C, Brietzke E, Grassi‐Oliveira R. Childhood maltreatment and inflammatory markers: a systematic review. Acta Psychiatrica Scandinavica. 2014 Mar 1;129(3):180-92.

The Conversation article misrepresents gross inconsistencies in the evidence of biological correlates representing biomarkers. There are as yet no biomarkers for migraines in the sense of a biological measurement that reliably distinguishes persons with migraines from other patient populations with whom they may be confused. See an excellent funny blog post by Hilda Bastian.

Notice the rhetorical trick in authors of The Conversation article’s assertion that

Migraine is considered to be a hereditary condition. But, except in a small minority of cases, the genes responsible have not been identified.

Genetic denialists like Oliver James  or Richard Bentall commonly phrased questions in this manner to be a matter of hereditary versus non-hereditary. But complex traits like height, intelligence, or migraines involve combinations of variations in a number of genes, not a single gene or even a few genes.. For an example of the kind of insights that sophisticated genetic studies of migraines are yielding see:

Yang Y, Ligthart L, Terwindt GM, Boomsma DI, Rodriguez-Acevedo AJ, Nyholt DR. Genetic epidemiology of migraine and depression. Cephalalgia. 2016 Mar 9:0333102416638520.

The Conversation article ends with some signature nonsense speculation about epigenetics:

However, stress early in life induces alterations in gene expression without altering the DNA sequence. These are called epigenetic changes, and they are long-lasting and may even be passed on to offspring.

Interested readers can find these claims demolished in Epigenetic Ain’t Magic by PZ Myers, a biologist who attempts to rescue an extremely important development concept from its misuse.

Or Carl Zimmer’s Growing Pains for Field of Epigenetics as Some Call for Overhaul.

What does this mean for doctors treating migraine patients?

The Conversation authors startle readers with an acknowledgment that contradicts what they have been saying earlier in their article:

Childhood maltreatment probably contributes to only a small portion of the number of people with migraine.

It is therefore puzzling when they next say:

But because research indicates that there is a strong link between the two, clinicians may want to bear that in mind when evaluating patients.

Cognitive behavior therapy is misrepresented as an established effective treatment for migraines. A recent systematic review and meta-analysis  had to combine migraines with other chronic headaches and order to get ten studies to consider.

The conclusion of this meta-analysis:

Methodology inadequacies in the evidence base make it difficult to draw any meaningful conclusions or to make any recommendations.

The Conversation article notes that the FDA has approved anti-epileptic drugs such as valproate and topiramate for treatment of migraines. However, the article’s claim that the efficacy of these drugs are due to their effects on epigenetics is quite inconsistent with what is said in the larger literature.

Clinicians specializing and treating fibromyalgia or irritable bowel syndrome would be troubled by the authors’ lumping these conditions with migraines and suggesting that a psychiatric consultation is the most appropriate referral for patients who are having difficulty achieving satisfactory management.

See for instance the links contained in my blog post, No, irritable bowel syndrome is not all in your head.

The Conversation article closes with:

Within a migraine clinic population, clinicians should pay special attention to those who have been subjected to maltreatment in childhood, as they are at increased risk of being victims of domestic abuse and intimate partner violence as adults.

That’s why clinicians should screen migraine patients, and particularly women, for current abuse.

It’s difficult to how this recommendation is relevant to what has preceded it. Routine screening is not evidence-based.

The authors should know that the World Health Organization formerly recommended screening primary care women for intimate abuse but withdrew the recommendation because of a lack of evidence that it improved outcomes for women facing abuse and a lack of evidence that no harm was being done.

I am sharing this blog post with the authors of The Conversation article. I am requesting a correction from The Conversation. Let’s see what they have to say.

Meanwhile, patients seeking health information are advised to avoid The Conversation.

Distress- the 6th vital sign for cancer patients?

A third or more of cancer patients experience significant psychological distress following their diagnosis. Yet a much smaller proportion receives any psychosocial services.

Cancer-Care-for-the-Whole-Patient-Meeting-Psychosocial-Health-NeedsThis situation is counter to recommendations from a number of sources, including the US Institute of Medicine report, Care of the Whole Patient, Meeting Psychosocial Health Needs. The gap between the proportion of patients experiencing distress and those getting services has led to widespread calls for implementing routine screening for distress. The assumption is that the breakdown between being distressed and getting services is patients getting identified and being referred to appropriate services.

There have been intense national and international campaigns by professional organizations first to recommend implementation of screening and then to mandate it as a condition of accreditation of cancer care settings. Increasingly, campaigns are organized around the slogan “distress is the sixth vital sign.” Promoters have sufficient political clout to get the slogan into the titles of articles in scientific journals, often with leaders of the field of psycho-oncology lending support as co-authors.

Holland, J. C., & Bultz, B. D. (2007). The NCCN guideline for distress management: a case for making distress the sixth vital sign. Journal of the National Comprehensive Cancer Network, 5(1), 3-7.

Bultz, B. D., & Johansen, C. (2011). Screening for distress, the 6th vital sign: where are we, and where are we going? PsychoOncology, 20(6), 569-57.

Watson, M., & Bultz, B. D. (2010). Distress, the 6th vital sign in cancer care. Psycho-oncologie, 4(3), 159-163.

The push to make distress accepted as the sixth vital sign for cancer patients is modeled after efforts to get pain designated as the fifth vital sign for general medical patients. In the late 1980s, it was recognized that pain management was grossly inadequate, with many patients’ pain going undetected and untreated. Pain was designated the fifth vital sign in general medical settings, with guidelines set for assessment and improved referral and treatment. These guidelines were first simply recommendations, but they grew to be mandated, with performance goals and quality of care indicators established to monitor their implementation in particular settings.

What is distress? Maybe not what you think

distressDistress was originally defined narrowly in terms of stress and anxiety and depressive symptoms. Early screening recommendations were for quick assessment with a distress thermometer modeled after the simple pain rating scale adopted in the campaign for pain as the fifth vital sign. Efforts were made to validate distress thermometers in terms of their equivalence to longer self-report measures of anxiety and depression, and in turn, interview-based measures of psychiatric disorder. Ratings on a distress thermometer were not seen as a substitute for longer assessments, but rather as a screening for whether longer assessments were needed. Patients who screened above a cutpoint on a distress thermometer would be identified for further assessment.

“Distress” was the preferred term, rather than stress or anxiety or depressive symptoms, because it was viewed as more neutral and not necessarily indicating that someone who wanted services had a psychiatric disorder. It was believed that many cancer patients did not seek services out of fear of being stigmatized and this vague term might avoid that raising that barrier to treatment.

However, the definition has now been extended to include a much broader range of needs and concerns. The widely cited definition of the NCCN of distress is

An unpleasant emotional experience of a psychological, social and/or spiritual nature which extends on a continuum from normal feelings of vulnerability, sadness and fears to disabling problems  such as depression, anxiety, panic, social isolation and spiritual crisis.

The emphasis is still on quick screening, but the distress thermometer is typically supplemented with a checklist of common problems. Particular items vary across recommendations for screening, but the checklist is meant to be a brief supplement to the distress thermometer. Canadians who have taken the lead in promoting distress as the sixth vital sign recommend a Modified Problem Checklist (PCL).

Click to Enlarge
Click to Enlarge

This list contains the 7 most common practical problems in our  settings (accommodation, transportation, parking, drug coverage, work/school, income/finances, and groceries); and 13 psychosocial problems (burden to others, worry about family/friends, talking with family, talking with medical team, family conflict, changes  in appearance; alcohol/drugs, smoking, coping, sexuality, spirituality, treatment decisions and  sleep). Participants indicate the presence or absence of each problem in the preceding week.

Despite the range of problems being assessed, the assumption is still that the predominant form of services that patients will seek as a result of being screened is some form of psychological counseling or psychotherapy.

Interventions usually assume one of four common forms: psychoeducation, cognitive-behavioural training (group or individual), group supportive therapy, and individual supportive therapy.

Support by professional organizations for screening of distress is quite widespread. Well-organized proponents exercise their political clout in making expression of enthusiasm for screening an obligatory condition for publishing in psycho-oncology journals. Dissenting critics and embarrassing data can be summarily sandbagged. Even when embarrassing data makes it through the review process, authors may be surprised to discover that their articles are accompanied by disparaging commentaries, to which they have not been offered an opportunity to respond. I have been publishing for over thirty years, and I have never before encountered the level of bullying that I have seen with papers concerning screening.

screeningYet, promotion of implementing routine screening for distress is based only on consensus of like-minded professionals, not the systematic evaluation of evidence that medical screening generally requires. Screening tests are common in medicine. The standard criteria for adopting a recommendation for screening is that it can be shown to improve patient outcomes beyond simply making available to patients and their providers the resources that are accessed by screening.

It is not sufficient that screening address a serious problem, it must also lead to improved outcomes. For instance, it is now recognized that although prostate cancer is a common and threatening disease, routine screening for prostate cancer of men without symptoms is likely to lead to overtreatment and side effects incontinence and loss of a sexual functioning, without any improvement in overall survival. Campaigns to promote  prostate specific antigen (PSA) testing have largely been discontinued. More generally, Choosing Wisely committees are systematically reevaluating the evidence for common forms of screening and withdrawing recommendations. Some well established screening procedures are losing their recommendation.

We undertook a systematic review of the literature concerning screening for distress and failed to find sufficient evidence to recommend it.

scrrening art
Click to Enlarge

Because of the lack of evidence of beneficial effects of screening cancer patients for distress, it is premature to recommend or mandate implementation of routine screening.

Other reviews have come to more favorable evaluations of screening,  arrived at by including nonrandomized trials or trials that chose number of referrals being made is a surrogate outcome in place of distress being reduced. However, for a patient getting referred to experience reduced distress, a complex pathway has to be crossed, starting with acceptance and completion of the referral and including receiving appropriate treatment at an appropriate level of intensity and frequency. Referrals, particularly when they are to outside the cancer’s care setting, are notoriously black holes. There are a few systematic data concerning the fate of referrals, but the general consensus is that many, perhaps most are not completed.

My colleagues and I also noted that the professional recommendations for screening have not been developed according to the standard procedures for making such recommendations. Development of professional guidelines is supposed to follow an orderly process of

  • Assembling a diverse and representative group of relevant stakeholders,
  • Systematically reviewing the literature with transparency in search criteria and method of synthesis and interpretation.
  • Publication of preliminary recommendations for public comment.
  • Revision of preliminary recommendations taking into account feedback.

In contrast, recommendations for screening have simply been released by professional groups assembled on the basis of previously known loyalty to the conclusion and with inattention to the lack of evidence showing that screening would improve outcomes. Notably missing from the “consensus” groups recommending screening are patients, frontline clinicians who will have to implement screening, and professionals from the community who would have to receive and evaluate referrals, notably primary-care physicians in most countries.

Nonetheless, the push for routine screening of cancer patients for psychological distress continues to gain momentum, with goals being set in many settings for the minimal proportion of cancer patients who must be screened.

The slogan “distress is the sixth vital sign” is not a testable empirical statement of the order of “depression is a significant risk factor for cardiac mortality.” Rather, it is best evaluated in terms of the use of terms, particularly “vital sign” and whether adopting slogan improves patient outcomes. Let us look at the notion of vital sign and then at the outcome of efforts to adopt pain has the fifth vital sign.

What is a vital sign?

According to Wikipedia

vital_signs_bot_image_blkVital signs are measures of various physiological statistics, often taken by health professionals, in order to assess the most basic body functions. Vital signs are an essential part of a case presentation. The act of taking vital signs normally entails recording body temperature, pulse rate (or heart rate), blood pressure, and respiratory rate, but may also include other measurements. Vital signs often vary by age.

In an excellent discussion of vital signs, Lucy Hornstein states

If someone other than the patient can’t see, hear, palpate, percuss, or measure it, it’s a symptom. Anything that can be perceived by someone else is a sign.

And

Vital signs are measured…and yield numeric results. Normal ranges are defined; values that fall outside those normal ranges are described with specific words (eg, bradycardia, tachypnea, hypothermia, hypertension).

A cough is a sign, but a headache is a symptom. Not that headaches are less “real,” they are just different.

With the standard definitions, pain cannot be a vital sign, only a symptom. The labeling of pain as a vital sign is metaphoric involves twisting the definition of a sign.

Something I will note now, but come back to later in the blog: patients cannot really argue against results of assessment of a vital sign. If repeated blood pressure readings indicate dystolic pressure above established cutoff, it is not left for the patient to argue “no, I do not have hypertension.” The notion is that a vital sign is objective and not subject to validation by patient self-report, although what to do about the vital sign may be interpreted in terms of other data about the patient, some of it from self-report. The point is that calling a measurement a “vital sign” claims particular authority for the results.

There have been numerous proposals for designating other vital signs in need of routine assessment and recording in medical records. These include (here I have extended the list from Wikipedia):

Pain as the fifth vital sign

Okay, so it is only metaphorically that pain can be considered a fifth vital sign. But what was nonetheless accomplished by designating it so in terms of improving its management? What can be learned that can be applied to designating distress as the sixth vital sign?

pain buttonThe pain-as-fifth-vital-sign (P5VS) campaign simply started with publicizing of high levels of untreated pain in medical populations, which in turn led to the consensus statements and mandated screening, similar to what is now occurring with declaring distress as the sixth vital sign.

1992. US Agency for Healthcare Quality Research (AHQR), issued guidelines documenting that half of surgical patients did not receive adequate post-surgical medication. The guidelines declared patients had a “right” to adequate pain measurement.

1995. American Pain Society (APS) issued a landmark consensus statement with guidelines for a quality improvement approach towards the treatment of acute and cancer pain [10], expanding upon its 1989 guidelines [11] for the treatment of pain. In his Presidential Address, Dr. James Campbell presented the idea of evaluating pain as a vital sign.

1998. The Veterans Health Administration (VHA) launched a national  P5VS initiative to pain thermometerimprove pain management for its patients, starting with documentation in the electronic medical record of assessment of patients’ self-report of pain.  It required use of a Numeric Rating Scale (NRS) in all clinical encounters.

P5VS campaigns were based on professional consensus, not appraisal of best evidence. When studies were later conducted, results did not demonstrate that the fifth vital sign campaign improved patient outcomes.

The title of a study of 300 consecutive patients before the start of the VA initiative and 300 afterwards says it all:

Measuring Pain as the 5th Vital Sign Does Not Improve Quality of Pain Management

The study examined 7 process indicators of quality of pain management fail to identify any improvement in

  • Subjective provider assessment (49.3% before versus 48.7% after).
  • Occurrence of a pain exam (26.3% versus 26.0%).
  • Orders to assess pain (11.7% versus 8.3%).
  • New pain medication prescribed (8.7% versus 11.0%)
  • Change in existing pain medication prescription (6.7%, 4.3%)
  • Other pain treatment (11.7% versus 13.7%).
  • Recording of follow-up plans (10.0%, 8.7%).

The initiative required that “patients indicating a score of four or about on a pain scale should receive comprehensive pain assessment and prompt intervention . . ’’

In a subsample of patients who reported substantial pain:

  • 22% had no attention to pain documented in the medical record of the visit which they reported.
  • 52% received no new therapy for pain at that visit.
  • 27% had no further assessment documented.

Our investigation of the P5VS…initiative at a single VA site has shown the routine documentation of pain levels, even with system-wide support and broad-based provider education, was ineffective in improving the quality-of-care.

carly-simon-havent-got-time-for-the-pain-1974
Carly Simon – Haven’t Got Time for the Pain

What was going wrong? It appears that front line clinicians making the pain assessments lacked the time or skills to take effective action. Pain assessments were typically conducted in encounters for which there are other reasons for the visit. Furthermore, pain assessments were collected outside of a clinical interaction in which the context or history could be discussed, which could likely lead to invalid ratings. When patients were asked only to rate current pain, it was unknown whether they took into account how much the pain bothered them, whether it was acute or chronic, or whether it reflected any change from past levels, all meaningful considerations. Other clinicians in the system either did not receive the ratings in a timely fashion or lacked the context to interpret the ratings.

Other studies [1, 2] similarly demonstrated that the P5VS campaign was by itself ineffective:

One potential reason for the insensitivity of routine pain screening in these studies is that all were conducted in outpatient primary and specialty care settings where chronic persistent or intermittent pain is much more common than acute pain. Routine pain screening that focuses on pain intensity “now” may not be sufficiently sensitive to detect important chronic pain that occurs episodically or varies with activity. In the VA primary care, the vast majority of pain problems are longstanding in nature, so sensitivity for chronic pain is important for any pain screening strategy in this setting.

The mandate that unrelieved pain must be addressed soon led to ineffective, inappropriate treatment that was not based on proper assessment. There was an increase in diagnostic tests that only confirmed existence of pain that was difficult to treat, notably chronic back pain. In the decade after the campaign to reduce pain was launched, costs of treating chronic back pain escalated without any demonstrated improvement in patient outcomes.

The guidelines had been promulgated with claims that addiction to opiates prescribed for acute pain was rare. But the evidence for that was only a brief 1980 letter in the New England Journal of Medicine indicating only four instances in treatment of 12,000 patients.

The campaign to improve pain control using routine ratings had an effect unanticipated by its proponents.

Dispensing opioids has almost doubled according to National Health and Nutrition Examination Survey data indicating that from 1988 to 1994 a total of 3.2% of Americans reported using opioids for pain, whereas from 2005 to 2008 a total of 5.7% reported use.

This significant increase has been associated with serious consequences, including an estimated 40 deaths per day due to prescription opioids.

Put simply

Improving pain care may require attention to all aspects of pain management, not just screening.

The pain as the fifth vital sign campaign involved mandated assessment of pain with a simple numerical scale at every clinical encounter, regardless of the reason for visit. The rating was typically obtained in the absence of any effort to talk to patients or to examine them in an effort to determine what were likely the multiple sources of their pain, its history, and their goals. Indeed, collecting these simple ratings may have become a substitute for having such discussions. The number on the rating scale came to characterize the patient for purposes of clinical decision-making, and may have led to overtreatment including escalating prescription of pain medication.

Is a good idea to consider distress the sixth vital sign?

Like pain, distress is not a vital sign by the conventional definition of the term. Yet to label it as such suggests that there is some sort of objective procedure involved in collecting ratings on a distress thermometer from patients.

Generally ignored in the promotion of screening is that most patients who indicate distress above established thresholds do not wish to receive a psychosocial service that they are not already receiving. Current guidelines for screening do not have a requirement of asking patients where they have any need for services. Instead, their response to the distress thermometer is used to tell them that they need intervention, with an emphasis on counseling.

When asked directly, most distressed patients reject the need for psychosocial services that they are not already getting, often outside the cancer center.  A rather typical study found that 14% definitely and an additional 29% maybe wanted to talk with a professional about their problems. Patients variously report

  • Already receiving services.
  • Believing they can solve the problems themselves.
  • Concentrating on the treating their physical illness takes precedence over receiving psychosocial and supportive services.
  • Services being offered to them are not needed, timely, or what they preferred.

A heightened score on a distress thermometer is a poor indication of whether patients are interested in receiving services that are listed on a screening sheet. Most do not want to receive a service, but most receiving services are not distressed. Think about it, looking at the problems listed on the screening form above. Many of the problems would be endorsed without patients having a heightened distress score. This poses for the dilemma for any interpretation of a score on a distress thermometer as if it were a vital sign.

Overall, thinking about distress as the sixth vital sign creates the illusion that a score on a distress thermometer is an authoritative, objective standalone indicator, much like a blood pressure reading. Actually, scores on a distress thermometer need to be discussed and interpreted. If distress is taken too seriously as the sixth vital sign, there is a risk that patients who do not meet the cut off for clinically significant distress will be denied an opportunity to discuss the problems that they might otherwise seek.

My colleagues and I undertook a study where we used results of screening for distress to attempt to recruit a sample of patients for an intervention trial evaluating problem-solving therapy as a way of reducing distress. It proved to be a discouragingly inefficient process.

  • We screened 970 cancer patients, of whom 423 were distressed, and, of these, 215 indicated a need for services. However, only 36 (4%) consented to participate in the intervention study.
  • 51% of the distressed patients reported having no need for psychosocial services and an additional 25% were already receiving services for their needs.
  • Overall, we had to screen 27 patients in order to recruit a single patient, with 17 hours of time required for each patient recruited.

Consider could have been accomplished if these 17 hours of were used instead to talk to patients who had indicated they wanted to talk to someone about their problems.

Designating distress as the sixth vital sign suggest false objectivity and validity to a procedure that has not demonstrated improvement in patient outcomes. It is an advertising slogan that is likely to prove ineffective and misdirect resources, just as the P5VS did.

 

 

Addressing Psychological Wounds, One Year Later

 

Photo by colemama via Flickr

Photo by colemama via FlickrS

As the anniversary of the Sandy Hook school shooting re-opens psychological wounds for young and old alike, we’re re-posting Shaili Jain’s post-Sandy Hook interview with  Dr. Victor Carrion, a Professor at the Stanford University School of Medicine and Director of the Stanford Early Life Stress Research Program at the Lucille Packard Children’s Hospital at Stanford. What follows is Dr. Jain’s original post.

 

“Susie Ehrens spoke of her daughter who escaped from Sandy Hook with a group of other first graders when the shooter paused.  Her daughter, she said, saw her friends and teacher slaughtered before she ran past lifeless bodies and a half a mile down the road” 

On December 14th, 2012 the unthinkable happened. A gunman fatally shot twenty children and six adult staff members in a mass murder at Sandy Hook Elementary School in the village of Sandy Hook in Newtown, Connecticut.  This incident is the second deadliest school shooting in American History.

Tragically millions of children, all around the world, are frequently exposed to all manner of traumatic experiences.  From those of human design such as bearing witness to shootings, inner city violence or the effects of living in a war zone or being the victims of child abuse to enduring the consequences of exposure to natural disasters such as a hurricanes, earthquakes or natural fires.So what is the impact of psychological trauma on children?

To understand more, I recently met with Dr. Victor Carrion, whose research focuses on the interplay between brain development and stress vulnerability.  He has developed treatments that focus on individual and community based interventions for stress related conditions in children and adolescents that experience traumatic stress.

Shaili Jain: If we consider the example of a child, of elementary school age, who is exposed to a horrific traumatic event such as Newtown what, as a child psychiatrist, would you expect to see over the coming days and weeks i.e. what would be a normal and expected reaction to such an event in an elementary school child?

Victor CarrionThe school-aged kid is going to have a difficult time understanding his/her emotional life. So, they may somatise e.g. complain of headaches and stomach aches and they are going to want to not go to school. They may not be psychologically minded enough to verbalize what they are struggling with. Kids sometimes do not have the vocabulary to talk about a traumatic event and sometimes they are still very concrete in their thinking.

 Also remember, because of media, even if we are not right where a trauma happened we can still be equally affected.  An example would be 9/11, where kids in California were following, minute by minute, everything that was happening in the news and when they started showing those pictures of people jumping from the towers that was traumatic for many kids. Our association, the AACAP (American Academy of Child & Adolescent Psychiatry), actually contacted the networks and they were very responsive and stopped showing those images as soon as we contacted them.

SJ: In your opinion, how best should parents, teachers and caregivers respond to such normal reactions?

VC: It will be important to really encourage discussion after something traumatic happened but not force it. Certainly, not even encourage it in very young kids that may not even know that something happened. Our belief now is that if the kid is 4 and 5 and this is not being discussed at school and they are not watching the news and they do not know that something terrible happened, there is no reason to talk to them about it.

 Obviously, if they directly witnessed or experienced something, that is a different story because, as you know, exposure to trauma is one of the strongest predictors of PTSD.

It is important is for caregivers to give children a message of safety and get the message that they are being taking care of and that they will be protected and that nothing will happen to their caregivers. This message of safety is important.

Another piece of this is that children should not be expected to be tough. One of the things that parents can actually model is that it is okay to cry, it is okay to have distress but parents have to be careful in how they balance that with maintaining their safety message and their authority message. They still have to give the message that I am okay enough to take care of you in a good way. But children certainly should be encouraged to express whatever feelings they may have about something that has occurred

Most children, exposed to trauma, are going to have a normal response and be okay with time. With a very small group of these kids, the response is going to continue and is going to become maladaptive and they need extra help. One of the things that is important for caregivers to recognize is when a child’s response becomes maladaptive, chronic or continuous. In that event, they should seek out professional help.

SJ: Let’s consider the more unfortunate scenario, that this child starts to develop signs/symptoms of a prolonged reaction to the trauma/an abnormal reaction: What are the typical manifestations of PTSD (posttraumatic stress disorder) in children of this age?

VC: Kids tend to show their re-experience of trauma through intrusive thoughts. This means thinking or talking about the trauma when they do not want to. So, they are playing basketball with friends and, all of a sudden, the images of the trauma do not let them enjoy the game or even play it. Or, they are doing their homework but they cannot because they are thinking about the traumatic event. Or they re-experience their trauma through what we call traumatic play. Traumatic play is a way for many children to communicate their experience especially if they are not that verbal.

Then there is avoidance. But with kids is it really avoiding or is it that the kid does not have the words to talk about what happened? There might be a cognitive inability to really talk about what happened but certainly we also see an avoidance of trauma related triggers. For example, if something traumatic happened and it was a rainy day then the next rainy day they may be particularly sensitive or nervous that day.  

We see emotional numbing quite often also: kids say that they can no longer feel sad when something bad happens. They feel happy when something good happens but not as good as they used to feel. They may go to a birthday and it is okay but they used to love birthdays before.

The other type of symptom is the physiological hyperarousability. That is what leads many kids to receive a misdiagnosis (especially kids that live in environments where they are surrounded by violence) of ADHD. Now, this gets very complicated, clinically, because kids that truly have ADHD are at increased risk of experiencing traumatic events. For example, they may not see the car coming and they go and cross the street. The kid that has ADHD is at increased risk of experiencing traumatic events which means they may end up with PTSD also.

Then, another thing as I said is that traumas are stressors to the system and you develop whatever you are vulnerable to. It may be that you do not develop PTSD but you develop OCD/a phobia as a consequence of experiencing a traumatic event.

We have always known that having anxiety puts you at risk for developing PTSD but what we have also seen in our data is that developing PTSD is a good predictor of developing other anxiety disorders after having PTSD. 

What we also see is that children tend to be egocentric and naturally narcissistic. In kids it is a helpful drive because they get the necessary attention and all that but that also means that if something bad happens, children take excessive responsibility for it and it creates this sense of guilt and guilt is a very good predictor of developing PTSD. This is not survivor’s guilt. This is guilt over an act. For example, “there was a fire and I could have prevented it and I did not”.” I was abused and that is because I provoked it or I made it happen”. Whenever there is that sense of guilt after a kid experiences a traumatic experience it is good to start some clinical remediation to correct those cognitive distortions.

SJ: How does this differ from PTSD in adults?

VC: Immediately, when we look at the first criterion for diagnosing PTSD, we already have an issue when it comes to kids. Criterion A requires that the traumatic event make you feel as though your life is in danger/threatened. But if you are younger than 7 or 8, you may not understand death as something that is universal and something that is irreversible.

One of the studies that we did is that we looked at children who had experienced separation or loss and were in that age group and compared them with kids that had experienced physical abuse, sexual abuse, and also had functional impairment. They really did not differ in terms of the amount of functional impairment that they had in their lives, in their personal relationships, and the amount of distress and so forth. So for children younger than 8, what I am saying is that separation or loss is considered a traumatic event. even if they might not have a full understanding of death or loss.

The symptoms of PTSD, in children as well as in adults, are mostly on and off. They are not there all the time and they tend to be triggered by cues. When those cues or triggers are there, that is when you see the symptoms. This becomes problematic if you are conducting a trial and at the end of the trial this group looks like it is doing well, it may be the case that the treatment worked but it might also be the case that there were no triggers/cues around those kids at that time. That is one of the reasons why we need to know about the neurofunctionality or the neuroscience of how traumatic stress impacts development.

For kids it is still a balance between internal and external resources, and it is like a mathematical equation.  So you may have a lot of coping and strength and that may be able to help you overcome the lack of support you have in your life or you may have total perfect support but you have so many risk factors to begin with like a previous history of trauma exposure or family history of anxiety disorder that you are more likely to have a post traumatic reaction. I am calling it a post traumatic reaction not necessarily PTSD because some of the work that we have done and also work done by Dr. Michael Scheeringa at Tulane University shows that children do not have to have all the criteria for PTSD listed in the DSM to experience functional impairment. For example, we showed that kids that have PTSD compared to kids that have a history of trauma and symptoms in 2 of the clusters are equally impaired. We still have work to do in terms of how we develop this diagnostic criterion for children. That is one of the things that Michael has done. He has proposed a number of criteria that has less symptoms and also that some symptoms might be somewhat different in children compared to adults

SJ: In terms of the neuroscience of PTSD, how might this look in terms of impact on child development from a psychophysiological, neuroimaging or neuroendocrinological point of view?

VC: One of the things that have been studied for a long time is the autonomic nervous system in children as well as in adults. It seems that those who have PTSD are actually a heterogeneous group and that physiology may help us differentiate between kids that dissociate versus all the kids that might display symptoms of aggression. For example, the kids that dissociate seem to have a lower heart rate when narrating a stressful event or a stressful story. Whereas, those that do not dissociate seem to have increased heart rate but increased heart rate does not seem to be a good marker because it depends where your baseline is. What seems to be a good marker is how long is the latency? i.e. how long it takes you to return to your baseline heart rate after a stressor. So, if the stressor increases your heart rate, kids that are vulnerable or have PTSD will take longer in coming back to a baseline heart rate.

 We concentrated on looking at cortisol and identifying what would be a good cortisol marker for this kids. What we find is that these kids have the normal circadian rhythmicity that you would expect (i.e. higher at the beginning of the day and going down at the end of the day) but then at the end of the day it seems to be elevated so these kids have high levels of cortisol. That is what we found about 10 years ago but what we found out years later is that that variable of” time since trauma” is very important. 

What we did is we looked at a big sample of kids and we looked at those that had had trauma during the past year and those that had trauma prior to that year. We hypothesized that our theory of increased cortisol was going to hold true for the kids that had it in the past year but not for the others. What we actually found was exactly that and we found 2 reverse correlations where if you had events in the past year, the higher your cortisol, the higher your symptoms of PTSD. Whereas, for the other individuals that had experienced trauma from a long time ago and were still with symptoms of PTSD, the more symptoms, the lower the level of cortisol.

But in general, I would say, that high pre-bedtime (before you go to bed) cortisol in kids, I am starting to think of that as a marker of pediatric PTSD.

Now, if you have these high levels of cortisol, the next normal question was to see what is going on in the brain because of the potential neurotoxicity of cortisol at high levels every day, right? So, we looked at kids who were experiencing chronic trauma i.e. physical abuse, sexual abuse and witnessing a lot of violence.

Cross sectionally there were no significant findings. But in 2007, we followed 15 kids for 1-1 ½ years and we saw that there was a correlation between high cortisol, (pre bedtime) cortisol, and decreased volume from time1 to time 2 of the hippocampus. 

Of course, the hippocampus is important for memory storage and retrieval so we did a task in functional MRI, a verbal declarative memory task, to look at encoding and retrieval in kids. We saw that in the control/healthy group, with no history of trauma and no PTSD symptoms, was activating significantly more hippocampus than the PTSD kids were. So we were not seeing the volume differences but, functionally, you can see that the hippocampus really does not work as well in kids with PTSD. 

We then decided to look at emotional regulation. We did the faces task and saw that kids that have PTSD activate their amygdala significantly earlier when viewing an angry face. When viewing a fearful face, there was a trend for their pre-frontal cortex to not be as activated as it was in the healthy controls. But the interesting thing about the amygdala activation is that, potentially, what we are talking about is a neuro functional marker of hyperarousability for these kids who have a history of exposure to interpersonal violence. For these kids, the face of someone angry is a cue/trigger and we here see the amygdala getting activated. 

So then, we started thinking that treatments that treat these kids better pay attention to emotional regulation, memory processing, and executive function. The other thing we realized is  that we could increase the empirical validity of some treatment interventions by demonstrating that they can lower cortisol or decrease amygdala function on this task and so forth.

SJ: What are the most common misperceptions/misunderstandings regarding the impact of traumatic stress on child development?

VC: There used to be this idea that children were resilient just by virtue of being children but there is no literature to really back that up. In fact, we know the opposite. We know that you are more vulnerable when you are younger, when you do not have defensive styles, when your brain is still developing, when your physiology is still developing. It affects you more.

SJ: What are effective treatments for children with PTSD? (psychological therapies and pharmacotherapies)

VC: Trauma focus cognitive behavioral therapy is the treatment of choice.  It is a treatment that was developed to treat children who have experienced sexual abuse but it has now been adapted to be used in different settings including for children who have witnessed  domestic violence.

One of the things that Judith Cohen (the developer of trauma focused CBT) and I are talking about is the need to develop algorithms for treatment.  So, the age of the kids, the type of trauma and duration of the trauma would determine which specific treatment a child would get.

But certainly, the first line of intervention for children that have PTSD is psychosocial interventions and it is not medication. Now, do I use medication? Yes. I use medication in 2 scenarios. One, when there is comorbidity and the comorbidity in PTSD is high, it is 80%. So if the child has major depression, in addition to the PTSD, I would want to treat that. That is one scenario. The other scenario is when the severity is so high that this individual may have difficulties engaging in their psychosocial treatment.

But the reality is that we have no pharmacological agent that would target all the neurotransmitter systems that traumatic stress impacts.

We actually developed a manual to treat kids called the Cue-Centred Treatment Protocol.  The whole idea here is that it is a hybrid. It has different components that we know help kids, it has: CBT, exposure and psycho education and insight orientated therapy. But the main thing that it does is that it empowers children to be their own agent of change. It is not so much about processing a narrative as teaching you how important a narrative is because the chances that these kids will continue to have traumas after we finish treatment is still pretty high and we want these kids to be equipped in knowing what to do.

 We did a randomized controlled trial in East Palo Alto and Hunters Point in Bayview at some schools there and the treatment has shown efficacy to decrease PTSD symptoms and anxiety symptoms when compared to kids put on a wait list.

There are some family interventions too. One is called parent-child psychotherapy. This is worked by Alicia Lieberman at UCSF 

 where she helps children age zero to 5. It gives treatment to both the parent and the child, it is more about their dyad, their relationship and that has also been shown to be effective.

SJ: What are the factors that determine how children, with PTSD, will respond to treatment?

VC: With children, there are 3 factors that we think are very important to the outcome of the psychosocial intervention: Intelligence, motivation, and psychological mindedness. If a child is motivated and they can talk about feelings and they are smart, then the treatments will likely work. For some special populations, like children with mental retardation that get traumatized or children in the juvenile justice system we still need more effective treatments.

SJ: What types of preventative interventions/public health measures do you think are key to reducing the amount of violence children in our society are exposed too?

VC:       One of the things that I have done for the past 3 years is that I have been part of this coalition in San Francisco where we have built an ecological approach to the problem of trauma. Rather than just concentrating on models or treatments for the individual, we think of the whole system. We think about their school, we think about their family and how can we, in one place, do preventive work or treatment.  We have developed this Centre for Youth Wellness (CYW) which is a place that integrates paediatric care with mental health. So, every time they come for their paediatric checks, they get additional screenings for trauma. In that way, we know very early if they had traumatic events or not and then we start working with them, but not only with them, with their families and with the primary care team that is taking care of them in the same place.

 The CYW is also co-located with the CAC i.e. the Child Advocacy Centre. The CAC is the place that, when something traumatic happens, the child will come here get their forensic evaluations and physical exams etc. So, if that family shows up with kids to the CAC, the other siblings can be enrolled right away in the Centre for Youth Wellness. So, we are concentrating a lot on prevention, on interdisciplinary work and concentrating on developing new treatment methods that are empirically validated.

At Ravenswood Family Health Centre, here in East Palo Alto, we have this model where we have a behavioral health worker working with the pediatricians.  We looked at referrals and found that when we did a “warm hand off” (between psychiatry and the behavioural health person) there was significantly more follow through and less no shows for treatment.

SJ: What do you envision will be key obstacles to progression in this field?  Or what are the major controversies in this field that need to be resolved?

VC:  The way that ground mechanisms work in terms of funding for 3 or 5 years or maybe even less than that.  This makes follow up research very difficult. We need longitudinal studies to advance our knowledge of what goes on in PTSD.

SJ: What do you envision will be key advances in the treatment/understanding/prevention of traumatic stress in children in the next 10-20 years?

VC: I think working with mathematicians will advance our field, because I think that mathematical formulas are going to help us understand how these variables interact with each other e.g. like genetics and severity of the traumatic event.

I get excited about treatment interventions that can demonstrate that they can actually alter the physiology of someone who struggles with PTSD.

I am excited to know more about how stressors and traumatic events impact the physical health of the individual, for example, through atherosclerosis or pro-inflammation and things like that.  This will inform not only our psychiatric practice but I think medicine in general and the role of environment in medicine.

 

Repeated mental health screens in the schools

child depressionA Dr. Simon Williams calls for repeated screening for depression in the schools, not once but regularly from age seven onward. You can see the press release here, but BMJ has his article behind a pay wall, so you either have to have a subscription to BMJ, order the article through a University library website, or send an email to Dr. Williams (simonwilliams@northwestern.edu ) requesting it. But here’s an excerpt.

Dr. Simons asks

Why then, despite this mounting evidence, and in a time where other types of screening (including bowel, breast, cervical, and prostate screens) are becoming more common in the UK, do we not already have school based mental health checks?

Many mental health problems across the lifespan including depression first express themselves in childhood and adolescence. Mental health problems limit academic performance and social development. But most mental health problems in children go untreated or inadequately treated, with schools and families, as well as the children themselves, bearing the costs. So how could anyone oppose repeated mental health screens in the schools?

It was once thought that if problems are serious and common and a means existed for screening for them, we should screen. Now it’s recognized that there has to be evidence that screening improves the outcomes of the people who are screened if it is to be justified. Lots of previous recommendations are being dropped. And the burden of proof whether we should screen falls on those who propose it, not those who remain skeptical.

Choosing wisely

The World Health Organization dropped recommendation for screening for intimate partner violence. Not because it’s believed that intimate partner violence is not a public health problem, but because studies do not show that routine screening improves women’s health or prevents exposure to more violence. Certainly there are situations in which professionals should ask whether women are victims of violence, but that’s not routine universal screening.

choosing wiselyMedical organizations in a number of countries have collaborated in Choose Widely programs that are reconsidering the evidence for screening. Many forms of screening are now discouraged: for breast cancer among young women, prostate cancer, ovarian, and lung cancer, and dementia.

Screening for childhood depression

Even the best screening instruments for depression do not produce a diagnosis suitable for decision-making about treatment. Screening must involve two stages, the administration of a brief screening instrument, and follow-up of children who screen positive with interviews to determine whether they actually are clinically depressed.

Most children screen positive on mental health inventories are false positives—they would not be suitable for mental health treatment. But determining that requires interviewing them. And that consumes resources that could be applied to improving the treatment of children who are already known to have mental health problems.

A fragmented system of care for child depression

Unless mental health professionals are stationed in schools or other personnel are given special training, determining whether a child screening positive is clinically depressed requires referral to outside professionals. Without these follow-up interviews, children who screen positive could falsely be labeled as having a mental health problem.

Teachers and other professionals agree on the need to address mental health problems and the costs of them going unaddressed, but they disagree about the labeling of who should get treatment. Teachers prefer to label troubled or troublesome children as having emotional or behavioral problems. They also miss a lot of childhood depression. Teachers also tend to resist what they see as stigmatizing labels like depression. The problem is that many of the children causing teachers’ problems do not have treatable mental health problems. So, there’s a mismatch between the children who teachers believe need treatment and those for whom mental health professionals feel can be diagnosed and referred into evidence-based treatments.

Let’s think about the fate of children who screen positive for depression or other mental health problems. Many of them won’t get further evaluation, and are left with a stigmatizing label that is not accurate. Furthermore, many of them who are true positive still won’t get adequate treatment. Their problems will remain with additional problem of stigmatization.

In many health systems and particularly the UK, responsibility for determining whether children who screen positive actually have treatable problems fall upon physicians who generally lack training or interest in making such evaluations. There is the risk that physicians will proceed to prescribing medication without obtaining formal diagnosis. Medication is not first line of treatment for most depressed children.

Cognitive behavioral therapy has been shown to be effective for children and adolescents, but access it is difficult. There are long waiting lists in countries like the UK or the Netherlands where psychotherapy is free or low cost. A child identified as depressed during the school year might have to wait until the school year is over before getting a first session of therapy.

In the United States, Medicaid provides coverage for treatment of low income children, but most psychologists do not accept Medicaid because its reimbursement is too low.

A classic book on screening states

Screening must be delivered in a well functioning total system if it is to achieve the best chance of maximum benefit and minimum harm. The system needs to include everything from the identification of those to be invited right through to follow-up after intervention for those found to have a problem.

Schools may seem the ideal place to identify children with mental health problems, but they are not the ideal situation to treat these problems. Furthermore, even within medical systems that have the capacity to treat mental health problems, the quality of care is generally inadequate and simply poor, with an adequate follow up.

For screening to improve child outcomes, we would need a very different organization of care and better communication between the educational, social services, medical, and mental health systems. There are formidable challenges to that happening.

Dr. William cites a meta-analysis, a systematic integration of data from lots of studies, as demonstrating the value of preventive interventions for depression. However, he’s confused in equating the evaluation of specialized programs of treatment with the evaluation of screening. Most children who were screened for mental health problems in the schools couldn’t access such programs. Furthermore, when you look closely at the studies in the meta-analysis, many of them are pitifully small and of low quality.

It would not be appropriate to generalize from the studies anything could conceivably be integrated within routine care on a large scale.

Should we simply ignore mental health problems in children? Of course not, but it would be much better to use scarce resources to improve the care of children we already know have mental problems, rather than put more children into a fragmented system of care that is not working well.

Dr. Williams estimates that it would cost £18million to screen every 7 year old in the UK one time, but recommends repeatedly screening all school age children.

follow your heartRegular mental health screens for children would be ineffective, costly, and would probably have negative consequences.