An open-minded, skeptical look at the success of “zero suicides”: Any evidence beyond the rhetoric?

  • Claims are spreading across social media that a goal of zero suicides can be achieved by radically re-organizing resources in health systems and communities. Extraordinary claims require extraordinary evidence.
  • I thoroughly searched for evidence backing claims of “zero suicides” being achieved.
  • The claims came up short, after expectations were initially raised by some statistics and a provocative graph. But any persuasiveness to these details quickly dissipated when they were scrutinized. Lesson: Abstract numbers and graphs are not necessarily quality evidence and dazzling ones can obscure a lack of evidence.
  • The goal of “zero suicides” has attracted support of Pharma and generated programs around the world, with little fidelity to the original concept developed in the  Henry Ford Health System in Detroit. In many contexts in which it is now being invoked, “zero suicides” is a vacuous buzz term, not a coherent, organizational strategy
  • Preventing suicide is a noble goal to which a lot of emotion gets attached. It also creates lucrative financial opportunities and attracts vested interests which often simply repackage existing programs for resale.
  • How can anyone oppose the idea that we should eliminate suicide? Clever sloganeering can stifle criticism and suppress embarrassing evidence to the contrary
  • Yet, we should not be bullied, nor distracted by slogans from our usual, skeptical insistence on those who make strong claims having the burden to provide strong evidence.
  • Deaths by suicide are statistically infrequent, poorly predicted events that occur in troubled contexts of interpersonal and institutional breakdown. These aspects can frustrate efforts to eliminate suicide entirely – or even accurately track these deaths.
  • Eliminating deaths by suicide is only very loosely analogous to wiping out polio and lots of pitfalls await those who get confused by a false equivalence.
  • Pursuit of the goal of “zero suicides,” particularly in under-resourced and not well-organized community settings can have unintended, negative consequences.
  • “Zero suicides” is likely a fad, to be replaced by next year’s fashion or maybe a few years after.
  • We need to step back and learn from the rise and fall of slogans and the unintended impact on distribution of scarce resources and the costs to human well-being.
  • My take away message is that increasingly sophisticated and even coercive communications about clinical and public health policies often harness the branding of prestigious medical journals. Interpreting these claims require a matching skepticism, critical thinking skills, and renewed demands for evidence.

Beginning the search for evidence for the slogan “Zero Sucide.”

zero tweetNumerous gushy tweets about achieving “zero suicides” drew me into a search for more information. I easily traced the origins of the campaign to a program at the Henry Ford Health System, a Detroit-based HMO, but the concept has now gone thoroughly international. My first Google Scholar search did not yield quality evidence from any program evaluations, but a subsequent Google search produced exceptionally laudatory and often self-congratulatory statements.

I briefly diverted my efforts to contacting authorities whom I expected might comment about “zero suicides.” Some indicated a lack of familiarity prevented them from commenting, but others were as evasive as establishment Republicans asked about Donald Trump. One expert, however, was forthcoming with an interesting article, which proved to have just right tone.  I recommend:

Kutcher S, Wei Y, Behzadi P. School-and Community-Based Youth Suicide Prevention Interventions Hot Idea, Hot Air, or Sham?. The Canadian Journal of Psychiatry. 2016 Jul 12:0706743716659245.

Continuing my search, I found numerous links to other articles, including a laudatory, Medical News and Perspectives opinion piece in JAMA behind a readily circumvented pay wall. There was also a more accessible source with a branding by New England Journal of Medicine.

Clicking on these links, I found editorial and even blatantly promotional material, not randomized trials or other quality evidence.

This kind of non-evidence-based publicity in highly visible medical journals is extraordinary in itself, although not unprecedented. Increasingly, the brand of particular medical journals is sold and harnessed to bestow special credibility on political and financial interests, has seen in 1 and 2.

NEJM Catalyst: How We Dramatically Reduced Suicide.

 NEJM Catalyst is described as bringing

Health care executives, clinician leaders, and clinicians together to share innovative ideas and practical applications for enhancing the value of health care delivery.

0 suicide takeaway
From NEJM Catalyst

The claim of “zero suicides” originated in the Perfect Care for Depression in a division of the Henry Ford Health System.

The audacious goal of zero suicides was part of the Behavioral Health Services division’s larger goal to develop a system of perfect care for depression. Our roadmap for transformation was the Quality Chasm report, which defined six dimensions of perfect care: safety, timeliness, effectiveness, efficiency, equity, and patient-centeredness. We set perfection goals and metrics for each dimension, with zero suicides being the perfection goal for effectiveness. Very quickly, however, our team seized on zero suicides as the overarching goal for our entire transformation.

The strategies:

We used three key strategies to achieve this goal. The first two — improving access to care and restricting access to lethal means of suicide — are evidence-based interventions to reduce suicide risk. While we had pursued these strategies in the past, setting the target at zero suicides injected our team with gumption. To improve access to care, we developed, implemented, and tested new models of care, such as drop-in group visits, same-day evaluations by a psychiatrist, and department-wide certification in cognitive behavior therapy. This work, once messy and arduous for the PDC team, became creative, fun, and focused. To reduce access to lethal means of suicide, we partnered with patients and families to develop new protocols for weapons removal. We also redesigned the structure and content of patient encounters to reflect the assumption that every patient with a mental illness, even if that illness is in remission, is at increased risk of suicide. Therefore, we eliminated suicide screens and risk stratification tools that yielded non-actionable results, freeing up valuable time. Eventually, each of these approaches was incorporated into the electronic health record as decision support.

The third strategy:

…The pursuit of perfection was not possible without a just culture for our internal team. Ultimately, we found this the most important strategy in achieving zero suicides. Since our goal was to achieve radical transformation, not just to tweak the margins, PDC staff couldn’t justly be punished if they came up short on these lofty goals. We adopted a root cause analysis process that treated suicide events equally as tragedies and learning opportunities.

Process of patient care described in JAMA

What happens to a patient being treated in the context of Perfect Depression Care is described in the JAMA  piece:

Each patient seen through the BHS is first assessed and stratified on the basis of suicide risk: acute, moderate, or low. “Everyone is at risk. It’s just a matter of whether it’s acute or whether it requires attention but isn’t emergent,” said Coffey. A patient considered to be at high risk undergoes a psychiatric evaluation the same day. A patient at low risk is evaluated within 7 days. Group sessions for patients also allow individuals to connect and offer support to one another, not unlike the supportive relationships between sponsors and “sponsees” in 12-step programs

The claim of Zero Suicides, in numbers and a graph

…A dramatic and statistically significant 80% reduction in suicide that has been maintained for over a decade, including one year (2009) when we actually achieved the perfection goal of zero suicides (see the figure below). During the PDC initiative, the annual HMO network membership ranged from 182,183 to 293,228, of which approximately 60% received care through Behavioral Health Services. From 1999 to 2010, there were 160 suicides among HMO members. In 1999, as we launched PDC, the mean annual suicide rate for these mental health patients was 110.3 per 100,000. During the 11 years of the initiative, the mean annual suicide rate dropped to 36.21 per 100,000. This decrease is statistically significant and, moreover, took place while the suicide rate actually increased among non–mental health patients and among the general population of the state of Michigan.

Improved_Suicide_Rates_Among_Henry_Ford_Medical_Group_HMO_Members

[This graph conflicts a bit with a graph in NEJM Catalyst that indicates suicides in the health care system were 0 suicides for 2008 and this continued through the first quarter of 2010]

It is clear that rates of suicide fluctuate greatly from year-to-year in the health system. It also appears from the graph that for most years during the program, rates of suicide among patients in the Henry Ford Health System were substantially greater than those of the general population in Michigan, which were relatively flat. Any comparisons between the program and the general statistics for the state of Michigan are not particularly informative. Michigan is a state of enormous health care disparities. During this period, there was a large insured population. Demographics differ greatly, but patients receiving care within an HMO were a substantially more privileged group than the general population of Michigan. During this time, there were many uninsured and a lot of annual movement in and out of the Henry Ford Health System. At any one time, only 60% of the patients within the health system were enrolled in the behavioral health system in which the depression program occurred.

A substantial proportion of suicides occur with individuals who are not previously known to health systems. Such persons are more represented in the statistics for the state of Michigan. Another substantial proportion of suicides occur in individuals with weakened or recently broken contact with health systems. We don’t know how the statistics reported for the health system accommodated biased departures from the health system or simply missing data. We don’t know whether behavior related to risk of suicide affected migration into the health care system or to the small group receiving behavioral healthcare through the health system. For instance, what became of patients with a psychiatric disorder in a comorbid substance use disorder? Those who were incarcerated?

Basically, the success of the program is not obvious within the noisy fluctuation of suicides within the Henry Ford Health System or the smaller behavioral health program. We cannot control for basic confounding factors or selective enrollment and disenrollment in the health care system, or even expelling from the behavioral health system of persons at risk.

 “Zero suicides” as a literal and serious goal?

The NEJM Catalyst article gave the originator of the program free reign for self-praise.

The most unexpected hurdles were skepticism that perfection goals like zero suicides were reasonable or feasible (some objected that it was “setting us up for failure”), and disbelief in the dramatic improvements obtained (we heard comments like “results from quality improvement projects aren’t scientifically rigorous”). We addressed these concerns by ensuring the transparency of our results and lessons, by collaborating with others to continually improve our methodological issues, and by supporting teams across the world who wish to pursue similar initiatives.

Our team challenged this assumption and asked, If zero is not the right goal for suicide occurrence, then what number is? Two? Twelve? Which twelve? In spite of its radicalism — indeed because of it — the goal of zero suicides became the galvanizing force behind an effort that achieved one of the most dramatic and sustained reductions in suicide in the clinical literature.

Will the Henry Ford program prove sustainable?

Edward Coffey moved to  President, CEO, and Chief of Staff at the Menninger Clinic 18 months before his article in the NEJM Catalyst. I am curious to what aspects of his Zero Suicides/Perfect Depression Care Program are still maintained at Henry Ford. As it is described, the program was designed with admirably short waiting times for referral to behavioral healthcare. If the program persists as originally described, many professionals are kept vigilant and engaged in activities to reduce suicide without any statistical likelihood of having the opportunity to actually prevent one.

In decades of work within health systems, I have found that once demonstration projects have run their initial course, their goals are replaced by new organizational  ones and resources are redistributed. Sooner or later, competing demands for scarce resources  are promoted by new slogans.

What if Perfect Depression Care has to compete for scarce resources with Perfect Diabetes Care or alleviation of gross ethnic disparities in cardiovascular outcomes?

A lot of well-meant slogans ultimately have unintended, negative consequences. “Make pain the 5th vital sign” led to more attention being paid to previously ignored and poorly managed pain. This was followed by mandated routine assessment and intervention, which led to unnecessary procedures and unprecedented epidemic of addiction and death from prescribed opioids. “Stamp out distress” has led to mandated screening and intervention programs for psychological distress in cancer care, with high rates of antidepressant prescription without proper diagnosis or follow-up.

If taken literally and seriously, a lofty, but abstract goal like Zero Suicide becomes a threat to any “just culture” in healthcare organization. If the slogan is taken seriously as resources are inevitably withdrawn, a culture of blame will emerge and pressures to distort easily manipulated statistics. Patients posing threats to the goal of zero suicide will be excluded from the system with an unknown, but negative consequences for their morbidity and mortality.

 Bottom line – we can’t have slogan-driven healthcare policies that will likely have negative implications and conflict with evidence.

 Enter Big Pharma

Not unexpectedly, Big Pharma is getting involved in promoting Zero Suicides:

Eli Lilly and Company Foundation donates $250,000 to expand Community Health Network’s Zero Suicides prevention initiative,

Major gift will save Hoosier lives through a suicide prevention network that responds to a critical Indiana healthcare issue.

 According to press coverage, the funds will go to:

The Lilly Foundation donation also provides resources needed to build a Central Indiana crisis network that will include Indiana’s schools, foster care system, juvenile justice program, primary and specialty healthcare providers, policy makers and suicide survivors. These partners will be trained to identify people at risk of attempting suicide, provide timely intervention and quickly connect them with Community’s crisis providers. Indiana’s state government is a key partner in building the statewide crisis network.

I’m sure this effort is good for  the profits of Pharma. Dissemination of screening programs into settings that are not directly connected to quality depression care is inevitably ineffective. The main healthcare consequences are an increase in antidepressant prescriptions without appropriate diagnoses, patient education, and follow-up. Substantial overtreatment results from people being identified without proper diagnosis who otherwise would not be seeking treatment. Care for depression in the community is hardly Perfect Depression Care.

It is great publicity for Eli Lilly and the community receiving the gift will surely be grateful.

Launching Zero Suicides in English communities and elsewhere

My academic colleagues in the UK assure me that we can simply dismiss an official UK government press release about the goal of zero suicides from Nick Clegg. It has been rendered obsolete by subsequent political events. A number commented that they never took it seriously, regardless.

Nick Clegg calls for new ambition for zero suicides across the NHS

The claims in the press release stand in stark contrast to long waiting times for mental health services and important gaps in responses to serious mental health crises, including lethal suicide attempts. However, another web link is to an announcement:

Centre for Mental Health was commissioned by the East of England Strategic Clinical Networks to evaluate activity taking place in four local areas in the region through a pilot programme to extend suicide prevention into communities.

The ‘zero suicide’ initiative is based on an approach developed by Dr Ed Coffey in Detroit, Michigan. The approach aims to prevent suicides by creating a more open environment for people to talk about suicidal thoughts and enabling others to help them. It particularly aims to reach people who have not been reached through previous initiatives and to address gaps in existing provision.

Four local areas in the East of England (Bedfordshire, Cambridgeshire & Peterborough, Essex and Hertfordshire) were selected in 2013 as pathfinder sites to develop new approaches to suicide prevention. Centre for Mental Health evaluated the work of the sites during 2015.

The evaluation found an impressive range of activities that had taken suicide prevention activities out into local communities. They included:

• Training key public service staff such as GPs, police officers, teachers and housing officers
• Training others who may encounter someone at risk of taking their own life, such as pub landlords, coroners, private security staff, faith groups and gym workers
• Creating ‘community champions’ to put local people in control of activities
• Putting in place practical suicide prevention measures in ‘hot spots’ such as bridges and railways
• Working with local newspapers, radio and social media to raise awareness in the wider community
• Supporting safety planning for people at risk of suicide, involving families and carers throughout the process
• Linking with local crisis services to ensure people get speedy access to evidence-based treatments.

The report noted that some of the people who received the training had already saved lives:

“I saved a man’s life using the skills you taught us on the course. I cannot find words to properly express the gratitude I have for that. Without the training I would have been in bits. It was a very public place, packed with people – but, to onlookers, we just looked like two blokes sitting on a bench talking.”

“Déjà vu all over again”, as Yogi Berra would say. This effort also recalls Bill Murray in the movie Groundhog Day, where he is trapped into repeating the same day over and over again.

A few years ago I was a scientific advisor for European Union funded project to disseminate multilevel suicide prevention programs across Europe. One UK site was among those targeted in this report. Implementation of the EU program had already failed before the plate of snacks was being removed from a poorly attended event. The effort quickly failed because it failed to attract the support of local GPs.

Years later, I recognize many of the elements of what we tried to implement, described in language almost identical to ours. There is no mention of the training materials we left behind or of the quick failure of our attempt at implementation.

Many of the proposed measures in the UK plan serve to generate publicity and do not any evidence that they reduce suicides. For instance, training people in the community who might conceivably come in contact with a suicidal person accomplishes little other than producing good publicity. Uptake of such training is abysmally low and is not likely to affect the probability that a person in a suicidal crisis will encounter anyone who can make a difference

Broad efforts to increase uptake of mental health services in the UK strain a system already suffer from unacceptably long waiting times for services. People with any likelihood of attempting suicide, however poorly predicted, are likely to be lost among persons seeking services with less serious or pressing needs.

Thoughts I have accumulated from years of evaluating depression screening programs and suicide intervention efforts

 Staying mobilized around preventing suicide is difficult because it is an infrequent event and most activations of resources will prove to false positives.

It can be tedious and annoying for both staff and patients to keep focused on an infrequent event, particularly for the vast majority of patients who rightfully believe they are not at risk for suicide.

Resources can be drained off from less frequent, but more high risk situations that require sustained intensity of response, pragmatic innovation, and flexibility of rules.

Heightened efforts to detect mental health problems increase access for people already successfully accessing services and decrease resources for those needing special efforts. The net result can be an increase in disparities.

Suicide data are easily manipulated by ignoring selective loss to follow-up. Many suicides occur at breaks in the system, where getting follow-up data is also problematic.

Finally, death by suicide is a health outcomes that is multiply determined. It does not lend itself to targeted public health approaches like eliminating polio, tempting though invoking the analogy may be.

Postscript

It is likely  that I exposed anyone reaching this postscript to a new and disconcerting perspective. What I have been saying is  discrepant with the publicity about “zero suicides” available in the media. The portrayal of “zero suicides” is quite persuasive because it is sophisticated and well-crafted. Its dissemination is well resourced and often financed by individuals and institutions with barely discernible – if at all – conflicts of financial and political interests. Just try to find any dissenters or skeptical assessments.

My takeaway message: It’s best to process claims about suicide prevention with a high level of skepticism, an insistent demand for evidence, and a preparedness for discovering that seemingly well trusted sources are not without agendas. They are usually  providing propaganda rather than evidence-based arguments.

Is dying a mental health issue?

Should a dying patient talking to a psychiatrist be diagnosed with adjustment disorder related to death?

 Dare we ask: Could impending death not be sufficiently psychologically distressing for patients to routinely benefit from psychotherapy?

2Presentation1Patients aware that they are dying often wish to talk to someone about their predicament. Should psychiatrists and psychologists be the first line professionals for such discussions? After all, aren’t many dying patients experiencing substantial psychological distress? Specialty mental health professionals would have the skills to differentially diagnose this distress and offer appropriate targeted treatment. And what about their ability to identify and address issues of suicidality?

Or should discussions be left to clergy and pastoral counselors, especially for patients of faith?

Raising these questions could easily get us into philosophical and spiritual issues where we might feel excused from having to bring in evidence. But a relatively large-scale and well-designed study has given us a relevant answer. Maybe not the answer that the investigators hoped to find and they probably will not like my further interpretation. And, sure, it is only one randomized trial, but results seem to speak exceptionally clearly about a number of issues.

The study was negative, but demonstrates just how much a well-designed negative trial can reveal.

The study appeared in the prestigious Lancet Oncology (Journal impact factor [JIF] = 21.12), along with a commentary.

Chochinov, H. M., Kristjanson, L. J., Breitbart, W., McClement, S., Hack, T. F., Hassard, T., & Harlos, M. (2011). Effect of dignity therapy on distress and end-of-life experience in terminally ill patients: a randomised controlled trial. The Lancet Oncology, 12(8), 753-762.

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The randomized trial was conducted with a large sample (441) of patients recruited from hospices and home-based palliative care in Australia, Canada, and the United States. Investigators compared their preferred intervention, dignity therapy (165 patients), to two comparison/ conditions – standard palliative care (140 patients) and client-centered care (136 patients).

 

Stated goal

This study represents the first randomized control trial of Dignity Therapy. We set out to determine if this novel psychotherapeutic approach would significantly outperform standard care, or Client Centered Care…on various measures of psychological, existential and spiritual distress.

Primary outcome. The primary outcome was distress, which sounds simple enough, but it was measured 23 different ways. No one variable was designated as the primary outcome for the purposes of evaluating the effectiveness or ineffectiveness of dignity therapy would be judged. There are also 22 different secondary outcomes, single items evaluating patients’ experience participating in the intervention.

The three conditions

Dignity Therapy provides patients with life-limiting illnesses an opportunity to speak about things that matter most to them. The conversations are recorded and transcribed to provide the basis for a document that patients can bequeath to individuals of their choosing.

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Patients were shown the Dignity Therapy question framework Table 1] and asked to consider what they might wish to speak about during their Dignity Therapy session(s); this initial introduction to, and explanation of Dignity Therapy took about 30 minutes. Within a few days, or as soon as a second meeting could be arranged, the therapist used the question framework to help elicit the patient’s recollections, hopes, wishes for loved ones; lessons learned and things they wanted remembered by those they were about to leave behind. Dignity Therapy is flexible enough to accommodate participant preferences and choices regarding content, but the ethos of questioning targets those things that might enhance a sense of meaning, purpose, continued sense of self, and overall sense of dignity. All Dignity Therapy sessions were audio-taped; these sessions usually took about 60 minutes. Upon completion, the audio-recording was transcribed verbatim and the transcript edited, to provide a clear and readable narrative. This transcript or `generativity document’ was returned to the patient..,[and] read to them in its entirety to ensure that no errors of omission or commission needed to be addressed (this final session usually took about 30 minutes). .. The final version of the generativity document was then given to the patient, to be passed along to a designated recipient of their choosing.

dignity therapy tell themTherapists for the dignity therapy were psychologists, psychiatrists, or experienced palliative care nurses.

Generativity is a key concept in dignity therapy.

Generativity or the ability to guide the next generation, encompasses how patients might find strength or comfort in knowing that they will leave behind something lasing and transcendent after death.

Some readers may recognize the similarity of the investigators’ concept of generativity and Erik Erikson’s life stage of generativity versus stagnation.

In Standard Palliative Care patients had access to a full range of palliative care support services, including specialist palliative care physicians and nurses with expertise pain and symptom management, social workers, clergy, and mental health professionals.

There were not, however, any components of standard palliative care directly comparable to the dignity therapy.

Client Centred Care was a supportive psychotherapeutic approach, in which the therapist guides patients through discussions focusing on here and now issues. These might include their illness and symptoms and what is being done to address symptom distress. However, in order to keep this condition distinct from dignity therapy, the therapist did not encourage discussion of issues of meaning and purpose. If these topics came up, the therapist redirected the conversation back to illness-related issues.

The therapist for client-centred care was a research nurse.

What was found.

nothingNo evidence was found that that dignity therapy reduced distress across 22 different measures of distress, including overall scores and subscale scores from an array of measures.

The 23 items representing secondary outcomes had only a few differences between the three groups, no more than would be expected by chance. We should be careful about the statistically significant results that were obtained, but perhaps patients were expressing appreciation that they had been randomized to the specialized treatment, as well as having the document to leave for family members. With only five items dignity therapy was found to be superior to both standard palliative care and client-centred care.

The investigators’ interpretation.

Despite the beneficial effects of Dignity Therapy, its ability to mitigate outright distress, such as depression, desire for death or suicidality, has yet to be proven. However, there is currently ample evidence supporting its clinical application for patients nearing death, as a means of enhancing their end-of-life experience.

While floor effects precluded our ability to demonstrate significant differences across study arms, our secondary outcomes revealed substantive benefits of Dignity Therapy. Using a post-study survey, patients who received Dignity Therapy were significantly more likely to report benefits, in terms of finding it helpful, improving their quality of life, their sense of dignity; changing how their family might see or appreciate them, and deeming it helpful to their family, compared to the other study arms.

The investigators were obviously passionate about their intervention and looked exhaustively for evidence of the efficacy of dignity therapy. They really did not find any.

What I liked about this trial.

I like the unusually large sample size and the inclusion of two different control/comparison groups the allowed answering different kinds of questions. This is certainly not an underpowered pilot study being passed off as a full randomized trial. The Standard Palliative Care group allowed determination of whether dignity therapy offered anything beyond routine care. And a reader definitely gets the sense that routine care in this study was neither no care or inadequate care, as it is with so many studies. The Client Centered Care condition pitted the investigators’ preferred intervention against a lower intensity intervention that provides support, but without an element that the investigators considered key to their intervention.

The intervention followed a structured standardized protocol. Standardized training was provided, along with group supervision and review of transcripts of recordings of actual sessions to ensure fidelity of delivery.

The study recruited from a variety of settings and had an excellent uptake from patients who were offered an opportunity to participate.

Patients were randomized with the investigators blinded as to group assignment.

What I like less

The investigators administered a full battery of potential outcome measures including total and subscale scores of

The Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Scale, Patient Dignity Inventory, Hospital Anxiety and Depression Scale, items from the Structured Interview for Symptoms and Concerns, Quality of Life Scale, and modified Edmonton Symptom Assessment Scale.

These measures tend to be moderately to highly correlated and so having this battery available for assessment of outcome represents considerable redundancy. The investigators not designating one or two measures as the primary outcomes set the stage for the investigators selecting a primary outcome after they knew the results, risking confirmatory bias and capitalization on chance.

The investigators had to contend with substantial lots of patients, not unexpectedly, because these are palliative care patients, but they did not avail themselves of a number of ways to provide estimates for the missing data and so analyses were not intention-to-treat.

This little reason to believe that this changed the results, however, because of the floor effect that they noted.

I did not like the positive spin put on the null findings of this trial. Confirmatory bias was clear in the abstract and extended to the discussion. The structured abstract conceded a lack of effect on distress, but cherry picked positive findings to emphasize out of an overall null set of secondary outcomes. In the interpretation section of the structured abstract offered:

Although the ability of dignity therapy to mitigate outright distress, such as depression, desire for death or suicidality, has yet to be proven, its benefits in terms of self-reported end-of-life experiences support its clinical application for patients nearing death.

The laudatory accompanying commentary.

The commentary on this article is an embarrassingly obvious attempt to spin and refute results the commentator did not want to accept.

Commentaries in peer-reviewed journals are typically not rigorously peer-reviewed. They tend to be written with an agenda, by reviewers who nominated themselves to write them. I have previously blogged about an unusual commentary in which the writer sought to destroy the credibility of an article she did not like, despite it having been accepted for publication. Most often, however, commentaries are laudatory and written with an awareness that the authors of the commentaries can get away with praise that would not survive peer-reviewed.

The commentator sought damage control in the face of an utter lack of significant findings. She tried to undermine the validity of an RCT for studying psychosocial interventions. It is true that clinical trials restrict participation to patients with sufficient cognitive intactness, but so do any talk therapies. Her criticism that the sample was not heterogeneous and representative was contradicted by demonstration most patients who were approached participated. Differences in baseline variables are a threat to the validity of results of an RCT, but one of the strengths of such a design is that it serves to minimize such differences. And the commentator gave no evidence that baseline differences between groups undermined the validity of this particular trial.

The commentator raised issues about the standardization of the treatment across settings, but ignored the efforts made to ensure fidelity of delivery. The commentator further ignored the efforts of the investigators to control for nonspecific factors by inclusion of both a standard care and a client centred/comparison control condition. Maybe the richness of standard care precludes finding any effect for the addition of dignity therapy, but that is a valuable finding. It sng that a specialized dignity therapy is not needed. Finally, the commentator’s suggestion that outcomes may not adequately measured is bewildering in the face of the investigators administering a battery of 22 measures for primary outcome and 23 measures for secondary outcome. What does she think is missing?

Given the effort to positively spin solidly null findings in both the article and the commentary, one has to ask under what conditions the investigators and commentator with and willing to concede that this is not a promising line of treatment development?

Why I consider this study important.

Although one does not make a definitive judgment on the basis of a single trial, there is little here to encourage further consideration of dignity therapy as an evidence-based therapy.

The investigators made the testable assumption that end-of-life is a time of considerable psychological distress. They designed an intervention to be delivered by mental health professionals to relieve that distress. They evaluated their intervention in an adequately powered randomized trial, but failed to find any evidence of an effect. The most likely reason is that this large representative sample of palliative care patients was simply not distressed enough to benefit from a mental health intervention.

One could argue that the intervention was not sufficiently intense or mental health oriented, but low baseline distress would preclude a more intense intervention succeeding. There is a floor effect going on, as the investigators recognize.

Basic pilot work would have revealed the surprisingly low levels of distress in this population. A specialty mental health oriented intervention may not be warranted with patients who are not specifically selected for distress. And furthermore, the minority of palliative care patients who show clinically significant distress may not benefit from an intervention like this. They probably would require something more intensive and specifically aimed at reducing distress, with evidence of the intervention having worked in other populations.

But the assumption that cancer patients suffer substantial psychological distress, and patients in palliative care particularly so, is so well entrenched that it is difficult to challenge. Certainly, if investigators applied for a NIH grant and stated that end-of-life is not a time of great psychological distress, they would have risked a low priority for funding.

Giving dying patients a chance to talk: Going from a feature of routine care to a treatment

The investigators failed to find that their structured intervention, dignity therapy offered benefits beyond routine care or a client centred care that had key elements removed: therapists for this condition were not allowed to discuss meaning or purpose.

Suppose investigators had found a therapy mainly provided by psychiatrists and psychologists yielded substantial reductions in distress. These findings would have reinforced existing views of palliative care patients as having high levels of distress. They would further have demonstrated the inadequacy of both good quality routine care and a client centred care modeled after what pastoral counselors offer in providing dying patients with opportunities to discuss their “recollections, hopes, wishes for loved ones; lessons learned and things they wanted remembered by those they were about to leave behind.”

Dignity therapy would be on its way to being an evidence-based treatment with demonstrated ability to reduce significant psychological distress.

And this would propel our moving what had been a feature of routine care to a formal treatment that is of necessity a billable procedure that ultimately requires a diagnosis psychiatrist and psychologist do not provide treatment without diagnosis of disorder. But with what diagnosis?

Presentation1
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The low levels of psychological distress do not indicate the likelihood of substantial psychiatric disorder in this population. There is already a suitable diagnostic category that is loose and limited in its validity, but that serves administrative purposes, adjustment disorder. Mental health professionals seeking to document the diagnosis of patients being treated with dignity therapy, but lacking any other formal psychiatric disorder, could always bill for adjustment reaction related to death. That mental health professionals wanted to treat the patient and the patient wanted treatment would in itself be an indication of distress and clinically significant impairment. And the cause of the disorder the dignity therapy targeted is impending death.

Making a diagnosis of adjustment disorder often is a successful resolution of acute compensation crisis of mental health professionals. They are not offered treatment in the absence of the diagnosis, they are treating adjustment disorder.

Psychiatrists and psychologists offer treatment in “sessions” that are of necessity of limited duration typically half hour to 50 minutes. They do so with a certain time pressure. They follow  schedules allowing only small time intervals between patients and no running over, even if the discussion is intense and productive.

In contrast, pastoral counselors do not require diagnoses for what they provide to patients. While there may be heavy demands on their time, they do not typically operate with rigidly timed “sessions” and will stay with the patient as long as needed, within practical limits. This particular trial of dignity therapy fails to find any evidence that what they do is less efficacious than a psychologist or psychiatrist.

Much of the content of dignity therapy will differ according to the religious faith of patients. It would seem that pastoral counselors could address these issues with greater authority and knowledge.

As an agnostic, I approached working with pastoral counselors in cancer care with skepticism as to whether they would take advantage of patients’ dying days to win them back to their faith. I never saw any of that happen. Rather, all the pastoral counselors I have ever seen have a deep respect for patients’ level of commitment to their faith – or lack thereof. I would characterize what they do is provide a presence for patients’ talking about things that matter to them, nondirectively guiding the conversation forward, but without imposition of their own views.

How do we evaluate what pastoral counselors do? If what they provide is not considered treatment, there is no issue of whether it is evidence-based treatment. It does not require that patients be distressed in order to be eligible for a discussion, nor that the distress be resolved for the discussion to be “successful.”

An example from primary care illustrates some of the “crisis” of medical care in the United States and in many countries that extends to cancer care, dignity therapy would be implemented.

Click to enlarge http://minnesota.cbslocal.com/2012/10/19/questions-can-trigger-split-visit-charge-at-docs-office/

Image Methods Of Psychosocial Intervention 2 4 13-1As detailed in a CBS news story, a woman sought a physical examination from her primary care physician, after not receiving regular care for some time. She came prepared with a long list of health questions for which she would seek answers in her appointment. The physician obtained reimbursement from insurance for the physical by billing for all of the specific tests and procedures that had been done. However, he billed the woman by the minute for the discussion. A commentator in the news segment discussing this said, in effect, ‘physicians get paid for doing procedures, not for whether they solve problems and not for talking about it.”

Cancer care is expensive, which means lucrative for both for-profit and not-for-profit settings that can obtain reimbursement. There is increasing emphasis on procedures that are billable to third-party payers and for efficient use of providers’ time.   Provision of basic emotional support and time for patients discussing their concerns are endangered features of routine cancer care. But we should be careful about efforts to preserve these features by making them billable mental health procedures. That entails an inevitable need for a diagnosis and for rationing talk time, restricting it to those patients having a mental health related disorder.

More generally, psychotherapy intervention trials in cancer care do not typically attract patients with clinically significant distress in great numbers. Across trials, only about a third of the patients are clinically distressed. That is about the same as what you find in primary care medical population waiting rooms.

Correspondingly, RCTs of psychotherapy for cancer patients often failed to show a benefit because the patient samples that are recruited are overall insufficiently distressed. Why are the patients there, then?

It is likely that with the increasing scarcity of talk time in routine care, patients are simply seeking a safe place where they will be listened to, and can express and reflect on their feelings, not necessarily solve problems or reduce distress. That can be an entirely valid goal in itself. But problems arise when these discussions are of necessity provided as treatment with mental health professionals. Issues of cost effectiveness and efficacy arise, for which formal evidence is required. And such treatment is typically in short supply, with long waiting lists.

This RCT of dignity therapy came about because a  psychiatrist passionate about what he provides for palliative care patients developed and evaluated a structured mental health treatment. Maybe it is not all bad that the trial was negative. We now have a greater chance of preserving supportive elements of palliative care, including time for patients to talk about their concerns, and can hold off rationing them.