Beyond the distress screening debacle: Rethinking, rebuilding psychosocial care for cancer patients

James C. Coyne, Ph.D.University of Groningen, University Medical

Center, Groningen, NLand

Institute for Health PolicyRutgers University, NJ, USA

jcoynester@gmail.com

Special Thanks

Josette Hoekstra-Weebers Christoffer Johansen Mecheline van der Linden Brett Thombs

But I have sole responsibility for any excesses or inaccuracies.

Screening Recommended and Now Mandated

Despite

Lack of evidence that improves outcomes vs patients and providers simply having access to same services without screening.

Lack of adherence of recommendations to standards for setting guidelines.

Guidelines for Guidelines

Institute of Medicine Committee on Standards for Developing Trustworthy Clinical Practice Guidelines (2011). Clinical practice guidelines we can trust. Washington, DC: National Academies Press.

Loblaw, D. A., Prestrud, A. A., Somerfield, M. R., et al. (2012). American Society of Clinical Oncology clinical practice guidelines: Formal systematic review–based consensus methodology. J Clin Oncol, 30(25), 3136-3140.

Shaneyfelt T. In guidelines we cannot trust. Arch Intern Med;172:1633-1634.

Evaluating Practice Guidelines

Practice guidelines from professional organizations notoriously biased and not evidence-based.

Standards developed for evaluating process by which guidelines are constructed and disseminated.

Systemic consideration of evidence and stakeholder involvement with opportunity to correct.

Guidelines for Distress Screening Deficient in

Systematic review of the literature. Transparency. Composition of guidelines committee

including formal involvement of patients, frontline clinicians, and other key stakeholders.

Articulation of guidelines in terms of strength of evidence.

External review, feedback, and revision.

Neglected voices in process of deciding that implementing screening and reduction in distress through counseling are the organizing activities of psycho-oncology:

Patients.Frontline clinical staff most affected by screening.Primary care physicians, community clinicians, and social services expected to receive referrals and provide treatment.

Mandating Screening

Perverse incentives.

Unintended consequences.

Routine screening threatens to

Aggravate existing disparities in receipt of services.

Further diminish and ration basic supportive elements of cancer care.

Accelerate trends making opportunities scarce for patients to talk about their concerns and limiting discussions to what is procedural and billable.

Screening bureaucratizes talking to patients

Imposes quality indicators with weak associations to quality of psychosocial care.

Rations opportunities for patients to talk. Requires mental health backup and further

screening. Requires patients to have repeated

discussions in order to get their needs met.

Will introduction of routine screening damage Dutch

psychosocial care?

Current Dutch Guideline: Detection of Need for Care does not comply with proposed international guidelines for mandated screening.

All cancer patients, not only those who screen positive for distress, are offered opportunity to talk to a professional about their needs and concerns, unless they explicitly indicate they do not want to do so.

Should we disconnect talking to patients and determining meetable unmet needs from routine screening for distress?

Screening is by definition rationing of patient opportunities to talk and receive services.

If a procedure is truly screening, it involves decision-making about access based on scoring above some cutpoint.

Changes in Medical Care that Threaten the Delivery of Psychosocial Services to

Cancer Patients

An American woman Susan Krantz, received national news attention when she complained about her physician charging her $50 for her having asked questions during her annual physical.

Her insurance company paid her physician for the physical, but not for answering her questions. She had not been warned of the extra charge ahead of time.

Talking to patients is not a (billable) procedure.

Conversations with the meter running.

“We’re not paid to solvepatients’ problems, we arepaid to do procedures.”

Emphasis on billable procedures and time efficiency devalues extended encounters needing to resolve complex medical and social problems for which there are not billable procedures within the cancer care setting.

Emphasis on time-efficiency and expensive, billable procedures

Has led to withdrawal of supportive elements from biomedical cancer care.

Has delegated psychosocial support to undervalued nurses and social workers whose vital work is threatened by not fitting the dominant model.

The curse of getting what you wanted.

Monitoring screening for distress with quality indicators:

Pfizer gives $10 million grant to American psychologist to develop quality indicators to monitor oncologists’ screening for distress.

American Mandated Screening Practices

Oncologists cannot close their medical records without indicating whether they have asked a patient about distress.

Oncologists can comply with quality indicators by asking simply “you feeling depressed?” and prescribing antidepressants to patients who answer “yes” without formal diagnosis, patient education, or follow-up.

Depending on context, mandated screening for

distress may

• Increase inappropriate prescription of psychotropic medication in absence of adequate diagnosis and follow up.

• Disrupt patients readily accessing services on their own by consuming scarce resources and requiring patient psychiatric evaluation for patients who screen positive.

• Increase health disparities.

No effect on pain outcomes.

Stricter monitoring of quality of care indicators increased prescription of more addictive pain medication without monitoring, leading to higher rates of addiction and death.

Large increase in costs of ineffective procedures, notably for lower back pain.

Learn from the disaster of making pain the 5th vital sign

Neither pain nor distressed are Vital signs

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.

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).

-Lucy Hornstein

Evaluating Screening for Distress

Screening for distress is useful only to the extent that it improves patient outcomes beyond any detection and treatment that is already provided as part of existing standard care.

Screening program must identify a significant number of distressed patients who are not already recognized, engage those patients in treatment, and obtain sufficiently positive outcomes to justify costs and potential harms from screening.

Our Formal Evaluation of Screening for Distress

Adopted the analytic framework of the U.S. Preventive Services Task Force (USPSTF) in searching for evidence of

(1) the efficacy of interventions for reducing distress; and

(2) the efficacy of routine screening in reducing distress among cancer patients.

.

Conclusion: Treatment studies reported modest improvement in distress symptoms, but only a single eligible study was found on the effects of screening cancer patients for distress, and distress did not improve in screened patients versus those receiving usual care.

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.

Hart, et al. (2012) "Meta-analysis of efficacy of interventions for elevated depressive symptoms in adults diagnosed with cancer.” Journal of the National Cancer Institute 104:13: 990-1004.

.

Hart S L et al. JNCI J Natl Cancer Inst 2012;104:990-1004

© The Author 2012. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

3 comparisons classified as “psychotherapeutic” were complex collaborative care interventions for depression emphasizing medication management.

These studies provided the bulk of the 527 patients in the authors' calculation of the effect size for psychotherapeutic intervention.

Of the 2 remaining studies, 1 randomly assigned 45 patients to either problem-solving or waitlist control and retained only 37 patients for analyses.

Final study contributed 2 effect sizes based on comparisons of 29 patients receiving CBT and 23 receiving supportive therapy to the same 26-patient no-treatment control group, thus violating the assumption of independence of effect sizes.

With Removal of Small and With Removal of Small and Inappropriately Classified StudiesInappropriately Classified Studies

No Eligible Studies Were Left

Why is there so little evidence?

Almost all studies of psychosocial interventions targeting distress do not include having elevated distress as entry criteria.

Most patients entering such trials are not sufficiently distressed to register a signficant effect (floor effect).

Most trials claiming efficacy depend on post hoc, underpowered comparisons of outcomes selected after results were known.

Policy decisions we must face

What are we going to do about considerable proportion of patients who want counseling, but do not have a diagnosable condition?

Is it against patient interests to classify opportunities to talk as treatment?

What are the unintended consequences of conceptualizing talk as treatment?

Bias in assuming that most cancer patients who want to talk want counseling.

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

Carlson et al, Brit J Cancer, 2004.

Four other systematic reviews

Variously indicate that

Screening may improve communication between patients and clinicians.

Stimulate discussions of psychosocial and mental health issues increase referrals to specialty services.

Referral: A problematic surrogate outcome

Making a referral unlikely to lead to improved patient outcomes.Many referrals not completed or for only one session.Large social disparities in patients’ ability to complete referrals and receive adequate exposure to care.Care in community often not adequate in quality, intensity, or follow up.

Screening consecutive patients can be an extremely inefficient way of

getting cancer patients into counseling/psychotherapy.

Screening of consecutive cancer patients to recruit for a RCT too inefficient to be recommended.

4% of 970 patients consented to trial participation.

27 patients needed to be screened to recruit a single patient.

17 hours staff time required for each patient recruited.

What went wrong?

Most patients who were distressed were either already receiving services or did not want them.

Simply asking patients if they wanted a discussion or services before screening would greatly increase efficiency of screening.

Pseudo-science of cutpoints

Unrealistic expectation a single cut point

valid across cancer sites, demographics, and treatment settings.

Most validations are with the HADS as “gold standard.”

Low sensitivity, specificity when used to

predict new uptake of services. Adequate validation study would exclude patients

already receiving services and those uninterested.

The yield of screening is greatly reduced when we take in to account the large proportion of patients –

Who are not interested in services. Who are already getting them elsewhere. For whom the services needed are not

available through the cancer center or readily coordinated from there.

Inconvenient findings

Distressed patients more likely to seek counseling, but most patients seeking counseling are not distressed.

Most distressed patients who are not in counseling do not want it.

Most patients receiving mental health services after a diagnosis of cancer have previously received the services.

Value of screening assumes alignment of patients

Wanting help (felt need).

Scoring above a clinical threshold on a screening questionnaire (normative need).

Seeking referral to psychological services (expressed need).

Distress Thermometer vs Patient Preference

Distress thermometer depends on patient self-report.

Most patients told they need psychological counseling on basis of score above cutpoint wil disagree.

Rather than screen--

Allow any patients who want to talk an opportunity to do so and renew offer often.

Ask patients if they wanted to know about available services, have needs for which these services might relevant.

Refer only if they were interested in services.

Follow up to ensure outcome.

Distress redefined

“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.”

Overly broad definition of distress

The expansion of the concept of distress provides an incoherent, unmanageable, and scientifically unmeasurable goal for the organization of psycho-oncology.

Evaluating Screening for Multiple Problems

Preventive services interventions in PC provide a model for evaluating screening for multiple needs.

PCPs encouraged to screen for many different conditions, some with psychosocial components (e.g., depression, intimate partner violence, alcohol abuse, smoking).

Impossible to determine which screening is beneficial and cost-effective, unless each evaluated separately.

What we can learn from literature

concerning screening for depression in medical settings?

Conclusions of Review

No trials have found that patients who undergo screening have better outcomes than patients who do not when the same treatments are available to both groups.

Existing rates of treatment, high rates of false-positive results, small treatment effects and the poor quality of routine care may explain the lack of effect seen with screening.

Developers of future guidelines should require evidence of benefit from randomized controlled trials of screening, in excess of harms and costs, before recommending screening.

Raffle, A and Gray, M. (2007). Raffle, A and Gray, M. (2007). Screening: Evidence and Screening: Evidence and PracticePractice. Oxford Press.. Oxford Press.

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.

What can we learn from a RCT of Dignity Therapy?

First randomized control trial of Dignity Therapy.

Goal was to determine if dignity therapy (165 patients) would outperform standard care (140 patients), or client centered care (136 patients) on 23 measures of psychological, existential and spiritual distress.

No superiority of dignity therapy to client centered counseling or standard care on any of the 23 measures of distress.

Some indication of a floor effect: representative sample of palliative care patients were not sufficiently distressed to register any benefit or difference between conditions.

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.

Problems arise when these discussions are of necessity provided only 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.

Billable procedures require a diagnosis

Should patients have free access to yoga?

Is yoga an evidence based treatment?

Can ask for evidence whether typical cancer patient attending yoga class obtains reduction in distress or sufficient exercise.

Can inform patients of evidence.

Can test whether there is anything distinctive about yoga beyond group breathing and stretching exercises.

But such evidence not necessarily relevant to patient preference for yoga classes.

Yoga currently a class, not a treatment.

Pitfalls of making it a treatment.

Thinking beyond the mandated screening debacle

Restatement of Problem

Diffuse, informal support and reassurance is already eroding in routine cancer care.

Patients want to talk about implications their diagnosis and treatment of cancer.

Minority want formal counseling or psychological therapies but some need more intensive services and follow up.

Pastoral counselors, peers in similar predicaments, GPs as preferred as mental health services.

Restatement of Problem

Distress weakly related to interest in service not already being received.

Most persons interested in services are not distressed.

Within limits, distress should not be basis for rationing.

Restatement of Problem

Many patients—particularly the older and socially disadvantage—have needs that cannot readily be addressed at the cancer center.

Cancer and its treatment disrupt existing the medical care and social services.

Rather simple referral, these patients need discussion, advocacy, negotiation, care management, and follow up.

Mental Health Problems

Given clinical epidemiology of mental health problems, those arising in cancer care are likely to be recurrences in patients with a relevant history of treatment.

Cancer and its treatment disrupt treatment.

Physical co-morbidity affects course and continued risk for mental health problems.

Mental Health Problems

Monitoring and follow up more of a priority than detecting new cases and subjecting them to poor follow up in routine care.

Routine care for mental health problems abysmal and probably worsened by cancer.

Thank you!

jcoynester@gmail.com

Follow me on Twitter@CoyneoftheRealm

Blog: Mind the Brain