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The Case Against Screening Cancer Patients for Distress James C. Coyne, Ph.D. Health Psychology Program University Medical Center, Groningen, NL and Institute for Health Policy Rutgers University, NJ, USA [email protected]

Where’s the evidence that screening for distress benefits cancer patients?

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“The case against screening for distress.” A presentation delivered as part of an invited debate with Alex Mitchell at the International Psycho Oncology Conference, Rotterdam, November 7, 2013

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Page 1: Where’s the evidence that screening for distress benefits cancer patients?

The Case Against Screening Cancer

Patients for Distress

James C. Coyne, Ph.D.Health Psychology Program

University Medical Center, Groningen, NLand

Institute for Health PolicyRutgers University, NJ, USA

[email protected]

Page 2: Where’s the evidence that screening for distress benefits cancer patients?

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.

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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.

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Evaluating Screening Recommendations

Screening for medical problems is commonplace in medical settings.

Once assumed clinicians should routinely screen for problems that have significant clinical and public health implications, if a means existed.

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Evaluating Screening Recommendations

Serious re-evaluation with the recognition that consultations with clinicians cannot accommodate screening for all problems.

More than simply targeting an important clinical problem, screening must lead to improvement in patient outcomes.

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Evaluating Screening Recommendations

Burden of Proof Falls on Those Who Would Recommend Screening to Demonstrate

Improves Patient Outcomes.

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Screening for Distress Evaluated

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.

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What Screening is Not

Definition excludes settings in which patients complete screening and responses are then used to structure discussions, regardless of whether the patients meet pre-established thresholds for distress.

Definition excludes situations in which a questionnaire is used to facilitate a conversation independent of patients’ level of distress.

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Great for the Dutch!

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.

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Our 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.

.

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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.

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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.

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Provisional work suggests that screening for psychological distress holds promise and is often clinically valuable, but it is too early to conclude definitively that psychological screening itself affects the psychological well-being of cancer patients.

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Four other systematic reviews ignore

High risk of bias in reporting of screening studies.

Test multiple endpoints measured at multiple timepoints cherry-picked with confirmatory bias.

Selective retention, lack of intent to treat analyses.

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Dodging the Basic Question?

Increasingly advocates of screening have the resources to test whether it improves outcomes over routine care, but dodge the question by excluding a routine care control.

“Previous work has already established the feasibility of screening in cancer settings, and the superiority of screening with triage to screening without triage (Carlson et al, 2010), so it seemed somewhat unethical not to offer some form of triage” (Carlson et al, BJC, 2012).

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Relevant Clinical Epidemiology Findings

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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.

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Trajectories of Distress

Much of the heightened distress reported by cancer patients is self-limiting or resolves within routine cancer care without specialty psychosocial or mental health services.

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Rate of overall decline in distress in routine care dwarfs any differences among conditions in screening studies.

Many of the minority of patients with persistent distress have prior problems or non-cancer related problems.

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Unmet Needs Do Not Equal Interest in Services

A substantial proportion of the cancer patients indicating unmet needs do not wish to receive services within the context of cancer care.

Rates of receipt of services not much higher after diagnosis than what was received before detection and diagnosis.

More interest in physical therapy and nutrition than specialty psychosocial and mental health services.

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Screening Does Not Substantially Increase

Uptake of Services.

Only a minority of cancer patients who screen positive for distress subsequently receive services.

Limited available data suggest that screening

is not a cost-effective way of getting cancer patients into services.

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The Pseudoscience of Validating Screening

Cutpoints

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Validation of Screening Instruments

Most guidelines indicate that screening for distress should make use of validated instruments with published cutpoints to identify distressed patients.

Screening instruments are most often validated in terms of their performance as measures of emotional distress

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Distress is not a vital sign.

Optimal cutpoint on distress thermometer varies between cancer sites, clinical settings, and health systems, and cultures.

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Validation of Screening Instruments

Inexplicable variations in cutpoints from study to study

Studies flawed by floating cutpoints, capitalizing on chance inclusion of patients already receiving treatment

Fallacy of assuming that for screening purposes, it is instruments that are being validated, not cutpoints

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Hospital Anxiety and Depression Scale

Applications of different factor analytic techniques fail to identify separate anxiety and depression subscales,

At best, the items of the HADS converge on a single general distress factor.

Problems with HADS in translation. Patients unable to follow changes in

response keys, direction of items.

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The HADS Should Not Be Used

Coyne JC, van Sonderen E: The Hospital Anxiety and Depression Scale (HADS) is dead, but like Elvis, there will still be citings. Journal of Psychosomatic Research 73:77-78

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Validation of Screening Instruments Against

Unmet Need

Measures of unmet need insufficiently developed psychometrically to serve as comparison for calculating opitmal cutpoints.

Individual need items vary widely in correlation with DT: a few strongly, few more moderately, rest null to weak correlations.

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What we can learn from literature

concerning screening for depression in medical settings

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Conclusions of ReviewConclusions 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.

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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.

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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.

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Depending on the 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.

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Screening for distress should be limited to well resourced settings… where it may not be needed.

Be prepared for unintended consequences.

Consider alternative uses of same resources.

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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.

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Alternatives to Screening

• Enhanced support, access to services, and Enhanced support, access to services, and follow up for patients already known to be follow up for patients already known to be distressed or socially disadvantaged.distressed or socially disadvantaged.

• Provide ready access for patients to discuss Provide ready access for patients to discuss unmet needs with professional and peer unmet needs with professional and peer counselors regardless of level of distress. counselors regardless of level of distress.

• Increase resources for addressing health Increase resources for addressing health disparities in access to psychosocial services.disparities in access to psychosocial services.

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Give patients time to talk and listen to them, don't let screening for distress get in the way.

Don't require cancer patients to interact through computer touchscreen assessments.

Do give them the opportunity to talk about their experiences, their needs, their concerns, and their preferences regardless of their level of distress.

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

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Where is the Evidence?

Advocates for screening need to demonstrate that implementation will not be associated with

Triaging

Rationing of services.

Reduction in the opportunity for cancer patients to discuss concerns with oncology staff.

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Routine screening for distress is currently not

an evidence-based practice.