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).

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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.

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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.

 

 

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