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August 1997
Volume 61 |
Number 8
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| Developing Outcome
Measures for Pain Management |
Hugh C. Gilbert, M.D.
Committee on Pain Management
For the last three years, the Committee on Pain Management has
been exploring the development of an instrument that could measure
outcomes in patients undergoing pain therapy by anesthesiologists.
Traditionally, physicians have focused attention on measuring
morbidity and mortality. ASA has sponsored closed-claim research
that has critically examined complications of anesthetic care
and liability. Likewise, ASA is an acknowledged leader in developing
evidence-based practice guidelines that identify appropriate strategies
for clinical care by anesthesiologists.
Three
of the guidelines approved to date address the practice of pain
medicine by anesthesiologists for acute postoperative pain, chronic
pain and cancer pain. Practice guidelines are important because
they indicate how physicians can appropriately integrate clinical
data with health resource utilization. They do not provide information
that assesses the influence of clinical care on the ability of
patients to perform daily activities, how patients feel or the
impact of care on personal health.
Practice guidelines define appropriate care options based upon
published evidence and expert consensus. Practice guidelines and
clinical pathways reflect the manner in which clinicians collate
clinical data and utilize health resources in diagnosing and treating
painful conditions. Figure 1 demonstrates
how a patient with a painful condition interfaces with health
care delivery systems. Note that health outcomes represent the
end of the process. Outcome measures examine subjective
and objective parameters that quantify how effective (or ineffective)
a medical therapy has impacted on the health and well-being of
patients.
Health outcomes measures:
- good practice
- increases accountability of services
- quantifies the value of interventions where traditional research
data may be impractical or lacking
- assists in determining resource allocations
- helps monitor and improve standards of care.
Outcome measures complement clinical pathways and practice guidelines
by examining subjective and objective data that quantify the effects
of therapy on the health and well-being of patients. Today, outcome
measures have become increasingly important in determining the
allocation of health care resources.
Historically, anesthesiologists have relied on three methods
for evaluating pain outcomes. First, global pain assessments such
as the McGill Pain Questionnaire (MPQ) have been employed to quantify
pain symptoms and how they change over time with treatment. While
global pain assessments such as the MPQ are valid, MPQ and similar
pain assessment instruments cannot of themselves measure health
outcomes completely. Second, program or symptom-specific assessments
that identify the strengths and weaknesses of a particular intervention
offer little opportunity to compare outcomes in the diverse populations
served by pain specialists. Finally, patient-specific assessments
are most desirable because they often identify the value of an
intervention in human terms.
A standardized outcome instrument could assist clinicians to
quantify the effect of their practice by comparing the responses
of their patients against statistical norms. Current outcome instruments
have been validated to measure patient satisfaction and health
improvement. Defining health resource utilization in economic
terms (direct and indirect expenses incurred) is critically important
when comparing different treatment plans. Economic audits require
a rational, fiscally responsible methodology that assesses both
the realized dollar value of the cost of care and the economic
impact of chronic pain when pain is either undertreated or inappropriately
treated. Pain therapy that results in negative outcomes adds expenses
and continues to further pain and suffering.
Outcome measurement of pain management is very complex. The ideal
instrument should be easily validated and administered, require
little effort to complete and be reliable across the entire pain
population. The Committee on Pain Management examined the current
literature regarding this new era of health assessment. Dimensions
such as measurements of physical, mental and social well-being
seemed to define the framework that has guided others in constructing
questions for outcome assessment.
Nine domains were identified as important in developing a pain
outcome assessment questionnaire. Table
1 lists the nine domains that, in the opinion of the committee,
could help anesthesiologists quantify the outcome of their pain
therapies. After examining the various standard assessment tools
that are currently available, the committee developed the "ASA
Nine" in order to help anesthesiologists validate outcome
of pain therapy.
The "ASA Nine" represents
nine items that assess the efficacy of pain therapy. Eight of
the nine items survey the patient (or in the case of pediatric
patients, their parents). Anesthesiologists who practice pain
management can develop a numeric scoring of patient responses.
A national data repository could also be established that could
provide the membership with a "snapshot" of their patients'
responses to national averages. It is hoped that examination of
patient responses will help quantify the outcome of therapy and
provide data that can help us measure the quality of our practices.
Most of the items included in the "ASA Nine" need no
explanation. The Committee on Pain Management is aware that some
of the domains may be difficult to quantify. This communication
is intended to update the ASA membership on our work in progress.
Since testing the
validity of an outcome instrument is difficult, utilization of
a standard outcome instrument is an attractive alternative. Readers
can examine the SF-36 and the
SF-12 using the Internet.
Bibliography:
- Melzack R. The McGill pain questionnaire: Major properties
and scoring methods. Pain. 1975; 1:277-299.
- Ware JE, Keller S, Bentler PM, et al: Comparisons of health
status measurement models and the validity of SF-36 in Great
Britain, Sweden, and USA. Qual Life Res. 1994; 3:68.
- Woolf S. Interim manual for clinical practice guideline development.
AHCPR Pub. No 91-0018, May, 1991.
Table 1
Domains of Pain Outcomes Measures
- Subjective Pain Assessment
- Restoration of Function
- Productivity
- Medical Findings
- Health Resource Utilization
- Mental Health
- Health Perception
- Patient Satisfaction
- Cost Analysis
"ASA Nine" Proposed Outcomes
Measures Version 0.1
| To be answered by pain patient: |
| 1. |
All things considered, the results of my pain
treatment were worth the cost. |
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1. Strongly disagree |
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2. Moderately disagree |
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3. Agree |
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4. Moderately agree |
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5. Strongly agree |
| 2. |
How satisfied are you with your pain treatment? |
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1. Completely satisfied |
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2. Somewhat satisfied |
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3. Neither satisfied nor dissatisfied |
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4. Somewhat dissatisfied |
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5. Completely dissatisfied |
| 3. |
How much pain have you (on average) had recently? |
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1. None |
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2. Mild |
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3. Moderate |
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4. Severe |
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5. Excruciating |
| 4. |
What effect on your overall health has your
pain treatment had? |
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1. Made it much worse |
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2, Slightly worse |
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3. No change |
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4. Slightly better |
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5. A great deal better |
| 5. |
Recently, how often has your pain interfered
with your activities (like visiting
friends, doing hobbies and working)? |
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1. All of the time |
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2. Most of the time |
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3. Some of the time |
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4. A little of the time |
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5. None of the time |
| 6. |
What effect has your pain treatment had on your
ability to perform daily activities? |
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1. Made it much worse |
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2. Slightly worse |
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3. No change |
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4. Slightly better |
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5. A great deal better |
| 7. |
Recently, how much of the time have you felt
"down in the dumps"? |
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1. All of the time |
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2. Most of the time |
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3. Some of the time |
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4. A little of the time |
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5. None of the time |
| 8. |
Since your pain treatment, has there been a
reduction in the need for medicines, appointments to your
physician or other consultants, unplanned emergency room visits
or unplanned hospital admissions? |
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1. There has been a significant reduction |
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2. There has been some reduction |
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3. There has been no change |
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4. There has been some increased usage |
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5. There has been a significant increased usage |
| To be answered by treating physician: |
| 9. |
In your professional assessment (e.g., physical
findings, diagnostic and/or laboratory testing), how has pain
treatment improved the health of your patient? |
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1. No improvement |
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2. Very mild improvement |
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3. Moderate improvement |
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4. Significant improvement |
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5. Restored to normal health |
Hugh C. Gilbert, M.D., is Assistant Clinical
Professor, Department of Anesthesiology, Northwestern University
Medical School, Chicago, Illinois.
E-mail the author.
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