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ASA NEWSLETTER
 
 
August 1997
Volume 61
Number 8
 

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
  1. Subjective Pain Assessment
  2. Restoration of Function
  3. Productivity
  4. Medical Findings
  5. Health Resource Utilization
  6. Mental Health
  7. Health Perception
  8. Patient Satisfaction
  9. 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.
1. Strongly disagree
2. Moderately disagree
3. Agree
4. Moderately agree
5. Strongly agree
2. How satisfied are you with your pain treatment?
1. Completely satisfied
2. Somewhat satisfied
3. Neither satisfied nor dissatisfied
4. Somewhat dissatisfied
5. Completely dissatisfied
3. How much pain have you (on average) had recently?
1. None
2. Mild
3. Moderate
4. Severe
5. Excruciating
4. What effect on your overall health has your pain treatment had?
1. Made it much worse
2, Slightly worse
3. No change
4. Slightly better
5. A great deal better
5. Recently, how often has your pain interfered with your activities (like visiting
friends, doing hobbies and working)?
1. All of the time
2. Most of the time
3. Some of the time
4. A little of the time
5. None of the time
6. What effect has your pain treatment had on your ability to perform daily activities?
1. Made it much worse
2. Slightly worse
3. No change
4. Slightly better
5. A great deal better
7. Recently, how much of the time have you felt "down in the dumps"?
1. All of the time
2. Most of the time
3. Some of the time
4. A little of the time
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?
1. There has been a significant reduction
2. There has been some reduction
3. There has been no change
4. There has been some increased usage
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?
1. No improvement
2. Very mild improvement
3. Moderate improvement
4. Significant improvement
5. Restored to normal health


Hugh C. Gilbert, M.D., is Assistant Clinical Professor, Department of Anesthesiology, Northwestern University Medical School, Chicago, Illinois.
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The views expressed herein are those of the authors and do not necessarily represent or reflect the views, policies or actions of the American Society of Anesthesiologists.

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