The Clinical Art of Pain Medicine: Balancing Evidence, Experience, Ethics, and Policy

Blackwell Synergy - Pain Medicine, Volume 6 Issue 4 Page 277-279, July 2005 (Full Text)
The Clinical Art of Pain Medicine: Balancing Evidence, Experience, Ethics, and Policy

* Rollin M. Gallagher, MD, MPH
Editor-in-Chief

Efficacy, effectiveness, morbidity risks, and costs are four metrics that inform our conscious clinical reasoning about treatment for each patient. These metrics also inform general treatment strategies for different patient groups defined by characteristics such as mechanism, disease, age, comorbidities, and insurance coverage. Physician factors such as bias and values, sometimes unconscious, may also affect clinical reasoning. The Spine Section herein, while arguing best practices for zygapophysial blocks, highlights the importance of carefully considering the source and meaning of our metrics in pain medicine practice.

Efficacy tells us about the chances of pain relief and its expected magnitude from any treatment, based on double-blind, placebo-controlled clinical trials in specific clinical populations. Effectiveness, a less precise metric usually derived from extended open label clinical trials and clinical experience, informs us of the performance of a treatment in a practice setting where factors such as convenience, comorbidities, and tolerability influence our decisions. Tricyclic antidepressants for neuropathic pain or depression are a good example––efficacy is established, but effectiveness in the field, which is enhanced by side-effects such as nighttime sedation and by once-a-day dosing convenience, is limited by both side-effect burden and concerns about toxicity and drug–disease interactions (e.g., arrhythmias, hypotension, urinary retention, suicide). Morbidity risks may emerge in early clinical trials, but sometime only after large populations are exposed to a particular drug or procedure in routine clinical practice over years or in large, postapproval multicenter trials. Nonsteroid anti-inflammatory drug (NSAIDS) (gastrointestinal and renal risk), Cox 2 inhibitors (cardiovascular risk), and spinal surgery for nonspecific low back pain (failed back surgery syndrome) are examples of risks that emerged in the public's awareness long after treatments were widely used in the field. Costs may influence practitioners’ decisions about what to recommend, and patients’ decisions about what prescriptions to fill and what advice to follow. Managed care plans require time-consuming preapproval for many treatments and may sanction physician outliers. Well-insured or wealthy patients often ignore cost, which for others may preclude filling a prescription or using it correctly ("a little is better than none"). As a general rule, when medicine fails to develop cost-effectiveness models for practice, a business model prevails and restricts practice. Business knows that withholding treatment for costs implies an administrative, rather than therapeutic, relationship to the patient, and that this position is uncomfortable for most physicians.

What is our metric for deciding when a procedure is justified for any one patient? Can we weigh the cost-effectiveness of a treatment against our patient's hopes for relief ? If initial treatment is ineffective, when does our own insecurity influence our decisions? When is consultation appropriate? Dr. Schofferman [1] reminds us that conventional wisdom based on extensive research suggests that a two-point reduction in pain on a 0–10 scale is clinically significant and that many investigators consider a 50% improvement to be significant when evaluating efficacy [2]. In our practices we chip away at the pain, using the additive benefit of several modalities to bring the pain down to a level that enables the patient to enjoy a meaningful quality of life. Ultimately, a level 4 may be as low as we can get without intolerable side-effects; if level 4 improves quality of life and achieves a patient's desired goals (if not complete relief, then return to work or other meaningful activity), we consider treatment successful. Complete relief often seems ephemeral in pain clinics for two reasons: first, the "simple" cases with one or a few isolated lesions causing pain that respond to a block or neuroablative procedure may be treated successfully before referral; second, the cases that are referred have more complex pain (multiple mechanisms, including progressive tissue damaging disease or central nervous system damage) or more complex clinical problems (e.g., medical or psychiatric comorbidities). This reality indicates the fundamental problem with our model of sequential care in pain medicine––we often do not see the patient until after a succession of treatment failures by others, and the resulting complications of poor pain relief [3].

Articles by Drs Barnsely [4] and Bogduk [5] in the Spine Section argue another perspective––that only complete relief from pain, no pain, is the gold standard outcome upon which treatments should be judged. Barnsley, in a study of a consecutive sample of patients who underwent neurotomy of the medial branches of the cervical dorsal rami to palliate chronic zygapophysial joint pain, used complete relief of pain as the indicator of successful outcome. This was obtained for 36 of 45 cases (80%) for a mean of 35 weeks and is, indeed, a very impressive result. Although this study is not placebo controlled, the magnitude of effect (complete relief) argues strongly for effectiveness. (A recent study of subanesthetic ketamine in complex regional pain syndrome [6], using a similar metric, similarly argues for the effectiveness of a new treatment in what many have considered a treatment-resistant disease). Bogduk's review of the evidence for the efficacy of steroid injections into lumbar zygapophysial joints uses the same criterion for success. However, his review suggests little more than placebo effect for this procedure when used in the lumbar region.

Schofferman's commentary [1] cogently present a different perspective. He argues that pain specialists, particularly experienced clinicians, often treat outliers, patients that do not conform to the strict selection criteria required in a research protocol. These patients may have several causes of pain and are more likely to have failed conventional treatment and to have comorbidites. He suggests that the clinical art of medicine, informed by but not dictated by evidence-based medicine (EBM), should determine our behavior as clinicians. He also suggests that ethical principles ("do no harm") inform these decisions––that not doing something that might relieve pain, when its potential harm is minimal and the chances of success reasonable, given the available information, is not "best practices."

I agree that practicing the clinical art of pain medicine should be guided by this combination of values (evidence, clinical needs, and ethics) in pain practice (see Dubois M, Pain Medicine 2005;6[3]). We should add to that equation the value of a mindfulness of social policy. This perspective is particularly important for a field engaged now in a struggle to establish its professional authority through EBM and public accountability. The physician caring for a patient with unrelenting pain feels a moral imperative to ease suffering. Some may respond by trying anything that might work. If it is well reimbursed, then, as Dr. Bogduk suggests, our economic "imperative" is satisfied, and we are gratified in testing our clinical skills. Many consider this posture irresponsible, because it jeopardizes our professional standing as a field. A more nuanced approach, recognizing all the factors that might influence outcome, is needed. Trying a procedure as an isolated treatment without addressing a patient's risks for poor outcome is unwise clinically and, to many, unethical because of its cumulative negative effects on social policy as regards our specialty. The ultimate negative outcome would be reducing the public's access to our effective treatments. Although today this behavior may be reimbursed, it reduces our professional authority and makes tomorrow's reimbursement for our effective procedures less likely. The highest clinical art imbeds procedures in a plan that addresses other salient risks, thus improving cost-effectiveness and enhancing our reputation. Ultimately, calm demeanor and reasoned judgment, informed by education, training, experience, ethical principles, and emerging evidence, is the medical product that society will deem invaluable.

1 Schofferman J. Commentary to a narrative review of intra-articular corticosteroid injections for low back pain. Pain Med 2005; 6( 4): 297– 8 .

2 Farrar J, Young J, LaMoreaux L, Werth J, Poole M. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001; 94: 149– 58.

3 Gallagher RM. Pain medicine and primary care: A community solution to pain as a public health problem. Med Clin North Am 1999; 83( 5): 555– 85.

4 Barnsley L. Percutaneous radiofrequency neurotomy for chronic neck pain: Outcomes in a series of consecutive patients. Pain Med 2005; 6( 4): 282– 6 .

5 Bogduk N. A narrative review of intra-articular corticosteroid injections for low back pain. Pain Med 2005; 6( 4): 287– 96 .

6 Correll GE, Maleki J, Gracely EJ, Muir JJ, Harbut RE. Subanesthetic ketamine infusion therapy: A restrospective analysis of a novel therapeutic approach to complex regional pain syndrome. Pain Med 2004; 5( 3): 263– 75.

More links: Racial and ethnic disparities in pain

Blackwell Synergy - Pain Medicine, Volume 6 Issue 1 Page 5-10, January 2005 (Article Abstract)
Pain Medicine
Volume 6 Issue 1 Page 5-10, January 2005

Louis W. Sullivan MD, Barry A. Eagel MD (2005) Leveling the Playing Field: Recognizing and Rectifying Disparities in Management of Pain
Pain Medicine 6 (1) , 5–10 doi:10.1111/j.1526-4637.2005.05016.x

Salimah H.Meghani, MSN, CRNP, Doctoral Candidate Nursing/MBE. (2005) Leveling the Playing Field: Does Pain Disparity Literature Suffer from a Reporting Bias?. Pain Medicine 6:3, 269–270The

Ethical Implications of Racial Disparities in Pain: Are Some of Us More Equal?
Allen Lebovits, PhD
Pain Medicine, Volume 6, Issue 1, Page 3-4, Jan 2005, doi: 10.1111/j.1526-4637.2005.05013.x

Some links: Racial and ethnic disparities in pain

Race, Ethnicity, and Pain Treatment: Striving to Understand the Causes and Solutions to the Disparities in Pain Treatment

Vence L. Bonham

The Journal of Law, Medicine & Ethics, Volume 28, Issue s4, Page 52-68, Mar 2001, doi: 10.1111/j.1748-720X.2001.tb00039.x

• Summary
• | References
• | Full Text PDF (1745 KB)

Disparities in Pain: Ethical Issues

Carmen Green, MD, Knox H. Todd, MD, Allen Lebovits, PhD, and Michael Francis, MD

Pain Medicine, Volume 7, Issue 6, Page 530-533, Nov 2006, doi: 10.1111/j.1526-4637.2006.00244.x

• Summary
• | References
• | Full Text HTML
• | Full Text PDF (60 KB)

Ethnic
Similarities and Differences in the Chronic Pain Experience: A
Comparison of African American, Hispanic, and White Patients

Robert R. Edwards, PhD, Mario Moric, PhD, Brenda Husfeldt, PhD, Asokumar Buvanendran, MD, and Olga Ivankovich, MD

Pain Medicine, Volume 6, Issue 1, Page 88-98, Jan 2005, doi: 10.1111/j.1526-4637.2005.05007.x

• Abstract
• | References
• | Full Text HTML
• | Full Text PDF (112 KB)

Blackwell Synergy - Pain Medicine, Volume 4 Issue 3 Page 277-294, September 2003 (Article Abstract)

Pain Medicine

Volume 4 Issue 3 Page 277-294, September 2003

To cite this article: Carmen R. Green MD, Karen O. Anderson PhD, Tamara A. Baker PhD, Lisa C. Campbell PhD, Sheila Decker PhD, Roger B. Fillingim PhD, Donna A. Kaloukalani MD, MPH, Kathyrn E. Lasch PhD, Cynthia Myers PhD, Raymond C. Tait PhD, Knox H. Todd MD, MPH, April H. Vallerand PhD, RN (2003) The Unequal Burden of Pain: Confronting Racial and Ethnic Disparities in Pain
Pain Medicine 4 (3) , 277–294 doi:10.1046/j.1526-4637.2003.03034.x
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Abstract
The Unequal Burden of Pain: Confronting Racial and Ethnic Disparities in Pain

* Carmen R. Green, MDaaUniversity of Michigan Medical School, Ann Arbor, Michigan; ,
* Karen O. Anderson, PhDbbM.D. Anderson Cancer Center Pain Research Group, Houston, Texas; ,
* Tamara A. Baker, PhDccUniversity of Michigan, School of Public Health, Ann Arbor, Michigan; ,
* Lisa C. Campbell, PhDddDuke University Medical Center, Durham, North Carolina; ,
* Sheila Decker, PhDeeUniversity of Iowa School of Nursing, Iowa City, Iowa; ,
* Roger B. Fillingim, PhDffUniversity of Florida College of Dentistry, Gainesville, Florida; ,
* Donna A. Kaloukalani, MD, MPHggWashington University, St. Louis, Missouri; ,
* Kathyrn E. Lasch, PhDhhNew England Medical Center, Boston, Massachusetts; ,
* Cynthia Myers, PhDiiUniversity of California Los Angeles, Los Angeles, California; ,
* Raymond C. Tait, PhDjjSt. Louis University School of Medicine, St. Louis, Missouri; ,
* Knox H. Todd, MD, MPHkkEmory University, Rollins School of Public Health, Atlanta, Georgia; and , and
* April H. Vallerand, PhD, RNllWayne State University College of Nursing, Detroit, Michigan

*
aUniversity of Michigan Medical School, Ann Arbor, Michigan; bM.D. Anderson Cancer Center Pain Research Group, Houston, Texas; cUniversity of Michigan, School of Public Health, Ann Arbor, Michigan; dDuke University Medical Center, Durham, North Carolina; eUniversity of Iowa School of Nursing, Iowa City, Iowa; fUniversity of Florida College of Dentistry, Gainesville, Florida; gWashington University, St. Louis, Missouri; hNew England Medical Center, Boston, Massachusetts; iUniversity of California Los Angeles, Los Angeles, California; jSt. Louis University School of Medicine, St. Louis, Missouri; kEmory University, Rollins School of Public Health, Atlanta, Georgia; and lWayne State University College of Nursing, Detroit, Michigan

Carmen R. Green, MD, University of Michigan Medical School, Department of Anesthesiology, 1500 East Medical Center Drive, 1H247 UH—Box 0048, Ann Arbor, Michigan 48109. Tel: (734) 936-4240; Fax: (734) 936-9091; E-mail: carmeng@umich.edu.
ABSTRACT


context.

Pain has significant socioeconomic, health, and quality-of-life implications. Racial- and ethnic-based differences in the pain care experience have been described. Racial and ethnic minorities tend to be undertreated for pain when compared with non-Hispanic Whites.

objectives.

To provide health care providers, researchers, health care policy analysts, government officials, patients, and the general public with pertinent evidence regarding differences in pain perception, assessment, and treatment for racial and ethnic minorities. Evidence is provided for racial- and ethnic-based differences in pain care across different types of pain (i.e., experimental pain, acute postoperative pain, cancer pain, chronic non-malignant pain) and settings (i.e., emergency department). Pertinent literature on patient, health care provider, and health care system factors that contribute to racial and ethnic disparities in pain treatment are provided.

evidence.

A selective literature review was performed by experts in pain. The experts developed abstracts with relevant citations on racial and ethnic disparities within their specific areas of expertise. Scientific evidence was given precedence over anecdotal experience. The abstracts were compiled for this manuscript. The draft manuscript was made available to the experts for comment and review prior to submission for publication.

conclusions.

Consistent with the Institute of Medicine's report on health care disparities, racial and ethnic disparities in pain perception, assessment, and treatment were found in all settings (i.e., postoperative, emergency room) and across all types of pain (i.e., acute, cancer, chronic nonmalignant, and experimental). The literature suggests that the sources of pain disparities among racial and ethnic minorities are complex, involving patient (e.g., patient/health care provider communication, attitudes), health care provider (e.g., decision making), and health care system (e.g., access to pain medication) factors. There is a need for improved training for health care providers and educational interventions for patients. A comprehensive pain research agenda is necessary to address pain disparities among racial and ethnic minorities.
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Please help with a study on pain patient narratives

If you have a few minutes, I would greatly appreciate your help with a research project I am involved in. We need people to fill out an online survey.

This survey is part of a project studying how pain patient narratives are perceived by others and how these stories impact their treatment. The University of Southern California Health Sciences Campus Institutional Review Board has determined that this research is exempt.

We will first ask you a little bit about yourself. Then you will read several vignettes (short stories) from people describing their experiences with chronic pain. For each of these vignettes we will ask you questions about the impression you get of the person.

If you would like to participate, please go to http://painnarratives.adamswenson.net/index.php

Please share this link with anyone who might be willing to participate.

Pain and patience

Eighteenth Century Collections Online -- Search Display

Dodsley, Robert. Pain and patience. A poem. By R. Dodsley. London, 1742 [1743]. 12pp. Literature and Language

Source Citation: Dodsley, Robert. Pain and patience. A poem. By R. Dodsley. London, 1742 [1743]. Eighteenth Century Collections Online. Gale Group.
http://galenet.galegroup.com/servlet/ECCO

Gale Document Number: CW3310212522

Pain Patient's Bill of Rights (CA)

SB 402 Health: opiate drugs.

BILL NUMBER: SB 402 CHAPTERED 10/10/97 BILL TEXT


CHAPTER 839

FILED WITH SECRETARY OF STATE OCTOBER 10, 1997
APPROVED BY GOVERNOR OCTOBER 9, 1997
PASSED THE SENATE SEPTEMBER 5, 1997
PASSED THE ASSEMBLY SEPTEMBER 2, 1997
AMENDED IN ASSEMBLY AUGUST 28, 1997
AMENDED IN ASSEMBLY JULY 22, 1997
AMENDED IN ASSEMBLY JUNE 30, 1997
AMENDED IN SENATE APRIL 24, 1997
AMENDED IN SENATE APRIL 2, 1997

INTRODUCED BY Senator Greene (Coauthors: Assembly Members Bordonaro and Miller)

FEBRUARY 18, 1997

An act to add Part 4.5 (commencing with Section 124960) to Division 106 of the Health and Safety Code, relating to health.

LEGISLATIVE COUNSEL'S DIGEST

SB 402, Greene. Health: opiate drugs. Existing law, the Intractable Pain Treatment Act, authorizes a physician and surgeon to prescribe or administer controlled substances to a person in the course of treating that person for a diagnosed condition called intractable pain, and prohibits the Medical Board of California from disciplining a physician and surgeon for this action. This bill would establish the Pain Patient's Bill of Rights and would state legislative findings and declarations regarding the value of opiate drugs to persons suffering from severe chronic intractable pain. It would, among other things, authorize a physician to refuse to prescribe opiate medication for a patient who requests the treatment for severe chronic intractable pain, require the physician to inform the patient that there are physicians who specialize in the treatment of severe chronic intractable pain with methods that include the use of opiates, and authorize a physician who prescribes opiates to prescribe a dosage deemed medically necessary.

SECTION 1. Part 4.5 (commencing with Section 124960) is added to Division 106 of the Health and Safety Code, to read:

PART 4.5. PAIN PATIENT'S BILL OF RIGHTS

124960. The Legislature finds and declares all of the following:

(a) The state has a right and duty to control the illegal use of opiate drugs.

(b) Inadequate treatment of acute and chronic pain originating from cancer or noncancerous conditions is a significant health problem.

(c) For some patients, pain management is the single most important treatment a physician can provide.

(d) A patient suffering from severe chronic intractable pain should have access to proper treatment of his or her pain.

(e) Due to the complexity of their problems, many patients suffering from severe chronic intractable pain may require referral to a physician with expertise in the treatment of severe chronic intractable pain. In some cases, severe chronic intractable pain is best treated by a team of clinicians in order to address the associated physical, psychological, social, and vocational issues.

(f) In the hands of knowledgeable, ethical, and experienced pain management practitioners, opiates administered for severe acute and severe chronic intractable pain can be safe.

(g) Opiates can be an accepted treatment for patients in severe chronic intractable pain who have not obtained relief from any other means of treatment.

(h) A patient suffering from severe chronic intractable pain has the option to request or reject the use of any or all modalities to relieve his or her severe chronic intractable pain.

(i) A physician treating a patient who suffers from severe chronic intractable pain may prescribe a dosage deemed medically necessary to relieve severe chronic intractable pain as long as the prescribing is in conformance with the provisions of the California Intractable Pain Treatment Act, Section 2241.5 of the Business and Professions Code.

(j) A patient who suffers from severe chronic intractable pain has the option to choose opiate medication for the treatment of the severe chronic intractable pain as long as the prescribing is in conformance with the provisions of the California Intractable Pain Treatment Act, Section 2241.5 of the Business and Professions Code.

(k) The patient's physician may refuse to prescribe opiate medication for a patient who requests the treatment for severe chronic intractable pain. However, that physician shall inform the patient that there are physicians who specialize in the treatment of severe chronic intractable pain with methods that include the use of opiates. 124961. Nothing in this section shall be construed to alter any of the provisions set forth in the California Intractable Pain Treatment Act, Section 2241.5 of the Business and Professions Code.

This section shall be known as the Pain Patient's Bill of Rights.

(a) A patient suffering from severe chronic intractable pain has the option to request or reject the use of any or all modalities in order to relieve his or her severe chronic intractable pain.

(b) A patient who suffers from severe chronic intractable pain has the option to choose opiate medications to relieve severe chronic intractable pain without first having to submit to an invasive medical procedure, which is defined as surgery, destruction of a nerve or other body tissue by manipulation, or the implantation of a drug delivery system or device, as long as the prescribing physician acts in conformance with the provisions of the California Intractable Pain Treatment Act, Section 2241.5 of the Business and Professions Code.

(c) The patient's physician may refuse to prescribe opiate medication for the patient who requests a treatment for severe chronic intractable pain. However, that physician shall inform the patient that there are physicians who specialize in the treatment of severe chronic intractable pain with methods that include the use of opiates.

(d) A physician who uses opiate therapy to relieve severe chronic intractable pain may prescribe a dosage deemed medically necessary to relieve severe chronic intractable pain, as long as that prescribing is in conformance with the California Intractable Pain Treatment Act, Section 2241.5 of the Business and Professions Code.

(e) A patient may voluntarily request that his or her physician provide an identifying notice of the prescription for purposes of emergency treatment or law enforcement identification.

(f) Nothing in this section shall do either of the following:

(1) Limit any reporting or disciplinary provisions applicable to licensed physicians and surgeons who violate prescribing practices or other provisions set forth in the Medical Practice Act, Chapter 5 (commencing with Section 2000) of Division 2 of the Business and Professions Code, or the regulations adopted thereunder.

(2) Limit the applicability of any federal statute or federal regulation or any of the other statutes or regulations of this state that regulate dangerous drugs or controlled substances.

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More Augustine on privation

From Against the Epistle of Manichaeus

For who can doubt that the whole of that which is called evil is nothing else than
corruption? Different evils may, indeed, be called by different names; but that which
is the evil of all things in which any evil is perceptible is corruption. So the corruption
of the educated mind is ignorance: the corruption of the prudent mind is imprudence;
the corruption of the just mind, injustice; the corruption of the brave mind, cowardice;
the corruption of a calm, peaceful mind, cupidity, fear, sorrow, pride. Again, in a
living body the corruption of health is pain and disease; the corruption of strength is
exhaustion; the corruption of rest is toil. Again, in any corporeal thing, the corruption
of beauty is ugliness; the corruption of straightness is crookedness; the corruption of
order is confusion; the corruption of entireness is disseverance, or fracture, or
diminution. . . . Enough has been said to show that corruption does harm only by
displacing the natural condition; and so, corruption is not nature, but against nature.
And if corruption is the only evil to be found anywhere, and if corruption is not
nature, no nature is evil.

On the Nature of Good

“Nature therefore which has been corrupted, is called evil, for assuredly when incorrupt it is good; but even when corrupt, so far as it is nature it is good, so far as it is corrupted it is evil.” 4