OT Appendix A

The Guideline for the Management of Opioid Therapy for Chronic Pain is the product of many months of diligent effort and consensus building among knowledgeable individuals from the Veterans Administration (VA), Department of Defense (DoD), academia, and guideline facilitators from the private sector. An experienced moderator facilitated the multidisciplinary Working Group that included primary care physicians, pain specialists, rehabilitation specialists, anesthesiologists, psychiatrists, psychologists, pharmacists, nurses, and social workers, as well as consultants in the field of guideline and algorithm development.

Development Process

"Only well-focused questions and search terms will lead to a successful search for evidence" (AHCPR, 1996). The process of developing this guideline was evidence-based whenever possible. Evidence-based practice integrates clinical expertise with the best available clinical evidence derived from systematic research. Where evidence is ambiguous or conflicting, or where scientific data are lacking, the clinical experience of the multidisciplinary Working Group was used to guide the development of consensus-based recommendations. The developers incorporated the evidence and recommendations into a format that would maximally facilitate clinical decision-making (Woolf, 1992). The review of the literature, evaluation of evidence, and development of the guideline proceeded in sequential steps.

The following six documents were identified by the Working Group as appropriate seed guidelines. They served as the starting point for the development of questions and key terms.

American Academy of Pain Medicine and American Pain Society. The Use of Opioids for the Treatment of Chronic Pain. (1996)
Canadian Pain Society. Use of opioid analgesics for the treatment of chronic noncancer pain - A consensus statement and guidelines from the Canadian Pain Society. (1998)
College of Physicians and Surgeons of Ontario. Evidence-Based Recommendations for Medical Management of Chronic Non-Malignant Pain. (2000)
Harden, R. Norman MD. Chronic Pain Therapy : Another Reappraisal. (2002)
Portenoy, R.K. Opioid therapy for chronic nonmalignant pain: a review of the critical issues. (1996)
Washington State Department of Labor and Industries. Guideline for Outpatient Prescription of Oral Opioids for Injured Workers with Chronic, Noncancer Pain. (2000)

Five researchable questions and associated key terms were developed by the Working Group after orientation to the seed guidelines and to goals that had been identified by the Working Group. The questions specified:

Population - characteristics of the target population
Intervention - diagnostic, screening, therapy, and assessment
Control - the type of control used for comparison
Outcome - the outcome measure for this intervention (morbidity, mortality, patient satisfaction, and cost)

A systematic search of the literature was conducted for each key question, starting with studies at the top of the hierarchy of study types—evidence-based reviews and clinical trials. In addition to PubMed, the following databases were searched: Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness (DARE), and Cochrane Central Register of Controlled Trials (CCTR). For PubMed, limits were set for language (English), data of publication (1998 through July 2002) and type of research (randomized controlled trial [RCT] and meta-analysis). For the CCTR, limits were set for date of publication (1998 through 2002).

The results of the search were organized and reported using reference manager software. At this point, additional exclusion criteria were applied. Typical exclusions were studies with physiological endpoints, or studies of populations that were not comparable to the population of interest. Once definitive clinical studies that addressed the question were identified, the search stopped. It was extended to studies/reports of lower quality only if there were no high quality studies.

Evidence Appraisal Reports for each of the five questions were prepared by the Center for Evidence-Based Practice at the State University of New York, Upstate Medical University, Department of Family Medicine and by ACS staff (These reports are available by request.) Each report covered:

Summary of findings
Methodology
Search terms
Resources searched
Articles critically appraised
Findings

The Working Group suggested some additional references. Copies of specific articles were provided to participants on an as-needed basis.

The clinical experts and the research team evaluated the evidence for each question according to criteria proposed by the U.S. Preventive Services Task Force (USPSTF) (2001). See "Rating the Evidence," below.

The Working Group participated in two face-to-face sessions to reach a consensus about the guideline recommendations and to prepare a draft document. The draft was revised by the experts through numerous conference calls and individual contributions to the document. The guideline presents evidence-based recommendations that have been thoroughly evaluated by practicing clinicians.. Nonetheless, this document is a work in progress. It will be updated every two years, or when significant new evidence is published.

Rating the Evidence

Evidence-based practice involves integrating clinical expertise with the best available clinical evidence derived from systematic research. The Working Group reviewed the evidence and graded it using the rating scheme developed by the USPSTF (2001). The experts themselves, after an orientation and tutorial on the evidence grading process, formulated Quality of Evidence ratings (see Table 1), a rating of Overall Quality (see Table 2), a rating of the Net Effect of the Intervention (see Table 3), and an overall Recommendation (see Table 4).

TABLE 1: Quality of Evidence (QE)
I	At least one properly done RCT
II-1	Well designed controlled trial without randomization
II-2	Well designed cohort or case-control analytic study
II-3	Multiple time series, dramatic results of uncontrolled experiment
III	Opinion of respected authorities, case reports, and expert committees

TABLE 2: Overall Quality
Good	High grade evidence (I or II-1) directly linked to health outcome
Fair	High grade evidence (I or II-1) linked to intermediate outcome; or Moderate grade evidence (II-2 or II-3) directly linked to health outcome
Poor	Level III evidence or no linkage of evidence to health outcome

TABLE 3: Net Effect of the Intervention
Substantial	More than a small relative impact on a frequent condition with a substantial burden of suffering; or A large impact on an infrequent condition with a significant impact on the individual patient level.
Moderate	A small relative impact on a frequent condition with a substantial burden of suffering; or A moderate impact on an infrequent condition with a significant impact on the individual patient level.
Small	A negligible relative impact on a frequent condition with a substantial burden of suffering; or A small impact on an infrequent condition with a significant impact on the individual patient level.
Zero or Negative	Negative impact on patients; or No relative impact on either a frequent condition with a substantial burden of suffering; or An infrequent condition with a significant impact on the individual patient level.

TABLE 4: Grade the Recommendation
A	A strong recommendation that the intervention is always indicated and acceptable
B	A recommendation that the intervention may be useful/effective
C	A recommendation that the intervention may be considered
D	A recommendation that a procedure may be considered not useful/effective, or may be harmful.
I	Insufficient evidence to recommend for or against - the clinician will use clinical judgment

Abstract of the USPSTF:

Once assembled, admissible evidence is reviewed at three strata: (1) the individual study, (2) the body of evidence concerning a single linkage in the analytic framework, and (3) the body of evidence concerning the entire preventive service. For each stratum, the Task Force uses explicit criteria as general guidelines to assign one of three grades of evidence: good, fair, or poor.
Good or fair quality evidence for the entire preventive service must include studies of sufficient design and quality to provide an unbroken chain of evidence-supported linkages that generalize to the general primary care population and connect the preventive service with health outcomes. Poor evidence contains a formidable break in the evidence chain, such that the connection between the preventive service and health outcomes is uncertain.
For services supported by overall good or fair evidence, the Task Force uses outcomes tables to help categorize the magnitude of benefits, harms, and net benefit from implementation of the preventive service into one of four categories: substantial, moderate, small, or zero/negative.
The Task Force uses its assessment of the evidence and magnitude of net benefit to make a recommendation, coded as a letter: from A (strongly recommended) to D (recommend against). It gives an "I" recommendation in situations in which the evidence is insufficient to determine net benefit (Harris et al., 2001).

Algorithms

The overall view of the Opioid Therapy for Chronic Pain guideline is presented in an algorithmic format. There are indications that this format improves data collection and clinical decision-making and helps to change patterns of resource use. It allows the clinician to follow a linear approach to critical information needed at the major decision points in the clinical process, and includes:

An ordered sequence of steps of care
Recommended observations
Decisions to be considered
Actions to be taken.

A clinical algorithm diagrams a guideline into a step-by-step decision tree. Standardized symbols are used to display each step in the algorithm (SMDMC, 1992). Arrows connect the numbered boxes indicating the order in which the steps should be followed.

	Rounded rectangles represent a clinical state or condition.
	Hexagons represent a decision point in the guideline, formulated as a question that can be answered Yes or No.
	Rectangles represent an action in the process of care.
	Ovals represent a link to another section within the guideline.

A letter within a box of an algorithm refers the reader to the corresponding annotation. The annotations elaborate on the recommendations and statements that are found within each box of the algorithm. Included in the annotations are brief discussions that provide the underlying rationale and specific evidence tables. A complete bibliography, which includes all the sources used-directly or indirectly-in the development of the text, is provided at the end of the document.

REFERENCES

Agency for Health Care Policy and Research (AHCPR). Manual for Conducting Systematic Review. Draft. August 1996. Prepared by Steven H. Woolf.

American Academy of Pain Medicine and American Pain Society. The Use of Opioids for the Treatment of Chronic Pain. (1996)

Canadian Pain Society. Use of opioid analgesics for the treatment of chronic noncancer pain – A consensus statement and guidelines from the Canadian Pain Society. (1998)

Cochrane Reviews, Cochrane Controlled Trials Register at http://www.update-software.com/cochrane .

College of Physicians and Surgeons of Ontario. Evidence-Based Recommendations for Medical Management of Chronic Non-Malignant Pain. (2000)

Harden, R. Norman MD. Chronic Opioid Therapy: Another Reappraisal. Available at http://www.ampainsoc.org/pub/bulletin/jan02/poli1.htm.

Harris RP, Helfand M, Woolf SH. Current methods of the U.S. Preventive Services Task Force. A review of the process. Am J Prev Med 2001.

Portenoy, R.K. Opioid therapy for chronic nonmalignant pain: a review of the critical issues. J Pain Symptom Manage. 1996 Apr; 11(4):203-17.

Society for Medical Decision-Making Committee (SMDMC). Proposal for clinical algorithm standards,MDMC on Standardization of Clinical Algorithms. In: Medical Decision Making 1992; 12(2):149-54.

United States Preventive Service Task Force (USPSTF). Guide to Clinical Preventive Services. 2nd edition. Baltimore: Williams and Wilkins, 1996.

VA 1996 External Peer Review Program. Contract No. V101(93) P-1369.

Washington State Department of Labor and Industries. Guideline for Outpatient Prescription of Oral Opioids for Injured Workers with Chronic, Noncancer Pain. (2000)

Woolf SH. Practice guidelines, a new reality in medicine II. Methods of developing guidelines. Archives of Intern Med 1992; 152:947-948.