National VA Pain Outcomes Working Group

NATIONAL VA PAIN MANAGEMENT COORDINATING COMMITTEE

VHA PAIN OUTCOMES TOOLKIT

**February 2003**

![](media/image1.png){width="1.0215277777777778in"
height="0.7527777777777778in"}

**DEPARTMENT OF VETERANS AFFAIRS**

**810 Vermont Avenue, N.W.**

**Washington, DC 20420**

**VHA PAIN OUTCOMES TOOLKIT**

**TABLE OF CONTENTS**

[SECTION 1: INTRODUCTION 2](#__RefHeading___Toc29952424)

[Veterans Health Administration (VHA) National Pain Management Strategy
2](#Sect1)

[Outcomes Toolkit Objectives 2](#__RefHeading___Toc29952426)

[Definition of Outcomes Measurement 2](#__RefHeading___Toc29952427)

[Why Measure Pain Outcomes? 3](#refheading___toc29952428)

[SECTION 2: SELECTING OUTCOMES MEASURES 4](#__RefHeading___Toc29952429)

[Pain Outcomes Focus 4](#pain-outcomes-focus)

[Type of Pain 4](#__RefHeading___Toc29952431)

[Practice Setting 5](#__RefHeading___Toc29952432)

[SECTION 3: MEASURING PATIENT-FOCUSED OUTCOMES
6](#__RefHeading___Toc29952433)

[Measuring Pain Intensity 7](#__RefHeading___Toc29952434)

[Measuring Pain Interference 9](#__RefHeading___Toc29952435)

[Measuring Emotional Distress 10](#__RefHeading___Toc29952436)

[Measuring Physical Capacities 12](#__RefHeading___Toc29952437)

[Measuring Employment Status 15](#measuring-employment-status)

[Measuring Healthcare Utilization/Costs
17](#measuring-healthcare-utilizationcosts)

[Measuring Patient Satisfaction 21](#__RefHeading___Toc29952440)

[Multidimensional Pain Outcomes Measures
24](#__RefHeading___Toc29952441)

[SECTION 4: PROCESS OUTCOMES MEASURES 26](#__RefHeading___Toc29952442)

[Measuring Process Outcomes 26](#__RefHeading___Toc29952443)

[SECTION 5: SPECIAL ISSUES 31](#__RefHeading___Toc29952444)

[Evaluating Medication Use Outcomes 31](#__RefHeading___Toc29952445)

[Measuring Family and Social Outcomes
37](#measuring-family-and-social-outcomes)

[Measuring Pain Outcomes in the Cognitively Impaired
38](#__RefHeading___Toc29952447)

[Using CPRS GUI and Vista Software to Track Pain Outcomes
42](#__RefHeading___Toc29952448)

[VHA External Peer Review Program (EPRP)
51](#vha-external-peer-review-program-eprp)

[SECTION 6: WEB LINKS FOR OUTCOMES RESOURCES
52](#__RefHeading___Toc29952450)

[REFERENCE LIST 53](#__RefHeading___Toc29952451)

[APPENDIX I 62](#PCRefList_OUTCOME_MEASURES_TOOL_KIT2__re)

[VHA Customer Satisfaction Survey Questions Pertaining To Pain
62](#__RefHeading___Toc29952453)

[APPENDIX II 64](#__RefHeading___Toc29952454)

[Attributes of a Successful Pain Management System
64](#__RefHeading___Toc29952455)

[APPENDIX III 66](#__RefHeading___Toc29952456)

[Examples of a Medical Record Pain Audit Tool 66](#Appen3)

[APPENDIX IV 67](#refheading___toc29952458)

[Examples of Possible Patient Education Survey Items 67](#appendix4)

[APPENDIX V 68](#__RefHeading___Toc29952460)

[Duke University Medical Center Competency Questionnaire
68](#__RefHeading___Toc29952461)

[APPENDIX VI 74](#__RefHeading___Toc29952462)

[Members of the VA National Pain Outcomes Workgroup
74](#__RefHeading___Toc29952463)

[APPENDIX VII 75](#refheading___toc29952464)

[Members of the VA National Pain Coordinating Committee
75](#__RefHeading___Toc29952465)

**VHA PAIN OUTCOMES TOOLKIT**

[]{#__RefHeading___Toc29952424 .anchor}[SECTION 1:
INTRODUCTION]{.underline}

[]{#Sect1 .anchor}

**Veterans Health Administration (VHA) National Pain Management
Strategy**

VHA has initiated a comprehensive national strategy for pain management.
The overall goal of the new VHA National Pain Management Strategy is to
prevent pain and suffering in persons receiving care in the veterans
healthcare system. The specific objectives of this strategy are to:

-   Provide a system-wide VHA standard of care for pain management that
    will reduce suffering from preventable pain.

-   Assure that pain assessment is performed in a consistent manner.

-   Assure that pain treatment is prompt and appropriate.

-   Include patients and families as active participants in pain
    management.

-   Provide for continual monitoring and improvement in outcomes of pain
    treatment.

-   Provide for an interdisciplinary, multi-modal approach to pain
    management.

-   Assure that clinicians practicing in the VHA healthcare system are
    adequately prepared to assess and manage pain effectively.

    []{#__RefHeading___Toc29952426 .anchor}Outcomes Toolkit Objectives

The VHA Pain Outcomes Toolkit was developed by the [VA National Pain
Outcomes Workgroup](#__RefHeading___Toc29952462), a subgroup of the [VA
National Pain Management Coordinating
Committee,](#__RefHeading___Toc29952464) as part of the VHA's National
Pain Management Strategy. The toolkit was designed to assist healthcare
providers and facilities devise methods and implement processes to
measure pain treatment outcomes. Measuring the effectiveness of pain
treatment and pain service delivery mechanisms is critical to the VHA's
goal of improved pain treatment services.

[]{#__RefHeading___Toc29952427 .anchor}Definition of Outcomes
Measurement

Outcomes measurement refers to "...the systematic collection and
analysis of information that is used to evaluate the efficacy of an
intervention" (Clark & Gironda, 2002). *Systematic collection* means
that data are gathered at multiple time points using the same methods or
instruments. *Analysis* refers to the process of condensing and
examining the data to identify meaningful trends or changes. Analysis
may indicate that changes in processes or practices should be undertaken
to improve treatment outcomes or to remove system barriers to care.

Usually, in clinical settings outcomes measures are collected before and
after an intervention with the assumption that any changes observed in
the measure can be attributed to the effects of the intervention.
However, it is important to remember that other known or unknown factors
also could account for the observed changes, particularly in healthcare
settings where multiple interventions or events may have transpired
between the initial assessment and the post-intervention assessment.
Therefore, multiple episodes of data collection are preferred as they
facilitate the identification of trends in the data that may be more
reliable indicators of intervention-related change.

[]{#refheading___toc29952428 .anchor}Why Measure Pain Outcomes?

There are several reasons that pain treatment outcomes monitoring are an
integral part of today's healthcare delivery systems. First and
foremost, treatment outcomes data are critical to insuring that patients
with pain receive effective and timely care. Outcomes data can be used
to direct treatment decisions to maximize success, to generate pain
treatment guidelines that in the past were based only on anecdotal
observations of treatment effectiveness, and to identify service
delivery system problems or barriers. Second, many government agencies,
accreditation bodies, professional societies, and other organizations
now require the collection and analysis of pain outcomes data. Within
the VHA, the National Pain Management Strategy includes objectives for
using outcomes to monitor the effectiveness of pain treatment. Outside
the VHA, pain outcomes measurement now is required by some major
healthcare accreditation agencies. For example, the Rehabilitation
Accreditation Commission (CARF) was one of the first to develop
elaborate outcomes standards for pain treatment programs. More recently,
standards for pain management across the spectrum of health care service
delivery settings have been adopted and applied by the Joint Commission
for the Accreditation of Healthcare Organizations (Rehabilitation
Accreditation Commission, 2002). Other national and local bodies also
have begun to recognize the necessity of monitoring the effects of pain
treatment. Pain treatment guidelines, such as those developed by the
Agency for Health Care Policy and Research (Agency for Health Care
Policy Reform, 1992, 1996) and the American Pain Society (American Pain
Society, 1995). Similarly, healthcare insurers have expressed an
interest in the cost effectiveness of pain treatment (Kulich & Lande,
1997), and may require that treatment effectiveness be established
before claims will be paid.

[]{#__RefHeading___Toc29952429 .anchor}

[SECTION 2: SELECTING OUTCOMES MEASURES]{.underline}

Selecting appropriate outcomes measures is the key to developing a
meaningful outcomes monitoring system. Three factors should be
considered as part of the outcomes selection process (Clark & Gironda,
2002):

-   Pain outcomes focus (patient focused or process focused)

-   Type of pain (acute, chronic, or pain at end-of-life)

-   Practice setting

## **Pain Outcomes Focus**

***Patient focused outcomes measures*** focus on changes in individuals'
pain experience following interventions. To quantify change, measures
must be administered at least twice (before and after treatment). For
treatments spanning lengthy time intervals, repeated administrations
(e.g., every month) may provide a more detailed picture of change.

Patient focused measures often are used to evaluate a single patient's
response to treatment. When they are used collectively to evaluate a
specific treatment intervention or program of interventions, they serve
as aggregate outcomes measures. The most common patient focused outcome
measure is pain intensity. Other measures might include pain-related
interference, emotional distress, or physical capacities.

***Process focused measures*** focus on the pain service delivery
system, and usually are components of performance improvement
activities. In some cases measures may be collected only once, but more
often they will be collected repeatedly over time to evaluate trends in
the measures or to assess the impact of a system intervention.

Results may be used to evaluate how well the pain service delivery
system is meeting facility goals, regulatory statutes, or accreditation
body (e.g., JCAHO) standards. Common measures include pain clinic
waiting times, adequacy of pain assessment and treatment documentation,
or compliance with patient pain education standards.

[]{#__RefHeading___Toc29952431 .anchor}**Type of Pain**

The selection of outcomes measures should include a consideration of the
type of pain most often treated in the setting of interest:

-   *Acute pain* typically refers to pain etiologically related to an
    injury, disease, or medical procedure (e.g., post operative pain)
    that is expected to be transitory.

-   *Cancer pain* is used to identify pain associated with active
    cancer.

-   *Chronic pain* is used to identify longstanding pain (typically pain
    that persists beyond the expected timeframe for healing) that is not
    due to cancer and is not expected to resolve on its own. Chronic
    pain may be constant (i.e., present all or most of the time), or
    episodic (i.e., periods of constant pain with intervening pain-free
    intervals).

Pain types are not necessarily mutually exclusive. An individual with
acute or cancer pain also may simultaneously experience chronic pain
from an unrelated condition. Distinctions between pain types are
important as appropriate treatments and associated outcomes measures may

vary for each. For example, if *acute* pain is the focus, primary
measures might include pain intensity and pain medication side effects.
When *chronic* pain is the focus, measures of

psychosocial functioning, pain interference, or other outcomes domains
likely are as important as pain intensity measures.

[]{#__RefHeading___Toc29952432 .anchor}**Practice Setting**

Practice setting refers to attributes of the pain service delivery
environment. Pain treatments may range from minimally complex (e.g.,
medication management) to highly technical (e.g., dorsal column
stimulator implants).

In general, pain service settings that require minimal resources and
utilize uncomplicated treatments may not warrant elaborate, expensive,
and time-consuming outcomes measurement practices when less complex
approaches would suffice. In contrast, more complex treatment settings
requiring greater resource investment or patient risk may want to
utilize broader, multi-domain outcomes measures in order to assess
change in a variety of pain experience areas.

The rational underlying this variation in outcomes approach is twofold.
First, from a cost-benefit perspective, when resource investment is
greater, such as in complex pain treatment settings, it is reasonable to
expect that outcomes should be improved. Utilization of more
comprehensive outcomes measures that assess function in a greater range
of domains may provide evidence of a greater range of treatment-related
improvements. Second, complex pain treatment settings are likely to
treat individuals with more complicated and severe pain conditions and
increased pain-related dysfunction that extends across multiple domains
of function. Therefore, more elaborate measures of outcomes may be
needed to accurately reflect both the extent of pain-related disability
and the degree of improvement attained.

[]{#__RefHeading___Toc29952433 .anchor}

**[SECTION 3: MEASURING PATIENT-FOCUSED OUTCOMES]{.underline}**

There are a multitude of patient focused pain measures available to
practitioners. Only brief descriptions of the most popular measures are
included in this document as many have been reviewed in detail elsewhere
(cf, Turk & Melzack, 2001).

Numerous experts in the field of pain and pain management have
encouraged a multidimensional perspective of pain that promotes
measurement of several key domains of the experience of pain when
conducting comprehensive pain assessments and/or when evaluating
outcomes of pain management efforts (cf, Block, Kremer, & Fernandez,
1998; Gatchel & Turk, 1998; Turk & Melzack, 2001). Most commonly these
include the domains of pain intensity or severity, pain interference
(variously measured as perceived disability, deficits in physical
capacity, decline in social or family relationships, and changes in
employment status or performance), and emotional distress. Kerns (1996),
in particular, has argued that these domains should be considered
primary, as opposed to secondary, outcome domains. Additional outcome
domains that are often viewed as important or critical include
healthcare utilization and costs as well as patient satisfaction.

The selection of specific patient focused measures should include a
consideration of demonstrated reliability and validity. Reliability
refers to the consistency of test results when administered under
identical circumstances (Johnston, Keith, & Hinderer, 1992). Two common
indices of reliability include measures of internal consistency, that
is, the degree to which items of a measure are intercorrelated, and
test-retest reliability, or the degree of stability of the measure over
a specific period of time. The typical statistical index of internal
consistency is the alpha statistic. Alphas range from 0 to 1.0 with
higher alphas indicating greater reliability. In general, indices above
.70 are considered adequate for clinical purposes. Test-retest
reliability commonly is expressed as a correlation, with indices above
.70 generally indicating adequate stability of the measure. Reliability
is necessary for a measure to be valid, but measures can be reliable but
not valid (Green, 1992).

Validity refers to how well the measure assesses or "captures" what it
was designed to measure (Johnston et al., 1992). There are a variety of
methods used to evaluate the validity of a measure which most often is
expressed using simple correlations. For example, one index of the
validity of a new measure of pain severity for persons with chronic pain
might be the overall correlation between scores on the new measure with
those on an already accepted measure of pain intensity. Note, however,
that these validity coefficients will be much smaller than the
instrument's reliability values. Typically, validity coefficients that
fall in the .30 or higher range provide good support of a measure's
validity in the dimension assessed, although coefficients as small as
.15 or lower also may support validity depending on the characteristics
of the measures examined.

Several pain accreditation bodies (e.g., Rehabilitation Accreditation
Commission) and professional associations (e.g., the American Congress
of Rehabilitation Medicine) require that facility or program outcomes
measures have demonstrated their reliability and validity (Johnston et
al., 1992; Rehabilitation Accreditation Commission, 2002). Whenever
possible, measures used to track VHA pain outcomes should conform to
these standards for reliability and validity. However, note that some
patient focused pain outcomes measures do not have such supporting data
available. In these cases additional caution should be exercised so as
to avoid conclusions that may be erroneous. In addition, it is
preferable that, when available, pain outcomes measures used in the VHA
have been validated with samples of veterans.

[]{#__RefHeading___Toc29952434 .anchor}

**Measuring Pain Intensity**

Pain intensity is the indicator used most often to evaluate the efficacy
of pain treatments. Intensity measures fall into three general
categories: Numeric Rating Scales, Visual Analog Scales, and Verbal
Rating Scales. Visual Analog Scales and Numeric Rating Scales consist of
a single item to quantify the intensity of "current", "usual", "least",
or "worst" pain. *Research indicates that "least" and "usual" pain
ratings provide the best estimate of actual pain intensity* (Jensen,
Turner, Turner, & Romano, 1996).

[Numeric Rating Scales (NRS)]{.underline}. Numeric rating scales utilize
a numeric range (typically 0 to 10 or 0 to 100) to quantify pain
intensity, can be administered in oral or written form, and are the most
commonly used method of assessing pain levels. Anchors parallel those
described above. Patients are instructed to choose a single number from
the 11 or 101-point options that best represents their pain. The NRS has
been found to be valid and reliable, and to be sensitive to changes in
acute, cancer, and chronic pain. *The numeric pain score utilized in the
VHA's Pain as the Fifth Vital Sign initiative relies on an 11-point NRS
measure*. In the VHA version of the measure, standardized anchors (0 =
"no pain" and 10 = "worst pain imaginable") have been selected to
encourage consistency across institutions and settings. The VHA's "Pain
as the 5^th^ Vital Sign Toolkit" (VHA, 2000: document available at
[www.vachronicpain.org](http://www.vachronicpain.org/)) may serve as a
helpful resource for adoption and utilization of this measure.

[Visual Analog Scales (VAS)]{.underline}. Visual analog scales rely on a
visual cue (usually a ten-centimeter line anchored with the phrases "no
pain" and "worst possible pain" or "excruciating pain") to evaluate pain
intensity. Usually the line is horizontal, although vertical
presentations (e.g., the "pain thermometer") also are available.
Instructions require that patients bisect the line at the point matching
their "current", "usual", "best", or "worst" level of pain. The pain
score is the length of the segment starting at "no pain" and terminating
at the point indicated by the respondee. Research has indicated that the
VAS is a valid and sensitive measure of pain intensity in patients with
acute, cancer, and chronic pain (Ogon, Krismer, Soellner, Kantner
Rumplmair, & et al, 1996; ; Breivik, Bjornsson, & Skovlund, 2000).
Comparisons between horizontal and vertical line presentations have
yielded mixed results, but there is some evidence that a horizontal
orientation may improve sensitivity of the measure (Ogon et al., 1996;
Jensen, Turner, Romano, & Fisher, 1999; Breivik & Skoglund, 1998).

[Verbal Rating Scales (VRS**)**]{.underline}. Verbal rating scales
consist of words or word-pairs used to describe pain that are rank
ordered along a continuum of severity. A score is assigned to the chosen
descriptor based on the empirically derived ranks of the chosen words
(Jensen & Karoly, 1992). Perhaps the most widely known VRS is the
*McGill Pain Questionnaire* (MPQ; Melzack, 1975a) which consists of 20
lists of descriptors of the sensory, affective, and evaluative
dimensions of pain (Melzack, 1975b). The standard scoring procedure
yields a Pain Rating Index (PRI) which is computed for each of the three
pain dimensions and may be summed to provide an overall PRI. The PRI is
sensitive to change and has been validated for use with acute, cancer,
and chronic pain populations (Davis, 1989; Lowe, Walker, & MacCallum,
1991; Sist, Florio, Miner, Lema, & Zevon, 1998).

From a practical point of view, the NRS or the VAS may be preferred to
the MPQ or other verbal scales as pain intensity measures as their
results can be treated as ratio-level data which allows for greater
latitude in analysis. When choosing between the VAS and the NRS, the
former may be preferred when the greatest measurement precision is
desirable, while the benefits of the latter are easier administration
and scoring.

Other validated pain intensity measures that might be considered include
the *Faces Pain Scale* (Bieri, Reeve, Champion, Addicoat, & Ziegler,
1990), which was originally developed to assess

pain in children but has been validated for use with the elderly (Herr,
Mobily, Kohout, & Wagenaar, 1998), and the *Pain Thermometer* (Choiniere
& Amsel, 1996).

[]{#__RefHeading___Toc29952435 .anchor}**Measuring Pain Interference**

> Measures of pain interference assess the nature and degree that pain
> negatively impacts one or more domains of functioning. Reductions in
> pain interference are important goals for treatment, and outcome
> measures sensitive to these changes should be incorporated into any
> outcomes package used in settings where prolonged pain is an issue.

[*Sickness Impact Profile* (SIP)]{.underline}. The SIP is a frequently
used 136-item measure of perceived impairment (Brown, 1995; Williams,
1988) with excellent test-retest reliability (.92) and internal
consistency (.94; Bergner, 1981). The instructions for the version most
often used with individuals with pain were altered by Turner and Clancy
(1988) to reflect pain-related impairment rather than general physical
impairment. The SIP contains two Domains (Physical and Psychosocial) and
a total of 14 subscales used to assess pain interference across a wide
range of functioning. The SIP scales have been found to be sensitive to
changes in functioning resulting from multidisciplinary pain treatment
(Jensen, Strom, Turner, & Romano, 1992), and they possess good
concurrent validity in chronic pain and cancer pain patients (Beckham,
Burker, Lytle, Feldman, & Costakis, 1997; Watt Watson & Graydon, 1989).
Based on the frequency that this instrument has been used in the pain
research literature, the SIP is the "gold standard" for detailed
assessment of self-reported pain interference.

*[Roland and Morris Disability Index (RMD)]{.underline}.* The RMD is a
24-item scale comprised of 23 SIP items and one additional item (Deyo,
1986). The RMD correlates most closely with the SIP Physical scale,
while the association with the SIP Psychosocial items is much lower
(Jensen et al., 1992). The scale has demonstrated good internal
consistency (Hsieh, Phillips, Adams, & Pope, 1992), sensitivity to
change (Jensen et al., 1992), discriminative validity (Leclaire, Blier,
Fortin, & Proulx, 1997), and, when used with chronic low back pain
patients, stability (Jensen et al., 1992). The RMD has been utilized in
a number of pain outcomes studies, and is useful as a brief measure of
self-perceived disability. However, data suggests that it may be less
sensitive to some psychosocial aspects of the pain experience than the
SIP.

[*Oswestry Low Back Pain Disability Questionnaire* (ODQ)]{.underline}.
The ODQ is a 10-item questionnaire assessing pain and pain-related
limitations in daily activities (Fairbank, Couper, Davies, & O\'Brien,
1980). Testee's choose 1 of 6 response options for each item, and scores
are summed across items. The ODQ has evidenced adequate stability
(Davidson & Keating, 2002) and internal consistency (Hsieh et al.,
1992), as well as discriminative validity (Leclaire et al., 1997) and
sensitivity to change (Davidson & Keating, 2002). ODQ item content
suggests that it may be most useful for patients with more severe
limitations or disability (Baker, Pynsent, & Fairbank, 1989).

[*Pain Disability Index* (PDI).]{.underline} The PDI (Pollard, 1984) is
a brief (7-item), easy to use measure of pain interference in physical
and psychosocial role performance that has good internal consistency
(*α* = .87; Tait, 1987) and one-week test-retest reliability (ICC *r* =
.91; Gronblad et al., 1993). Research indicates that it is sensitive to
change (Strong, Ashton, & Large, 1994), and it has been validated for
use with chronic and post-operative pain patients (Pollard, 1984).
Although less comprehensive than the SIP, the PDI may be useful when a
short but psychometrically sound measure of general pain interference is
desired.

[]{#__RefHeading___Toc29952436 .anchor}**Measuring Emotional Distress**

Significant pain often is accompanied or preceded by emotional distress
and emotional status and traits can have a significant impact on
treatment outcome. Thus, comprehensive pain outcomes approaches should
include methods to assess the varieties of emotional distress. There are
numerous emotional distress instruments available for use. The measures
that follow were selected based upon on brevity, ease of use, and
general acceptance among pain researchers for outcomes assessment.

> [Depression Measures]{.underline}. The *Beck Depression Inventory*
> (BDI) is a brief (21-item) measure of depressive symptoms and
> complaints (Beck, 1987). The BDI possesses adequate psychometric
> properties (Beck, 1988), and is sensitive to multidisciplinary pain
> clinic treatment changes (Kleinke, 1991). A newer version of the BDI
> (BDI-II) now is available that may be more sensitive to core symptoms
> of depression (Beck, Steer, Ball Roberta, & Ranieri, 1996).
>
> A frequently used alternative to the BDI is the 20-item *Center for
> Epidemiologic Studies-Depression Scale* (CES-D: Radloff, 1977). The
> CES-D has both high internal reliability (α = .85) in normal
> populations and good concurrent validity when used with individuals
> with chronic pain (Beckham et al., 1997; Radloff, 1977).

[Anxiety Measures]{.underline}. The most frequently used measure of
anxiety today is the *State-Trait Anxiety Inventory* (STAI). The STAI is
a 40-item self-report inventory of state anxiety (current anxiety) and
trait anxiety (propensity to experience anxiety). There is a high
concordance between pain and anxiety (Polatin, Kinney, Gatchel, Lillo, &
Mayer, 1993), and the STAI is widely used as a pain outcomes measure. It
has acceptable psychometric properties (Spielberger, Gorsuch, Lushene,
Vagg, & Jacobs, 1983), and it is sensitive to change (Mongini,
Defilippi, & Negro, 1997).

[Pain-related Fear]{.underline}. Recent data suggest that pain-related
fear may be a key component in the development and maintenance of
pain-related physical disability (McCracken, Faber, & Janeck, 1998).
Pain-related fear (also referred to as *kinesiophobia*) may be defined
as the constellation of fearful feelings and avoidance behaviors in
anticipation of a re-experiencing of painful sensations or of a
re-injury (Kori, Miller, & Todd, 1990). Research has demonstrated that
for some individuals with chronic pain pain-related fear may mediate
treatment-related improvement (Vlaeyen, de Jong, Geilen, Heuts, & van
Breukelen, 2001).

The *Pain Anxiety Symptoms Scale* (PASS; McCracken, Zayfert, & Gross,
1992) is one of the two most frequently used measures of pain-related
fear. The PASS includes 40 items distributed across four subscales
measuring pain-related anxiety symptoms (cognitive and physiological),
escape and avoidance behaviors, and pain-related fears (McCracken,
Zayfert, & Gross, 1992). The PASS has adequate internal consistency
(McCracken et al., 1992), good predictive validity (McCracken et al.,
1998), and acceptable validity (McCracken, Gross, Aikens, & Carnrike,
1996).

The *Tampa Scale of Kinesiophobia* (TSK; Kori et al., 1990) is perhaps a
better measure of pain-related fear. The TSK is a 17-item instrument
with items assessing pain-related fear of movement or of pain sensations
due to concerns about injury or reinjury (Kori et al., 1990). Recent
data suggest that the TSK may be a better predictor of a range of pain
symptoms and behaviors (Crombez, Vlaeyen, Heuts, & Lysens, 1999), and it
has been found to be a better predictor of disability than pain
intensity, biomedical signs and symptoms, or negative emotionality
measures (Crombez et al., 1999; Vlaeyen et al., 1999). A revised version
of the TSK (TSK-R; 12 items) now is available that has been validated
with veterans treated for chronic pain in outpatient and inpatient
settings (Cohen, Clark, & Gironda, 2003; Gironda, Clark, & Young, 2003).
The TSK-R demonstrates good reliability, and exploratory (Cohen et al.,
2003) and confirmatory (Gironda et al., 2003) factor analyses have
identified two factors that account for the majority of TSK-R score
variance: fear of (re)injury and morbid somatic focus. The TSK-R can be
downloaded from the
[www.vachronicpain.org](http://www.vachronicpain.org/) website.

[]{#__RefHeading___Toc29952437 .anchor}**Measuring Physical Capacities**

*Physical capacities* denotes an individual\'s theoretical physical
capabilities that are limited by physical status variables such as
strength, endurance, and range of motion. In contrast, *functional
capacities* refer to an individual\'s \"maximum work abilities\"
(Dabatos, Rondinelli, & Cook, 2000), or their peak performance in
specified tasks. As self-reports of physical capacities among
individuals with chronic pain often do not correspond with their actual
physical capabilities (Clark, 1996), objective physical capacity
measures may serve as better indicators of treatment-related changes in
this domain.

At present there are no \"gold standard\" objective outcomes measures of
pain-related physical or functional capacity in use within the VHA or
private sector health care systems. Instead, a variety of methods have
been employed in attempts to quantify treatment related changes in the
physical abilities of individuals with pain.

[Practitioner Ratings]{.underline}. The most common physical capacity
measures employed as outcomes indicators in pain clinic settings are
practitioner ratings (usually on a 0 to 5 scale) of strength,
flexibility, and sensory or motor function. Indeed, practitioner ratings
have long been used in neurological evaluations and in assessments
conducted by physical therapists or other rehabilitative disciplines.
Ratings are based on physical examination findings and on task
performance. Advantages of this approach are that physical capacity
ratings are easy to generate, require little additional time, and
necessitate minimal external equipment.

Unfortunately, practitioner ratings are subject to the standard range of
observer biases (Hoyt, 2000) and often lack consistent scale anchors,
which reduce their reliability and validity. Additionally, despite their
apparent objectivity, practitioner ratings are in fact highly subjective
since they rely on each individual\'s clinical experience and
internalized schema, which may account for their poor inter-rater
reliabilities (Deyo, 1988; Elam et al., 1991; Lieberman et al., 1996).

[Observational Measures]{.underline}. A number of observational measures
have been employed to quantify changes in the physical capacities of
individuals with chronic pain. Several intricate behavioral ratings
scales of physical impairment or functional capacities have been
developed primarily for pain research (e.g., Follick, Ahern, & Aberger,
1985; Keefe & Block, 1982). Typically, these methods utilize trained
observers either to record the frequency of key behaviors or to rate
observed physical function during a series of standardized tasks.
Interrater or interobserver agreement coefficients establish the
reliability of measurement, and resulting scores demonstrate the
necessary correspondence with alternative measures of the same
functions.

Observational measures are of limited value in most clinical settings as
they require extensive rater training, detailed recording and scoring,
lengthy administrations, elaborate data analysis, and, frequently,
videotaped records. Nevertheless, if sufficient resources are available,
observational measures may be of great value.

An alternative type of observational measure that has been used to track
general rehabilitation outcomes is the *Functional Independence Measure*
(FIM; Keith, Granger, Hamilton, & Sherwin, 1987). The FIM is a
collection of 18-items assessing patients\' independence in selected
areas of function. Testers must attain a criterion level of competence
with the instrument before they begin administrations. Testers then rate
the testee\'s level of independence on each item, based on the tester\'s
observations of their abilities. Good to excellent FIM interrater
reliabilities have been reported (Hamilton, Laughlin, Fiedler, &
Granger, 1994), and validity with several patient groups has been
established (Dodds, Martin, Stolov, & Deyo, 1993; Oczkowski & Barreca,
1993; Wilson, Houle, & Keith, 1991). Although most VHA and private
sector inpatient rehabilitation services use the FIM as an index of
function and to benchmark rehabilitation outcomes, the FIM is less
useful for measuring pain-related physical capacities or treatment
outcomes. FIM items were designed to assess functional capacities in
patients with relatively severe disabilities, such as those associated
with strokes or traumatic brain injuries. Individuals with less
pervasive conditions, such as those with chronic pain, tend to score
very high on the instrument even prior to treatment interventions due to
their high baseline functional status. As a result, initial FIM scores
approach the ceiling of the instrument allowing little room to
discriminate function between individuals or to assess treatment-related
change.

[\"Biometric\" Approaches]{.underline}. Biometric approaches rely on
various hardware devices to quantify physical function, capacities, or
movement. They may include physiological recordings of autonomic or
somatic nervous system activity, measures of motor output (e.g., force,
speed, weight), or three-dimensional computerized representations of
motion or movement collected during standardized tasks. There are
numerous biometric \"systems\" approaches marketed by private vendors
that purport to be reliable and valid measures of functional capacities.
Each of these approaches is based on unique combinations of measures and
hardware that are presumed to either simulate actual functional
behaviors or predict functional capacities. Biometric approaches often
are utilized in injury litigation cases or in federal or state
disability decisions (e.g., Social Security disability or Worker\'s
Compensation) where questions concerning functional capacities exist.

Although the comprehensive nature and precision of biometric approaches
to physical capacity measurement is appealing, they are not suitable for
general use as pain outcomes measures for numerous reasons. First, they
require lengthy administration times (typically 3 to 4 hours or more)
that far exceed available time intervals. Second, their hardware cost is
substantial (approximately \$12,000 to \$100,000), and many charge
additional fees for each completed assessment. Third, for the most part
they were designed to assess work-related performance (i.e., functional
capacities) rather than physical capacities per se. Thus, many of the
simulated work tasks that form the basis of these biometric approaches
may not be relevant to a VHA patient population characterized by
multiple disabilities, low rates of employment, and sedentary
lifestyles.

[Performance Measures]{.underline}. Performance measures are those where
objective indices of function (e.g., time to complete, number of
repetitions completed, degree of incline obtained, grip strength) during
an assigned task are recorded and compared either to normative or
clinical data or to pretreatment indices of function. Several of these
measures have generated substantial research interest and have been
found to be reliable and valid indicators of function. For example, the
dual inclinometer method of assessing trunk range of motion has been
found to be reliable (Keeley et al., 1986), has demonstrated good
correspondence with flexion and extension X-ray results (Mayer, Kishino,
Keeley, Mayer, & Mooney, 1985), and has been adopted as the \"standard\"
method for assessing spinal mobility by the American Medical Association
(Engelberg, 1993). Similarly, hand dynameters have been found to be the
most accurate available measure of hand strength (Mathiowetz, Weber,
Volland, & Kashman, 1984), as long as standardized grip positions are
employed (Mathiowetz, Rennells, & Donahoe, 1985). However, most
performance measures of range of motion or strength lack evidence of
validity or reliability. For example, physical therapists traditionally
rely on goniometers when assessing range of motion despite concerns
regarding their reliability when used in cervical (Nilsson, 1995),
lumbar (Rondinelli, Murphy, Esler, Marciano, & Cholmakjian, 1992), or
extremity (Rome & Cowieson, 1996) assessments.

Alternatives include more integrated performance measures such as the
*Physical Capacities Evaluation* (PCE; Clark, 1996), which is loosely
based on an instrument developed by Woods (1989). The PCE is comprised
of a collection of performance tasks that assess extremity and back
function. Unfortunately, it is not practical for general clinical use as
it requires the availability of a therapeutic pool to administer.
Additionally, like other integrated measures which employ subtests or
subtasks**,** the PCE yields a single overall score based on performance
on a series of tasks utilizing different muscle groups. As a result,
when pain-related limitations are confined to a single body area (e.g.,
lower extremities), the resulting summed scores tend to minimize the
severity of the individual\'s dysfunction and may mask the extent of
actual treatment-related changes that are obtained.

[Current Status Summary]{.underline}. At present there are no "gold
standard" physical capacities outcomes measures available to pain
practitioners. Standardization of assessment methods is lacking, and
practitioner ratings of function remain very popular despite numerous
studies demonstrating their poor reliability. Although there are a few
commercial systems that may eventually provide adequate validation data,
they are very expensive and time intensive, limiting their utility for
clinical settings. The best-supported performance measures, which tend
to be less resource intensive, are the dual inclinometer method of
assessing changes in trunk range of motion, and the use of hand
dynameters to evaluate upper extremity strength. In settings where rapid
assessment is necessary, current alternatives appear limited to
goniometer measures or practitioner ratings until alternative approaches
are developed and validated.

## **Measuring Employment Status**

Among the most common criteria used to evaluate chronic non-cancer pain
treatment program success are return to work and improvements in
disability compensation status. In fact, support for the effectiveness
of multidisciplinary pain centers (MPCs) is largely based on data that
document the success of these programs in returning participants to work
and in closing disability claims (Flor, Fydrich, & Turk, 1992).
Furthermore, CARF requires that accredited pain rehabilitation programs
consider return to work as a key outcome domain (Rehabilitation
Accreditation Commission, 2002). Work status also may be an important
variable in evaluating the success of acute or cancer pain interventions
in the context of a broad focus on psychosocial functioning.

[Employment Status Measures]{.underline}. Unlike other outcomes
variables, assessment of changes in employment status does not
necessarily involve the administration of validated instruments to
gather work-related data. Instead, current employment status usually is
elicited as a routine component of an initial screening or more
comprehensive pain assessment interview. In this context, recent
employment history also is elicited and may include assessment of a
range of indicators of work functioning. It is important to note that,
depending on the goals of the program or intervention and the population
being served, return to work may or may not be viewed as a viable
outcome. However, a broad array of alternative work-related variables
may be reasonable to consider as measures of the effectiveness of the
program or intervention.

Most commonly, work status is measured as a categorical variable in
which the participant is characterized as being employed full-time,
part-time, or not at all. Usually student status is coded in a similar
manner for these purposes. Persons who report that he or she works to
maintain a household and/or provides childcare or other care giving
usually is coded as such, as is retired status. Successful outcome
usually is measured by an improvement (moving "up" in categories) in
employment status.

An alternative to this practice is to consider employment as a
continuous variable in which paid work is coded in terms of number of
days, weeks, or months over a specific period of time that the
individual was employed or unemployed. Outcome is measured as a change
in this variable as a function of the pain intervention.

Another alternative method is based on an evaluation of progress toward
individually established goals for employment. For example, a veteran
participating in a chronic pain management program may set a goal of
reducing absenteeism from work. Or another veteran receiving treatment
for chronic upper extremity pain may have a goal of vocational
retraining for an alternative career. Progress toward these specific
goals may be used as important measures of successful pain management.

Resolution of claims for disability or withdrawal from disability roles
that impact availability for employment may be important outcomes for
some programs or individuals. However, most experts and available data
are consistent in supporting a view that this is often an unlikely
outcome. For example, the extensive evaluation that usually accompanies
a disability determination, and the strong social and financial
incentives associated with receipt of disability compensation support
this claim.

For some veterans, including retirees or persons already established as
being disabled, an increase in avocational activities may be appropriate
measure of pain treatment success. Volunteering in a work setting,
increases in household chores or activities around the home, initiation
of hobbies, or other changes consistent with general productiveness may
serve as appropriate outcomes indicators.

## **Measuring Healthcare Utilization/Costs**

Over the past decade there has been a dramatic change in patterns of
reimbursement or payment for healthcare delivery. Historically,
healthcare has been delivered almost entirely with an emphasis on
health-related outcomes, whereas "cost-effectiveness" was only a minor
concern. This perspective has now been replaced by the need to attend to
major societal and economic forces that demand that the costs of care
serve as a primary factor in determining healthcare service delivery. In
this environment, the only viable pain management system is one that
emphasizes efficiency and cost-effectiveness.

It has been estimated that over \$125 billion is now spent on direct and
indirect costs related to chronic non-cancer pain alone (Okifuji, Turk,
& Kalauokalani, 1999). The need to balance the delivery of humane pain
management and restrictions on the availability of funds for these
services is a critical issue. A successful pain management system is one
that is able to demonstrate cost-effectiveness, rather than
effectiveness alone.

Despite several published reports that support the cost-effectiveness of
multidisciplinary approaches to pain management (e.g., Ferrell &
Griffith, 1994; Turk, 1996), challenges to the strength of these data
are common, particularly from the perspective of healthcare system
administrators. Federico (1996) for example, emphasizes the need for
increased standardization and guidelines for pain care as well as
published research data from scientifically rigorous controlled studies
that report on the relative cost-effectiveness of pain treatment
programs.

[Cost-Effectiveness]{.underline}. Demonstrations of both effectiveness
and efficiency in the management of pain are at the core of any
discussion of "cost-effectiveness". The availability of multifactorial
data using methods proposed in this Toolkit that document improved
patient outcomes is an important, if not essential, component of this
process. However, as noted above, demonstrations of efficacy of an
intervention or program may not be sufficient in the current managed
care environment where resources are limited. In addition, it is
increasingly important that costs associated with the delivery of pain
management services also are assessed using methods judged to be
reliable and valid. Ultimately, cost-effectiveness can be judged only
through a close inspection of benefits (or harm) for persons receiving
pain management services in direct comparison to costs associated with
these services.

Direct comparison of two or more pain management interventions for the
same pain condition and/or sample of patients is probably the most
common strategy for examining and reporting on the relative
cost-effectiveness of the interventions. For example, Flor, Turk, and
their colleagues in their examination of the cost effectiveness of MPCs
derived their indices by a comparison of effects of MPCs versus surgical
costs for the same conditions (Flor et al., 1992; Turk, 1996).

An important concept in discussions of the cost-effectiveness of pain
management systems of care is that of cost-offset. Cost-offset refers to
the delayed benefits of an intervention that can be operationalized as
reductions in healthcare costs subsequent to the intervention that are
reasonably believed to be attributable to the pain intervention. For
example, pain management intervention cost-offset effects can be
attributed if there is a demonstration of a reduction in healthcare
system utilization and associated costs during the 12 months immediately
following a pain management intervention relative to the 12 months
immediately preceding the delivery of the service.

[Measuring Healthcare Utilization And Associated Costs.]{.underline}
There is a wide range of variables that may be targeted for developing
estimates of costs associated with pain management services. The most
common strategy for examining healthcare system utilization is some
method for counting activities best characterized as direct patient care
services. Depending on the specific facility, type of program, and
population served, and the specific purpose of the analyses, it may
prove useful to distinguish between medical and surgical, rehabilitation
medicine, and mental health services, and/or pain-relevant utilization
versus utilization unrelated to the pain condition. There also may be a
specific reason to set a threshold for some categories of service
utilization, such as an analysis of extensive utilization of a specific
outpatient clinic.

Examples of some relevant utilization indices are presented below:

+-----------------------+-----------------------+-----------------------+
| **Type of Service**   | **Site of Service**   | **Measure**           |
+-----------------------+-----------------------+-----------------------+
| **Medical**           | Emergency Department  | Number of visits      |
|                       |                       |                       |
|                       |                       | Procedures performed  |
+-----------------------+-----------------------+-----------------------+
|                       | Inpatient             | Number of admissions/ |
|                       |                       | Episodes of care      |
|                       |                       |                       |
|                       |                       | Bed days of care      |
|                       |                       |                       |
|                       |                       | Procedures performed  |
+-----------------------+-----------------------+-----------------------+
|                       | Outpatient            | Number of primary     |
|                       |                       | care visits           |
|                       |                       |                       |
|                       |                       | Number of specialty   |
|                       |                       | care visits           |
|                       |                       |                       |
|                       |                       | Number of specialty   |
|                       |                       | clinics with \>3      |
|                       |                       | visits in 6 month     |
|                       |                       | period                |
|                       |                       |                       |
|                       |                       | Number of pain clinic |
|                       |                       | or other pain-related |
|                       |                       | specialty clinic      |
|                       |                       | visits                |
|                       |                       |                       |
|                       |                       | Procedures performed  |
+-----------------------+-----------------------+-----------------------+
| **Rehabilitation      | Inpatient             | Number of admissions/ |
| Medicine**            |                       | Episodes of care      |
|                       |                       |                       |
|                       |                       | Bed days of care      |
|                       |                       |                       |
|                       |                       | Procedures performed  |
+-----------------------+-----------------------+-----------------------+
|                       | Outpatient            | Number of visits      |
|                       |                       |                       |
|                       |                       | Procedures performed  |
+-----------------------+-----------------------+-----------------------+
| **Mental Health**     | Emergency Department  | Number of visits      |
|                       |                       |                       |
|                       |                       | Procedures performed  |
+-----------------------+-----------------------+-----------------------+
|                       | Inpatient             | Number of admissions/ |
|                       |                       | Episodes of care      |
|                       |                       |                       |
|                       |                       | Bed days of care      |
|                       |                       |                       |
|                       |                       | Procedures performed  |
+-----------------------+-----------------------+-----------------------+
|                       | Day Treatment         | Number of days of     |
|                       |                       | care                  |
|                       |                       |                       |
|                       |                       | Procedures performed  |
+-----------------------+-----------------------+-----------------------+
|                       | Outpatient            | Number of visits      |
|                       |                       |                       |
|                       |                       | Procedures performed  |
+-----------------------+-----------------------+-----------------------+

Costs associated with the use of both prescribed and non-prescribed
(over-the-counter) analgesic medications (e.g., opioids) and other
medications commonly used for pain management (e.g., benzodiazepines,
non-steroidal anti-inflammatories, anticonvulsants, tricyclic
antidepressants) are another important measure of healthcare utilization
(see Section 5 for more information). Substantial cost savings may be
realized by substituting generic or other less expensive medications for
those that are more costly, *provided that equivalent outcomes are
attained*.

For individual veterans, these utilization indicators can be derived
from CPRS GUI (see Section 5 for more information). Utilization of
non-VHA services and medications most often require patient self-report
and/or reports from significant others. Use of standardized methods for
eliciting data related to non-VHA utilization is recommended. Efforts to
corroborate these self-report via acquisition of outside medical and
pharmacy records, with the consent of the veteran, can enhance
confidence in their accuracy.

When it is desirable to obtain utilization data for groups of veterans,
for example, a cohort of participants in a pain management program, it
may be helpful to consult with experts from the local Information
Resource Management (IRM) office who may be able to extract summaries or
aggregated data for your specific purposes (see Section 5 for more
information).

Attributing costs to healthcare system utilization is another
potentially useful step in the process of examining cost-effectiveness.
Costs for most direct patient care services (e.g., outpatient visits,
bed days of care in an inpatient medical unit) provided in VHA
facilities can be calculated by multiplying units of service by mean
unit costs obtained by consulting with Decision Support System (DSS)
personnel. Costs for services received in non-VHA settings may be
estimated from private sector values for the region in which the service
was provided. Pharmacy costs can usually be obtained from local
authorities. Additional costs associated with pain-related diagnostic
procedures and non-pharmacological pain interventions can be calculated
in a similar manner. Once monetary values for services are obtained,
changes in actual medical costs occurring from pretreatment to
posttreatment can be computed. However, when focusing specifically on
medical utilization effects of pain interventions it may be important to
distinguish between *pain-related* visits or costs and those that are
attributable to other factors (e.g., preventive health care or unrelated
medical conditions) where we would not expect to see any impact of pain
treatment.

When evaluating the cost effectiveness of pain treatment, costs
associated with the provision of the pain management intervention also
should be examined. For some multidisciplinary pain centers the
intensity of services provided and costs associated with them may be
unexpectedly high when administrative and other indirect costs are
considered. Equipment and supply costs are also important to include in
these analyses. Only then can the potential cost savings of pain
interventions be computed accurately.

[]{#__RefHeading___Toc29952440 .anchor}**Measuring Patient
Satisfaction**

Patient satisfaction is an important aspect of care that influences
patient behavior and treatment outcomes. The American Pain Society
Commission on Quality Assurance Standards has stated that patient
satisfaction with clinical services received is part of the quality
assurance of care delivery. Patient satisfaction is included as an
outcome variable in the revised APS Patient Outcomes Questionnaire (APS,
1995). Satisfied patients are more likely to comply with treatment and
establish better relationships with their providers, whereas
dissatisfied patients tend to comply poorly with their prescribed
therapeutic regimens (Aharony & Strasser, 1993; Carr-Hill, 1992). The
difficulty in measuring patient satisfaction stems from the
heterogeneity of patient satisfaction measures, the lack of clarity
concerning the meaning of satisfaction and its relationship to other
measures, and whether respondents can separate satisfaction with pain
management from satisfaction with other aspects of care such as the
caring dispositions of health care providers (Hester, Miller, Foster, &
Vojir, 1997; Hudak & Wright, 2000). Factors such as the organizational
context and the provider type (chiropractic care vs. primary care
physicians) also can influence patient satisfaction reports (Hester et
al., 1997; Solomon, Bates, Panush, & Katz, 1997).

This discussion is not intended to make specific recommendations or
present detailed reviews of patient satisfaction questionnaires.
Comprehensive reviews of patient satisfaction measures are provided
elsewhere in the literature (e.g., Ferris, 1992; Pascoe, 1983). Rather,
general principles are reviewed to assist in choosing a measure based on
the user's intent, and information concerning the pain-related content
of the national VHA customer satisfaction survey of healthcare
experiences of patients also is presented.

### [Characteristics of Satisfaction Measures]{.underline}. Patient satisfaction measures differ in their content (focus or substance of the measure) and their method (how the measure is administered and presented). Hudak and Wright (2000) suggest that the content of patient satisfaction 

### questionnaires be classified along four axes: global vs. multidimensional, care vs. treatment outcome, generic vs. disease specific, and direct vs. indirect. Some questionnaires may assess only single dimensions of the pain experience (e.g., pain intensity ratings). In contrast, multidimensional measures are query multiple dimensions of service and care. Examples of multidimensional measures include the Patient Satisfaction Questionnaire (PSQ) and the Client Satisfaction Questionnaire (CSQ; Larson, Attkisson, Hargreaves , et al., 1983; Ware, Snyder, Wright, et al, 1979). The PSQ is a 43-item questionnaire reflecting six dimensions of quality related to hospital care: access to care, availability of services, technical quality of care, interpersonal care, communication, and financial aspects of care. The dimensions of care examined in the CSQ include the physical surroundings, general satisfaction, and the interpersonal and technical aspects. Global measures are considered less informative than multidimensional measures and tend to produce scores that are skewed towards high levels of satisfaction (Ferris, 1992). Multidimensional measures typically are more reliable and have higher levels of validity than the global measures (Sitzia & Wood, 1997). 

The PSQ and CSQ are examples of generic measures that can be used to
assess patient satisfaction in any clinical setting. The content of
these measures is broad enough to allow comparisons across conditions
and settings, but unlike disease-specific measures, they cannot reflect
sources of satisfaction/dissatisfaction unique to a particular disease
or health care setting. The Patient Satisfaction Scale (PSS) is a
multidimensional *disease-specific* measure of patient satisfaction
designed specifically to assess satisfaction among patients with low
back pain (Cherkin, Deyo, & Berg, 1991). If the focus of satisfaction
assessment is with care (the patient's rating of the quality of the
medical care process), a generic measure is appropriate. However, if the
focus is treatment outcome (the patient's rating of a particular
treatment intervention), a disease-specific measure will more precisely
gauge patient satisfaction (Hudak & Wright, 2000).

Another way to evaluate measures is whether they use direct or indirect
scales to assess satisfaction. The PSQ is an example of an indirect
method as it assesses patients' attitudes about the health system or
care in general. The CSQ and the PSS are examples of direct measures
that require patients to think about the services they received when
answering questions. Direct measures are considered more precise than
the indirect measures when probing satisfaction with specific medical
encounters or treatment interventions.

Patient satisfaction measures also differ in the methods used to
administer the instrument. Measures may be factual (what actually
occurred) or affective (the patient's perception of what occurred),
questions may be open-ended or closed, they may be self- or interviewer
administered, and they may utilize varied response formats (e.g. 4, 5,
or 6-point scales). Each of these methods has their advantages and
disadvantages depending on the setting and the user's purpose. More
detailed explanations of the methods used in patient satisfaction
measures are available elsewhere (e.g., see Cleary, 1997; Ferris, 1992;
Hudak & Wright, 2000; Ware & Hays, 1988).

[Choosing Patient Satisfaction Measures.]{.underline} In summary, the
following general principles should be considered when choosing a
patient satisfaction measure:

1.  Multidimensional measures are preferred over single dimension
    measures due to their wider breadth of information. Multidimensional
    measures may be supplemented by a global measure.

2.  The actual items in the measure should be carefully examined in
    relation to the clinical setting and patient population. It may be
    desirable to add questions to address dimensions not covered in the
    standardized measure.

3.  Assess satisfaction with care separately from satisfaction with
    treatment outcome.

4.  Direct measures are preferred over indirect measures when probing
    satisfaction with specific medical encounters or treatment
    interventions.

5.  Use of both closed and open-ended questions is recommended for a
    better understanding of patient satisfaction.

6.  Interview non-responders and patients who have left the program to
    probe for sources of dissatisfaction.

### [National VHA Customer Satisfaction Survey.]{.underline} Since 1995, the Office of Quality and Performance has administered a mailed customer satisfaction survey in an effort to systematically assess those ambulatory care experiences identified by veterans as priority components of high quality medical care. Beginning in the spring of 2002, the Survey of Healthcare Experiences of Patients (SHEP) is surveying random samples of all patients seen by a provider. Information about this project and customer satisfaction data is available at the Office of Quality and Performance website, [**http://vaww.oqp.med.va.gov/DEFAULT.asp**](http://vaww.oqp.med.va.gov/DEFAULT.asp)

The survey results report scores for Veteran Health Service Standards,
Overall Quality, and Provider Wait Times. Scores are provided for each
VISN and scores are reported at the national, VISN, VAMC, and clinic
organization levels. Veterans Health Service Standards (VHSS) are
summary scores that reflect patient satisfaction in the following
domains:

-   **Outpatient** -- Access, Continuity of Care, Courtesy, Education
    and Information, Emotional Support, Overall Care Coordination, Visit
    Coordination, Pharmacy (mailed), Pharmacy (pickup), Specialist Care,
    Patient Preferences.

-   **Inpatient** - Access, Courtesy, Education and Information,
    Emotional Support, Physical Comfort, Family Involvement, Transition,
    Overall Care Coordination, and Patient Preferences.

The inpatient survey data domain Physical Comfort includes specific
questions about pain experience and treatment.

Future analyses of functional status and healthy behavior data from the
SF-12V Health Survey is planned. The SF-12V is included in the mailed
satisfaction survey to both inpatients and outpatients. The SF-12V
includes questions that assess the functional impact of pain. A
web-based application is being developed that will support online
dynamic access to SHEP data as it is collected with tools to analyze the
information more extensively.

Questions incorporated in the 2002 National Survey and SF-12V that
relate to pain treatment or outcomes are presented in [Appendix
I.](#PCRefList_OUTCOME_MEASURES_TOOL_KIT2__re)

[]{#__RefHeading___Toc29952441 .anchor}**Multidimensional Pain Outcomes
Measures**

Multidimensional pain outcomes measures are used to assess
treatment-related change in several outcomes domains simultaneously.
Major advantages of this approach are that they can be used for
benchmarking outcomes across facilities (when facilities utilize the
same instrument), they tend to be better integrated, and they may be
shorter than collections of unidimensional measures that cover the same
outcomes domains. Major disadvantages are that they are more complex and
may require increased administration, scoring, and interpretation time.
Therefore, multidimensional measures are best utilized in intensive
chronic pain treatment settings where the measurement of pain-related
changes across all outcomes domains is desirable.

*[West Haven -- Yale Multidimensional Pain Inventory
(WHYMPI).]{.underline}* The WHYMPI (Kerns, Turk, & Rudy, 1985) is a
comprehensive measure of pain-related functioning that has been
identified as one of the most frequently used measures of the chronic
pain experience (Mikail, DuBreuil, & D\'Eon, 1993). The MPI is comprised
of 52 items comprising three sections and 12 subscales. Section one
consists of five scales measuring a range of pain-related experiences,
including pain intensity, pain interference, negative mood, life
control, and perceived support. Section two contains three scales
measuring the responses of significant others to the patients'
expressions of pain. The third section includes four activity scales.
The WHYMPI has good internal consistency (α = .70 - .90) and adequate
two-week test-retest reliabilities (r = .62 - .91; Kerns et al., 1985).
Criterion-related, concurrent, and factorial validity has been
demonstrated in numerous studies for heterogeneous samples of persons
with chronic, non-cancer pain, and for several specific non-cancer and
cancer pain samples, It has been used extensively in outcome research
and has been demonstrated to be sensitive to treatment-related change
(e.g., Altmaier, Lehmann, Russell, Weinstein, & Kao, 1992; Kerns, Turk,
Rudy, & Holzman, 1986). WHYMPI cluster analyses have revealed a
three-group typology (dysfunctional, interpersonally distressed, and
adaptive copers) of patients with chronic pain (Turk & Rudy, 1990). This
typology may assist clinicians in attempting to match pain interventions
to patient characteristics identified by the WHYMPI. Advantages of the
WHYMPI are that it has been validated specifically with veterans, it
assesses most of the relevant pain outcomes domains, and it provides an
excellent assessment of the interpersonal aspects of individual's pain
experiences.

*[Pain Outcomes Questionnaire- VA (POQ-VA)]{.underline}*. The *POQ-VA*
is an outcomes package developed for use with veterans and consisting of
intake (45 items), post-treatment (28 items), and follow-up (36 items)
questionnaires. The *POQ-VA* represents the culmination of a five-year
cooperative effort with the American Academy of Pain Management to
revise, improve, and adapt a preexisting pain outcomes instrument (the
*National Pain Data Bank*) for use with VA patients experiencing pain.
The *POQ-VA* is the only pain instrument developed specifically to
assess treatment outcomes across all of the pain-related domains of
functioning identified by the Rehabilitation Accreditation Commission
(2002) as essential for comprehensive outcomes measurement. Outcomes
domains include pain intensity, pain interference (ADLs, Mobility),
Negative Affect, Vitality (activity level), pain-related fear (Fear),
vocational functioning, patient satisfaction, and medical resource
utilization from intake through follow-up. Core *POQ-VA* (formerly known
as the National Pain Data Bank VA-Version 2.0) scales have been found to
have adequate to high internal reliability and good stability (Gironda,
Azzarello, & Clark, 2002), and generalizability coefficients, which are
indices of the fidelity of true score measurement (Heaton, Chelune,
Talley, Kay, & Curtiss, 1993), indicated excellent scale reliability.
Validation studies using veterans treated in outpatient and inpatient
pain treatment settings revealed that the *POQ-VA* demonstrated good
concurrent validity in relation to a number of widely accepted "gold
standard" measures of pain-related impairment (Clark & Gironda, 2000;
Clark, Gironda, & Young, 2003), as well as good sensitivity to
treatment-related change (Clark et al., 2003). Confirmatory factor
analysis has revealed that the *POQ-VA* scales reflect a stable latent
factor structure representing two higher-order factors (emotional
distress and pain interference; Young, Clark, & Gironda, 2003). The
*POQ-VA* is available for downloading from the
[www.vachronicpain.org](http://www.vachronicpain.org/) website, and also
is available in a short form version (*POQ-SF*).

*[Brief Pain Inventory (BPI).]{.underline}* The BPI (Cleeland & Ryan,
1994) is a 32-item inventory that assesses pain history, pain intensity,
response to medication/treatment, and pain interference. The BPI has
been translated into many languages, and it has been validated for use
with cancer and chronic disease pain patients. Factor analyses have
identified two-factors of pain severity and pain interference across
samples and language versions (Caraceni et al., 1996; Radbruch et al.,
1999; Saxena, Mendoza, & Cleeland, 1999; Wang, Mendoza, Gao, & Cleeland,
1996).

Note, however, that psychometric data thus far primarily apply to cancer
and chronic disease samples rather than to individuals with chronic
non-cancer pain. In addition, although the brevity of the BPI is a
potential advantage, its scope is less comprehensive than the other
available multidimensional instruments. Thus, although it may be the
outcomes measure of choice with respect to individuals with cancer pain
other instruments may be preferred when changes across many outcomes
domains are important.

[]{#__RefHeading___Toc29952442 .anchor}**[SECTION 4: PROCESS OUTCOMES
MEASURES]{.underline}**

Process outcomes dimensions or "service delivery outcomes" (Clark &
Gironda, 2002) focus on monitoring and improving pain service delivery
systems. Often they are part of facility Performance Improvement (PI)
efforts. Accreditation organizations such as JCAHO often focus more on
process outcomes, although some JCAHO standards may relate to patient
focused outcomes as well. For example, while the patient's self-report
of pain could be used as a patient focused outcome to determine the
effectiveness of pain treatment, when it is used as evidence of
compliance with pain screening and documentation policies it is acting
more as a process outcome. As a process outcome, the *intent* of the
patient's self-report of pain changes from evaluating the effectiveness
of the pain intervention provided to evaluating the service delivery
system.

Generally, the way in which process outcome measures are gathered
differs from the manner that patient outcome measures are collected.
Process measures usually involve tracking or monitoring aspects of
service delivery or patient documentation. Rarely do process measures
involve the use of validated instruments. Instead, process outcomes most
often are measured by reviewing medical record documentation or facility
records.

Process outcome measures may be developed to evaluate pain policy
compliance or to assess compliance with pain standards promulgated by
external organizations such as JCAHO. Often they are used to evaluate
the impact of a system intervention designed to improve service
delivery. Examples of some pain process outcomes are changes in pain
clinic waiting times, compliance with the mandate to routinely collect
pain scores as the Fifth Vital Sign, proportion of pain patients
undergoing repetitive medical diagnostic procedures, percentage of
individuals with significant pain who receive pain education, and
others.

When developing or selecting pain process measures, one must first
define the process that is of interest. Often this may be accomplished
by referring to relevant facility or national policies or external pain
standards. In this regard, it may be helpful to review the list of
attributes of successful pain management systems developed for the
VHA/Institute for Healthcare Improvement Pain Management Collaborative
Project which is presented in [Appendix
II](#__RefHeading___Toc29952454). This document defines numerous process
standards for pain management excellence that also may be useful as
measures of pain process outcomes.

[]{#__RefHeading___Toc29952443 .anchor}**Measuring Process Outcomes**

Process outcome measures data may be extracted from a variety of
sources, including medical records (including CPRS), patient interviews
or surveys, PI monitors, and local or national patient care data files.

[Chart Reviews]{.underline}. Chart reviews or audits can be either
electronic or paper. Data collection forms and compliance checklists
often are used to compare the quality of service delivery provided to an
individual patient with system standards of care. In most settings it is
not necessary to evaluate every case receiving the targeted service.
Instead, a predesignated number of randomly selected charts can be
reviewed at established intervals.

Samples of some chart review forms are included in [Appendix
III.](#Appen3) Often it will be necessary to revise existing audit tools
or to develop new tools to evaluate process outcomes. When developing
pain compliance templates or audit tools, developers may find it useful
to consult

several articles that address this issue (Clark & Gironda, 2002;
Ferrell, Wisdom, Rhiner, & Alletto, 1991; Ferrell, McCaffery, & Ropchan,
1992).

[Patient Interviews and Satisfaction Surveys]{.underline}. When process
outcomes measures require that data from service consumers be gathered,
patient interviews or surveys can be utilized to assess the pain process
outcome dimensions. Patient interviews should be structured and
standardized so that each consumer responds to identical questions.
Opportunities for additional comments can be incorporated at the end of
the interview.

When designing patient surveys or questionnaires for use, item wording,
clarity, and reading level should be considered and adjusted to meet the
target population's verbal abilities (Clark & Gironda, 2002). A pain
process evaluation tool that includes both a chart audit and a patient
interview that was tested for content validity, interrater reliability,
practicality of administration and test/retest reliability, is included
available from Ferrell, Whedon, & Rollins (1995).

[Performance Improvement Monitors]{.underline}. Most healthcare
institutions have in place numerous PI indicators that are used to track
different aspects of care. Often these indicators will overlap with pain
service delivery outcomes. For example, medication error monitors will
include cases where pain-related medications were dispensed incorrectly.
Or, facility clinic waiting times monitors will gather data on pain
clinic waiting times as well as on other clinics. Many additional areas
of overlap are possible.

If existing PI monitors do not cover critical pain service delivery
components, consideration should be given for developing new PI monitors
that address the relevant pain service delivery issues. For example, a
monitor might be established for determining the percentage of patients
with pain greater or equal to a trigger value of four who undergo
detailed pain assessments.

[Patient Care Data Files]{.underline}. Aggregated pain service delivery
outcomes data also can be extracted from patient care files maintained
either locally or nationally. Local files may contain pain scores
collected at locally determined intervals that may be aggregated across
patients to evaluate changes in the effectiveness of overall pain care
provided by the institution. Alternately, facilities utilizing clinical
reminders for pain may be able to evaluate various aspects of pain care
delivery (see Section 5 for a more detailed discussion).

**Key Process Outcomes Monitors**

There are five key pain service delivery processes that are central to
excellence in pain care:

-   Comprehensive pain assessment has occurred

-   Treatment/Clinic waiting times are reasonable

-   Patients and their families receive education about pain treatment
    options and their rights and responsibilities

-   A pain plan of care is present

-   Providers are educated regarding appropriate pain care

[Pain Assessment]{.underline}. The VHA National Pain Management Strategy
mandates that pain assessment is performed in a consistent manner. As
stated in the *Pain as the 5^th^ Vital Sign Toolkit*, "reliable and
comprehensive assessment of pain is the cornerstone of effective pain
management", and that "effective pain management hinges on the
availability of a thorough and reliable assessment of pain". The
importance of pain assessment is highlighted by research showing that
the failure to routinely assess pain and pain relief is the most common
reason for the undertreatment of pain in U.S. hospitals (American Pain
Society, 1999).

JCAHO standards (*[http://WWW.jcaho.org](http://WWW.jcaho.org/))* that
address the importance of pain assessment are:

-   PE.1.4: Pain is assessed in all patients.

-   RI.1.2.8: Patients have the right to appropriate assessment and
    management of pain

Evidence that comprehensive pain assessment is occurring requires that
documentation of completed assessments be present in the medical record.
Assessments may be in the form of provider consultation reports,
provider progress notes, or completed pain assessment templates. Note
that the presence of numeric pain *scores* in the medical record is not
sufficient evidence that pain *assessment* has occurred. Routine pain
screening for the presence and intensity of pain, as outlined in the
"Pain as the 5^th^ Vital Sign" directive, should lead to completion of a
comprehensive pain assessment when some specific pain intensity
threshold is reached (e.g., a pain score of \>3 on a 0-10 numeric rating
scale).

[Waiting Times]{.underline}. One of the goals of the VHA National Pain
Management Strategy is to "assure that pain treatment is prompt and
appropriate". Waiting times are an important aspect of this goal. JCAHO
also emphasizes the importance of waiting times as illustrated in the
following standard:

-   RI.1.2.8: Patients have the right to appropriate assessment and
    management of pain.

Examples of waiting times relevant to pain service delivery adequacy
include:

-   Waiting time between clinic referral and first available appointment

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-   Waiting time between stated clinic appointment time and the time the
    patient actually is seen

-   Waiting time between the initiation of a pain medication order and
    the administration of the pain medication (inpatient setting)

-   Waiting time between the patient's pain medication request and the
    time the medication is dispensed (inpatient setting)

Some waiting times may be calculated based on evidence present in CPRS
(e.g., number of days between clinic referral and scheduled
appointment). Others will require that specific monitors be established
to quantify the time intervals. Waiting times and other process measures
also can be assessed using patient questionnaires. The American Pain
Society Patient Outcome Questionnaire (American Pain Society, 1995) is
an example of a questionnaire that examines several process domains
including medication waiting times.

[Patient Education]{.underline}. Patient education is another important
component of pain service delivery systems. The importance of education
efforts is addressed in the VHA National Pain Management Strategy
objective to "include patients and families as active participants in
pain management". Similarly, the 1992 AHCPR Acute Pain Management
guidelines (Acute Pain Management Guideline Panel, 1992) include patient
education as one of four major pain management goals. JCAHO standards
also address the importance of pain education:

-   PF.1.7: Patients are taught that pain management is a part of
    treatment. A positive outcome requires an understanding of pain, the
    risk for pain, and the importance of effective pain management.

-   RI.1.2: Patients are involved in all aspects of their care

-   RI.1.2.8: Patients have the right to appropriate assessment and
    management of pain.

Appropriate components of education for individuals with pain include
information regarding diagnosis and prognosis, possible effects on
emotional, social, and familial functioning or roles, treatment rights
and responsibilities, and available treatment options including their
risks, side effects, and known complications.

Evidence of patient and family education may be found in general
progress notes, specific patient education forms, or patient education
templates. Alternatively, pain patients or their family members could be
interviewed or surveyed regarding the type and nature of pain education
they received. Navas & Sommer (1999) provide information on potential
sources for patient surveys. Examples of possible patient education
survey items are presented in [Appendix IV](#appendix4).

[Pain Plan of Care]{.underline}. In order to systematically treat pain,
a pain plan of care (i.e., treatment plan) should be present in the
medical record. Ideally, plans of care should include a description of
the pain treatment methods that will be utilized, their frequency,
treatment goals, methods that will be used to measure progress towards
the stated goals, and evidence that the person with pain was involved in
the development of the pain treatment plan. Pain plans of care should be
active as long as pain continues to be defined by the patient as a
significant problem, and they need to be reviewed and revised whenever
significant changes in the person's condition are observed, or when the
treatment methods selected have not been effective.

JCAHO standards that address the importance of pain treatment plans
include:

-   PF.1.7: Patients are taught that pain management is a part of
    treatment

-   RI.1.2: Patients are involved in all aspects of their care

-   RI.1.2.8: Patients have the right to appropriate assessment and
    management of pain.

-   CC.6.1: The discharge process provides for continuing care based on
    the patient's assessed needs at the time of discharge.

The adequacy of pain plans of care usually is assessed by reviews of
inpatient or outpatient records. Chart review checklists can be
developed to facilitate these reviews. Exemplary plans will include the
components noted above, along with evidence of ongoing reassessment of
the individual's pain problems and response to treatment and
documentation of any multidisciplinary involvement in treatment.

[Provider Education]{.underline}. Assuring that providers are educated
in appropriate pain management treatment methods is another stated
objective of VHA National Pain Management Strategy. The JCAHO standard
that directly applies to this issue is:

-   RI.1.2.8: Patients have the right to appropriate assessment and
    management of pain.

Provider education has been recognized as a critical component in the
provision of appropriate pain treatment services. The AHCPR Cancer Pain
Guidelines (Jacox, Carr, & Payne, 1994) identifies inadequate provider
education as a major barrier to effective pain management. In fact,
eight of the ten goals of the Cancer Pain Guidelines are related to
staff education and competency. Traditional voluntary educational
approaches such as continuing medical education (CME) activities have
not led physicians to improve how they manage pain or other medical
problems (Davis et al., 1999; Weissman, 1996). Alternatives to voluntary
pain CME approaches may include attendance at mandatory training
activities, completion of formal web-based training courses, self-study,
or experiential-based training.

The selection of process monitors for staff education in pain will
depend on the pain training approach adopted in each locale of interest.
*Attendance* *monitors* simply document that staff have participated in
the designated pain training. The training activities may take place at
the local facility or at regional or national conferences or meetings.
Education tracking systems, which are operating at all VHA sites, can be
utilized to document staff participation in pain education activities.
In contrast, *competency monitors* require a demonstration of knowledge
or

skill. Competency approaches to training may utilize knowledge tests to
document that participants have demonstrated some criterion level of
pain knowledge before credit for the training is awarded.

More elaborate approaches may rely on tests of pain knowledge and
attitudes administered prior to and following a program of pain
education to quantify changes induced by the training activities. Margo
McCaffery has developed and validated a reliable test of nurses' pain
knowledge and health provider attitudes
([*http://mayuday.coh.org/Instruments/k&a.htm*](http://mayuday.coh.org/Instruments/k&a.htm))
that could be utilized as a measure of the effectiveness of provider
education. An example of a pain knowledge test is included in [Appendix
V.](#__RefHeading___Toc29952460)

There are several resources available to all VHA sites to educate
clinical staff on pain issues and to assess pain management knowledge.
Each VHA VISN Library has received a copy of the following pain
management educational resources: 1) *Assessing Complicance with the New
JCAHO Pain Management Standards for Complex Organizations* (includes 2
videos); 2) *Pain Management (*CD-Rom); 3) Pain *Management Patient
Education Manual* ; and 4) *Pain Management: An Interactive CD-ROM for
Clinical Staff Development*. Contact your VISN Librarian for assistance
in locating these items. The CD-ROM's include knowledge tests which are
scored for per cent of correct responses. Minimum scores can be selected
as a local competency criterion.

[]{#__RefHeading___Toc29952444 .anchor}

**[SECTION 5: SPECIAL ISSUES]{.underline}**

[]{#__RefHeading___Toc29952445 .anchor}Evaluating Medication Use
Outcomes

The multifactorial nature of pain, particularly chronic pain, makes it
necessary to evaluate the outcomes of pharmacologic treatment using
multiple criteria (Kozma, 1995; Kozma, Reeder, & Schulz, 1993; Ortmeier,
1997; Turk & Okijuji, 1998). For instance, it is not enough that a drug
may produce a significant improvement in a specific clinical endpoint,
e.g. an improved adverse drug event (ADE) profile. The improved ADE
profile also must lead to improved outcomes (Kozma, 1995).

The ECHO (Economic, Clinical and Humanistic Outcomes) model provides a
theoretical framework for the identification, collection and use of
outcomes data to assess pharmaceutical treatment alternatives (Kozma,
1995; Kozma et al., 1993; Ortmeier, 1997). The model proposes causal
relationships among diseases, health outcomes and decisions about
medical care interventions.

The ECHO model assumes that the outcomes of medical care can be
classified along three general dimensions: clinical, economic, and
humanistic outcomes. These dimensions are defined as follows:

-   *Clinical outcomes*: medical events that occur as a result of
    disease or treatment (pain reduction, side effect profile).

-   *Economic outcomes*: direct, indirect, and intangible costs compared
    with the consequences of medical treatment alternatives (ER/clinic
    visits, cost of hospital care, cost of lost productivity, drugs and
    supplies).

-   *Humanistic outcomes*: consequence of disease or treatment on
    patient functional status or quality of life measured along several
    dimensions (e.g., physical function, social function, general health
    and well being, sleep, increased activity level, patient
    satisfaction).

The use of the ECHO model should assist in identifying and selecting
outcomes for inclusion in pharmacoeconomic analyses, identifying
important patient populations for the treatment alternatives of
interest, and assessing the relative value of competing alternatives
(Kozma et al., 1993). The application of this model to pain
pharmaceutical therapy outcomes is presented in Figure 1.

Figure 1. Evaluating Pain Treatment Outcomes: the ECHO Model.

[Clinical Outcomes]{.underline}. Figure 1 illustrates the process
whereby health care providers evaluate clinical indicators of disease or
symptoms (pain intensity, non verbal cues of pain) and make decisions
regarding treatment alternatives. Clinical indicators, used as the basis
for selection of treatment alternatives, are surrogates for clinical
outcomes. Treatment modifiers (e.g., compliance with therapy, side
effects, dosing interval) may affect both clinical indicators and
clinical outcomes.

-   [Pain ratings]{.underline}. Pain rating scales such as the Numeric
    Rating Scale have been used to monitor pharmacotherapy outcomes. It
    is important to recognize that pain scales alone are not sufficient
    to evaluate the overall response to treatment or patient
    satisfaction with drug therapy. Patients may express satisfaction
    with treatment despite having severe pain (Ward & Gordon, 1996;
    McNeill, Sherwood, Starck, & Thompson, 1998). Even though patients
    may not experience an improvement in pain intensity, other quality
    of life measures (general activity and sleep) may improve
    significantly, resulting in improved patient satisfaction.
    Additionally, patients may indicate that they still have pain but do
    not wish to receive a stronger dose of pain medication (McNeill et
    al., 1998).

-   [Drug related problems]{.underline}. Pharmaceutical care is an
    outcome oriented, cooperative, systematic approach to providing drug
    therapy directed at the improvement of all dimensions of health
    related quality of life (Hepler, 1996). The identification of drug
    related problems (DRPs) are central to the pharmaceutical care
    process. Drug related problems have been defined as "*an undesirable
    event, a patient experience that involves, or is suspected to
    involve drug therapy, and that actually, or potentially, interferes
    with a desired patient outcome*" (Hepler & Strand, 1990). DRP's have
    been grouped into the following major types:

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-   Needing pharmacotherapy but not receiving it (a drug indication)

-   Taking or receiving the wrong drug

-   Taking or receiving too little of the correct drug

-   Taking or receiving too much of the correct drug

-   Experiencing an adverse drug reaction

-   Experiencing a drug-drug or drug-food interaction

-   Not taking or receiving the drug prescribed

-   Taking or receiving a drug for which there is no valid medical
    indication

Since the pharmaceutical care model is applicable to specialty practice,
DRPs may be used to monitor and evaluate medication outcomes in pain
management.

-   [Medical Utilization]{.underline}**.** Hospital admissions,
    readmissions, and length of stay have been used to evaluate
    medication outcomes. Medication use may be responsible for
    hospitalizations or prolonged hospital stays in cases of therapeutic
    failure or significant adverse drug events or toxicity. Like
    hospitalizations, unscheduled clinic visits and emergency room
    visits also may reflect the effects of pharmacotherapy, and can be
    used to evaluate medication outcomes.

[Economic Outcomes]{.underline}. Economic outcomes are described in
terms of cost and consequences of treatment and are derived from the
direct cost of providing medical care, the direct non-medical costs
associated with obtaining care, and the indirect costs linked to lost
productivity related to illness. As depicted in Figure 1, economic
outcomes have intermediaries introduced from the clinical and humanistic
sides of the model. The clinical side includes the direct costs of
medical care associated with each treatment, including medication,
laboratory, emergency room visit, inpatient hospitalization, and return
visit costs. The humanistic side includes productivity costs associated
with time lost from work. Direct non-medical costs include expenses for
transportation to the hospital or physician's office for treatment,
lodging for family members during treatment, and home health care
expenses. Economic outcomes may be expressed as ratios of costs to
benefits (in dollars), cost effectiveness (e.g., number of painful
exacerbations versus treatment expenses), or utility (e.g., changes in
quality-adjusted life-years; Kozma et al., 1993).

[Humanistic Outcomes.]{.underline} Humanistic outcomes refer to patient
evaluations of the impact of treatment on their lives e.g.,
health-related quality of life, satisfaction with care, and functional
status. Pharmacotherapy may influence humanistic outcomes to the degree
that it affects the

patient's ability to engage in or enjoy his/her activities of daily
living. For example, the anxiolytic, antidepressant and hypnotic effects
of certain drugs may enhance quality of life while adverse drug
reactions such as insomnia, memory loss, or impotence may negatively
affect it.

Patients may express satisfaction with pain management despite having
high levels of pain intensity. In fact, patient *dissatisfaction* with
pain management and their desire for stronger pain medications have been
related to the degree at which pain interferes with general activities
and sleep (McNeill et al., 1998), rather than to pain intensity per se.

[Recommendations for Medication Use Outcome Measures]{.underline}.
Specific recommendations for pharmacotherapy outcome measures are
presented in the following table. In many clinical settings it often is
difficult to isolate the effects of an individual pain intervention on
observed changes in patient functioning or reported distress. Patients
may be involved in multiple treatments simultaneously (e.g.,
pharmacotherapy, physical therapy, psychotherapy), each of which may
contribute to observed outcomes in unique ways. Similarly, patients with
pain often may be treated with multiple classes of medications which
complicate judgments regarding the efficacy of any specific agent.
Therefore, when evaluating pharmacotherapy effectiveness it is important
to be aware of concurrent treatments or medications that may be
contributing to the obtained outcomes. Sometimes it will not be possible
to determine the differential effectiveness of each treatment component.

Medication Use Outcome Measures

+--------------+-----------------------+------------------------------+
| **Outcome    | **Outcome Measures**  | **What to Measure?**         |
| Surrogate**  |                       |                              |
+--------------+-----------------------+------------------------------+
| ***Clinical  |                       |                              |
| Outcomes***  |                       |                              |
+--------------+-----------------------+------------------------------+
| Pain Rating  | Patient's perceived   | Pain intensity by means of   |
|              | pain rating           | validated scales e.g., the   |
|              |                       | pain NRS or the VAS.         |
+--------------+-----------------------+------------------------------+
| Drug Related | Needing               | \# of patients that are not  |
| Problems     | pharmacotherapy but   | taking or receiving required |
|              | not receiving it (a   | pain medication              |
|              | drug indication)      |                              |
|              |                       | Medication administration    |
|              | Receiving the wrong   | errors                       |
|              | drug                  |                              |
|              |                       | Compliance behavior          |
|              | Not taking or         |                              |
|              | receiving the drug    |                              |
|              | prescribed            |                              |
+--------------+-----------------------+------------------------------+
|              | Taking or receiving   | \# of patients being under   |
|              | too little or too     | or over treated              |
|              | much of the correct   |                              |
|              | drug                  |                              |
+--------------+-----------------------+------------------------------+
|              | Experiencing an       | \# of patients experiencing  |
|              | adverse drug reaction | an ADE                       |
|              |                       |                              |
|              |                       | \# and types of ADEs         |
+--------------+-----------------------+------------------------------+
|              | Experiencing a        | \# of patients experiencing  |
|              | drug-drug, drug-food  | a drug-drug, drug-food       |
|              | interaction           | interaction                  |
|              |                       |                              |
|              |                       | drug-drug, drug-food         |
|              |                       | interaction sequelae         |
+--------------+-----------------------+------------------------------+
|              | Taking or receiving a | \# of patients receiving     |
|              | drug for which there  | duplicate pharmacological    |
|              | is no valid medical   | agents                       |
|              | indication            |                              |
|              |                       | \# of patients on            |
|              |                       | polypharmacy                 |
+--------------+-----------------------+------------------------------+
| Hosp         | Admissions,           | \# of hospital admissions or |
| italizations | re-admissions and/or  | readmissions                 |
|              | length of stay due to |                              |
|              | ADEs associated to    | Time to readmission (days)   |
|              | pain-related drug     |                              |
|              | therapy or failure of | Length of hospital stay      |
|              | drug therapy to       | (days)                       |
|              | control pain.         |                              |
+--------------+-----------------------+------------------------------+
| Unscheduled  | Unscheduled clinic    | \# of unscheduled clinic     |
| clinic       | visits, emergency     | visits                       |
| visits,      | room visits due to    |                              |
| emergency    | ADEs associated to    | \# of emergency room visits  |
| room visits  | pain-related drug     |                              |
|              | therapy or failure of |                              |
|              | drug therapy to       |                              |
|              | control pain.         |                              |
+--------------+-----------------------+------------------------------+

+--------------+-----------------------+------------------------------+
| **Outcome    | **Outcome Measures**  | **What to Measure?**         |
| Surrogate**  |                       |                              |
+--------------+-----------------------+------------------------------+
| ***Economic  |                       |                              |
| Outcomes***  |                       |                              |
+--------------+-----------------------+------------------------------+
| Direct cost  | Cost of drugs,        | Drug costs                   |
| of providing | re-treatment due to   |                              |
| medical care | drug failure,         | Cost per day of              |
|              | hospitalizations,     | hospitalization              |
|              | office visits, allied |                              |
|              | health treatment (PT, | Office visit and allied      |
|              | OT, RT), laboratory   | health costs including       |
|              | work, X-Rays,         | nursing and pharmacy time    |
|              | prosthetics/medical   |                              |
|              | equipment             | Laboratory test costs        |
|              |                       |                              |
|              |                       | Radiographic test costs      |
|              |                       |                              |
|              |                       | Dollar value of prosthetics  |
|              |                       | and medical equipment        |
+--------------+-----------------------+------------------------------+
| Direct       | Transportation to the | Transportation and lodging   |
| non-medical  | hospital or           | related costs accrued by the |
| costs        | physician's office,   | patient and caregiver        |
| associated   | lodging, toll &       |                              |
| to obtaining | parking fees          | Hired caregiver costs        |
| care         |                       |                              |
+--------------+-----------------------+------------------------------+
| Indirect     | Time lost from work,  | Lost income from time lost   |
| costs        | reduced productivity  | from work or reduced         |
| associated   |                       | productivity.                |
| with lost    |                       |                              |
| productivity |                       | Include time lost from work  |
| related to   |                       | of caregiver.                |
| illness      |                       |                              |
+--------------+-----------------------+------------------------------+
| *            |                       |                              |
| **Humanistic |                       |                              |
| Outcomes***  |                       |                              |
+--------------+-----------------------+------------------------------+
| Patient      | Patient 's            | Patient satisfaction by      |
| satisfaction | satisfaction with     | means of patient             |
| with therapy | pharmacotherapy for   | satisfaction questionnaires  |
|              | pain management       | e.g., the APS-POQ            |
+--------------+-----------------------+------------------------------+
| Daily        | Pharmacotherapy       | \# of adverse drug events    |
| functioning  | effects on physical   |                              |
|              | and psychosocial      | Changes in measures of daily |
|              | functioning           | activity, physical capacity, |
|              |                       | social and sexual            |
|              |                       | functioning, mood, pain      |
|              |                       | intensity, sleep, and        |
|              |                       | vitality                     |
+--------------+-----------------------+------------------------------+

## **Measuring Family and Social Outcomes**

Contemporary models of the experience of pain emphasize the social, and
particularly the family, context (Jacob & Kerns, 2001; Otis, Cardella, &
Kerns, in press). This perspective encourages attention to the role of
the social environment in the development and maintenance of the
experience of pain and in understanding processes of adaptation and
adjustment. Conversely, the model draws attention to the impact of pain
on important interpersonal relationships.

Involvement of the family in pain management efforts is explicitly
stated as an objective of the VHA National Pain Management Strategy.
This objective is most commonly manifested as documented efforts to
provide education to family members (and significant others) in the
context of patient-oriented pain management. Active inclusion of
significant others in the comprehensive assessment of pain,
collaborative treatment planning, in the delivery of pain interventions,
and in reassessment is indicated by the perspective described above. In
certain situations, active participation of significant others in these
processes is likely to be critical to effective pain management. For
example, the spouse of a demented and uncommunicative veteran may be
critical in evaluating pain severity and its impacts on functioning, in
the reliable delivery of pain medications, and in assessing the efficacy
of the intervention. Education of and active collaboration with the
spouse in the development of an intervention plan may be essential.
Another example comes from multidisciplinary pain management centers
that commonly expect significant others to become active participants in
the program. These factors should be considered in the development of a
comprehensive set of outcome measures for evaluating individual or
program success.

Attention to the broader social and cultural context of pain also has
been emphasized. Increasingly research has documented reliable racial
and ethnic differences in the experience of pain including variables
such as pain perception, treatment seeking, and analgesic
responsiveness. Attention to cultural diversity factors in the
development and implementation of a comprehensive system for effective
pain management is critical, and in the delivery of
individually-tailored plans for pain management.

[Measuring Family Outcomes]{.underline}. Consistent with the VHA
National Pain Management Strategy objectives and the JCAHO pain
management standards is the need for reliable documentation of
pain-relevant family education. Development of a system for performance
improvement in this domain that focuses on ongoing monitoring, feedback,
and performance improvement efforts is indicated.

Depending on the scope and goals of a specific pain intervention or
program, inclusion of any of a number of family-relevant outcomes
measures also may be indicated. The process for selecting these measures
should be informed by the principles outlined earlier in this Toolkit.
Measures in this area range from those that are broad in scope and not
specifically related to pain management (e.g., the Locke-Wallace Marital
Adjustment Scale; (Locke & Wallace, 1959) to those that are
behaviorally-specific and pain-relevant (e.g., the significant other
response scales from the West Haven-Yale Multidimensional Pain
Inventory; Kerns et al., 1985). Standardized measures of potentially
important outcome domains (e.g., significant other adherence to
recommendations for pain medication delivery, significant other
satisfaction with pain treatment efforts) are not yet available and may
need to be developed for a specific purpose. A comprehensive review of
the available measures in this area has recently been published (Jacob &
Kerns, 2001).

[]{#__RefHeading___Toc29952447 .anchor}**Measuring Pain Outcomes in the
Cognitively Impaired**

The assessment of pain to plan interventions and assess outcome relies
on strategies for the communication of the patient's subjective
experience to the clinician. Cognitive impairment can interfere with
this communication and poses a difficult challenge to the accurate
assessment of pain and pain treatment outcomes.

[Elderly Veterans]{.underline}. Elderly veterans are a group with a high
prevalence of pain and substantial risk for cognitive impairment.
Estimates of the prevalence of pain in nursing home settings range from
45% to 80% (Ferrell, 1991; Fox, Raina, & Jadad, 1999). The prevalence
among community-dwelling elderly has been estimated at between 25% and
50% (Ferrell, 2000); Parmalee,1996).

Cognitive impairment is likely to be encountered routinely in assessing
pain in the elderly. The overall prevalence of non-dementia cognitive
impairment among community-dwelling elderly has been estimated between
10.7% and 23.4% with prevalence increasing by age (Unverzagt et al.,
2001); Di Carlo, Baldereschi, Amaducci, Maggi, Grigoletto, Scarlato, &
Inzitari, 2000). The overall prevalence of elderly with dementia has
been estimated to be 5% to 10%. Age-specific studies indicate that the
prevalence of dementia doubles with every five years of age at least up
to age 90 to 95 (Kukull & Ganguli 2000). The likelihood of cognitive
impairment and dementia increases with residential placement status. The
fastest growing segment of the U.S. population consists of persons older
than the age of 85 years with 15% meeting the criteria for dementia
(Henderson 1990). Approximately one-half of the U.S. population lives to
the age of 75 years and nearly one quarter live to the age of 85 (Berg
1994).

The percentage of elders complaining of one or more pain problems is
similar between cognitively intact and mildly to moderately impaired
persons. However, persons with severe cognitive impairment tend to
report fewer complaints (Parmalee, 1996). Nevertheless, fewer verbal
complaints does not necessarily mean less pain. It may reflect changes
in communication ability associated with cognitive impairment such as
reduced initiation of verbal behavior. *Failure to report pain should
not be assumed to mean the absence of pain.*

[Other groups with cognitive impairment]{.underline}. Pain assessment
has not been studied in other adult groups with risk for cognitive
impairment such as the developmentally disabled and persons with
traumatic brain injury (Schwartz, 1999; Bryant et al, 1999). In the
absence of data with other groups, strategies that have proven to have
utility with cognitively impaired elders provide a starting point for
use with these populations. Instruments developed for use with children
also could be of value, but have not been systematically studied for use
with cognitively impaired adults (Gagliese, 2001).

Clinicians assessing pain in cognitively impaired persons need to
consider the multidimensional qualities of pain. Pain has emotional,
cognitive, and sensory qualities that are manifested in personal and
interpersonal behaviors. These qualities may be assessed through
structured inquiry and structured observation.

[Assessment of the Presence and Intensity of Pain.]{.underline}
Assessment of the presence and intensity of pain is accomplished through
the use of patient self-report, observational measures and proxy report.
Unidimensional pain intensity scales can be used to quantify pain
intensity and track that dimension. Most of these scales have not been
adequately cross-validated in groups of cognitively impaired adults, so
the score on one scale cannot be assumed to reflect the same score on
another scale. To assess outcomes across patients, the same scale should
be used in the same fashion with all of the persons being assessed. To
assess outcomes within a single patient over time, the same scale should
be used in same fashion in each assessment.

[Self-report of pain presence and intensity]{.underline}. Self-report of
pain presence and intensity requires that the patient communicate the
existence of pain through verbal or nonverbal behaviors and rate the
intensity of the pain along a dimension encompassing no pain to the
worst possible pain. This requires some degree of abstract reasoning.
Several studies have demonstrated that elderly patients with mild to
moderate cognitive impairment can respond reliably to measures of pain
intensity (Chibnall & Tait, 2001; Ferrell, Ferrell, & Rivera, 1995;
Manz, Mosier, Nusser-Gerlach, Bergstrom, & Agrawal, 2000; Weiner,
Peterson, & Keefe, 1998).

Reliability can be increased by referencing the question in the here and
now and using the same instrument repeatedly over time as a cognitively
impaired individual's ability to use self-report scales can improve with
practice. The interviewer needs to focus the assessment question in
order to obtain the most accurate results for interpretation. It is
helpful to ask the patient "How much pain are you having right now?"
instead of "How much pain have you had over the last week or month". The
latter questions require additional integration of information and
demand more cognitive ability (Ferrell, 2000).

Techniques drawn from the assessment of children's pain might improve
reliability and validity of self-report (McGrath & Gillespie, 2001).
Clinicians should inquire about the patient's definition of pain to
determine to what extent the patient perceives pain as a sensory,
emotional, and behavioral event. This will help the clinician in
educating the patient about the use of the self-report tool and aid in
the interpretation of the individual's response. It also can be helpful
to *calibrate* the tool for use with a single patient by asking him or
her to describe painful events that have been experienced that
correspond to different pain intensities. Patients can be prompted with
common events that occur in a clinical setting such as needle sticks.

There are four main forms of pain intensity scales that have been
studied for use with the cognitively impaired elderly: *Verbal
Descriptor Scales, Numeric Rating Scales, Visual Analog Scales* and
*Facial Picture Scales*. Different patients show different abilities to
complete each of these forms, so if a patient is not able to complete
one type of scale, it is worthwhile to try an alternative form. Up to
83% of mild to moderately impaired elderly and 30% of severely impaired
elderly are able to complete at least one type of scale (Ferrell et al.,
1995; Manz et al., 2000).

*Verbal Descriptor Scales* ask the patient to choose a phrase to
describe pain intensity. The *Present Pain Intensity Scale* of the
McGill Pain Inventory is one standard example. Completion rates between
65% and 79% have been demonstrated in samples of cognitively impaired
adults (Herr & Garand, 2001; Krulewitch et al., 2000).

The *Numeric Rating Scale* asks patients to rate their pain on an
eleven-point range from no pain to worst possible pain. Many cognitively
impaired patients can respond to a verbal presentation of the scale,
while others may require a graphic presentation of the pain numerals.
Both vertical and horizontal presentations have been found to be
effective. Some patients prefer a vertical presentation in the form of a
pain thermometer. Between 47% and 58% of cognitively impaired adults
were able to complete this scale (Herr & Garand, 2001).

*Facial Picture Scales* consist of a series of progressively distressed
facial expressions. The patient is asked to pick the face that
corresponds to their current level of pain intensity. These tools were
designed for use with pediatric populations. Limited data is available
regarding their use in cognitively impaired adult populations. The
*Faces Pain Scale* and the *Wong-Baker Faces Scale* are examples of this
class of instrument. Unfortunately, these scales are likely to tap
affective components of pain as well as pain intensity which can
complicate interpretation. Completion rates for the *Faces Pain Scale*
in cases of mild to moderately impaired elders range from 50% to 76%.
Only 20% to 41% of severely impaired patients may be able to complete
the scale (Manz et al., 2000; Scherder, 2000; Krulewitch et al., 2000).

The *Visual Analog Scale* is a 10 cm horizontal or vertical line with
anchors at each end of "no pain" and "worst possible pain" (or some
analogous phrase). This tool is easy to complete, but is thought to
require more abstract thinking ability than other tools (Gagliese,
2001). Completion rates in cases of mild to moderately impaired elders
ranged from 52% to 76%. Only 41% of elders with severe impairment were
able to complete the scale (Krulewitch et al., 2000).

In cases of mild to moderate impairment, clinicians may choose to
utilize a verbal descriptor scale or numeric rating scale depending on
patient ability to complete the scale. In cases of severe impairment,
patients are likely to prefer a verbal descriptor scale. Observations of
pain behaviors along with self-report can help to strengthen confidence
in self-report ratings.

[Observation of pain behaviors]{.underline}. In cases where patients are
not able to provide a reliable self-report, pain behaviors can be
assessed to help determine the presence and intensity of pain (turk, et
al., 1985; fordyce 1976). These include cues such as changes in posture
and gait, nonverbal vocalizations, facial expressions and changes in
usual behaviors. However, many of these behaviors are not specific to
pain and can be easily misinterpreted in cases of cognitive impairment.
Behavioral observations also are subject to inadequate sensitivity.
Severe cognitive impairment can limit the patient's behavioral
repertoire even in the presence of pain (Oberlander, Grunau, Pitfield,
Whitfield, & Saul, 1999).

Family members can aid clinicians in identifying pain behaviors.
However, surrogate reporting of pain tends to be inaccurate. Family
members tend to overestimate pain intensity, while health care providers
tend to underestimate pain severity (Desbiens & Mueller-Rizner, 2000;
Weiner, Peterson, & Keefe, 1999; Bowman, 1994).

Observation of pain behaviors must occur in a structured manner to have
validity. Target behaviors need to be identified for each patient .The
assessment should take place when these behaviors are most likely to
occur. Staff members need to be trained to reliably identify the
behaviors (Keefe, Lumley, Anderson, Lynch, Studts, & Carson, 2001).
Observations of facial reactions have been shown to be good indicators
of pain in adults with cognitive impairment, but require extensive
training and equipment (Hadjistavropoulos, LaChapelle, MacLeod, Snider,
& Craig, 2000; Hadjistavropoulos & Clark, 2001).

Pain behavior checklists can be helpful in guiding assessment.
Assessment of pain behavior should include observation during rest and
during movement or usual daily activities (Hadjistavropoulos et al.,
2000; Weiner, Pieper, McConnell, Martinez, & Keefe, 1996). However,
there is a lack of checklists that have demonstrated adequate validity
and reliability in adults with cognitive impairment.

The *Checklist of Nonverbal Pain Indicators* is a six-item checklist
that has been developed to assess pain behaviors at rest and during
movement in cognitively impaired elderly. It also incorporates a verbal
descriptor scale. It has demonstrated reliability and validity in an
initial study with patients with hip fractures (Feldt, 2000; Feldt,
Ryden, & Miles, 1998). However, the instrument has not been validated in
other types of pain. In addition, the checklist's reliability has not
been tested in groups of differing degree of cognitive impairment.

[Assessment of Other Dimensions of Pain]{.underline}. Pain is a complex,
multidimensional experience that includes cognitive, emotional and
behavioral factors as well as pain presence and intensity. Assessment of
pain in persons with cognitive impairment should include attention to
mood and beliefs that affect the patient's pain experience and contexts
that affect the patient's pain behavior. Specific instruments for use of
assessment of these components of pain have not been studied in patients
with cognitive impairment. However, clinicians should consider including
standard instruments for use with patients who have mild to moderate
cognitive impairment.

[Summary and Recommendations]{.underline}**.** Research on assessment of
pain in cognitively impaired adults has focused on elderly adults with
dementias. The results of many studies suggest that most persons with
mild to moderate cognitive impairment can provide reliable report of
pain intensity using standard numeric-rating scales.

Verbal descriptors scales are easier to complete for some patients,
especially those with more severe impairment. Persons with cognitive
impairment seem to have the most difficulty with the Visual Analogue
Scale. One way to help facilitate better understanding of the pain
intensity scale rating with a patient is to establish the intensity
rating of a past, common pain event, such as stubbing a toe or having a
mild burn. The patient is then instructed to compare that pain intensity
from that event to the pain condition being assessed. This technique can
be used with numeric rating scales or verbal descriptors.

Observations of pain behaviors strengthen confidence in self-report
ratings. It is important to assess pain behaviors using a standardized
format and to assess pain both at rest and with movement. Surrogates
such as medical staff and family members can provide important adjunct
information about pain behaviors, but surrogates tend to underestimate
or overestimate pain intensity.

[]{#__RefHeading___Toc29952448 .anchor}**Using CPRS GUI and Vista
Software to Track Pain Outcomes**

[Document the Pain Score Vital Sign.]{.underline} In 1999, the
Vitals/Measurements package, Version 4.0, was enhanced to include a pain
score as the 5^th^ Vital Sign. All facilities that are using the VHA
Information Systems and Technology Architecture (VistA) and Computerized
Patient Record System Graphical User Interface (CPRS GUI) can enter pain
scores electronically when other vital signs are entered. This can be
done in the Vitals package, and from the CPRS GUI Cover Sheet, or
Encounter Form under the Notes tab. The pain score is supposed to be
recorded in every patient record at regular intervals to document
changes in pain intensity. Instructions for recording a pain score in
the computerized patient record can be found in the Pain as the 5^th^
Vital Sign Toolkit
(<http://vaww.va.gov/pain_management/508FrameTest2.htm>). Instructions
for Viewing and Entering Vitals in the Computerized Patient Record
System (CPRS) User Guide, GUI version. If you have questions about the
software or the instructions, please contact your local Information
Resources Management (IRM) service office or your local Clinical
Application Coordinator (CAC).

[Document Information Relating to Pain Management]{.underline}. Sites
can use Clinical Reminders and Reminder Dialogs to record data related
to pain management as progress note text, or encounter data, such as
vital signs and health factors.

As a decision support tool, Clinical Reminders:

-   Provide timely information about patients' health maintenance
    schedules

-   Assist in compliance with VHA performance measures

-   Assist in compliance with Health Promotion and Disease Prevention
    Guidelines

-   Assist in targeting patients with particular diagnoses and
    procedures or site-defined criteria

-   Provide pertinent information for clinical decision making

Reminder Dialogs can be created and linked to Clinical Reminders and
accessed from the CPRS GUI Notes during Progress Note editing. Reminder
Dialogs can be set up to:

-   Prompt for data entry of information to resolve/satisfy Clinical
    Reminders

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-   Provide reminder resolution by recording Health Factors and
    Education Topics

-   Add text to progress notes

-   Update patient encounter data and Vital Signs

-   Place orders

The Health Factors and Education Topics that are recorded to resolve the
reminders can later be used to report on pain management outcomes.

### 

### [Clinical Reminders for Pain Management Sponsored by the VA National Pain Management Coordinating Committee]{.underline}. As a continuation of VHA\'s commitment to pain management, the National Pain Management Strategy Coordinating Committee has sponsored the development of pain reminders and reminder dialogs that sites can use to document pain management in the patient\'s electronic record. These reminders may be used independently of one another, or as a group, depending on local preferences and installation methods and they were designed to be used with either inpatients or outpatients.

-   Pain History

-   Pain Management Education

-   Clinician Pain Plan of Care

-   Clinician Pain Reassessment

-   Nurse Pain Plan of Care

-   Nurse Pain Reassessment

Criteria for the development of these reminders were:

1)  The reminders should meet or exceed existing JCAHO and CARF
    requirements regarding pain assessment and treatment

2)  The reminders should be consistent with existing (e.g., Post
    Operative Pain) and forthcoming (e.g., Chronic Opioid Therapy)
    treatment guidelines

3)  The reminders should be of some use for local pain treatment
    outcomes monitoring

These reminders and reminder dialogs are posted to the Clinical
Reminders website under Examples and How-to's
(<http://vista.med.va.gov/reminders/Pain.htm>).

The packed reminders and dialogs can be downloaded by sites as local
reminders and adapted to the needs of the individual site. There are
also background and instructional documents for each reminder, as well
as tips for using the reminders and a pain history self-report form that
can be printed and given to patients to fill out prior to data entry.

Example: Pain History reminder dialog

![](media/image2.png){width="5.990972222222222in"
height="3.3722222222222222in"}

Example: Pain History reminder dialog expanded

![](media/image3.png){width="5.990972222222222in" height="4.19375in"}

A number of Health Factors are recorded as the reminders are processed
that resolve the reminders, and provide data for outcomes reports. This
is an example of some health factors created by processing these
reminders dialogs:

> Category
>
> Health Factor Date
>
> V-PAIN ACCEPTABLE
>
> V-PAIN ACCEPTABLE 0 11/13/2002
>
> V-PAIN EDUCATION BARRIERS
>
> V-PAIN Patient/Family Outcome 11/15/2002
>
> V-PAIN HISTORY
>
> V-PAIN HISTORY RECORDED 11/13/2002
>
> V-PAIN LEAST
>
> V-PAIN LEAST 4 11/13/2002
>
> V-PAIN NEW PAIN CATEGORY
>
> V-PAIN NEW PAIN 11/13/2002
>
> V-PAIN PLAN OF CARE
>
> V-PAIN CLINICIAN PLAN OF CARE 11/13/2002
>
> V-PAIN CLINICIAN REASSESSMENT 11/15/2002
>
> V-PAIN NURSE PLAN OF CARE 11/13/2002
>
> V-PAIN NURSE REASSESSMENT 11/15/2002
>
> V-PAIN PRIMARY PAIN LOCATION
>
> V-PAIN LOC ABDOMEN 11/13/2002
>
> V-PAIN USUAL
>
> V-PAIN USUAL 8 11/13/2002

[Creating Local Clinical Reminders and Reminder Dialogs to Record Data
on Pain Management.]{.underline} Sites can create their own local
Reminders to prompt users to enter the pain score or to document
information on pain management. Many sites have already created a pain
screening reminder to remind staff to record pain scores for every
patient. If the reminder was due, it would display on the CPRS GUI
Coversheet. Sites could set the reminder logic to make the reminder due:

-   If the patient did not have any pain score

-   Once a year if the current pain score was =\< 3

-   Once a month if the pain score was \> 3

Sites do not have to create pain reminders and dialogs from scratch.
Since the *Pain, the 5^th^ Vital Sign Toolkit* was released in the
winter of 1999, many sites have developed reminders and reminder dialogs
related to pain screening, pain assessment, and pain management. If you
find another site that has pain reminders and dialogs that work well for
them, they might be willing to share them directly via the Reminder
Exchange Utility. Or they may have posted them to the Clinical Reminders
Examples and How-to's web page. In any case, users should work closely
with their local Clinical Application Coordinator (CAC) to develop
Clinical Reminders and Reminder Dialogs that are appropriate for their
needs.

[Reporting Pain Management Outcomes]{.underline}. Users can retrieve
information about pain management outcomes from the electronic patient
record using the reporting functionality of Health Summary and Clinical
Reminder packages.

Ad Hoc Health Summary Reports

The Health Summary application provides ad hoc reporting functionality
that can be used to create a quick, one-time reminder report. Users can
select items from a list of Health Summary components to create an ad
hoc report that contains information about pain reminders, health
factors and education topics. These are some of the components that
provide pain management information:

-   CLINICAL REMINDERS BRIEF (CMB)

-   CLINICAL REMINDERS DUE (CR)

-   CLINICAL REMINDERS MAINTENANCE (CM)

-   CLINICAL REMINDERS SUMMARY (CRS)

-   PCE EDUCATION (ED)

-   PCE EDUCATION LATEST (EDL)

-   PCE HEALTH FACTORS ALL (HF)

-   PCE HEALTH FACTORS SELECTED (SHF)

Example setup for an ad hoc Health Summary Report

![](media/image4.png)

Example display of an ad hoc Health Summary Report

![](media/image5.png){width="6.496527777777778in"
height="3.6770833333333335in"}

Once the user has designed a report that provides useful information,
users should contact their local CAC. The CAC can create a Health
Summary report with the same parameters and add it to the list of Health
Summary reports that displays on the CPRS GUI reports tab and allows
access by multiple users at the site.

Example of Health Summary report output
![](media/image6.png){width="6.504166666666666in"
height="3.6465277777777776in"}

The CPRS GUI Reports tab will only produce Health Summary reports for
the current patient. The Health Summary options in the roll and scroll
version of Health Summary provides the means to produce reports for
several patients at one time:

-   [Patient Health Summary Option]{.underline} - displays or prints a
    health summary for one or more patients, or a group of patients by
    location, such as the operating room, ward, or clinic.

-   [Ad Hoc Health Summary Option]{.underline} - lets users select any
    or all health summary components and assign component
    characteristics for one or more patients.

-   [Range of Dates Patient Health Summary Option]{.underline} - lets
    users print health summaries of a specified, pre-defined health
    summary type for multiple patients. After patients are selected, the
    user can pick a date range. Data for summaries is based on the date
    range.

-   [Visit Patient Health Summary]{.underline} - lets users print health
    summaries of a specified, pre-defined health summary type for
    multiple patients.

-   [Hospital Location Health Summary]{.underline} - lets users print or
    display on your screen health summaries for all patients at specific
    or multiple hospital locations (ward, clinic, or operating room).

[Developing Health Summary Reports]{.underline}. For more information on
creating Health Summary Reports, users should consult the Health Summary
User Manual and Health Summary Technical Manual located in the VistA
Documentation Library (VDL) (<http://vista.med.va.gov/vdl/>).

Contact your local Clinical Application Coordinator for assistance in
creating Health Summary reports. You could also talk to other sites to
see what Health Summary reports they have found to be useful.

Additional assistance may be obtained by participating in the Clinical
Reminders conference call that is held the third Friday of each month.
This is a forum where sites can share information and ask questions
related to reminders and reminder dialogs. Refer to the Clinical
Reminders website for information about past and future presentations
(<http://vista.med.va.gov/reminders/confcalls.htm>).

[Clinical Reminder Reports]{.underline}. Clinical Reminder Reports can
be a powerful data extraction tool for measuring pain outcomes. They can
be created to report summary or detailed level information about pain
reminders that are due or reminders that have been satisfied. Reminder
Reports also can provide clinical coordinators with data extracted based
on reminder definitions.

Reminder Reports:

-   Provide a tool for tracking compliance with reminders

-   Can look at overall performance for a stop code or provider panel,
    or can drill down to a team of patients or to a single clinic

-   Can measure change over time

Reminder Reports can be set up for:

-   Individual patients, location, OE/RR team, PCMM provider or PCMM
    team

-   Inpatient, outpatient, selected hospital locations

-   All clinic stops, selected clinic stops, or selected clinic groups

-   Previous encounters or future appointments

-   Encounter beginning and ending date range

-   Effective due date

-   Detailed or summary report output

-   Reminder category or individual reminder

Reminder reports can be used to:

-   Identify outpatients in a panel who have reminders due

-   Aggregate reporting for a service line

-   Create patient specific reports for intervention

-   Identify inpatients with a reminder due

-   Identify patients who are scheduled for a clinic visit in the next
    month who need an intervention

-   Identify patients who have left the clinic in the past week who have
    missed an intervention

-   Track patient education

-   Track patients with certain characteristics or needs

Selection criteria can be saved in a report template so the report can
be run on a recurring basis.

Example of a Detailed Reminder Report - lists due patients for a single
reminder

Example of a Summary Reminder Report - totals applicable/due counts for
multiple reminders

Reminder reports can be printed as a formatted report or as delimited
output so the data can be exported to a spreadsheet program, such as
Microsoft EXCEL. These data then can be presented in a variety of
formats.

Example of a reminder report with delimiters (\^) that can be imported
into a spreadsheet:

Clinical Reminders used to trigger reminder reports do not have to be
the same as the reminders that are displayed. Separate reminders often
are needed for reporting versus cover sheet assignment

.

Refer to the following sites for further information about reminder
reports:

-   VistA Documentation Library (VDL) <http://vista.med.va.gov/vdl/>

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-   Clinical Reminders web page: <http://vista.med.va.gov/reminders/>

-   VistA University web page:
    <http://vaww.vistau.med.va.gov/vistau/default.htm>

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-   Reminder Reports Presentation: Reminder Reports for Provider
    Feedback and Performance Tracking:
    <http://vista.med.va.gov/reminders/confcalls.htm>

Contact your local CAC for assistance in creating reminder reports. You
could also talk to users at other sites to see what reminder reports
they have developed for pain management.

#  

## 

## **VHA External Peer Review Program (EPRP)**

The VHA Office of Quality and Performance's Performance Measurement
Program (PMP) establishes a set of performance monitors that are
consistent with the strategic goals of the VHA and designed to assure
quality, access, and satisfaction with care provided in VHA facilities.
As a step toward the establishment of the performance monitors, the PMP
calls for the development of performance indicators. Once the precise
definitions of the indicators and scientifically sound methods for data
collection and validation have been developed, these indicators have the
potential to be established as performance monitors with established
thresholds for benchmarking performance.

The External Peer Review Program (EPRP) supports the VHA Performance
Measurement Plan by conducting a systematic review of a representative
sample of medical records each quarter to monitor compliance with
standards, and reports progress toward established goals to VHA
leadership. At the current time, records are sampled from primary care
clinics and eight additional ambulatory settings (e.g., cardiology
clinic).

Consistent with the VHA National Pain Management Strategy, the PMP
included a pain-relevant monitor in their FY00 and FY01 reports. EPRP
reported quarterly on the proportion of records sampled that had a
documented pain score (i.e., 0-10 numeric rating of pain intensity) in
the immediately preceding 12 months. By the fourth quarter of FY01, 98%
of records sampled nationally had a documented pain score in the
preceding 12 months. Subsequently these performance monitors were
discontinued and a new set of pain-relevant monitors that are more
consistent with the current state of activities in the VHA system have
been developed.

Beginning in FY02, the PMP and EPRP instituted three new pain-relevant
performance indicators. Once the scientific validity of these indicators
are established via a period of monitoring, these indicators have the
potential to be designated as performance monitors upon which facility
and VISN performance will be evaluated. These pain indicators are:

-   Percent of patients with pain assessed on a scale of 0-10 on the
    most recent visit

-   Percent of patients with pain reported \> 3 with an intervention
    recorded

-   Percent of patients with a pain intervention recorded who had a
    follow-up assessment (pain management effectiveness evaluated).

It may be reasonable to consider using these EPRP indicators as targets
for performance improvement, as process measures, and/or as outcome
measures for evaluating the performance of organized system for
improving pain management.

[]{#__RefHeading___Toc29952450 .anchor}

**SECTION 6: WEB LINKS FOR OUTCOMES RESOURCES**

**Chart reviews**:

<http://www.cityofhope.org/prc/web/pdf/pain_audit_tools.pdf>

**International Association for the Study of Pain-Desirable
Characteristics For Pain Treatment Facilities**

<http://www.iasp-pain.org/desirabl.html>

**JCAHO standards**:

[http://www.jcaho.org](http://www.jcaho.org/)

<http://www.partnersagainstpain.com/html/inst/inst.htm>

**Pain Outcomes Instruments**

National Pain Data Bank-VA Revised version:
[www.vachronicpain.org](http://www.vachronicpain.org/)

Tampa Scale of Kinesiophobia-Revised:
[www.vachronicpain.org](http://www.vachronicpain.org/)

**Provider Education:**

<http://www.cityofhope.org/prc/web/html/rn_needs.htm>

<http://www.cityofhope.org/prc/web/html/brief_pain.htm>

<http://www.cityofhope.org/prc/web/html/rehab_professionals.htm>

[http://www.cityofhope.org/prc/web/pdf/Knowledge%20and%20Attitudes%20Survey.pdf](http://www.cityofhope.org/prc/web/pdf/Knowledge and Attitudes Survey.pdf)

<http://www.cityofhope.org/prc/web/pdf/controlling_pain.pdf>

[*http://mayuday.coh.org/Instruments/k&a.htm*](http://mayuday.coh.org/Instruments/k&a.htm)

**Rehabilitation Accreditation Commission- Pain Program
Standards/Outcomes**

**Assessment**

[www.carf.org](http://www.carf.org/)

**VHA CPRS Clinical Reminders and Reminder Reports**

-   VistA Documentation Library (VDL) <http://vista.med.va.gov/vdl/>

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-   Clinical Reminders web page: <http://vista.med.va.gov/reminders/>

-   VistA University web page:
    <http://vaww.vistau.med.va.gov/vistau/default.htm>

```{=html}
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```
-   Reminder Reports Presentation: Reminder Reports for Provider
    Feedback and Performance Tracking:
    <http://vista.med.va.gov/reminders/confcalls.htm>

**VHA Learning Catalog**)

http://vaww.sites.lrn.va.gov/VACatalog/

(Type in "Pain" in the left search box to locate pain resources)

**VHA National Customer Survey Information**

<http://vaww.oqp.med.va.gov/DEFAULT.asp>

**VHA Pain as the 5^th^ Vital Sign Toolkit**

<http://vaww.va.gov/pain_management/508FrameTest2.htm>

**VHA Pain Management Website**

<http://vaww.va.gov/pain_management/>

**VHA/DOD Post Operative Pain Guidelines**

<http://www.oqp.med.va.gov/cpg/pain/pain_base.htm>

[]{#__RefHeading___Toc29952451 .anchor}

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**APPENDIX I**

[]{#__RefHeading___Toc29952453 .anchor}**VHA Customer Satisfaction
Survey Questions Pertaining To Pain**

**[VHA 2002 Inpatient Customer Satisfaction Survey]{.underline}**

31\. When you had pain, was it usually severe, moderate, or mild?

Severe Moderate Mild Didn\'t have pain

32\. How many minutes after you asked for pain medicine did it usually
take before you got it?

0 to 5 minutes

6 to 10 minutes

11 to 15 minutes

16 to 30 minutes

More than 30 minutes

Never got pain medicine

Never asked for pain medicine

Didn\'t have pain

33\. Do you think that the hospital staff did everything they could to
help control your pain?

Yes, definitely Yes, somewhat No Didn\'t have pain

34\. Overall, how much pain medicine did you get?

Not enough Right amount Too much Didn\'t have pain

35\. Sometimes people who are in pain don\'t ask for pain medication.
Was this true for you?

Yes No Didn\'t have pain

36\. If you answered yes to the question above, was it because\...

You were concerned it might be habit forming

A patient should expect to put up with some pain

You felt it would be a bother if you asked for it

No one told you pain medication was available

You were concerned about possible side effects

You were concerned about what might happen if you mixed pain medications
with your other medication

Other

**[Questions from SF-12V on 2002 Inpatient and Outpatient
Surveys]{.underline}**

60\. During the past 4 weeks, how much did *pain* interfere with your
normal work (including both work outside the home and housework)?
(*Outpatient question 68)*

Not at all A little bit Moderately Quite a bit Extremely

68\. Have you been treated by a VA provider for chronic pain in the past
12 months? (*77)*

Yes No

69\. If you have been treated by a VA provider for chronic pain, please
rate the effectiveness of your pain treatment? (*Outpatient question
78*)

Poor Fair Good Very Good Excellent

The above questions address patient satisfaction with different domains
of their pain management experience. These domains include *staff
disposition to treat pain* (questions 32-34), *pain interference with
activities of daily living* (question 60), and *treatment effectiveness*
(questions 34, 69). The National VHA Customer Satisfaction Survey -
Survey of Healthcare Experiences of Patients is an instrument that can
be used for benchmarking purposes and comparisons across VA Medical
Centers.

[]{#__RefHeading___Toc29952454 .anchor}

**APPENDIX II**

[]{#__RefHeading___Toc29952455 .anchor}**Attributes of a Successful Pain
Management System**

(Cleeland, Schall, Nolan, Reyes-Gibby, Paice, Resenburg, Tollett, &
Kerns, 2000).

Selection of important measures for assessing process outcomes of a pain
management system may be informed by consideration of several key
attributes of a successful system of care. The following list of
attributes of a successful pain management system were developed by the
planning committee and core faculty for the VHA/Institute for Healthcare
Improvement Pain Management Collaborative Project chaired by Charles
Cleeland, Ph.D. Operationalization of these attributes and translation
or selection of specific measures or indicators of process and/or
outcome may be a reasonable approach to establishing the effectiveness
of a pain management system of care.

**Assessment is routine and timely**

-   Pain ratings are obtained and documented as "the 5th vital sign"
    during every clinical encounter, including telephone follow-ups and
    following drug administration

-   Pain screening and assessment is completed on admission and
    documented

-   Protocols for assessment consistent with good clinical practice are
    developed

**Access to appropriate level of treatment**

-   Pain management is provided by a multidisciplinary team with the
    primary care provider as the central link

-   An integrative treatment plan is informed by a comprehensive pain
    assessment

-   Specialty consults are available to the primary care provider

-   Referrals to specialized pain clinics are made when needed

**Treatment protocols in place and understood**

-   Protocols are available for the most common conditions and are used
    to establish care plans

-   Reminders for adherence to the care plan are built into the system

-   Standards for time between assessment of pain and action and for
    response time for medication requests are established

**Healthcare providers knowledgeable**

-   An educational plan is in place at the institutional level

-   Different strategies including one-on-one consultations, unit based
    programs, and grand rounds are considered

-   Providers have competencies to manage 80% of the conditions they see

**Patients and families are knowledgeable**

-   A plan for education is in place

-   Educational information about pain is supplied to all patients and
    caregivers

-   Educational information is provided prior to admission or surgery,
    and is part of discharge planning

-   The impact of the education is monitored and the need for additional
    interventions determined

**Pain management standards in place**

-   A facility-wide policy for pain is established that meets JCAHO
    standards

-   A standard nursing policy is established for pain management

-   Limits are set for acceptable variation for key parameters within
    the system

**Performance improvement plan in place**

-   System goals for key outcomes are agreed on

-   A schedule for review of progress is established

Necessary improvements to the system are identified and implemented

[]{#__RefHeading___Toc29952456 .anchor}**APPENDIX III**

[]{#Appen3 .anchor}

**Examples of a Medical Record Pain Audit Tool**

***Medical Record Review - Pain Management***

**James A. Haley Veterans Affairs Hospital, Tampa, Florida**

**Patient:** **Date: Diagnosis:** **Unit / Clinic:**

1.  **Pain assessed using 0 -- 10 scale at initial contact:** □ Yes □ No
    Pain Score: \_\_\_\_\_\_\_\_

2.  **Type of Pain:** □ Acute □ Cancer □ Chronic □ No Pain

3.  **Pain Assessment in Progress Notes**: □ Yes □ No □ NA

4.  **Assessment includes:** □ Quantity □ Location □ Quality □ Duration
    □ Patient's Goal

5.  **Pain recorded on Vital Sign Flowsheet/ GUI** □ Yes □ No □ NA Why:
    \_\_\_\_\_\_\_\_\_\_\_\_\_

6.  **Pain Scale Used** □ Yes □ No Highest Pain Score: \_\_\_\_\_\_

> Lowest Pain Score: \_\_\_\_\_\_

(Pain level reported most often in last 48 hours or 3 mo) Most frequent
level: \_\_\_\_\_\_

7.  **The plan of care addresses pain** Medical: □ Yes □ No □ NA
    Nursing: □ Yes □ No □ NA

8.  **The plan of care was altered if pain \> 3 or the patient's goal
    not met** □ Yes □ No □ NA

9.  **Pain education documented** □ Yes □ No □ NA

10. **Effectiveness of medication evaluated using 0 --10 scale** □ Yes □
    No □ NA

(was plan evaluated at next clinic visit?)

11. **Was pain management included in DC plan /instructions?** [□ Yes □
    No □ NA]{.smallcaps}

12. **Was pain education included in DC plan / instructions?** [□ Yes □
    No □ NA]{.smallcaps}

    []{#refheading___toc29952458 .anchor}**APPENDIX IV**

    []{#appendix4 .anchor}

    **Examples of Possible Patient Education Survey Items**

I received an explanation of how may pain would be relieved.

**Disagree Not Sure Agree**

I would have liked a better explanation.

**Disagree Not Sure Agree**

Please rate the adequacy of explanation of what was done for you.

**Excellent Very Good Good Fair Poor**

Please rate the adequacy of answers to your questions.

**Excellent Very Good Good Fair Poor**

When you had questions to ask did you always get answers you could
understand?

**Yes No Not Sure**

How much information was given to you during your hospital stay/visit?

**Not enough Right amount Too much I didn\'t need or want information**

Were you informed of the next step in your health care?

**Yes Yes, sometimes No**

Were you told of the medication side effects before going home?

**Yes No Not necessary, I knew the information Not necessary, no
medications**

Were you provided with enough information to know how to care for
yourself after discharge from the hospital?

**Yes No**

[]{#__RefHeading___Toc29952460 .anchor}**APPENDIX V**

[]{#__RefHeading___Toc29952461 .anchor}**Duke University Medical Center
Competency Questionnaire**

(Reproduced with the permission of Shashidhar Kori, M.D.)

\[Q1\] What is your specialty?

\(A\) Pediatrics

\(B\) OB/GYN

\(C\) Medicine

\(D\) Surgery

\(E\) Psych

\(F\) Family Medicine

\(G\) Other

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q2\] (Complete the blank). Studies indicate that more than

\_\_\_\_\_% of the cancer pain experienced by terminally ill

patients can be effectively controlled using currently

available oral therapies.

\(A\) Twenty

\(B\) Ninety

\(C\) Fifty

\(D\) Fifteen

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q3\] The addition of psychological intervention (e.g.,

relaxation training, imagery, activity pacing) to medical

management can result in a significant improvement in pain

relief.

\(T\) True

\(F\) False

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q4\] Patients often describe bone pain as:

\(A\) Shooting

\(B\) Deep and aching

\(C\) Spasms and cramping

\(D\) Colicky

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q5\] Which of the following classes of drugs can be effective

adjuvants to morphine when treating specific types of

pain?

\(A\) NSAIDS

\(B\) Antidepressants

\(C\) Anticonvulsants

\(D\) All of the above

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q6\] When titrating morphine, the dose should never be raised

by more that 25% over a 24-hour period.

\(T\) True

\(F\) False

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q7\] Which of the following are true about NSAIDS?

\(A\) NSAIDs are contraindicated in patients allergic

to aspirin.

\(B\) NSAIDs should be used with caution in patients

with renal dysfunction.

\(C\) NSAIDs can be useful analgesics in patients

with cancer pain.

\(D\) All of the above are true.

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q8\] To calculate the equivalent daily parenteral dose of 30 mg

of oral morphine, divide the oral dose of morphine by 3.

\(T\) True

\(F\) False

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q9\] The most appropriate oral regimen for a patient requiring

80 mg of intravenous morphine in the preceding 24 hours

is:

\(A\) Propoxyphene and acetaminophen (Darvocet)

\(B\) Tramadol (Ultram)

\(C\) Continuous release oxycodone plus oxycodone

immediate release for breakthrough pain

\(D\) Oral meperidine (Demoral)

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q10\] When pain related to nerve damage or dysesthesia occurs,

which of the following may be an effective adjuvant to

morphine:

\(A\) Amitriptyline (Elavil)

\(B\) Scopolamine

\(C\) Gabapentin (Neurontin)

\(D\) Both A and C above

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q11\] Due to concerns about addiction and tolerance, morphine or

other strong opioids should not be used in patients with

nonmalignant chronic pain.

\(T\) True

\(F\) False

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q12\] Completing a history and physical are the first steps of

an effective assessment of all types of pain.

\(T\) True

\(F\) False

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q13\] When beginning opioid therapy it is useful to do which of

the following:

\(A\) Initiate therapy for constipation

\(B\) Tell the patient that drowsiness and pruritis

may improve

\(C\) Encourage the patient to take the medication

only when in severe pain

\(D\) Both A and B above

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q14\] Appropriate agents for PCA (patient controlled analgesia)

include all of the following except:

\(A\) Morphine

\(B\) Meperidine

\(C\) Fentanyl

\(D\) Hydromorphone

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q15\] Most patients on opioid therapy require individually

titrated doses of potent bowel stimulants such as:

\(A\) Senna (Senokot)

\(B\) Bisacodyl (Dulcolax)

\(C\) Docusate (Colace)

\(D\) Either A or B above

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q16\] If a patient\'s pain is relieved by distraction, the pain

is most likely psychogenic in origin.

\(T\) True

\(F\) False

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q17\] When a patient can no longer swallow, all of the following

are appropriate alternative routes of opioid

administration except:

\(A\) Transmucosal

\(B\) Subcutaneous

\(C\) Intramuscular

\(D\) Rectal

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q18\] Health care providers accurately assess the pain of

patients.

\(T\) True

\(F\) False

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q19\] Children feel less pain than adults.

\(T\) True

\(F\) False

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q20\] Clinically significant respiratory depression is a common

problem when appropriately dosing opioids in the

management of moderate to severe pain.

\(T\) True

\(F\) False

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q21\] Relaxation, visualization, and distraction are examples of

techniques useful to treat which of the following types of

pain:

\(A\) Neuropathic

\(B\) Visceral

\(C\) Acute

\(D\) Malignant

\(E\) All of the above

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q22\] All of the following are true about meperidine (Demerol)

except:

\(A\) Meperidine is useful to treat rigors.

\(B\) Meperidine increases the risk of seizures.

\(C\) Meperidine is the drug of choice to treat

sickle cell pain crises and post op pain.

\(D\) Meperidine is more likely to cause chemical

dependency than morphine.

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q23\] The dosing of Percocet is limited by the following:

\(A\) The amount of opioid in the product

\(B\) The amount of acetaminophen in the product

\(C\) The amount of aspirin in the product

\(D\) The amount of ibuprofen in the product

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q24\] Long-acting opioids have the following advantages over

short-acting preparations:

\(A\) More consistent blood levels

\(B\) Less potential for abuse

\(C\) Convenience of dosing

\(D\) All of the above

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q25\] Patients with chronic pain syndromes can build up their

activity level most effectively if they try to do as much

as they can and let pain be their guide.

\(T\) True

\(F\) False

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Q26\] All of the following are true about codeine except:

\(A\) The active metabolite of codeine is morphine.

\(B\) Codeine in combination with acetaminophen is a

schedule III compound.

\(C\) 60 mg of codeine is a stronger analgesic than

600 mg of ibuprofen.

\(D\) Nausea and vomiting is common with codeine.

Please enter your response here \>\>

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

[]{#__RefHeading___Toc29952462 .anchor}**APPENDIX VI**

[]{#__RefHeading___Toc29952463 .anchor}**Members of the VA National Pain
Outcomes Workgroup**

+-----------------------------------+-----------------------------------+
| **Michael E. Clark, PhD, Chair**  | **Robert Kerns, PhD**             |
|                                   |                                   |
| Clinical Director, Pain Program   | Chief, Psychology Service (116B)  |
| (116B)                            |                                   |
|                                   | VA Connecticut Healthcare System  |
| James A. Haley Veterans Affairs   |                                   |
| Hospital                          | 950 Campbell Ave.                 |
|                                   |                                   |
| 13000 B. B. Downs Blvd.           | West Haven, CT 06516              |
|                                   |                                   |
| Tampa, FL 33612-4798              | 203.937.3841                      |
|                                   |                                   |
| 813.972.2000 x7484; 7112; 7114    | Fax: 203.937.4951                 |
|                                   |                                   |
| Fax: 813.978.5867                 | e-mail: <robert.kerns@med.va.gov> |
|                                   |                                   |
| e-mail:                           |                                   |
| <michael.clark2@med.va.gov>       |                                   |
|                                   |                                   |
| Website:                          |                                   |
| [www.vachronicpain.or             |                                   |
| g](http://www.vachronicpain.org/) |                                   |
+-----------------------------------+-----------------------------------+
| **Michael H. Craine, PhD**        | **Ruth Markham, EDS**             |
|                                   |                                   |
| Section Chief, Psychology (116B)  | 4179 Riverboat Rd.                |
|                                   |                                   |
| Denver VAMC                       | Suite 200                         |
|                                   |                                   |
| 1055 Clermont St.                 | Salt Lake City, UT 84123          |
|                                   |                                   |
| Denver, CO 80220                  | 801.904.4545                      |
|                                   |                                   |
| 303.399.8020, ext. 2577           | Fax: 801.904.4782                 |
|                                   |                                   |
| Fax: 303.393.5076                 | e-mail: <ruth.markham@med.va.gov> |
|                                   |                                   |
| <michael.craine@med.va.gov>       |                                   |
+-----------------------------------+-----------------------------------+
| **Julie A. Jones, RN, CNS**       | **Mitchell Nazario, Pharm. D.**   |
|                                   |                                   |
| Black Hills HCS                   | Pharmacy Service (119)            |
|                                   |                                   |
| VABHHS                            | San Juan VAMC                     |
|                                   |                                   |
| 500 North 5^th^ Street            | 10 Casia St.                      |
|                                   |                                   |
| Hot Springs, SD 57747             | San Juan, PR 00921-3201           |
|                                   |                                   |
| 605.745.2000, ext. 2469           | 787.641.7582, ext. 11476          |
|                                   |                                   |
| Fax: 601.745.2802                 | <mitchell.nazario@med.va.gov>     |
|                                   |                                   |
| <julie.jones2@med.va.gov>         |                                   |
+-----------------------------------+-----------------------------------+

[]{#__RefHeading___Toc29952464 .anchor}

[]{#refheading___toc29952464 .anchor}**APPENDIX VII**

[]{#__RefHeading___Toc29952465 .anchor}**Members of the VA National Pain
Coordinating Committee**

+------------------------+---------------------+-----------------------+
| John Booss, MD         | Martha Bryan, EdD   | Michael E. Clark, PhD |
|                        |                     |                       |
| Director,              | Assistant Director, | Clinical Director,    |
| Neurology---field      | Health Services     | Chronic Pain          |
| based                  | Research and        | Rehabilitation        |
|                        | Development Service | Program (116B)        |
| VAMC (200)             |                     |                       |
|                        | 1400 I Street,      | Bruce B. Downs Blvd.  |
| West Haven, CT 06516   | Suite 700           |                       |
|                        |                     | Tampa, Fl             |
| Phone: 203.932.5711;   | Washington, DC      |                       |
| ext. 3544              | 20420               | 813.972.2000 x 7484;  |
|                        |                     | 7112; 7114            |
| Fax: 203.937.4755      | Phone: 202.408.3665 |                       |
|                        |                     | fax: 813.903.4847     |
| e:<booss.              | e:                  |                       |
| john@westhaven.va.gov> | <martha.b           | e:                    |
|                        | ryan@hq.med.va.gov> | <micha                |
|                        |                     | el.clark2@med.va.gov> |
+------------------------+---------------------+-----------------------+
| Audrey Drake, RN, MSN, | Robert Kerns, PhD   | Ruth Markham, SLC OI  |
| CNAA                   |                     |                       |
|                        | Chief, Psychology   | 295 Chipeta Way       |
| Program Director,      | Service             |                       |
| Nursing (118)          |                     | Salt Lake City, UT    |
|                        | VA Connecticut HCS  | 84108                 |
| VACO                   |                     |                       |
|                        | West Haven, CT      | Phone : 801.588.5842  |
| 810 Vermont Ave. NW    | 06516               |                       |
|                        |                     | fax: 801.588.5004     |
| Washington, DC 20420   | Phone :             |                       |
|                        | 203.937.3841        | e:                    |
| Phone : 202.273.8424   |                     | <rut                  |
|                        | fax: (203) 937-4951 | h.markham@med.va.gov> |
| fax: 202.273.9066      |                     |                       |
|                        | e:                  |                       |
| e:                     | <rober              |                       |
| <audre                 | t.kerns@med.va.gov> |                       |
| y.drake@hq.med.va.gov> |                     |                       |
+------------------------+---------------------+-----------------------+
| Jack Rosenberg, MD     | Richard W.          | Paul Rousseau, MD     |
|                        | Rosenquist, MD      |                       |
| VISN 11                |                     | ACOS for GEC          |
|                        | Dir., Pain Medicine |                       |
| Coordinator for Pain   | Division            | VAMC; 650 E. Indian   |
| Mgmt.                  |                     | School Road           |
|                        | Dept. of Anesthesia |                       |
| 2215 Fuller Road       |                     | Phoenix, AZ 85012     |
|                        | University of Iowa  |                       |
| Ann Arbor, MI 48105    | Hospitals           | Phone : 602.277.5551  |
|                        |                     |                       |
| Phone : 734.936.5842   | Iowa City, Iowa     | fax: (602) 222-6514   |
|                        | 52242               |                       |
| fax: 734.769.7056      |                     | e:                    |
|                        | Phone :             | <ArizonaMD@aol.com>   |
| e:                     | 319.356.2320        |                       |
| <jackrose@umich.edu>   |                     |                       |
|                        | fax : 319.356.2940  |                       |
|                        |                     |                       |
|                        | e:                  |                       |
|                        | <richard-ro         |                       |
|                        | senquist@uiowa.edu> |                       |
+------------------------+---------------------+-----------------------+
| Charles D Sintek, MS,  | Anne Turner         | Jane H. Tollett, RN,  |
| RPh, BCPS              |                     | PhD                   |
|                        | Health Education    |                       |
| Clinical Pharmacy Mgr. | Officer             | National Pain         |
| (119B)                 |                     | Management            |
|                        | Employee Education  | Coordinator           |
| VAMC; 1055 Clermont    | System              |                       |
| ST.                    |                     | VHACO (114)           |
|                        | Suite 500 Medical   |                       |
| Denver, CO 80220       | Forum               | 810 Vermont Ave., NW  |
|                        |                     |                       |
| Phone: 303.393.2806    | 950 22^nd^ St.,     | Washington, DC 20420  |
|                        | North               |                       |
| Fax: 303.393.4624      |                     | Phone: 202.273.8537   |
|                        | Birmingham, Al      |                       |
| e:                     | 35203               | Fax: 202.273.9131     |
| <char                  |                     |                       |
| les.sintek@med.va.gov> | Phone 205-731-1812  | e:                    |
|                        | ex 310              | <jane.t               |
|                        |                     | ollett@hq.med.va.gov> |
|                        | Fax 205-731-1824    |                       |
|                        |                     |                       |
|                        | e :                 |                       |
|                        | <anne               |                       |
|                        | .turner@lrn.va.gov> |                       |
+------------------------+---------------------+-----------------------+