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OBJECTIVE:
To discuss the assessment and
monitoring of mucositis and pro-
vide an overview of instruments
available to assess or measure
mucositis.
DATA SOURCE:
Published journal articles, texts,
and clinical experience.
CONCLUSION:
The lack of consistent use of valid
and reliable instruments for the
assessment of mucositis have lim-
ited progress in the prevention
and management of mucositis.
IMPLICATIONS FOR NURSING
PRACTICE:
Nurses play a key role in the as-
sessment of oral cavity changes.
Using valid and reliable measures
will foster the ability to predict
risk for mucositis and to test the
effectiveness of protocols for its
prevention and treatment.
ASSESSMENT AND
MEASUREMENT OF
ORAL MUCOSITIS
JUNE EILERS AND JOEL B. EPSTEIN
ACCURATE oral assessment is critical for the pre-
vention and treatment of mucositis in patients
receiving antineoplastic therapy. A comprehen-
sive review of the literature indicates that treat-
ment for mucositis remains inadequate.1-3 Use of
valid and reliable instruments is necessary to measure speciļ¬c
changes in the oral cavity so that the effectiveness of interventions
can be clearly articulated. In addition, use of tools that are not
valid and reliable limits the ability to compare outcomes between
interventions and across trials.
There is a wide range in the reported rates of mucositis,4 related
in part to variability across diseases and therapies and to under-
reporting of mucositis as a secondary endpoint of cancer trials.
Poor study designs, small sample sizes, limited assessments of
compliance, and limited use of validated measures of mucositis
have also restricted the development of optimal models. The
purposes of this article are to discuss: (1) criteria for evaluating the
validity and reliability of instruments, (2) how to select an instru-
ment, including concerns with the adaptation of existing instru-
ments, and (3) the use of multiple instruments.
ASSESSMENT AND MEASUREMENT
Measurement is an essential component of scientiļ¬c research.5
There is a need for mucositis measurement scales in research
evaluating prophylactic and therapeutic agents in the clinical
setting and in clinical practice to improve performance and patient
outcomes. Effectiveness of interventions and standardized oral
care protocols for mucositis can be evaluated only with assessment
data collected in an organized, systematic manner using valid and
reliable instruments. The typical reports that the oral cavity looks
ā€œbetterā€ or ā€œworse,ā€ or has ā€œextensive mucositis,ā€ do not provide
the clinician with the information necessary to plan care.
Selection of the most appropriate instrument to assess mucositis
requires examination of the goals of the assessment. A critical fact
that should guide instrument selection is recognition that the best
From the Department of Oncology/He-
matology, The Nebraska Medical Center,
Omaha, NE; and the Department of Oral
Medicine and Diagnostic Sciences, College
of Dentistry, University of Illinois, Chi-
cago, IL.
June Eilers, PhD, APRN, BC: Oncology/
Hematology Clinical Nurse Specialist,
Clinical Nurse Researcher, The Nebraska
Medical Center, Omaha, NE. Joel Epstein,
DMD, MSD, FRCD: Professor and Head,
Department of Oral Medicine and Diag-
nostic Sciences, College of Dentistry, Di-
rector, Interdisciplinary Program in Oral
Cancer, Cancer Center, University of Illi-
nois, Chicago, IL.
Address reprint requests to June Eilers,
PhD, APRN, BC, 6604 S 86th St, Ralston,
NE 68127.
Ā© 2004 Elsevier Inc. All rights reserved.
0749-2081/04/2001-0005$30.00/0
doi:10.1053/S0749-2081(03)00136-0
22 Seminars in Oncology Nursing, Vol 20, No 1 (February), 2004: pp 22-29
instrument is the one that measures the right
things accurately. The selection process requires
awareness of how to evaluate instruments.
Instruments must be both valid and reliable if
they are to produce the data necessary to guide
practice and improve outcomes.6 Validity is re-
lated to whether an instrument or tool actually
measures what it purports to measure. A number
of terms are used to describe different types of
validity7 (see Table 1). Reliability refers to the
ability of an instrument to measure something in
a consistent and reproducible manner, reļ¬‚ecting
both random and systematic error in measure-
ment when an instrument is used (see Table 1).
The purpose of an instrument also determines
the necessary psychometric and other properties
and how those properties can be tested.8 Instru-
ments may be designed to measure cross-sectional
differences between subjects at a point in time.
These are identiļ¬ed as discriminative instruments
and can be used when no established external
criterion or gold standard is available. It is impor-
tant that these instruments are able to limit the
amount of error in measurement and capture
change when it is present yet not identify change
that is not present. For measurement of mucositis,
which involves change over time, this concept is
particularly important. A second purpose is pre-
dicting or attempting to classify subjects into sets
of predeļ¬ned measurement categories based on a
gold standard. A third purpose involves evaluating
or detecting the longitudinal change within sub-
jects individually or in a group; these are referred
to as evaluative instruments.
MUCOSITIS AS A SIDE EFFECT
Mucositis is an important toxicity of cancer
treatment, and it needs valid and reliable
measurement.9 The increased recognition among
health care providers of the importance of mucosi-
tis is evidenced by the multidisciplinary National
Institute of Health conferences in 1989 and
2000,10,11 recent plenary and educational sessions
at the meetings of the American Society of Clini-
cal Oncology, the Oncology Nursing Society, and
the Multinational Association of Supportive Care
Cancer/International Society for Oral Oncology;
and this issue of Seminars in Oncology Nursing.
The importance of mucositis among patients and
families is supported by patientsā€™ identiļ¬cation of
it as the most bothersome side effect of high-dose
therapy12 and radiation therapy for head and neck
cancers.13
Critical analysis of the existing literature on
mucositis supports the need for instruments to
accurately reļ¬‚ect the changes seen in the oral
cavity with mucositis, to articulate the potential of
antineoplastic agents to damage mucous mem-
branes so that risk of mucositis can be deter-
mined, and to test the effectiveness of interven-
tions to prevent and treat mucositis. It is
important to document the normal progression of
oral cavity changes seen as mucositis develops
and resolves. Knowledge regarding the usual
changes seen and the underlying pathobiology of
mucositis14,15 can help guide measurement. In
addition, Sonisā€™ evolving model14,15 provides a
framework for improved understanding of the pro-
cess of mucositis, and suggests that mucositis
measurement scores should indicate more exten-
sive involvement during the ulcerative phase than
during the initial or healing phases. Just as a
wound specialist determines interventions based
on the stage of the wound, nurses and others
should similarly base their oral care interventions
on the phases of this pathobiologic process.
Careful assessment of the oral cavity after anti-
neoplastic therapy can ascertain the degree and
duration of changes in the oral cavity and articu-
late the clinical changes seen during progression
and resolution of the lesions, including those that
might be due to clinical trauma from speaking or
eating. The mechanisms by which chemotherapy
leads to oral mucosal damage and the degree of
TABLE 1.
Criteria for Instrument Validity and Reliability
Evaluation of validity-the ability to measure what is
intended to be measured
Face validity-Includes relevant items (weakest form of
validity)
Content validity-Adequately covers topic
Criterion validity-Performance compared with
established instruments
Construct validity-Theoretical soundness of
instrument
Evaluation of reliability- the ability to measure in a
consistent and reproducible manner
Internal consistency-Correlations of multiple indicators
of concept within instrument
Testā€“retest reliability-Repeat performance with same
subject
Inter-rater reliability-Performance by equally trained
individuals
ASSESSMENT AND MEASUREMENT OF ORAL MUCOSITIS 23
damage are poorly understood.16 Surprisingly, it is
not known which antineoplastic drugs are se-
creted in saliva and whether the presence of drugs
in salivary excretion causes additional tissue dam-
age. Lists of chemotherapy agents with high po-
tential for mucous membrane damage are incon-
sistent. There is a lack of adequate information
regarding what constitutes the dose at which risk
of mucositis increases, and what combinations of
agents may decrease the threshold for mucositis.
Just as knowing the emetogenic potential of a
chemotherapy protocol guides interventions for
nausea and vomiting,17 knowledge regarding the
likelihood of mucositis with a given protocol facil-
itates assessment and targeted therapies. Grading
the severity of mucosal reactions across multiple
courses of treatment can measure the degree of
involvement with each course of therapy, thus
enhancing prediction of probable mucositis with
the next course, and decisions about prophylactic
protocols.
The mucositis caused by antineoplastic agents
may also be manifested throughout the gastroin-
testinal and genitourinary tract, causing esophagi-
tis, gastroenteritis, and cystitis. Because the
mouth is readily accessible and visible, and the
other sites are not, the oral cavity can serve an
index of other mucosal tissue damage in the body.
Indeed, it has been noted that ā€œthe mouth often
tells us even more than it says.ā€18 The systemic
nature of mucositis can necessitate reduction of
antineoplastic therapy doses and treatment de-
lays, potentially inļ¬‚uencing response to cancer
treatment.19-21 Thus, it is important to assess mu-
cositis over time.
Mucositis can alter normal oral functions, espe-
cially nutritional intake and speech. For each of
these changes, pain is the most common symptom
that patients report, thus oral cavity function is
highly dependent on the effectiveness of pain
management. For this reason, the ability to eat
(measured in some oral assessment instruments)
may be more of an indicator of unrelieved pain
than a measure of mucositis severity.
When salivary gland function is altered by cel-
lular damage from antineoplastic therapies, pa-
tients experience varying degrees of xerostomia or
dry mouth, accompanied by a high degree of dis-
tress. Permanent loss of salivary function is ex-
pected in radiation therapy when the treatment
ļ¬eld includes the salivary glands, but in the che-
motherapy setting xerostomia will typically im-
prove over time. Accurate data regarding what to
expect are not readily available because of the
lack of adequate assessment measures and incon-
sistent reporting.22,23 Thick saliva is another con-
cern of patients who have varying degrees of xe-
rostomia because it interferes with eating, may
aggravate nausea or stimulate vomiting in nause-
ated patients, and ultimately results in weight
loss. Some aspects of saliva that may be assessed
by nurses include clinical report of dryness or
thick saliva by patients, overall impression, volu-
metric measurement, and viscosity.
The fact that mucositis is not limited to the oral
cavity adds to the challenge for the clinician. Pa-
tients with mucositis in the throat and esophagus
experience increased pain and may require sys-
temic analgesia.24 The need to assess pain with
mucositis is not questioned. However, the integra-
tion of pain as a component of an oral assessment
measure that renders a composite score may not be
as optimal as measuring it separately, particularly
when multiple dimensions of pain are important to
assess.
In contrast to the patientā€™s expressed concerns
about pain or dry mouth, health care professionals
often focus more on tissue changes including ulcer-
ation and erythema. The ulcerations are especially
important in the immune-suppressed patient be-
cause of the risk of secondary systemic infection
caused by the loss of barrier function. Treatment of
infections in these patients can cause additional
challenges because the use of multiple antimicrobial
agents alters the normal microbial balance in the
oral cavity. This can result in an overgrowth of
organisms such as yeast that can complicate the
assessment of changes.
ORAL CAVITY ASSESSMENTS
Oral assessments can be conducted by a wide
variety of individuals, including research as-
sistants, dental personnel, nurses, aides, lay care-
givers, and patients. Oral assessment needs to be
preceded by thorough training, requires attention
to detail, and must be performed consistently.
Timing of assessments in terms of frequency
and sequence vis-a`-vis eating, oral care, pain, and
the pathobiological process is important. DeWalt
and Haines25 found that changes in the oral cavity
could be noted within 4 hours if stressors were
present and no interventions were initiated. The
performance of oral hygiene before an oral assess-
ment and the quality of that oral care may inļ¬‚u-
ence the ļ¬ndings because elapsed time from the
last cleansing and or rinsing could affect the pres-
24 EILERS AND EPSTEIN
ence of debris and the amount of moisture
present. In addition, selection and timing of inter-
ventions for pain will inļ¬‚uence reports of pain
intensity, which if included in the oral assess-
ment, will affect the results. Finally, the Sonis
model14,15 suggests an expected trajectory of tis-
sue damage, breakdown, and healing if the patient
does not experience additional complications. As-
sessments need to be completed at a frequency
that allows for the identiļ¬cation of measurable
changes in oral tissue during each phase of the
model. If assessment is too infrequent, it may not
identify important changes as mucositis develops
and resolves, but if it is too frequent, it may result
in excessive patient burden and data.
Appropriate lighting is critical to adequately view
all areas of the oral cavity. Halogen light sources are
the standard in research studies. Individuals per-
forming regular assessments in the clinical setting
can use an otoscope or ophthalmoscope as a light
source; at home, individuals may need to rely on
ļ¬‚ashlights. A tongue blade or dental mirror and
gauze provide assistance for visualization of the oral
cavity. The gauze can be wrapped around the tongue
to allow retraction from side to side. For some pa-
tients, not all areas may be easily visualized because
of mucosal pain or a sensitive gag reļ¬‚ex.
The goal of the assessment determines the ex-
tensiveness of the exam. Although it may not be
realistic to expect staff nurses to conduct an ex-
tensive assessment for every oncology patient,
regular assessments are essential in patients re-
ceiving antineoplastic treatments that cause mu-
cosal damage. Unfortunately, implementation of
this practice has been inconsistent, even within
bone marrow transplant centers.26 Establishment
of oral care standards that include consistent as-
sessment27,28 is an important means through
which nurses can facilitate assessment.
ASKING THE RIGHT QUESTIONS
A variety of oral cavity-related problems have
been identiļ¬ed as occurring in individuals re-
ceiving chemotherapy,6 including sore mouth, sore
gums, mouth ulcers, sore lips, dry lips, sore tongue,
dry mouth, and taste change. Similarly, individuals
receiving radiation therapy to the head and neck
region13 will experience a variety of oral problems
including dry mouth, mouth sores, taste changes,
pain, and sore throat. Although the cluster of symp-
toms may vary, in most instances the oral cavity
changes are not limited to one symptom.
The term mucositis commonly refers only to
erythema and ulceration, not to the other changes
seen in the oral cavity. Because consensus has not
been reached on the essential components for oral
assessment in patients treated for cancer, it is
important to consider the intent and use of termi-
nology. For example, discussions about ā€œmucosi-
tisā€ may refer only to lesions, whereas discussions
about ā€œoral cavity changesā€ should refer to xero-
stomia, ability to swallow, etc. Therefore, one
must determine which changes will be assessed,
how data will be used, and who will be completing
the assessment. In addition, it is important to
understand that mucositis can have an impact on
quality of life29,30 particularly the patientā€™s affec-
tive state.31 In studies for which the outcome(s)
involve the impact of changes in the oral cavity, it
may be relevant to differentiate the intensity of
the patientā€™s experience and the impact of that
experience on quality of life.
Mucositis as an acute side effect has received
considerable attention, but chronic effects in the
oral cavity have also begun to be addressed. Acute
complications include ulcerations, mucositis,
hemorrhage, dry mouth, candidiasis, taste
changes, and pain. Chronic complications include
dry mouth, mucosal sensitivity, soft-tissue and
osteonecrosis, and dysphagia. Distinction be-
tween effects helps to understand the nature and
impact of various changes such as ulceration
(acute effect) and xerostomia (chronic effect).
Measurement tool(s) chosen should reļ¬‚ect the
purpose of the data collection any time oral cavity
assessments are planned. Validity and reliability
are essential for both research and clinical instru-
ments. Depending on how the data will be used,
research instruments may require more detail
than clinical instruments and should be able to
show clinically signiļ¬cant differences if they ex-
ist.32 Instruments used by clinicians on a regular
basis in the clinical setting must be relevant for
the questions being asked, clear, concise, easy to
use, clinically feasible in the setting, and provide
relevant data for management.
Prevention and treatment trials for mucositis
have had varied endpoints (eg, tissue speciļ¬c in-
jury scales, symptom assessment, and/or func-
tional assessment). Outcomes may include alter-
ations in comfort level (eg, pain) or changes in
speech, swallowing, oral intake of food and medi-
cation, and salivary function. Measures of tissue
speciļ¬c change that include mucosal ulceration
(size and number of ulcerations present), the ar-
eas of the oral cavity involved, and tissue redness
ASSESSMENT AND MEASUREMENT OF ORAL MUCOSITIS 25
(erythema) are needed to assess mucositis. For
example, Stokman et al33 reported correlations
between degree of trypan blue staining and sever-
ity of oral mucositis, thus linking cell death (in-
ability to exclude trypan blue in vitro) with clini-
cal observations of degree of oral mucosal injury.
At the other end of the spectrum, overall oral
cavity assessment scales may be useful from a
clinical perspective to track general status and
document patient experience. Such general as-
sessment data may also be useful in the testing,
licensing, and marketing of oral care products.
Understanding of the desired outcome(s) of a spe-
ciļ¬c intervention will direct selection of the instru-
ment and extensiveness of the examination. If the
purpose is to test the effectiveness of prophylactic or
therapeutic interventions, assessment must focus
on the oral cavity changes that accompany cancer
treatment. For example, Janken et al23 conducted a
study to determine if nursing interventions im-
proved the amount of moisture in the oral cavity. If
the goal of an intervention is to improve plaque
control and/or removal of accumulated debris, these
variables should be included. If the identiļ¬cation of
possible infections is a concern, clinical criteria for
infection need to be stated, a thorough examination
performed, and appropriate cultures collected. If
decreased tissue damage is the anticipated outcome,
a speciļ¬c tissue damage scale should be used as a
primary endpoint. If a change in comfort level is
anticipated, a patient self-report pain scale should
be used. If any of the aforementioned changes are
not directly related to the intervention, they do not
need to be included in the instrument(s).
SELECTING AN INSTRUMENT
A measure of mucositis must be able to detect
change over time and to discriminate mucosi-
tis from other changes (eg, is any moisture that is
present an indication of recent oral hygiene or an
indicator of salivary gland function?). Just as se-
lection of the correct measurement instrument is
essential for research studies, selection of an as-
sessment tool for routine use is also important for
optimal care outcomes. The knowledge, skills, and
abilities required to perform oral assessment must
be considered when selecting an instrument.34 If
the instrument requires specialized training, sup-
port staff and lay individuals may not have the
skills necessary for reliable use of the instrument.
When the instrument includes functional activi-
ties such as speech, mastication, and swallowing,
a patient who is on a ventilator or otherwise
unable to respond will obviously limit completion
of the assessment. Self-report of subjective phe-
nomena such as discomfort or dryness requires
patient participation as well.
A primary clinical goal of oral assessment is to
assist in developing comprehensive oral care pro-
tocols to improve the patientā€™s functional status,
control pain, promote nutrition, identify the pres-
ence of infection, and assess progress of oral
changes.35 In addition to the aforementioned cri-
teria for selection of a tool, the potential user must
also consider practicality for the user and poten-
tial burden for patients. See Table 2 for questions
that can guide instrument selection.
Beck36 set the stage for the study and measure-
ment of oral cavity changes in patients receiving
chemotherapy with her Oral Exam Guide. Be-
cause of the increased incidence of mucositis in
patients receiving high-dose chemotherapy with
or without hematopoietic cell transplant, studies
of mucositis conducted in this population have
driven the development and testing of instru-
ments that focus predominantly on speciļ¬c oral
cavity changes and rate them on various scales.
Examples include the Oral Assessment Guide,37
the Oral Mucosa Rating Scale,38 and the 34-item
and 20-item Oral Mucositis Index39,40 (see Table
3). The majority of these instruments focus pri-
marily on aspects of mucosal tissue damage such
as erythema and ulceration, as well as less com-
mon changes such as edema and atrophy.
A second approach is the use of scales that
grade toxicity, which are generally used in the
conduct of cancer treatment clinical trials to de-
termine whether treatment should reduced or de-
layed. A Canadian group, the Western Consortium
for Cancer Nursing Research, convened a multi-
disciplinary panel of experts for the development
TABLE 2.
Instrument Selection: Asking the Right Questions
What information regarding the oral cavity is needed?
How will the data collected be used?
Does the instrument address the necessary areas of
concern?
Does the instrument have established validity and
reliability?
Is the instrument able to provide the speciļ¬city needed?
Who will be conducting the assessment?
What skill/training is needed to complete the
assessment?
26 EILERS AND EPSTEIN
TABLE 3.
Cancer-Focused Assessment Tools Yielding a Numerical Rating as a Score
Title Components Addressed Rating Approach Used Comments
Oral Exam
Guide
(OEG)36
Three components to exam guide
A. Visual inspection/observation by clinician: Lips
(texture, color, moisture), tongue (texture, color,
moisture), mucous membranes of palate, uvula &
tonsillar fossa (color, moisture), gingival (color,
moisture), teeth (shine, debris) dentures (ļ¬t), saliva,
voice, ability to swallow
B. Perception by patient: Lips, tongue, gingival,
saliva, teeth, dentures, taste, voice, eating
C. Physical condition: Level of consciousness,
breathing habits, diet, self-care ability.
Each aspect is rated on 1
to 4 scale: 1 Ļ­ normal/
no problem, with
increasing alterations/
problems to rating of 4
Provides for collection of extensive
data
Potential primarily as a research
tool, not seen as readily useable
by clinician
Varied criteria for rating categories
does not allow for ready use of
instrument unless clinician has
tool in sight.
Solicits subjective input from
patient regarding subjective
experience
Oral
Assessment
Guide
(OAG)37
Clinician assessment: Voice, swallow, lips, tongue,
saliva, mucous membranes, gingival, and
teeth/dentures
Each aspect is rated on a
1 to 3 scale: 1 Ļ­
normal, 2 Ļ­ altered but
not loss of function or
barrier breakdown, 3 Ļ­
loss of function or
barrier breakdown
Includes both oral cavity functions
and physical aspects. Clear,
concise, and clinically relevant to
direct care clinician. Ease of
rating scale allows for ready use
of instrument by clinician once
learn eight areas to assess. Used
in multiple clinical settings. Does
not include speciļ¬c measure of
size or extent of lesions
Does not differentiate the various
areas of the mucous membranes
Oral
Mucosa
Rating
Scale
(OMRS)38
Type and severity of clinically evident oral mucosal
changes: atrophy, erythema, ulceration, and
pseudomembranous, hyperkeratotic, lichenoid, and
edematous changes.
0 to 3 rating scale (normal
to severe)
Developed to classify and quantify
oral mucosal changes and
disease
Includes separate scales for pain and dryness Visual analogue scale. No
dryness/worst possible
dryness and no pain/
worst possible pain
Does not include functional
performance
Separates subjective complaints
from objective changes (lesions)
Oral
Mucositis
Index
(OMI)39,40
34-Item OMI-Clinician (usually dental professional)
assessment; 11 atrophy items (lips, labial mucosa,
buccal mucosa, ļ¬‚oor of mouth, soft palate & tongue);
11 ulcer/pseudomembrane items (lips, labial mucosa,
buccal mucosa, ļ¬‚oor of mouth, tongue) 10 erythema
items (lips, labial mucosa, buccal mucosa, ļ¬‚oor of
mouth, tongue)
Atrophy, ulceration,
erythema, edema.
Scored from 0 (none) to
3 (severe) and are
summed for a total
score
Uses a strong dental focus. Format
assumes clinical examiners have
sufļ¬cient experience to recognize
and score the types and grades
of changes the tool measure
20-Item OMI Clinician assessment: rates four types of
mucosal changes in nine anatomic areas: atrophy
(dorsal tongue), edema (lateral tongue), erythema
upper and lower labial mucosa, right & left buccal
mucosa, ļ¬‚oor of mouth, soft palate, and dorsal,
lateral, and ventral tongue; ulceration or
pseudomembrane (upper and lower labial mucosa,
right and left buccal mucosa, ļ¬‚oor of mouth, soft
palate, and dorsal, lateral and ventral tongue)
Same rating scale Modiļ¬ed to facilitate use by
nondental health professionals
(deleted items less likely to be
accurately and reliably assessed
by nondental health
professionals)
Exclusively objective measure of
oral tissue injury in mucositis.
Does not include functional or
subjective assessment (pain)
Provides for erythema and
ulceration subscores.
Oral
Mucositis
Assessment
Scale
(OMAS)
Two components: Clinician assessment-Objective
measures of mucositis: erythema and
ulceration/pseudomembrane in eight anatomic
locations of the oral cavity
Patient report-Two subjective outcomes-pain and
difļ¬culty swallowing and ability to eat
Erythema-0 (none) to 2
(severe) ulceration/
pseudomembrane
formation, 0 (no lesion)
to 3 (Ļ¾3 cm sq)
Patient report on 100 mm
visual analog scales: 0
(no problem) to 100
(worst problem)
Ability to eat-categorical
scale-types of food
Provides for quantiļ¬able statistical
measurement of functional,
objective, and subjective
parameters within one brief tool
that is clinically relevant and
presented in an easily used
format with a reproducible
scoring system. Focuses on
mucous membranes does not
include other oral cavity changes.
Works well for multi-site study that
includes nondental health
professionals as examiners.
Quantiļ¬cation of size of lesions
requires more training than
briefer clinical tools
ASSESSMENT AND MEASUREMENT OF ORAL MUCOSITIS 27
of a descriptive staging system to measure the
progressive severity of chemotherapy-induced
oral cavity changes.41 A similar staging approach
to mucositis is the basis for the common toxicity
criteria used by the World Health Organization42
and the National Cancer Institute.43 In addition to
speciļ¬c grading criteria for chemotherapy and
transplant, the National Cancer Institute has de-
veloped grading criteria for radiation therapy that
are used by the Radiation Therapy Oncology
Group.44 Although these grading scales have been
extremely useful in national and international tri-
als, they do have limitations in their ability to
examine a broader spectrum of objective, subjec-
tive, and functional outcomes.
Both of the approaches described above have
limitations in studies of prophylactic or therapeu-
tic agents, which require precise measurement of
oral cavity changes such as erythema and ulcer-
ation, as well as the effects of the agents on sub-
jective and functional outcomes such as pain and
ability to eat. Recognition of this measurement
gap stimulated the development and testing of the
Oral Mucositis Assessment Scale by a multidisci-
plinary group of content experts45 (see Table 3)
and another detailed research scale.46
It is important to recognize that modiļ¬cations
to an existing instrument potentially alter the
psychometric properties, thus if researchers or
clinicians modify an instrument, the speciļ¬c
changes should be articulated and the revised
instrument tested for validity and reliability. This
process has been demonstrated by McGuire et
al,40 who reduced the somewhat complex 34-item
Oral Mucositis Index to the 20-item Oral Mucositis
Index, an instrument more easily completed by
non-dental health professionals such as nurses.
Thorough assessment may require use of more
than one measure or modiļ¬cation of an existing
measure. Both of these decisions require addi-
tional planning. When an intervention is targeted
to decrease pain, it is important to include a valid
and reliable measure of pain. This pain assess-
ment can be accomplished using a numerical as-
sessment such as a 0 to 10 visual analogue or
numerical rating scale; asking questions speciļ¬c
to pain with swallowing, worst pain, and least
pain; a comprehensive multidimensional pain in-
strument, or the pain item on the Oral Mucositis
Assessment Scale.45 If an intervention is targeted
to prevent xerostomia or increase moisture of the
mucous membranes, it may be necessary to add a
more speciļ¬c measure of salivary function.23,47
Deciding what to do with the presence of infec-
tion in the oral cavity is complex. Some could
argue that infection (ie, thrush or candida) should
be included as part of an instrument. This ap-
proach is problematic because the thrush inter-
feres with visualization of the extent of ulcerative
lesions and can actually be present independent of
ulcerative mucositis lesions. Similarly, herpes vi-
ral infections in aplastic patients can cause ulcer-
ation, visual changes in the mucosal tissue, and
severe pain. Because institutions can also vary in
their prophylaxis, diagnosis, and treatment of oral
infections, nurses may need to rely on dental
associates to assist with diagnosis of infections.
CONCLUSION
Accurate assessment of the oral cavity changes
that accompany cancer treatment is essential
for optimal patient outcomes. Regular use of ac-
curate assessment measures and participation in
clinical research studies will enable nurses to ad-
dress unanswered questions about mucositis. Be-
cause the mouth provides a window to other mu-
cous membranes in the body,18 this assessment
can also provide for increased attention to gastro-
intestinal tract and other changes secondary to
therapies that affect mucous membranes. Having
the knowledge, skills, and abilities to rigorously
assess or measure mucositis will position oncology
nurses to make a difference for patients.
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ASSESSMENT AND MEASUREMENT OF ORAL MUCOSITIS 29

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Articulo mucositis 1

  • 1. OBJECTIVE: To discuss the assessment and monitoring of mucositis and pro- vide an overview of instruments available to assess or measure mucositis. DATA SOURCE: Published journal articles, texts, and clinical experience. CONCLUSION: The lack of consistent use of valid and reliable instruments for the assessment of mucositis have lim- ited progress in the prevention and management of mucositis. IMPLICATIONS FOR NURSING PRACTICE: Nurses play a key role in the as- sessment of oral cavity changes. Using valid and reliable measures will foster the ability to predict risk for mucositis and to test the effectiveness of protocols for its prevention and treatment. ASSESSMENT AND MEASUREMENT OF ORAL MUCOSITIS JUNE EILERS AND JOEL B. EPSTEIN ACCURATE oral assessment is critical for the pre- vention and treatment of mucositis in patients receiving antineoplastic therapy. A comprehen- sive review of the literature indicates that treat- ment for mucositis remains inadequate.1-3 Use of valid and reliable instruments is necessary to measure speciļ¬c changes in the oral cavity so that the effectiveness of interventions can be clearly articulated. In addition, use of tools that are not valid and reliable limits the ability to compare outcomes between interventions and across trials. There is a wide range in the reported rates of mucositis,4 related in part to variability across diseases and therapies and to under- reporting of mucositis as a secondary endpoint of cancer trials. Poor study designs, small sample sizes, limited assessments of compliance, and limited use of validated measures of mucositis have also restricted the development of optimal models. The purposes of this article are to discuss: (1) criteria for evaluating the validity and reliability of instruments, (2) how to select an instru- ment, including concerns with the adaptation of existing instru- ments, and (3) the use of multiple instruments. ASSESSMENT AND MEASUREMENT Measurement is an essential component of scientiļ¬c research.5 There is a need for mucositis measurement scales in research evaluating prophylactic and therapeutic agents in the clinical setting and in clinical practice to improve performance and patient outcomes. Effectiveness of interventions and standardized oral care protocols for mucositis can be evaluated only with assessment data collected in an organized, systematic manner using valid and reliable instruments. The typical reports that the oral cavity looks ā€œbetterā€ or ā€œworse,ā€ or has ā€œextensive mucositis,ā€ do not provide the clinician with the information necessary to plan care. Selection of the most appropriate instrument to assess mucositis requires examination of the goals of the assessment. A critical fact that should guide instrument selection is recognition that the best From the Department of Oncology/He- matology, The Nebraska Medical Center, Omaha, NE; and the Department of Oral Medicine and Diagnostic Sciences, College of Dentistry, University of Illinois, Chi- cago, IL. June Eilers, PhD, APRN, BC: Oncology/ Hematology Clinical Nurse Specialist, Clinical Nurse Researcher, The Nebraska Medical Center, Omaha, NE. Joel Epstein, DMD, MSD, FRCD: Professor and Head, Department of Oral Medicine and Diag- nostic Sciences, College of Dentistry, Di- rector, Interdisciplinary Program in Oral Cancer, Cancer Center, University of Illi- nois, Chicago, IL. Address reprint requests to June Eilers, PhD, APRN, BC, 6604 S 86th St, Ralston, NE 68127. Ā© 2004 Elsevier Inc. All rights reserved. 0749-2081/04/2001-0005$30.00/0 doi:10.1053/S0749-2081(03)00136-0 22 Seminars in Oncology Nursing, Vol 20, No 1 (February), 2004: pp 22-29
  • 2. instrument is the one that measures the right things accurately. The selection process requires awareness of how to evaluate instruments. Instruments must be both valid and reliable if they are to produce the data necessary to guide practice and improve outcomes.6 Validity is re- lated to whether an instrument or tool actually measures what it purports to measure. A number of terms are used to describe different types of validity7 (see Table 1). Reliability refers to the ability of an instrument to measure something in a consistent and reproducible manner, reļ¬‚ecting both random and systematic error in measure- ment when an instrument is used (see Table 1). The purpose of an instrument also determines the necessary psychometric and other properties and how those properties can be tested.8 Instru- ments may be designed to measure cross-sectional differences between subjects at a point in time. These are identiļ¬ed as discriminative instruments and can be used when no established external criterion or gold standard is available. It is impor- tant that these instruments are able to limit the amount of error in measurement and capture change when it is present yet not identify change that is not present. For measurement of mucositis, which involves change over time, this concept is particularly important. A second purpose is pre- dicting or attempting to classify subjects into sets of predeļ¬ned measurement categories based on a gold standard. A third purpose involves evaluating or detecting the longitudinal change within sub- jects individually or in a group; these are referred to as evaluative instruments. MUCOSITIS AS A SIDE EFFECT Mucositis is an important toxicity of cancer treatment, and it needs valid and reliable measurement.9 The increased recognition among health care providers of the importance of mucosi- tis is evidenced by the multidisciplinary National Institute of Health conferences in 1989 and 2000,10,11 recent plenary and educational sessions at the meetings of the American Society of Clini- cal Oncology, the Oncology Nursing Society, and the Multinational Association of Supportive Care Cancer/International Society for Oral Oncology; and this issue of Seminars in Oncology Nursing. The importance of mucositis among patients and families is supported by patientsā€™ identiļ¬cation of it as the most bothersome side effect of high-dose therapy12 and radiation therapy for head and neck cancers.13 Critical analysis of the existing literature on mucositis supports the need for instruments to accurately reļ¬‚ect the changes seen in the oral cavity with mucositis, to articulate the potential of antineoplastic agents to damage mucous mem- branes so that risk of mucositis can be deter- mined, and to test the effectiveness of interven- tions to prevent and treat mucositis. It is important to document the normal progression of oral cavity changes seen as mucositis develops and resolves. Knowledge regarding the usual changes seen and the underlying pathobiology of mucositis14,15 can help guide measurement. In addition, Sonisā€™ evolving model14,15 provides a framework for improved understanding of the pro- cess of mucositis, and suggests that mucositis measurement scores should indicate more exten- sive involvement during the ulcerative phase than during the initial or healing phases. Just as a wound specialist determines interventions based on the stage of the wound, nurses and others should similarly base their oral care interventions on the phases of this pathobiologic process. Careful assessment of the oral cavity after anti- neoplastic therapy can ascertain the degree and duration of changes in the oral cavity and articu- late the clinical changes seen during progression and resolution of the lesions, including those that might be due to clinical trauma from speaking or eating. The mechanisms by which chemotherapy leads to oral mucosal damage and the degree of TABLE 1. Criteria for Instrument Validity and Reliability Evaluation of validity-the ability to measure what is intended to be measured Face validity-Includes relevant items (weakest form of validity) Content validity-Adequately covers topic Criterion validity-Performance compared with established instruments Construct validity-Theoretical soundness of instrument Evaluation of reliability- the ability to measure in a consistent and reproducible manner Internal consistency-Correlations of multiple indicators of concept within instrument Testā€“retest reliability-Repeat performance with same subject Inter-rater reliability-Performance by equally trained individuals ASSESSMENT AND MEASUREMENT OF ORAL MUCOSITIS 23
  • 3. damage are poorly understood.16 Surprisingly, it is not known which antineoplastic drugs are se- creted in saliva and whether the presence of drugs in salivary excretion causes additional tissue dam- age. Lists of chemotherapy agents with high po- tential for mucous membrane damage are incon- sistent. There is a lack of adequate information regarding what constitutes the dose at which risk of mucositis increases, and what combinations of agents may decrease the threshold for mucositis. Just as knowing the emetogenic potential of a chemotherapy protocol guides interventions for nausea and vomiting,17 knowledge regarding the likelihood of mucositis with a given protocol facil- itates assessment and targeted therapies. Grading the severity of mucosal reactions across multiple courses of treatment can measure the degree of involvement with each course of therapy, thus enhancing prediction of probable mucositis with the next course, and decisions about prophylactic protocols. The mucositis caused by antineoplastic agents may also be manifested throughout the gastroin- testinal and genitourinary tract, causing esophagi- tis, gastroenteritis, and cystitis. Because the mouth is readily accessible and visible, and the other sites are not, the oral cavity can serve an index of other mucosal tissue damage in the body. Indeed, it has been noted that ā€œthe mouth often tells us even more than it says.ā€18 The systemic nature of mucositis can necessitate reduction of antineoplastic therapy doses and treatment de- lays, potentially inļ¬‚uencing response to cancer treatment.19-21 Thus, it is important to assess mu- cositis over time. Mucositis can alter normal oral functions, espe- cially nutritional intake and speech. For each of these changes, pain is the most common symptom that patients report, thus oral cavity function is highly dependent on the effectiveness of pain management. For this reason, the ability to eat (measured in some oral assessment instruments) may be more of an indicator of unrelieved pain than a measure of mucositis severity. When salivary gland function is altered by cel- lular damage from antineoplastic therapies, pa- tients experience varying degrees of xerostomia or dry mouth, accompanied by a high degree of dis- tress. Permanent loss of salivary function is ex- pected in radiation therapy when the treatment ļ¬eld includes the salivary glands, but in the che- motherapy setting xerostomia will typically im- prove over time. Accurate data regarding what to expect are not readily available because of the lack of adequate assessment measures and incon- sistent reporting.22,23 Thick saliva is another con- cern of patients who have varying degrees of xe- rostomia because it interferes with eating, may aggravate nausea or stimulate vomiting in nause- ated patients, and ultimately results in weight loss. Some aspects of saliva that may be assessed by nurses include clinical report of dryness or thick saliva by patients, overall impression, volu- metric measurement, and viscosity. The fact that mucositis is not limited to the oral cavity adds to the challenge for the clinician. Pa- tients with mucositis in the throat and esophagus experience increased pain and may require sys- temic analgesia.24 The need to assess pain with mucositis is not questioned. However, the integra- tion of pain as a component of an oral assessment measure that renders a composite score may not be as optimal as measuring it separately, particularly when multiple dimensions of pain are important to assess. In contrast to the patientā€™s expressed concerns about pain or dry mouth, health care professionals often focus more on tissue changes including ulcer- ation and erythema. The ulcerations are especially important in the immune-suppressed patient be- cause of the risk of secondary systemic infection caused by the loss of barrier function. Treatment of infections in these patients can cause additional challenges because the use of multiple antimicrobial agents alters the normal microbial balance in the oral cavity. This can result in an overgrowth of organisms such as yeast that can complicate the assessment of changes. ORAL CAVITY ASSESSMENTS Oral assessments can be conducted by a wide variety of individuals, including research as- sistants, dental personnel, nurses, aides, lay care- givers, and patients. Oral assessment needs to be preceded by thorough training, requires attention to detail, and must be performed consistently. Timing of assessments in terms of frequency and sequence vis-a`-vis eating, oral care, pain, and the pathobiological process is important. DeWalt and Haines25 found that changes in the oral cavity could be noted within 4 hours if stressors were present and no interventions were initiated. The performance of oral hygiene before an oral assess- ment and the quality of that oral care may inļ¬‚u- ence the ļ¬ndings because elapsed time from the last cleansing and or rinsing could affect the pres- 24 EILERS AND EPSTEIN
  • 4. ence of debris and the amount of moisture present. In addition, selection and timing of inter- ventions for pain will inļ¬‚uence reports of pain intensity, which if included in the oral assess- ment, will affect the results. Finally, the Sonis model14,15 suggests an expected trajectory of tis- sue damage, breakdown, and healing if the patient does not experience additional complications. As- sessments need to be completed at a frequency that allows for the identiļ¬cation of measurable changes in oral tissue during each phase of the model. If assessment is too infrequent, it may not identify important changes as mucositis develops and resolves, but if it is too frequent, it may result in excessive patient burden and data. Appropriate lighting is critical to adequately view all areas of the oral cavity. Halogen light sources are the standard in research studies. Individuals per- forming regular assessments in the clinical setting can use an otoscope or ophthalmoscope as a light source; at home, individuals may need to rely on ļ¬‚ashlights. A tongue blade or dental mirror and gauze provide assistance for visualization of the oral cavity. The gauze can be wrapped around the tongue to allow retraction from side to side. For some pa- tients, not all areas may be easily visualized because of mucosal pain or a sensitive gag reļ¬‚ex. The goal of the assessment determines the ex- tensiveness of the exam. Although it may not be realistic to expect staff nurses to conduct an ex- tensive assessment for every oncology patient, regular assessments are essential in patients re- ceiving antineoplastic treatments that cause mu- cosal damage. Unfortunately, implementation of this practice has been inconsistent, even within bone marrow transplant centers.26 Establishment of oral care standards that include consistent as- sessment27,28 is an important means through which nurses can facilitate assessment. ASKING THE RIGHT QUESTIONS A variety of oral cavity-related problems have been identiļ¬ed as occurring in individuals re- ceiving chemotherapy,6 including sore mouth, sore gums, mouth ulcers, sore lips, dry lips, sore tongue, dry mouth, and taste change. Similarly, individuals receiving radiation therapy to the head and neck region13 will experience a variety of oral problems including dry mouth, mouth sores, taste changes, pain, and sore throat. Although the cluster of symp- toms may vary, in most instances the oral cavity changes are not limited to one symptom. The term mucositis commonly refers only to erythema and ulceration, not to the other changes seen in the oral cavity. Because consensus has not been reached on the essential components for oral assessment in patients treated for cancer, it is important to consider the intent and use of termi- nology. For example, discussions about ā€œmucosi- tisā€ may refer only to lesions, whereas discussions about ā€œoral cavity changesā€ should refer to xero- stomia, ability to swallow, etc. Therefore, one must determine which changes will be assessed, how data will be used, and who will be completing the assessment. In addition, it is important to understand that mucositis can have an impact on quality of life29,30 particularly the patientā€™s affec- tive state.31 In studies for which the outcome(s) involve the impact of changes in the oral cavity, it may be relevant to differentiate the intensity of the patientā€™s experience and the impact of that experience on quality of life. Mucositis as an acute side effect has received considerable attention, but chronic effects in the oral cavity have also begun to be addressed. Acute complications include ulcerations, mucositis, hemorrhage, dry mouth, candidiasis, taste changes, and pain. Chronic complications include dry mouth, mucosal sensitivity, soft-tissue and osteonecrosis, and dysphagia. Distinction be- tween effects helps to understand the nature and impact of various changes such as ulceration (acute effect) and xerostomia (chronic effect). Measurement tool(s) chosen should reļ¬‚ect the purpose of the data collection any time oral cavity assessments are planned. Validity and reliability are essential for both research and clinical instru- ments. Depending on how the data will be used, research instruments may require more detail than clinical instruments and should be able to show clinically signiļ¬cant differences if they ex- ist.32 Instruments used by clinicians on a regular basis in the clinical setting must be relevant for the questions being asked, clear, concise, easy to use, clinically feasible in the setting, and provide relevant data for management. Prevention and treatment trials for mucositis have had varied endpoints (eg, tissue speciļ¬c in- jury scales, symptom assessment, and/or func- tional assessment). Outcomes may include alter- ations in comfort level (eg, pain) or changes in speech, swallowing, oral intake of food and medi- cation, and salivary function. Measures of tissue speciļ¬c change that include mucosal ulceration (size and number of ulcerations present), the ar- eas of the oral cavity involved, and tissue redness ASSESSMENT AND MEASUREMENT OF ORAL MUCOSITIS 25
  • 5. (erythema) are needed to assess mucositis. For example, Stokman et al33 reported correlations between degree of trypan blue staining and sever- ity of oral mucositis, thus linking cell death (in- ability to exclude trypan blue in vitro) with clini- cal observations of degree of oral mucosal injury. At the other end of the spectrum, overall oral cavity assessment scales may be useful from a clinical perspective to track general status and document patient experience. Such general as- sessment data may also be useful in the testing, licensing, and marketing of oral care products. Understanding of the desired outcome(s) of a spe- ciļ¬c intervention will direct selection of the instru- ment and extensiveness of the examination. If the purpose is to test the effectiveness of prophylactic or therapeutic interventions, assessment must focus on the oral cavity changes that accompany cancer treatment. For example, Janken et al23 conducted a study to determine if nursing interventions im- proved the amount of moisture in the oral cavity. If the goal of an intervention is to improve plaque control and/or removal of accumulated debris, these variables should be included. If the identiļ¬cation of possible infections is a concern, clinical criteria for infection need to be stated, a thorough examination performed, and appropriate cultures collected. If decreased tissue damage is the anticipated outcome, a speciļ¬c tissue damage scale should be used as a primary endpoint. If a change in comfort level is anticipated, a patient self-report pain scale should be used. If any of the aforementioned changes are not directly related to the intervention, they do not need to be included in the instrument(s). SELECTING AN INSTRUMENT A measure of mucositis must be able to detect change over time and to discriminate mucosi- tis from other changes (eg, is any moisture that is present an indication of recent oral hygiene or an indicator of salivary gland function?). Just as se- lection of the correct measurement instrument is essential for research studies, selection of an as- sessment tool for routine use is also important for optimal care outcomes. The knowledge, skills, and abilities required to perform oral assessment must be considered when selecting an instrument.34 If the instrument requires specialized training, sup- port staff and lay individuals may not have the skills necessary for reliable use of the instrument. When the instrument includes functional activi- ties such as speech, mastication, and swallowing, a patient who is on a ventilator or otherwise unable to respond will obviously limit completion of the assessment. Self-report of subjective phe- nomena such as discomfort or dryness requires patient participation as well. A primary clinical goal of oral assessment is to assist in developing comprehensive oral care pro- tocols to improve the patientā€™s functional status, control pain, promote nutrition, identify the pres- ence of infection, and assess progress of oral changes.35 In addition to the aforementioned cri- teria for selection of a tool, the potential user must also consider practicality for the user and poten- tial burden for patients. See Table 2 for questions that can guide instrument selection. Beck36 set the stage for the study and measure- ment of oral cavity changes in patients receiving chemotherapy with her Oral Exam Guide. Be- cause of the increased incidence of mucositis in patients receiving high-dose chemotherapy with or without hematopoietic cell transplant, studies of mucositis conducted in this population have driven the development and testing of instru- ments that focus predominantly on speciļ¬c oral cavity changes and rate them on various scales. Examples include the Oral Assessment Guide,37 the Oral Mucosa Rating Scale,38 and the 34-item and 20-item Oral Mucositis Index39,40 (see Table 3). The majority of these instruments focus pri- marily on aspects of mucosal tissue damage such as erythema and ulceration, as well as less com- mon changes such as edema and atrophy. A second approach is the use of scales that grade toxicity, which are generally used in the conduct of cancer treatment clinical trials to de- termine whether treatment should reduced or de- layed. A Canadian group, the Western Consortium for Cancer Nursing Research, convened a multi- disciplinary panel of experts for the development TABLE 2. Instrument Selection: Asking the Right Questions What information regarding the oral cavity is needed? How will the data collected be used? Does the instrument address the necessary areas of concern? Does the instrument have established validity and reliability? Is the instrument able to provide the speciļ¬city needed? Who will be conducting the assessment? What skill/training is needed to complete the assessment? 26 EILERS AND EPSTEIN
  • 6. TABLE 3. Cancer-Focused Assessment Tools Yielding a Numerical Rating as a Score Title Components Addressed Rating Approach Used Comments Oral Exam Guide (OEG)36 Three components to exam guide A. Visual inspection/observation by clinician: Lips (texture, color, moisture), tongue (texture, color, moisture), mucous membranes of palate, uvula & tonsillar fossa (color, moisture), gingival (color, moisture), teeth (shine, debris) dentures (ļ¬t), saliva, voice, ability to swallow B. Perception by patient: Lips, tongue, gingival, saliva, teeth, dentures, taste, voice, eating C. Physical condition: Level of consciousness, breathing habits, diet, self-care ability. Each aspect is rated on 1 to 4 scale: 1 Ļ­ normal/ no problem, with increasing alterations/ problems to rating of 4 Provides for collection of extensive data Potential primarily as a research tool, not seen as readily useable by clinician Varied criteria for rating categories does not allow for ready use of instrument unless clinician has tool in sight. Solicits subjective input from patient regarding subjective experience Oral Assessment Guide (OAG)37 Clinician assessment: Voice, swallow, lips, tongue, saliva, mucous membranes, gingival, and teeth/dentures Each aspect is rated on a 1 to 3 scale: 1 Ļ­ normal, 2 Ļ­ altered but not loss of function or barrier breakdown, 3 Ļ­ loss of function or barrier breakdown Includes both oral cavity functions and physical aspects. Clear, concise, and clinically relevant to direct care clinician. Ease of rating scale allows for ready use of instrument by clinician once learn eight areas to assess. Used in multiple clinical settings. Does not include speciļ¬c measure of size or extent of lesions Does not differentiate the various areas of the mucous membranes Oral Mucosa Rating Scale (OMRS)38 Type and severity of clinically evident oral mucosal changes: atrophy, erythema, ulceration, and pseudomembranous, hyperkeratotic, lichenoid, and edematous changes. 0 to 3 rating scale (normal to severe) Developed to classify and quantify oral mucosal changes and disease Includes separate scales for pain and dryness Visual analogue scale. No dryness/worst possible dryness and no pain/ worst possible pain Does not include functional performance Separates subjective complaints from objective changes (lesions) Oral Mucositis Index (OMI)39,40 34-Item OMI-Clinician (usually dental professional) assessment; 11 atrophy items (lips, labial mucosa, buccal mucosa, ļ¬‚oor of mouth, soft palate & tongue); 11 ulcer/pseudomembrane items (lips, labial mucosa, buccal mucosa, ļ¬‚oor of mouth, tongue) 10 erythema items (lips, labial mucosa, buccal mucosa, ļ¬‚oor of mouth, tongue) Atrophy, ulceration, erythema, edema. Scored from 0 (none) to 3 (severe) and are summed for a total score Uses a strong dental focus. Format assumes clinical examiners have sufļ¬cient experience to recognize and score the types and grades of changes the tool measure 20-Item OMI Clinician assessment: rates four types of mucosal changes in nine anatomic areas: atrophy (dorsal tongue), edema (lateral tongue), erythema upper and lower labial mucosa, right & left buccal mucosa, ļ¬‚oor of mouth, soft palate, and dorsal, lateral, and ventral tongue; ulceration or pseudomembrane (upper and lower labial mucosa, right and left buccal mucosa, ļ¬‚oor of mouth, soft palate, and dorsal, lateral and ventral tongue) Same rating scale Modiļ¬ed to facilitate use by nondental health professionals (deleted items less likely to be accurately and reliably assessed by nondental health professionals) Exclusively objective measure of oral tissue injury in mucositis. Does not include functional or subjective assessment (pain) Provides for erythema and ulceration subscores. Oral Mucositis Assessment Scale (OMAS) Two components: Clinician assessment-Objective measures of mucositis: erythema and ulceration/pseudomembrane in eight anatomic locations of the oral cavity Patient report-Two subjective outcomes-pain and difļ¬culty swallowing and ability to eat Erythema-0 (none) to 2 (severe) ulceration/ pseudomembrane formation, 0 (no lesion) to 3 (Ļ¾3 cm sq) Patient report on 100 mm visual analog scales: 0 (no problem) to 100 (worst problem) Ability to eat-categorical scale-types of food Provides for quantiļ¬able statistical measurement of functional, objective, and subjective parameters within one brief tool that is clinically relevant and presented in an easily used format with a reproducible scoring system. Focuses on mucous membranes does not include other oral cavity changes. Works well for multi-site study that includes nondental health professionals as examiners. Quantiļ¬cation of size of lesions requires more training than briefer clinical tools ASSESSMENT AND MEASUREMENT OF ORAL MUCOSITIS 27
  • 7. of a descriptive staging system to measure the progressive severity of chemotherapy-induced oral cavity changes.41 A similar staging approach to mucositis is the basis for the common toxicity criteria used by the World Health Organization42 and the National Cancer Institute.43 In addition to speciļ¬c grading criteria for chemotherapy and transplant, the National Cancer Institute has de- veloped grading criteria for radiation therapy that are used by the Radiation Therapy Oncology Group.44 Although these grading scales have been extremely useful in national and international tri- als, they do have limitations in their ability to examine a broader spectrum of objective, subjec- tive, and functional outcomes. Both of the approaches described above have limitations in studies of prophylactic or therapeu- tic agents, which require precise measurement of oral cavity changes such as erythema and ulcer- ation, as well as the effects of the agents on sub- jective and functional outcomes such as pain and ability to eat. Recognition of this measurement gap stimulated the development and testing of the Oral Mucositis Assessment Scale by a multidisci- plinary group of content experts45 (see Table 3) and another detailed research scale.46 It is important to recognize that modiļ¬cations to an existing instrument potentially alter the psychometric properties, thus if researchers or clinicians modify an instrument, the speciļ¬c changes should be articulated and the revised instrument tested for validity and reliability. This process has been demonstrated by McGuire et al,40 who reduced the somewhat complex 34-item Oral Mucositis Index to the 20-item Oral Mucositis Index, an instrument more easily completed by non-dental health professionals such as nurses. Thorough assessment may require use of more than one measure or modiļ¬cation of an existing measure. Both of these decisions require addi- tional planning. When an intervention is targeted to decrease pain, it is important to include a valid and reliable measure of pain. This pain assess- ment can be accomplished using a numerical as- sessment such as a 0 to 10 visual analogue or numerical rating scale; asking questions speciļ¬c to pain with swallowing, worst pain, and least pain; a comprehensive multidimensional pain in- strument, or the pain item on the Oral Mucositis Assessment Scale.45 If an intervention is targeted to prevent xerostomia or increase moisture of the mucous membranes, it may be necessary to add a more speciļ¬c measure of salivary function.23,47 Deciding what to do with the presence of infec- tion in the oral cavity is complex. Some could argue that infection (ie, thrush or candida) should be included as part of an instrument. This ap- proach is problematic because the thrush inter- feres with visualization of the extent of ulcerative lesions and can actually be present independent of ulcerative mucositis lesions. Similarly, herpes vi- ral infections in aplastic patients can cause ulcer- ation, visual changes in the mucosal tissue, and severe pain. Because institutions can also vary in their prophylaxis, diagnosis, and treatment of oral infections, nurses may need to rely on dental associates to assist with diagnosis of infections. CONCLUSION Accurate assessment of the oral cavity changes that accompany cancer treatment is essential for optimal patient outcomes. Regular use of ac- curate assessment measures and participation in clinical research studies will enable nurses to ad- dress unanswered questions about mucositis. Be- cause the mouth provides a window to other mu- cous membranes in the body,18 this assessment can also provide for increased attention to gastro- intestinal tract and other changes secondary to therapies that affect mucous membranes. Having the knowledge, skills, and abilities to rigorously assess or measure mucositis will position oncology nurses to make a difference for patients. REFERENCES 1. Clarkson JE, Worthington HV, Eden OB. Interventions for preventing oral mucositis for patients with cancer receiving treatment. Cochrane Database Syst Rev 2003;3:CD000978. 2. Rubenstein EB , et al. Clinical practice guidelines for the prevention and treatment of cancer therapy-induced oral and gastrointestinal mucositis. Cancer 2003 (in press). 3. Plevova P. Prevention and treatment of chemotherapy- and radiotherapy-induced oral mucositis: a review. Oral On- cology 1999;35:453-454. 4. Avritscher EBC, Cooksley C, Elting LS. Scope and epide- miology of oral and gastrointestinal mucositis. Semin Oncol Nurs 2004;20:xx-xx. 5. Streiner DL, Norman GR. Health Measurement Scales: A Practical Guide to Their Development and Use. New York, NY: Oxford: 1995. 6. Sitzia J, Dikken C, Hughes J. Psychometric evaluation of a questionnaire to document side-effects of chemotherapy. J Adv Nurs 1997;25:999-1007. 7. Jacobson SF. Evaluating instruments for use in clinical nursing research. In: Frank-Stromborg M, Olsen SJ, eds. In- 28 EILERS AND EPSTEIN
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