Vol. 67 No.

2 February 2024 Journal of Pain and Symptom Management 157

Original Article

Psychometric Properties of the Japanese Version of the

Edmonton Functional Assessment Tool 2
Yuto Zogo, RPT, MS, Keita Hoshino, RN, MS, Kensuke Serizawa, ROT, Akira Iwase, ROT, and
Tetsuya Tsuji, MD, PhD
Department of Rehabilitation Medicine/ Palliative Care Team (Y.Z., K.S., A.I.), Yokohama City Minato Red Cross Hospital, Kanagawa,
Japan; Department of Palliative Care Nursing/ Palliative Care Team (K.H.), Yokohama City Minato Red Cross Hospital, Kanagawa, Japan;
Department of Rehabilitation Medicine (T.T.) Keio University School of Medicine, Tokyo, Japan

Abstract
Context. Physical symptoms such as pain and cancer-related fatigue limit physical function and activities of daily living among
patients with terminal cancer, which can lead to a decline in quality of life. Therefore, comprehensive functional impairments
should be evaluated to determine the progression of the disease and the effectiveness of palliative treatment.
Objective. To validate the psychometric properties of the Japanese version of the Edmonton Functional Assessment Tool 2
(EFAT2-J).
Methods. We developed a Japanese version of the EFAT-2 in accordance with international guidelines. To verify the reliabil-
ity and validity of the EFAT2-J, patients were evaluated by a physiotherapist and a nurse separately, and correlations with existing
evaluation scales for physical function, physical symptoms, and quality of life were analyzed, respectively. The significance level
was set at 5%.
Results. Twenty patients participated in the reliability measurement. The average EFAT2-J scores were 7.95 § 4.12 for physi-
cal therapists and 7.20 § 4.23 for nurses, and the intraclass correlation coefficient was 0.95. The weighted kappa coefficient (k)
for each item was 0.57−1.00. Fifty-five patients participated in the validity measurement. The EFAT2-J showed significant corre-
lations with Eastern Cooperative Oncology Group Performance Status and the Karnofsky Performance Scale, Barthel Index,
and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative Care
sub-item “physical function.”
Conclusion. These results indicate that the EFAT2-J has robust psychometric properties and is useful for evaluating physical
function in patients with terminal cancer, and thus may be an acceptable clinical instrument in research and practice. J Pain
Symptom Manage 2024;67:157−166. © 2023 The Authors. Published by Elsevier Inc. on behalf of American Academy of Hospice and Pallia-
tive Medicine. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)

Key Words
Evaluation, palliative care, physical function, rehabilitation, terminal cancer

Key Message Introduction

This article describes a prospective observational study
that aimed to validate the psychometric properties of the
Japanese version of the Edmonton Functional Assessment
Tool 2 (EFAT2-J). The results indicate that the EFAT2-J
has robust psychometric properties and is useful for eval-
uating physical function in patients with terminal cancer.
Cancer-related fatigue,1 respiratory distress, and
bone metastasis2 are known to limit physical function
and activities of daily living (ADL) in patients with ter-
minal cancer, resulting in decreased quality of life
(QOL) and the need for appropriate rehabilitation
and responses by palliative care teams.

Address correspondence to: Tetsuya Tsuji, MD, PhD, Department Accepted for publication: 2 November 2023.
of Rehabilitation Medicine, Keio University School of Medi-
cine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
E-mail: t.tsuji@keio.jp
Ó 2023 The Authors. Published by Elsevier Inc. on behalf of 0885-3924/$ - see front matter
American Academy of Hospice and Palliative Medicine. This is an https://doi.org/10.1016/j.jpainsymman.2023.11.001
open access article under the CC BY license
(http://creativecommons.org/licenses/by/4.0/)
158 Zogo et al.
The aim of rehabilitation in patients with terminal
cancer is to achieve the best possible QOL for patients
and their families.3 In such patients, rehabilitation
such as exercise therapy has been shown to improve
physical function,4,5 QOL,5 and fatigue.4,5
To administer appropriate cancer rehabilitation to
patients with terminal cancer, it is necessary to assess their
actual physical function status and self-care ability. East-
ern Cooperative Oncology Group Performance Status
(ECOG-PS)6 and the Karnofsky Performance Scale
(KPS)7 are commonly used as assessment tools for physi-
cal function in patients with cancer. ECOG-PS is a five-
point scale ranging from zero to four that is primarily
used to assess physical function during active treatment
phases such as chemotherapy. It is widely used in cancer
care settings around the world and has been reported to
have high reliability and validity.8−11 The KPS is an assess-
ment scale that provides scores from 0% to 100% on an
11-point scale depending on the medical condition,
work, and status regarding assistance in daily life, and its
high reliability and validity have been verified.10−13
However, for both ECOG-PS and KPS, when the
evaluation target is a patient with terminal cancer, the
score is clustered at the lower limit and a floor effect is
likely to occur. In addition, slight changes in physical
function cannot be evaluated, making them insuffi-
cient for determining the effect of cancer
rehabilitation.14,15 Palliative Performance Status16 and
the Edmonton Functional Assessment Tool 2 (EFAT-
2)14 have been developed in the field of palliative care.
The Palliative Performance Status guides the assess-
ment of functional performance and provides a frame-
work for measuring progressive decline in physical
function. However, to our knowledge, no studies have
been conducted on rehabilitation using this tool. On
the other hand, the EFAT-2 is a physical function
assessment tool specialized for patients with terminal
cancer, and its validity and reliability have been
verified.14,17,18 The EFAT-2 has the potential to detect
more clinically relevant changes and is an excellent
tool for measuring and recording more rarefied gains
in function.14,19 As a result, the physical symptoms asso-
ciated with cancer itself and its treatment can be
assessed from multiple perspectives.
The EFAT-2 has the following features. It can com-
prehensively assess functional impairments specific to
patients with terminal cancer, including physical, men-
tal, and social functions of daily living. The assessment
items are a low load on patients, making it easy to
administer even to those with terminal cancer. The
floor effect is unlikely to occur and the scoring criteria
are clarified in a manual. The system is expected to be
useful as a tool for sharing information among multiple
professions, selecting palliative treatment and rehabili-
tation content, and determining discharge destinations
and directions.20,21
Vol. 67 No. 2 February 2024
Although the EFAT-2 is widely used in Europe and
the United States, the Japanese version has not yet
been validated. The goals of this study were to validate
the psychometric properties of the Japanese version of
the EFAT-2 (EFAT2-J) and to clarify its reliability and
validity. The EFAT2-J is expected to be widely used as a
physical function assessment tool for patients with ter-
minal cancer, and to be an acceptable clinical instru-
ment in research and practice.
Methods
Study Design and Participants
This prospective observational study included all
patients who had been admitted to Yokohama City Min-
ato Red Cross Hospital (Yokohama-city, Kanagawa,
Japan) from January 2021 to March 2022 and those for
whom the palliative care team had received a consulta-
tion request from the attending physician. Within this
time period, patients were consecutively sampled by
type of psychometric property.
The eligibility criteria were as follows: 1) patients
with cancer whose palliative care team received a
request for consultation from the attending physician,
and 2) cases for which oral and written consent was
obtained for participation in this study. The exclusion
criteria were: 1) cases estimated to have a prognosis of
less than one month; 2) cases judged by the researcher
to be deemed unsuitable for the safe conduct of the
study because of clinical signs of death22; 3) patients
receiving curative treatment for cancer at the time of
participation; and 4) patients under the age of 18 years.
Terminal cancer is defined in Dietz’s classification23
as the period from the maintenance stage, when the
tumor is growing, recurrence and metastasis are pro-
gressing, and functional impairment is progressing, to
the palliative care-oriented stage, when the patient is
no longer able to receive active treatment.
In this study, patients who requested a consultation
with the palliative care team during their hospitaliza-
tion and those who were not treated for curative pur-
poses during their hospitalization were included in the
best supportive care policy. Therefore, the stage of the
recruited patients corresponds to terminal cancer.
Furthermore, age, gender, cancer type, cancer stage
(TNM classification),24 comorbidities, length of hospi-
tal stay, rehabilitation, primary reasons for hospitaliza-
tion, and patient outcomes were investigated from the
patients’ medical records.
Ethical Considerations
This study was approved by the Medical Ethics Com-
mittee of Yokohama City Minato Red Cross Hospital
(approval no. 2020-32). The purpose and content of
the research and the use of data were fully explained to
Vol. 67 No. 2 February 2024 Japanese Edmonton Functional Assessment Psychometric
the patients in writing, and the research was conducted
after obtaining consent.
Palliative Care Team
The study site was an acute-care hospital but has a
palliative care team consisting of multidisciplinary
professionals (e.g., doctors, nurses, pharmacists, clini-
cal psychologists, dental hygienists, medical social
workers, rehabilitation specialists) as a specialized
palliative consultation service in which the attending
physician requests a consultation with the palliative
care team regarding treatment for the patient’s phys-
ical and psychiatric symptoms. In response to a con-
sultation request, the palliative care team proposes,
for example, treatment with opioid analgesics to treat
the patient’s secondary pain caused by the disease.
Ward rounds are conducted five times a week by doc-
tors, nurses, and pharmacists. During regular confer-
ences, the treatment plan, patient distress, life
expectancy, and patient and family wishes are shared.
Rehabilitation specialists participate in the rounds
and conferences once a month and provide consulta-
tion on indications for rehabilitation, guidance on
movement methods to avoid pain, positioning, and
breathing methods.
Sample Size
To verify the reliability of the EFAT2-J, estimates and
confidence interval (CI) widths were set with reference
to previous studies, and sample sizes were calculated
using the method reported by Bonett et al.25 As a
result, when the estimated value was 0.9 and the CI
width was 0.1, the sample size was 15 patients, and the
target number of patients was set to 20 in consideration
of feasibility. To verify the validity of the EFAT2-J, the
estimated value was 0.8 and the CI width was 0.1, refer-
ring to previous studies. The sample size was then
calculated using the method reported by Moinester
et al.26 As a result, the sample size was calculated to be
55 patients, and the target number of patients was set
at 55, also in light of feasibility.
Tool
The original EFAT-214 was developed as a physical
function assessment tool for specialized for patients
with terminal cancer. The EFAT-2 is a rating scale com-
posed of 10 question items and PS designed to measure
physical symptoms and physical function in patients
with terminal cancer. The 10-question items evaluate
the status of various main functions, including commu-
nication, mental status, pain, dyspnea, balance, mobil-
ity, locomotion, fatigue, motivation, and ADL. Each
item is scored on a four-point scale from zero (func-
tional) to three (severely impaired), with the total score
ranging from zero to 30.
159
In addition, to summarize the patient’s PS, the scale
has one final item (range 0−3), which is not calculated
as part of the total score.
EFAT2-J Creation Procedure
The translation procedure followed the guidelines
set forth by the International Society for Pharmacoeco-
nomics and Outcomes Research (ISPOR) task force.27
First, as advance preparation, we contacted the original
authors and editorial company (SAGE Publications) to
obtain permission to create a Japanese version of the
EFAT-2. It was difficult to contact the original author,
so permission was obtained from the co-author.17
First, the EFAT-2 was translated by two physiothera-
pists who were fluent in English and experts in cancer
rehabilitation. The translated versions were then com-
pared and integrated to create a single version. Second,
a doctor who was an expert in cancer rehabilitation but
not involved in the translation confirmed the trans-
lated version.
In addition, we asked a science communications
company to reverse-translate the translated EFAT-2 so
that the original author could confirm whether the
expression of the translated EFAT-2 had the same con-
cepts and meanings as the original version. Finally, we
asked the original authors to review the back-transla-
tions and compared those versions with the original to
check whether they were equivalent.
Psychometric Properties
The reliability and validity of the EFAT2-J need to be
evaluated to verify its accuracy in regard to the target
population28 in Japan. COnsensus-based Standards for
the selection of health Measurement INstruments
(COSMIN)29 is an international standard for scale
research, and clearly shows the points that researchers
should keep in mind when examining scale characteris-
tics. In the COSMIN checklist, scale characteristics are
divided into three areas: reliability, validity, and respon-
siveness.30 Although distinct from the scale characteris-
tics, interpretability is also included because it is an
important concept in deciding whether scale scores
can be used in clinical settings. Therefore, the present
study examined the reliability, validity, and interpret-
ability of the Japanese version of the EFAT-2.
The reliability of the EFAT2-J was evaluated using
inter-rater reliability. A physiotherapist and a nurse
evaluated the same patient separately. The assessment
period for each patient was set within three days after
the palliative care team received the consultation
request, referring to previous studies.18
In addition, EFAT-2 evaluation manuals31 were dis-
tributed to each evaluator, and preuse education was
provided. As preuse education, the evaluator was
instructed three times (about 30 minutes each) on the
EFAT-2 method and evaluation manual.
160 Zogo et al.
Validity was tested for content validity, criterion
validity, and construct validity. Content validity is a con-
cept that looks at the scale as a whole and reassesses
whether it contains the necessary questions to assess
the concepts32 for which the EFAT2-J was designed.
The content validity of the EFAT-2 has been tested,14
and it is expected to have a similar scale structure. In
terms of criterion validity, correlations between the
ECOG-PS and KPS, the gold standard assessment tools
for physical function in patients with cancer, were eval-
uated. Prior to the revision of the EFAT-2, the EFAT33
made the same assessments. However, the EFAT-2 is
considered to be a more useful tool for the assessment
of physical function in patients with cancer and is
expected to correlate well with the ECOG-PS and KPS.
In addition, construct validity was checked to deter-
mine whether the EFAT2-J reflects the ability to per-
form ADL, physical symptoms, and QOL. The ability to
perform ADL was validated using the Barthel Index
(BI),34 which is scored on a scale from 0 to 100 points,
with higher scores indicating higher daily indepen-
dence. Construct validity with the BI has been veri-
fied,18 and the same strong correlation is expected. For
physical symptoms, the Edmonton Symptom Assess-
ment System Revised Japanese version (ESAS-r-J)31 was
used. The ESAS-r is a validated, patient-reported, symp-
tom assessment tool that is widely used for patients with
terminal cancer.35−37 The ESAS-r assesses nine physical
and psychological symptoms (pain, tiredness, drowsi-
ness, nausea, lack of appetite, shortness of breath,
depression, anxiety, and well-being) on an 11-point Lik-
ert scale (0−10; 0 = no symptoms, 10 = worst possible
symptoms). The ESAS-r-J has been validated.38 We also
evaluated the severity of all nine symptoms of the
ESAS-r on a four-point verbal rating scale (none, mild,
moderate, or severe), and an overall score for all nine
items was used.39 The ESAS-r was predicted to have a
moderate correlation with the EFAT2-J because it is a
subjective tool that assesses only physical symptoms.
For QOL, the European Organization for Research
and Treatment of Cancer Quality of Life Question-
naire-Core 15-Palliative Care (EORTC QLQ-C15-
PAL)40 was used. The EORTC QLQ-C15-PAL has been
widely used in the palliative care field in recent years
and has been validated in Japan.41 It is composed of 15
questions and includes two functional scales (physical
and emotional function), two multi-item symptom
scales (fatigue and pain), and five single-item symptom
scales (nausea and vomiting, dyspnea, insomnia, appe-
tite loss, and constipation). Response options to these
14 items are scored on a four-point Likert scale: 1 (not
at all), 2 (a little), 3 (quite a bit), and 4 (very much).
An additional item, the global health/quality-of-life
scale, uses a seven-point numerical scale from one
(very poor) to seven (excellent). Higher scores on the
functional scale and global health/quality-of-life scale
Vol. 67 No. 2 February 2024
indicate a better QOL, whereas higher symptom scales
indicate a lower QOL. All scores were transformed
from 0 to 100 by linear transformation according to the
EORTC QLQ-C15-PAL scoring manual.42 Because the
EORTC QLQ-C15-PAL is a subjective assessment, con-
struct validity predicted moderate correlations with
common sub-items (physical function, fatigue, pain,
and dyspnea). On the other hand, the noncommon
sub-items and global QOL predicted weak correlations.
All patients were evaluated simultaneously using the
BI, ESAS-r-J, EORTC QLQ-C15-PAL, and EFAT2-J.
With the validation of each construct concept valida-
tion, screening of each assessment with the EFAT2-J is
expected.
Furthermore, the distribution of scores on the
EFAT2-J and physical function assessments, ECOG-PS
and KPS, as well as the “floor−ceiling effect,” were
examined. The floor−ceiling effect affects the ability of
the measure to detect deterioration or improvements
in physical function, respectively. The ECOG-PS was
expected to have a higher percentage at the lower end
of the scale because of its narrow rating scale of zero to
four. We predicted that although the KPS is an 11-point
rating scale, this study focused on late-stage cancers, so
the percentages would be less concentrated on the
lower limit compared with the ECOG-PS, but more
concentrated on the lower limit compared with the
EFAT2-J. The floor−ceiling effects on the ECOG-PS
and KPS scores were used as reference values to exam-
ine the EFAT2-J.
Statistical Analysis
Descriptive statistics were determined by calculating
the total number, mean § standard deviation, and
median (1st to 3rd interquartile range) for each item
related to patient characteristics. The statistical analysis
method for psychometric properties is as follows. The
intraclass correlation coefficient (ICC) and weighted
kappa (k) were used for inter-rater reliability. In this
study, we used ICC (2.1), which shows absolute agree-
ment. An ICC of 0.7 is commonly used as a threshold
of acceptable reliability.43 Weighted k statistics are fre-
quently used for scale items that include two or more
possible responses to reflect the degree of interob-
server disagreement more accurately. According to
conventional cutoffs for interpreting weighted k statis-
tics, reliability has been interpreted as follows: almost
perfect (0.81−1.00), substantial (0.61−0.80), moderate
(0.41−0.60), fair (0.21−0.40), or slight (0.00−0.20).44
For internal consistency, we used Cronbach’s a coeffi-
cient. Cronbach’s a was calculated to determine the
degree of internal reliability of the 10 items of the
EFAT2-J. If there are many items in the assessment that
correspond to the same underlying dimension, the
score of one item should correlate with those of the
other items and the a value should be high. If
Vol. 67 No. 2 February 2024 Japanese Edmonton Functional Assessment Psychometric 161

Table 1
Basic and Medical Information
Reliability (n = 20) Validity (n = 55)

Age (years) 74.7 § 8.93 73.9 § 10.8

Gender (n)
Cancer type (n)
Cancer stage (TNM system; n)
Comorbidities
Length of hospital stay (days)
Rehabilitation
Primary reason for hospitalization
Outcome for patient (n)
Male 12 30
Female 8 25
Lung 8 12
Gastrointestinal 6 17
Breast 4 11
Genitourinary 2 6
Other 0 9
(I/ II/ III/IV) 0/0/2/18 0/0/6/49
Cardiac disease 0 2
Respiratory disease 2 1
Orthopedic disease 2 5
Cerebrovascular disease 1 2
16 (9.5−25.0) 14 (9.0−23.0)
Physical therapy 6 24
Occupational therapy 1 6
Speech and language therapy 0 1
Worsening of disease condition 8 30
Pain management 7 16
Palliative radiation therapy 3 7
Palliative chemotherapy 2 2
(Discharge/transfer to hospital/death) 18/1/1 37/8/10

Cronbach’s a is too high, however, it suggests a high
level of item redundancy. Cronbach’s a should be
above 0.70, but probably not higher than 0.90.45
Spearman’s rank correlation coefficient was used for
validation. In this study, we validated the strength of
the correlation coefficients between the total score of
the EFAT2-J and each measure. Following established
guidelines, the following categories were used for
Spearman’s rank correlation coefficient s: ≥ 0.5,
strong; ≥ 0.3 to < 0.5, moderate; and < 0.3, weak.46
The ECOG-PS, KPS, BI, and ESAS-r-J were compared
based on total scores. For the EORTC QLQ-C15-PAL,
each variable was calculated according to the scoring
manual42 and compared using the total score of each
sub-item.
Regarding interpretability, the score distribution of
each physical function evaluation (EFAT2-J, ECOG-PS,
KPS) was shown in a histogram, and the skewness was
calculated. In addition, a floor−ceiling effect was rec-
ognized when the ratio of nonscoring and full-scoring
individuals exceeded 15% of the total.47
The significance level was set at two-sided P < 0.05.
IBM SPSS Statistics 27.0 (Armonk, NY) was used for all
statistical analyses.
Results
Sample Characteristics
As this was a prospective observational study, we col-
lected data until the specified target number of sam-
ples was reached. Therefore, reliability and validity
were based on 20 and 55 patients, respectively. The
characteristics of each sample in regard to reliability
and validity are shown in detail in Table 1. For reliabil-
ity and validity testing, the following patients were
excluded from the 44 and 93 recruited during the
study period, respectively: one and five patients without
cancer; five and eight patients who did not consent to
the study; nine and 12 patients whose prognosis was
estimated to be less than one month; three and three
patients who had clinical signs of death and were
deemed by the researchers to be unfit to safely partici-
pate in the study; and six and 10 patients who were
receiving radical cancer treatment at the time of the
study.
Psychometric Properties
Fig. 1 shows the average score for each item on the
EFAT2-J in all 55 patients. The mean total score was
10.31 § 6.28. The mean score for each rater of the
EFAT2-J was 7.95 § 4.12 for the physical therapists and
7.20 § 4.23 for the nurses.
Cronbach’s a coefficient for internal consistency
across the EFAT2-J was 0.81 for physical therapists and
0.82 for nurses. The inter-rater reliability (ICC 2.1) for
the EFAT-2J total score was 0.95 (95% CI; 0.83−0.98),
and the standard error of the mean was 1.03. Table 2
shows the results of the analysis of the reliability of
each assessment item on the EFAT2-J. The weighted k
coefficients for each item ranged from 0.57 to 1.00.
Table 3 shows the results of the analysis of the validity
of the EFAT2-J. A significant correlation was found
between the EFAT2-J and ECOG-PS, KPS, BI, ESAS-r-J,
and EORTC QLQ-C15-PAL sub-item (physical func-
tion, fatigue, pain) according to Spearman’s rank cor-
relation coefficient (P = 0.94, −0.95, −0.95, 0.30,
−0.84, 0.49, and 0.28, respectively).
162 Zogo et al. Vol. 67 No. 2 February 2024

Fig. 1. The average score for each item on the EFAT2-J (n = 55). EFAT2-J, the Japanese version of the Edmonton Functional
Assessment Tool 2; ADL, activities of daily living.

Figs. 2−4. There were zero no-scorers and zero full-

Table 2 scorers on the EFAT2-J, indicating the absence of any
Reliability of the EFAT2-J Items (n = 20)
floor−ceiling effects. By contrast, regarding ECOG-PS,
Weighted k 95% confidence interval SEM
(lower, upper) there were no full-scorers or ceiling effect, but there
were 10 no-scorers and a floor effect (18.2%), and the
Communication 1.00 1.00, 1.00 0.00 scores tended to cluster in the lower end of the range.
Mental status 0.78 0.37, 1.19 0.21
Pain 0.75 0.57, 0.93 0.09 Regarding the KPS, there were zero no-scorers and
Dyspnea 0.96 0.90, 1.02 0.03 full-scorers, and no floor−ceiling effect was observed.
Balance 0.94 0.83, 1.06 0.06 The KPS histogram showed a tendency for scores to
Mobility 0.93 0.79, 1.07 0.07
Locomotion 0.64 0.43, 0.86 0.11 cluster in the middle.
Fatigue 0.66 0.40, 0.93 0.13
Motivation 0.57 0.25, 0.89 0.16
ADL 0.78 0.62, 0.95 0.08
Performance status 0.87 0.77, 0.97 0.05 Discussion
SEM: standard error of the mean, ADL: activities of daily living. The purpose of this study was to create and validate
the psychometric properties of a Japanese version
The results regarding the EFAT2-J, the scores of the EFAT-2, the reliability and validity of which
(mean, minimum, maximum) for each physical func- have been verified in other English-speaking
tion assessment, and the floor−ceiling effect are shown countries.14,17,18 As a result, the EFAT2-J developed in
in Table 4. Additionally, histograms are shown in this study in accordance with the guidelines of the

Table 3
Validity of the EFAT2-J Items
Variable (vs, variable EFAT2-J) Spearman’s rank 95% confidence interval P-value
(n = 55) correlation (lower, upper) (Prob>|r|)

ECOG-PS 0.94 0.90, 0.97 <.001a

KPS −0.95 −0.97, −0.91 <.001a
BI −0.95 −0.97, −0.92 <.001a
ESAS-r-J 0.30 0.03, 0.53 0.03a
EORTC QLQ-C15-PAL Global quality of life −0.01 −0.28, 0.26 0.93
Physical function −0.84 −0.91, −0.74 <.001a
Emotional function −0.18 −0.43, 0.10 0.20
Fatigue 0.49 0.26, 0.68 <.001a
Nausea and vomiting 0.24 −0.25, 0.30 0.86
Pain 0.28 0.01, 0.52 0.04a
Dyspnea 0.18 −0.10, 0.43 0.20
Insomnia 0.23 −0.04, 0.48 0.09
Appetite loss 0.23 −0.05, 0.47 0.09
Constipation 0.14 −0.14, 0.39 0.32
EFAT2-J: Japanese version of the Edmonton Functional Assessment Tool 2, ECOG-PS: Eastern Cooperative Oncology Group Performance Status, KPS: Karnofsky
Performance Scale, BI: Barthel Index, ESAS-r-J: Edmonton Symptom Assessment System Revised Japanese version, EORTC QLQ-C15-PAL: European Organization
for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative Care.
r: Spearman’s rank correlation coefficient.
a
P < 0.05.
Vol. 67 No. 2 February 2024 Japanese Edmonton Functional Assessment Psychometric 163

Table 4 The ISPOR Task Force has stated that inconsistent

Physical Function Evaluation Scores and Floor−Ceiling translation methodologies make comparisons between
Effects (n = 55) the same measures difficult, and that measures that
EFAT2-J ECOG-PS KPS
have not gone through the proper translation process
Score (min−max) 30−0 4−0 0−100 are inappropriate for international collaborative
Average score 10.3 § 6.28 2.45 § 1.09 54.2 § 20.9 research.26 Therefore, measures should be translated
Lowest score 26 4 10 according to the formal procedure laid out by the
Highest score 1 1 90
Floor effect (%) 0 (0.0%) 10 (18.2%)a 0 (0.0%) guidelines of the ISPOR Task Force. In this study, trans-
Ceiling effect (%) 0 (0.0%) 0 (0.0%) 0 (0.0%) lation was performed according to this formal proce-
EFAT2-J: Japanese version of the Edmonton Functional Assessment Tool 2, dure. As a next step, this study used the EFAT2-J to
ECOG-PS: Eastern cooperative oncology group performance status, KPS: Kar-
nofsky performance scale.
examine the psychometric properties of Japanese
a
Floor effect. patients.
Concerning the inter-rater reliability (ICC 2.1) of
ISPOR Task Force was shown to have excellent reliabil- the EFAT2-J total score, as expected, it was confirmed
ity and validity, and is therefore expected to be useful to have high reliability (0.95). In a previous study,18 the
as a physical function evaluation tool for patients with ICC (3.1) was 0.85, which was the same result as this
terminal cancer. To our knowledge, this is the first study. In addition, the evaluators in the present study
study to clarify the reliability and validity of a Japanese were physiotherapists and nurses who were shown to
version of the EFAT-2, which is important because eval- have high inter-rater reliability, even though they had
uation scales for patients with terminal cancer must be different occupations. As for the inter-rater reliability
able to evaluate a wide range of functions and abilities of each evaluation item, the weighted k coefficient was
from independent to almost bedridden patients.19 0.57−1.00, confirming that the reliability was almost

Fig. 2. Histogram of EFAT2-J scores (n = 55). EFAT2-J, Japanese version of the Edmonton Functional Assessment Tool 2.

Fig. 3. Histogram of ECOG-PS (n = 55). ECOG-PS: Eastern cooperative oncology group performance status.
164 Zogo et al.
Fig. 4. Histogram of KPS scores (n = 55). KPS: Karnofsky performance scale.
perfect, as expected. The EFAT-2 has been reported to
have a k coefficient of 0.17−0.96,17 and the results of
the present study were high overall. The reason for this
may be that the use of the evaluation manual and the
provision of education before use were effective.
In terms of content validity, the overall internal con-
sistency of the EFAT2-J was 0.81−0.82 (Cronbach’s a
coefficient), the same result as in the previous study.14
Cronbach’s a coefficient should exceed 0.70, but it is
desirable not to exceed 0.90.45 Therefore, it was con-
firmed that the results of this study were valid and that
the items were consistent.
Criterion validity was demonstrated by the strong
positive correlations observed between ECOG-PS
(P = 0.94) and the EFAT2-J, and the strong negative
correlations between the KPS (P = −0.95) and the
EFAT2-J. The results were as predicted.
In terms of construct validity, strong correlations were
also observed with BI (P = −0.95), an ADL evaluation
scale, and the EORTC QLQ-C15-PAL sub-item “physical
function” (P = −0.84), an evaluation scale for QOL. The
concurrent validity of BI (r = −0.77) has been confirmed
in a previous study.18 To our knowledge, this is the first
time a high correlation has been found between ECOG-
PS, KPS, and the EORTC QLQ-C15-PAL sub-item “physi-
cal function.” These results suggest that the EFAT2-J is a
valid and useful scale for evaluating physical function, the
ability to carry out ADL, and the physical function
domains of QOL among patients with terminal cancer.
On the other hand, we found a weak correlation with
the ESAS-r-J (P = 0.30), a moderate correlation with sub-
item “fatigue” (P = 0.49) on the EORTC QLQ-C15-PAL,
and a weak correlation with sub-item “pain” (P = 0.28).
Similar to the EORTC QLQ-C15-PAL, the EFAT2-J has
sub-items for “pain” and “fatigue”; therefore, we assumed
that they were related. However, the correlation was mod-
erate or weak, suggesting that the ESAS-r-J and EORTC
QLQ-C15−PAL should be evaluated independently of
the EFAT2-J. On the other hand, “dyspnea” also exists as
a sub-item, but no correlation was observed. This suggests
that the EFAT2-J sub-item “dyspnea” was related to the
Vol. 67 No. 2 February 2024
oxygen dose and did not correlate with the subjective
QOL evaluation. No other items were present in the
EFAT2-J sub-items, so it is possible that no correlation
was obtained. Global QOL may also have been subjective
and comprehensive and not correlated. Another factor
was that the type of cancer was not identified. Different
types of cancer have different effects on global QOL.48
−50
This needs to be examined in a future study.
We also verified the floor−ceiling effect of the
EFAT2-J and each physical function evaluation
(Table 4). Consistent with expectations, the lowest
ECOG-PS score was clustered at 15% or higher
(18.2%), and a floor effect was recognized. As previ-
ously reported,14,15 the ECOG-PS score tends to cluster
at the lower end of the scale and can easily produce a
floor effect; thus, it was reconfirmed that the ECOG-PS
score is insufficient for determining the effectiveness of
cancer rehabilitation without being able to evaluate
slight changes in physical function when the subject of
the evaluation is a patient with terminal cancer. The
EFAT2-J and KPS showed no floor−ceiling effect, as
there were zero no-scorers and full-scorers. In addition,
EFAT2-J scores were not clustered at the lower limit,
which indicates that EFAT2-J may help determine the
effectiveness of physical function assessments in
patients with terminal cancer. On the other hand, the
KPS had no floor effect, which was not predicted. This
suggests that the effect of excluding patients with a
prognosis of less than one month and those in the
near-death stage requires further investigation. The his-
tograms in Figs. 2−4 show that the KPS values are con-
centrated in the center, while those for the EFAT2-J
are concentrated on the left side. Therefore, we consid-
ered that the EFAT2-J scores may be more dispersed
than the KPS values when excluding patients with can-
cer at the end of life.
The results of these psychometric properties indi-
cate that the EFAT2-J has high reliability and validity,
and is therefore expected to be useful as a physical
function assessment tool for patients with terminal can-
cer. The EFAT2-J also showed associations with existing
Vol. 67 No. 2 February 2024 Japanese Edmonton Functional Assessment Psychometric
physical function assessment measures and other con-
cepts, suggesting that it contains a variety of constructs.
Furthermore, compared with existing measures of
physical function among patients with cancer, our find-
ings were less likely to produce a floor effect, suggest-
ing that the EFAT2-J is a valid instrument for assessing
physical function in patients with terminal cancer.
Therefore, the EFAT2-J is capable of assessing physical
function in frail patients without increasing patient
burden. Furthermore, it is expected that the EFAT2-J
will increase its use in Japan and allow comparison of
results both domestically and internationally.
As mentioned above, in the future, the EFAT2-J is
expected to be widely used as a physical function assess-
ment scale for patients with terminal cancer and to be
utilized internationally in rehabilitation medicine and
clinical research.
Limitations and Future Recommendations
This study does have some limitations. First, the
responsiveness of the EFAT2-J was not investigated. Sec-
ond, because the patients in this study had cancer and
had requested a consultation with the palliative care team
after admission to a general ward, the results may not
reflect those of patients with a prognosis of less than one
month or those in a near-death period who would be
admitted to hospice care. Based on the above, as a pros-
pect, changes in scores before and after rehabilitation
need to be investigated, and the reactivity of the EFAT2-J
needs to be verified on a larger scale. In addition, it will
also be necessary to verify whether the EFAT2-J actually
reflects the effects of rehabilitation in practice. Further-
more, whether the EFAT2-J is suitable for patients with
cancer at the end of life, such as those in multicenter and
palliative care units, needs to be confirmed.
Conclusion
The EFAT2-J has been appropriately translated
under the ISPOR Task Force, and has been shown to
have appropriate inter-rater reliability and content
validity. Furthermore, it was highlighted that the
EFAT2-J had high reliability, even if the raters had
different occupations. In addition, it showed strong
correlations between the ECOG-PS, KPS, BI, and
EORTC QLQ-C15-PAL sub-item “physical function,”
indicating good criterion and construct validity.
Additionally, floor effects are unlikely to occur even
in patients with terminal cancer, which may contrib-
ute to clinical research in such patients and in reha-
bilitation medicine.
Disclosures and Acknowledgments
The authors thank the following for their assistance
in various stages of the study: Eduardo Bruera and
165
Sharon Watanabe for the translation of and permission
to use the EFAT-2; Dinesh Samuel for teaching me
about the EFAT-2 manual; Nobuya Ibara for helping
with the translation work; Naoki Miyazaki, Kengo Naga-
shima, and Noriyuki Ishida for providing statistical
advice at the early stage of project development; and
Noriko Tamakoshi for providing copyright advice.
Moreover, we would like to thank FORTE Science
Communications (https://www.forte-science.co.jp/)
for English language editing. The authors confirm that
they do not have any conflicts of interest to disclose.
This research received no specific funding/grant from
any funding agency in the public, commercial, or not-
for-profit sectors.
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