Symptom Burden of Cancer Patients: Validation of the German M. D. Anderson Symptom Inventory: A Cross-Sectional Multicenter Study
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Vol. - No. - - 2014 Journal of Pain and Symptom Management 1
Brief Methodological Report
Symptom Burden of Cancer Patients:
Validation of the German M. D. Anderson
Symptom Inventory: A Cross-Sectional
Multicenter Study
Heike Schmidt, MD, Charles S. Cleeland, PhD, Alexander Bauer, PhD,
Margarete Landenberger, PhD, Prof, and Patrick Jahn, RN, PhD
Institute for Health and Nursing Science, Medical Faculty, Martin-Luther-University Halle-
Wittenberg (H.S., A.B., M.L., P.J.); The University of Texas M. D. Anderson Cancer Center (C.S.C.),
Houston, Texas, USA; and Nursing Research Unit, University Hospital Halle (Saale) (P.J.), Halle,
Germany
Abstract
Context. Cancer patients frequently suffer from various symptoms often
impairing functional status and quality of life. To enable timely supportive care,
these symptoms must be assessed adequately with reliable tools.
Objectives. This study aimed to validate the German version of the M. D.
Anderson Symptom Inventory (MDASI).
Methods. This was a multicenter, cross-sectional, observational study. At five
German university hospitals, 697 cancer patients aged from 18 to 80 years
undergoing active anticancer treatment were recruited to participate in the study.
For the validation, reliability (Cronbach’s alpha), construct validity (factor
analysis), known group validity (Eastern Cooperative Oncology Group
Performance Status), and convergent divergent analyses were calculated.
Results. Of the 980 patients who were eligible, 697 patients were included
and agreed to participate in the study (71%). Reliability analysis showed good
internal consistencies for the MDASI set of symptoms (Cronbach’s alpha
coefficient ¼ 0.82; 95% CI ¼ 0.78, 0.84) and for the set of interference items
(Cronbach’s alpha coefficient ¼ 0.857; 95% CI ¼ 0.484, 0.87). Factor analysis
resulted in a one-factor solution (general symptoms; eigenvalue ¼ 4.26) with a
psychological (distress and sadness) and a gastrointestinal subscale (nausea and
vomiting). Convergent and divergent analyses showed significant correlations
between symptom burden and distress and global health-related quality of life
(subscale of the European Organization for Research and Treatment of Cancer
Quality of Life Questionnaire-C30 Version 3.0.).
Conclusion. The MDASI-German version is a valid tool for measuring patient-
reported symptom severity and symptom interference in German cancer patients.
It is easily applicable and can be used by German clinicians and researchers for
Address correspondence to: Heike Schmidt, MD, Medi- Magdeburger Strasse 8, Halle 06097, Germany.
cal Faculty, Institute for Health and Nursing Sci- E-mail: heike.schmidt@medizin.uni-halle.de
ence, Martin-Luther-University Halle-Wittenberg, Accepted for publication: April 29, 2014.
Ó 2014 U.S. Cancer Pain Relief Committee. 0885-3924/$ - see front matter
Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jpainsymman.2014.04.0072 Schmidt et al. Vol. - No. - - 2014
screening and monitoring purposes and the comparison of international
data. J Pain Symptom Manage 2014;-:-e-. Ó 2014 U.S. Cancer Pain Relief
Committee. Published by Elsevier Inc. All rights reserved.
Key Words
Cancer, symptom burden, Validation, M. D. Anderson Symptom Inventory
Introduction lack of appetite loads on both the factors.1 A
component score of symptom severity can be
Cancer patients often suffer from various dis-
calculated by taking the average of the 13 items
ease- or treatment-related symptoms that may
together.8 Symptom interference with daily
impair their functional status and result in
activities is measured by six functional scales
high symptom burden. Unrelieved symptoms
regarding general activity, mood, work, relations
can limit therapy options and reduce quality of
with others, walking, and enjoyment of life.
life.1 In clinical practice, symptoms might persist
Interference is also rated on a zero to 10 NRS,
unrecognized and undertreated because, when
zero being ‘‘did not interfere’’ and 10 being
not asked, patients might not report their symp-
‘‘interfered completely.’’ The mean of the inter-
toms exhaustively. Furthermore, considerable
ference items can be used to represent overall
numbers of clinicians underestimate symptom
symptom distress. Symptom burden is defined
intensity.2,3 Therefore, to enable tailored sup-
as the sum of symptom severity and symptom
portive care measures, all relevant symptoms
interference.8
have to be assessed correctly and frequently
Because scores of single items can be
including the patients’ perceptions. Patient-
directly understood and implied in daily care
reported outcomes (PROs) are more and more
without further computing, the MDASI can
accepted as significant measures of symptom
be used easily to screen or to monitor symp-
intensity and interference as well as of health-
toms throughout the course of the treatment.
related quality of life.1,4e6 However, comprehen-
It has been translated and validated in many
sive standardized assessments are still not widely
languages including French, Taiwanese, and
used in daily clinical practice despite the many
Russian.9e16
available and valid questionnaires. To facilitate
The main objective of this study was to gather
implementation of PRO measures in everyday
representative information about symptom
practice, it is important not only to provide valid
severity, symptom interference, and symptom
but also feasible questionnaires that assess rele-
burden within a large heterogeneous popula-
vant symptoms.7
tion of cancer patients undergoing active anti-
The M. D. Anderson Symptom Inventory
cancer treatment in different settings. To test
(MDASI) is a comparatively short self-
and provide a relatively short disease-specific in-
administered questionnaire that was developed
strument with a short recall period feasible for
and validated to measure symptom intensity
screening and monitoring for future use in clin-
and interference in cancer patients.1 It com-
ical routine, we decided to use the German
prises 19 numeric rating scales (NRSs) regarding
version of the MDASI (MDASI-G), which had
the presence and intensity of common symp-
already been linguistically validated, and to
toms and functional restrictions. The MDASI as-
perform a psychometric validation of this tool.
sesses the severity of 13 symptoms at their worst
in the last 24 hours on a zero to 10 NRS, with
zero being ‘‘not present’’ and 10 being ‘‘as bad
as you can imagine.’’1 The symptom scales repre- Methods
sent two underlying structures, namely a general Study Design
symptom severity factor (pain, fatigue, disturbed The study was designed as a multicenter,
sleep, distress [emotional], shortness of breath, cross-sectional, observational study to investi-
drowsiness, dry mouth, sadness, difficulty gate symptom severity and symptom interfer-
remembering, and numbness or tingling) and ence in a heterogeneous population of
a gastrointestinal factor (nausea and vomiting); cancer patients in different settings. TheVol. - No. - - 2014 Validation of the MDASI-G 3
validation study was carried out alongside the Statistical Analysis
large descriptive study. Recruitment took place Scoring of the symptom severity and symp-
at the oncology departments of five German tom interference scales including the handling
university hospitals and aimed to fulfill conve- of missing values was carried out as described in
nience samples of 150 inpatients and outpa- the MDASI User Guide.8 Descriptive statistics
tients per center. were used to give an account of symptom preva-
lence, severity, and interference. In accordance
Participants with the methodology used in the original En-
Inclusion Criteria. Patients aged between 18 glish language validation study and studies vali-
and 80 years, diagnosed with cancer, and un- dating the MDASI for foreign languages, our
dergoing active anticancer treatment with an validation analysis plan included examination
Eastern Cooperative Oncology Group Perfor- of reliability, known-group validity, and analysis
mance Status (ECOG PS) of three or lower of convergence and divergence. To establish
who gave written informed consent were reliability, we examined the internal consistency
eligible to participate in the study. (Cronbach’s alpha coefficient). To establish
convergent validity, we performed a convergent
Exclusion Criterion. Patients lacking sufficient and divergent analysis by testing the correlation
knowledge of the German language were not of symptom burden (sum of the means of symp-
eligible. tom severity and symptom interference) with
DT and global health-related quality of life
Data Sources (EORTC QLQ-C30 global scale). To examine
To perform the psychometric validation, we the underlying constructs that the MDASI-G is
used the linguistically validated MDASI-G pro- supposed to measure, we performed an explor-
vided by the M. D. Anderson Cancer Center. In atory factor analysis on our validation sample.
addition, patients filled out the Distress Ther- Because other language versions of the MDASI
mometer (DT), which is a short screening showed various factor solutions,1,9,12,13,15,16 we
tool for measuring self-reported distress on a chose exploratory factor analysis over confirma-
zero to 10 NRS,17 and the two general ques- tory factor analysis to better understand the
tions of the European Organization for constructs being assessed by the MDASI-G. All
Research and Treatment of Cancer Quality of analyses were carried out using SPSS Version
Life Questionnaire-C30 (EORTC QLQ-C30), 18 (SPSS, Inc., Chicago, IL).
Version 3.0, regarding global health-related
quality of life.18 Demographic and disease-
related data (age, gender, marital status, edu-
cation level, disease type, model of care, and
Results
type of treatment) also were collected. Participants
Of the 980 patients who were eligible, 697
Ethical Considerations patients were included and agreed to partici-
As study data were not available for the phy- pate in the study (71%). Recruitment sites
sicians treating the participants, there was no were internal medicine (n ¼ 268, 38.5%), gy-
direct advantage, for example application of necology (n ¼ 146, 20.9%), surgery (n ¼ 104,
supportive measures, for the participants. To 14.9%), radiotherapy (n ¼ 93, 13.3%), urology
reduce the burden on the patients, we limited (n ¼ 58, 8.3%), head and neck (n ¼ 19, 2.7%),
the number of items to be answered and did and dermatology (n ¼ 7, 1.0%) wards. Recruit-
not use the problem checklist of the DT or ment rates are shown in Table 1; demographic
another comparable reference questionnaire and disease-related data are shown in Table 2.
assessing symptoms and functional impair- As nonparticipants did not give permission to
ments. Patients who were not willing to partic- collect any data, the reasons for nonparticipa-
ipate also did not give permission to save any tion could not be examined.
data. Therefore, reasons for nonparticipation
could not be elicited. The study was approved Descriptive Analyses of the MDASI-G
by the local ethics committees of the partici- Descriptive analyses were performed
pating university hospitals. following the instructions given in the MDASI4 Schmidt et al. Vol. - No. - - 2014
Table 1 between one and three, moderate if it was rated
Recruitment Rates between four and six, and severe if it was rated
Center Asked, n Recruited, n (%) equal or greater than seven on the zero to 10
1 320 150 (47.9) NRS. Descriptive results for means, symptom
2 156 150 (96.1) prevalence, and severity are presented in
3 196 158 (80.6) Table 3.
4 143 97 (67.8)
5 165 142 (86.1)
Statistical Analyses
Reliability. We examined internal consistency
user guide.8 Eleven patients did not complete by calculating the Cronbach’s alpha coefficient.
the required seven items of symptom severity Following the rule of thumb by George and Mal-
and two patients did not complete the lery, alpha values greater than 0.9 are rated excel-
required four items of symptom interference. lent, greater than 0.8 as good, greater than 0.7 as
Following the National Comprehensive Can- acceptable, and values lower than 0.6 as doubt-
cer Network guidelines for the assessment of ful.20 Analysis showed good internal consis-
pain19 and the original validation study,1 we tencies for the MDASI set of symptom items
defined symptom severity as mild if it was rated (Cronbach’s alpha coefficient ¼ 0.82; 95%
CI ¼ 0.80, 0.84) and for the set of interference
Table 2 items (Cronbach’s alpha coefficient ¼ 0.84;
Participants’ Demographic and Clinical 95% CI ¼ 0.82, 0.86; Table 3).
Characteristics (N ¼ 697)
Characteristics n (%) Missing Construct Validity. Construct validity was as-
Age (y), mean (SD) a
60.6 (12.9) 109 sessed by factor analysis regarding the symptom
Gender scales. The data were suitable for factor analysis
Female 349 (50.1)
Marital status 693 4
(Kaiser-Meyer-Olkin criterion ¼ 0.80). The cor-
Married, living with partner 469 (67.3) relation matrix with Z-standardized values
Living alone 223 (32.0) showed highest correlations between distress
Education level 663 34
Primary school 9 (1.3)
and sadness (r ¼ 0.78; 95% CI ¼ 0.74, 0.82)
Compulsory (9) y 254 (36.4) and nausea and vomiting (r ¼ 0.67; 95%
Middle school 252 (36.2) CI ¼ 0.58, 0.74). Lowest correlations were
High school 148 (21.2)
ECOG PS 681 16
found between vomiting and difficulty remem-
0 (Fully active) 88 (12.6) bering (r ¼ 0.087; 95% CI ¼ 0.007, 0.18)
1 (Restricted but ambulatory) 267 (38.3) and between poor appetite and numbness
2 (Ambulatory, capable of 171 (24.5)
self-care)
(r ¼ 0.07; 95% CI ¼ 0.02, 0.16).
3 (Capable of only limited 155 (22.2) The number of factors was identified using ei-
self-care) genvalues together with the scree plot and par-
Disease type 670 27
Gastrointestinal 194 (27.8)
allel analysis. The scree plot shows the factors
Breast 97 (13.9) against the respective eigenvalues (Fig. 1). Par-
Genitourinary 65 (9.3) allel analysis ‘‘involves extracting eigenvalues
Pulmonary 62 (8.9)
Gynecological 58 (8.3)
of random data sets that parallel the actual
Head & Neck 52 (7.5) data set with regard to the number of cases
Brain 6 (0.9) and variables. Factors are retained as long as
Other 136 (19.5)
Model of care 693 4
the ith eigenvalue from the actual data is greater
Inpatient 430 (61.7) than the ith eigenvalue of the random data
Outpatient and day clinic 263 (37.7) set.’’21 Results of parallel analysis, eigenvalues,
Type of treatmentb
Operation 407 (58.4)
and the scree plot resulted in a possible three-
Chemotherapy 511 (73.3) factor solution. Principal axis factor analysis
Radiotherapy 195 (28.0) with varimax rotation was carried out for the
ECOG PS ¼ Eastern Cooperative Oncology Group Performance 13 MDASI-G symptom items. The eigenvalues
Status.
However, no statistical difference between age groups at the re-
of the three factors were 4.26, 1.41, and 1.20,
cruiting centers was found, P ¼ 0.7. respectively explaining 52.9% of the variance
a
Mean age had to be computed for n ¼ 588 participants because
one center documented age groups (n ¼ 109).
(32.8%, 10.9%, and 9.2%, respectively). Factor
b
Patients may have received one or more treatments. 1 included affective symptoms with distress,Vol. - No. - - 2014 Validation of the MDASI-G 5
Table 3
Descriptive Results of MDASI-G Referring to the Last 24 Hours
MDASI-G Last 24 Hours
(N ¼ 697) n Mean (SD) Milda (%) Moderateb (%) Severec (%) Cronbach’s a
13 Symptom severity items 2.2 (1.5) d d d 0.82d
Minimum 0,
Maximum 6.7
Pain 679 2.5 (2.7) 29.8 20.4 10.2 0.81
Fatigue 679 3.3 (2.7) 33.7 28.7 14.3 0.79
Nausea 671 1.2 (2.3) 18.9 8.6 5.3 0.81
Disturbed sleep 681 2.9 (3.0) 28.8 21.1 14.5 0.81
Distress 676 3.1 (3.0) 26.1 24.5 16.1 0.81
Shortness of breath 677 2.0 (2.6) 26.5 14.9 9.2 0.82
Difficulty remembering 677 1.2 (1.9) 26.7 8.5 3.0 0.82
Poor appetite 681 2.2 (2.9) 22.8 13.8 12.3 0.80
Drowsiness 681 1.7 (2.3) 29.0 14.9 5.5 0.80
Dry mouth 680 2.7 (2.9) 28.3 20.9 13.2 0.81
Sadness 668 2.7 (2.9) 26.8 20.8 12.5 0.80
Vomiting 683 0.6 (1.6) 10.0 3.0 2.7 0.81
Numbness or tingling 681 2.2 (2.7) 26.1 16.1 10.5 0.82
Six symptom interference items 3.0 (2.3) d d d 0.84d
Minimum: 0,
Maximum: 10
General activity 659 3.8 (3.3) 29.3 21.1 22.4 0.82
Mood 670 2.9 (2.7) 33.6 24.7 11.2 0.83
Work 634 4.0 (3.6) 22.5 19.7 25.1 0.82
Relations with others 668 1.5 (2.3) 24.8 10.6 5.5 0.86
Walking 671 3.3 (3.3) 24.1 18.5 21.5 0.83
Enjoyment of life 675 2.5 (2.8) 28.0 19.1 11.5 0.84
a
$1e3.
b
$4e7.
c
>7e10, respectively, on a zero to 10 rating scale.
d
Cronbach’s alpha coefficient for subscale. All other coefficients: Cronbach’s alpha if symptom is deleted.
sadness, and sleep disturbance. Factor 2 In addition, we performed a hierarchical clus-
included general symptoms with fatigue, drows- ter analysis to explore the symptom patterns.
iness, shortness of breath, dry mouth, difficulty Results are presented in the dendrogram
remembering, and numbness. Factor 3 (Fig. 2). The cluster analysis again reveals high
included gastrointestinal symptoms with interdependencies between single symptoms,
nausea, vomiting, and lack of appetite. Pain leading to sparsely selective clusters and low in-
loaded with 0.4 on the first factor, 0.31 on the tracluster distances22 In accordance with the
second, and 0.28 on the third factor. factor analysis, the affective and the gastrointes-
In analyzing the factor loadings, it must be tinal symptom domains are moderately promi-
noted that only distress and sadness and nausea nent. Thus, the results of the cluster analysis
and vomiting had factor loadings higher than are partly consistent with the factor analysis.
0.8. Factor loadings are shown in Table 4. Reli-
ability analysis for the suggested factor solution Known-Group Validity. Known-group validity
showed a Cronbach’s alpha coefficient for the (sensitivity) was examined by comparing the
first factor of 0.73 (95% CI ¼ 0.69, 0.76), for MDASI-G total scores between patients with
the second factor of 0.73 (95% CI ¼ 0.68, low functional status (ECOG PS score $2)
0.75), and for the third factor of 0.69 (95% and patients with high functional status
CI ¼ 0.65, 0.73). The first factor, however, (ECOG PS score #1). As expected, the total
showed an increase of Cronbach’s alpha to MDASI-G scores for symptom severity, symp-
0.88 if disturbed sleep was deleted and only tom interference, and symptom burden were
distress and sadness were tested. For the third significantly higher for patients with a low
factor, Cronbach’s alpha increased to 0.78 if functional status (Table 5).
poor appetite was deleted. Taking these results
into account, we decided on a one-factor solu- Convergent and Divergent Analysis. To examine
tion (general symptoms) with an affective and convergent validity, we calculated the correla-
a gastrointestinal subscale. tions between symptom burden (mean ¼ 5.2,6 Schmidt et al. Vol. - No. - - 2014
Fig. 1. Screeplot.
SD ¼ 3.5), distress (mean ¼ 5.1, SD ¼ 2.7), patients, consistent with the psychometrically
and global health-related quality of life validated versions in other languages. The
(mean ¼ 49.4, SD ¼ 22.8). Pearson’s correla- MDASI-G is applicable for patients with
tion coefficient (r) between symptom burden different diagnoses and in different treatment
and global health-related quality of life was settings. The very small number of ‘‘missings’’
r ¼ 0.66 (95% CI ¼ 0.70, 0.62) and be- suggests a high degree of compliance and
tween symptom burden and distress r ¼ 0.60 good feasibility for everyday practice. Analysis
(95% CI ¼ 0.56, 0.65). Both were signifi- showed good internal consistencies for the
cant two-sided correlations. MDASI set of symptom items and for the set
of interference items. The calculated values
Discussion for Cronbach’s alpha, with 0.82 for the MDASI
set of symptom items and 0.84 for the set of
The study demonstrates that the MDASI-G is
interference items, are comparable with other
a valid and reliable tool for assessing symptom
validation studies.1,9e16 For example, Cron-
intensity and interference in German cancer
bach’s alpha for the symptom items was re-
Table 4 ported by Nejmi et al.10 as 0.78, by Ivanova
Factor Loadings for Symptom Intensity Items et al.12 as 0.80 and by Yun et al.11 as 0.91.
Factor Loadings Construct validity was assessed by factor anal-
ysis. After careful consideration, we decided
Symptom Item Factor 1 Factor 2 Factor 3
on a one-factor solution with gastrointestinal
Distress 0.90 0.08 0.08 and affective subscales. This result is consistent
Sadness 0.90 0.05 0.15
Disturbed sleep 0.50 0.31 0.11
with other validation studies identifying under-
Pain 0.40 0.31 0.28 lying constructs of a gastrointestinal fac-
Shortness of breath 0.02 0.64 0.15 tor,1,9,14,16 an emotional and affective factor,
Fatigue 0.33 0.59 0.35
Drowsiness 0.21 0.59 0.29
and a general severity component.9,12,15 As in
Difficulty remembering 0.20 0.59 0.03 other validation studies,1,9,12,14,15 the known-
Numbness 0.01 0.57 0.01 group validity was satisfactory, showing signifi-
Dry mouth 0.18 0.47 0.33
Vomiting 0.05 0.02 0.86
cant differences in symptom burden for
Nausea 0.12 0.13 0.86 patients with ‘‘good’’ and ‘‘poor’’ ECOG PS.
Poor appetite 0.22 0.30 0.59 To limit the burden for patients, we did not
Method: Principal axis factor analysis with varimax rotation. apply a detailed reference questionnaire toVol. - No. - - 2014 Validation of the MDASI-G 7
Fig. 2. Hierarchical Cluster Analysis. Dendrogram showing relative distances between item clusters.
establish concurrent validity but carried out a with moderate and severe intensity. If assessed
convergent and divergent analysis with global on a regular basis, these symptoms could be
scores for distress and global health-related taken care of early by psycho-oncologic coun-
quality of life. It would have been interesting, seling. The result that 20.4% of the patients re-
however, to compare the results of a question- ported moderate pain should likewise trigger
naire not using a zero to 10 scale, for example, efforts to optimize symptom management.
the EORTC QLQ-C30 with the MDASI, as was Furthermore, the assessment of symptoms in
done in other studies.9 connection with functional impairments is of
The descriptive results show to what extent importance to anticipate possible supportive
patients are still suffering from symptom needs after discharge and the planning of
burden despite supportive therapy options. after-care.
Although, corresponding to other studies, the In summary, these findings emphasize the
observed low rates of vomiting indicate the suc- importance of integrating PRO measures in
cess of antiemetic treatment. Comparable with everyday clinical practice. However, ‘‘assess-
other studies,1,9,12,16 fatigue was among the ment is not enough’’ to optimize supportive
most prevalent and most severe symptoms, a therapy.23 It is of great importance that rele-
finding that might motivate clinicians to vant scores of symptoms, for example, mild
perform screening and offer guideline-based and severe are followed by special diagnosis
treatment. In addition, distress, sadness, and and treatment if necessary. Pathways of diag-
sleep disturbance were reported frequently nosis and treatment have to be established
Table 5
Known-Group Validity
ECOG PS ECOG PS ECOG ECOG
0e1 2e4 0e1 2e4 Mean Difference
Parameters N N Mean (SD) Mean (SD) (95% CI) P-value
Symptom severity 282 307 20.9 (16.7) 34.7 (18.6) 13.8 (16.7, 10.9)8 Schmidt et al. Vol. - No. - - 2014
and implemented. Health care professionals generously; the nursing departments of the
have to be trained in interpreting results and five participating University hospitals who car-
acting accordingly. Our findings of symptom ried out the study; and Professor Tito Mendo-
severity and functional impairments despite za, Dipl. Psych., Dirk Rennert, and Dr. rer. Nat.
existing supportive options might be inter- Christine Lautenschl€ager for their fruitful
preted against the background that this pro- discussion.
cess in Germany is still evolving.
The study had several limitations. The cross-
sectional design did not allow for examining References
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10. Nejmi M, Wang XS, Mendoza TR, Gning I,
This work was supported in part by ProKID
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declare no conflicts of interest. Symptom Manage 2010;40:75e86.
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